Digestive Health

We’ve been told for decades that a child who doesn’t start the day with a good breakfast is entering school at a serious disadvantage. The brain needs a good supply of energy to learn optimally. So the standard wisdom goes. Subsidized school breakfast programs have been built around this chestnut. But, is there solid evidence to support the notion that simply adding a morning meal to a child’s schedule will improve his or her school performance? It sounds like common sense, but is it just one of those old grandmother’s nuggets that doesn’t stand up under close scrutiny?

A recent study from Spain suggests that the relationship between breakfast and school performance is not merely related to the nutritional needs of a growing brain. Using data from nearly 4,000 Spanish children aged 4-14 collected in a 2017 national health survey, the investigators found “skipping breakfast and eating breakfast out of the home were linked to greater odds of psychosocial behavioral problems than eating breakfast at home.” And, we already know that, in general, children who misbehave in school don’t thrive academically.

There were also associations between the absence or presence of certain food groups in the morning meal with behavioral problems. But the data lacked the granularity to draw any firm conclusions – although the authors felt that what they consider a healthy Spanish diet may have had a positive influence on behavior.

The findings in this study may simply be another example of the many positive influences that have been associated with family meals and have little to do with what is actually consumed. The association may not have much to do with the family gathering together at a single Norman Rockwell sitting, a reality that I suspect seldom occurs. The apparent positive influence of breakfast may be that it reflects a family’s priorities: that food is important, that sleep is important, and that school is important – so important that scheduling the morning should focus on sending the child off well prepared. The child who is allowed to stay up to an unhealthy hour is likely to be difficult to arouse in the morning for breakfast and getting off to school.

It may be that the child’s behavior problems are so disruptive and taxing for the family that even with their best efforts, the parents can’t find the time and energy to provide a breakfast in the home.

On the other hand, the study doesn’t tell us how many children aren’t offered breakfast at home because their families simply can’t afford it. Obviously, the answer depends on the socioeconomic mix of a given community. In some localities this may represent a sizable percentage of the population.

So where does this leave us? Unfortunately, as I read through the discussion at the end of this paper I felt that the authors were leaning too much toward further research based on the potential associations between behavior and specific food groups their data suggested.

For me, the take-home message from this paper is that our existing efforts to improve academic success with food offered in school should also include strategies that promote eating breakfast at home. For example, the backpack take-home food distribution programs that seem to have been effective could include breakfast-targeted items packaged in a way that encourage families to provide breakfast at home.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

We’ve been told for decades that a child who doesn’t start the day with a good breakfast is entering school at a serious disadvantage. The brain needs a good supply of energy to learn optimally. So the standard wisdom goes. Subsidized school breakfast programs have been built around this chestnut. But, is there solid evidence to support the notion that simply adding a morning meal to a child’s schedule will improve his or her school performance? It sounds like common sense, but is it just one of those old grandmother’s nuggets that doesn’t stand up under close scrutiny?

A recent study from Spain suggests that the relationship between breakfast and school performance is not merely related to the nutritional needs of a growing brain. Using data from nearly 4,000 Spanish children aged 4-14 collected in a 2017 national health survey, the investigators found “skipping breakfast and eating breakfast out of the home were linked to greater odds of psychosocial behavioral problems than eating breakfast at home.” And, we already know that, in general, children who misbehave in school don’t thrive academically.

There were also associations between the absence or presence of certain food groups in the morning meal with behavioral problems. But the data lacked the granularity to draw any firm conclusions – although the authors felt that what they consider a healthy Spanish diet may have had a positive influence on behavior.

The findings in this study may simply be another example of the many positive influences that have been associated with family meals and have little to do with what is actually consumed. The association may not have much to do with the family gathering together at a single Norman Rockwell sitting, a reality that I suspect seldom occurs. The apparent positive influence of breakfast may be that it reflects a family’s priorities: that food is important, that sleep is important, and that school is important – so important that scheduling the morning should focus on sending the child off well prepared. The child who is allowed to stay up to an unhealthy hour is likely to be difficult to arouse in the morning for breakfast and getting off to school.

It may be that the child’s behavior problems are so disruptive and taxing for the family that even with their best efforts, the parents can’t find the time and energy to provide a breakfast in the home.

On the other hand, the study doesn’t tell us how many children aren’t offered breakfast at home because their families simply can’t afford it. Obviously, the answer depends on the socioeconomic mix of a given community. In some localities this may represent a sizable percentage of the population.

So where does this leave us? Unfortunately, as I read through the discussion at the end of this paper I felt that the authors were leaning too much toward further research based on the potential associations between behavior and specific food groups their data suggested.

For me, the take-home message from this paper is that our existing efforts to improve academic success with food offered in school should also include strategies that promote eating breakfast at home. For example, the backpack take-home food distribution programs that seem to have been effective could include breakfast-targeted items packaged in a way that encourage families to provide breakfast at home.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

We’ve been told for decades that a child who doesn’t start the day with a good breakfast is entering school at a serious disadvantage. The brain needs a good supply of energy to learn optimally. So the standard wisdom goes. Subsidized school breakfast programs have been built around this chestnut. But, is there solid evidence to support the notion that simply adding a morning meal to a child’s schedule will improve his or her school performance? It sounds like common sense, but is it just one of those old grandmother’s nuggets that doesn’t stand up under close scrutiny?

A recent study from Spain suggests that the relationship between breakfast and school performance is not merely related to the nutritional needs of a growing brain. Using data from nearly 4,000 Spanish children aged 4-14 collected in a 2017 national health survey, the investigators found “skipping breakfast and eating breakfast out of the home were linked to greater odds of psychosocial behavioral problems than eating breakfast at home.” And, we already know that, in general, children who misbehave in school don’t thrive academically.

There were also associations between the absence or presence of certain food groups in the morning meal with behavioral problems. But the data lacked the granularity to draw any firm conclusions – although the authors felt that what they consider a healthy Spanish diet may have had a positive influence on behavior.

The findings in this study may simply be another example of the many positive influences that have been associated with family meals and have little to do with what is actually consumed. The association may not have much to do with the family gathering together at a single Norman Rockwell sitting, a reality that I suspect seldom occurs. The apparent positive influence of breakfast may be that it reflects a family’s priorities: that food is important, that sleep is important, and that school is important – so important that scheduling the morning should focus on sending the child off well prepared. The child who is allowed to stay up to an unhealthy hour is likely to be difficult to arouse in the morning for breakfast and getting off to school.

It may be that the child’s behavior problems are so disruptive and taxing for the family that even with their best efforts, the parents can’t find the time and energy to provide a breakfast in the home.

On the other hand, the study doesn’t tell us how many children aren’t offered breakfast at home because their families simply can’t afford it. Obviously, the answer depends on the socioeconomic mix of a given community. In some localities this may represent a sizable percentage of the population.

So where does this leave us? Unfortunately, as I read through the discussion at the end of this paper I felt that the authors were leaning too much toward further research based on the potential associations between behavior and specific food groups their data suggested.

For me, the take-home message from this paper is that our existing efforts to improve academic success with food offered in school should also include strategies that promote eating breakfast at home. For example, the backpack take-home food distribution programs that seem to have been effective could include breakfast-targeted items packaged in a way that encourage families to provide breakfast at home.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Infants who were introduced to a low-protein diet – high in fruit, vegetables, and roots – ate more fruits and vegetables at 12 and 18 months of age, compared with those who ate a conventional diet, in a new study.

The “Nordic diet” has shown health benefits in children and adults, but has not been studied in infants, said Ulrica Johansson, MD, of Umeå (Sweden) University, in a presentation on the study at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition.

A healthy and sustainable diet early in life could have a significant impact on future health, Dr. Johansson said in an interview.

Dr. Johansson and colleagues aimed to investigate the effect of a Nordic diet in infants aged 4-18 months in the OTIS trial. All infants were breastfed or formula-fed at baseline.
 

Study methods and results

A total of 250 infants aged 4-6 months were randomized to consuming a Nordic diet or a conventional diet. Those in the Nordic group received exposures to Nordic foods and flavors, including Nordic fruit, berries, vegetables, and roots. Those in the conventional group received baby food products that followed the current Swedish dietary recommendations for infants. The researchers collected data on dietary intake, biomarkers, and growth from baseline up to 18 months of age.

Notably, acceptance of all the flavors in the Nordic diet was high, including those with sour or bitter taste, such as cranberry and white radish, Dr. Johansson said in her presentation. Food refusals were few, and did not differ among the Nordic food offerings.

At both 12- and 18-month follow-ups, infants in the Nordic group consumed 42%-45% more fruits and vegetables compared with those in the conventional group (P < .001). Plasma folate levels also were significantly higher in the Nordic group compared with in the conventional group, at both 12 months and 18 months (P < .001 and P < .003, respectively).

The daily mean protein intake ranged from 17% to 29% lower in the Nordic group compared with in the conventional group, at both 12 months and 18 months. The intake of protein in terms of g/kg of body weight was significantly lower in the Nordic group, at both time points. Lower protein intake was confirmed by blood urea nitrogen measurements.

The protein intake in the Nordic group still fell within the safe level recommended for healthy growth in young children by the World Health Organization, noted Dr. Johansson, and no significant differences were observed in growth between the groups. Total energy intake, iron status, and duration of breastfeeding also remained similar between the groups throughout the study period.

Parents received support from research nurses via social media and monthly clinic visits, which she believes contributed to the success of the intervention, she said.
 

Nordic diet offers feasible encouragement of healthy eating

The key message for clinicians, and for parents of young children, is that “the protein-reduced, Nordic diet is both feasible and safe for infants’ growth, nutritional requirements, and development during the complementary feeding period,” Dr. Johansson said in an interview. “Thus, it may serve as a healthy and environmentally sustainable diet alternative for infants and their parents in the future.”

“Nordic foods are feasible to use when exposing infants to a variety of flavors so that healthy food preferences can be established early in life; Nordic berries and some root vegetables are preferable when introducing bitter and sour tastes during the sensitive period,” she added.

“Multicomponent interventions with long-term follow-up are required to advance the field of child nutrition research,” Dr. Johansson emphasized. Home-based interventions are lacking, and “more studies are needed to bridge the gap in research between the transfer period from baby food to family food at 1-2 years of age.”

Large, randomized controlled studies of Nordic diet during infancy and later childhood are needed as well, said Dr. Johansson. “The long-term effects of the Nordic diet during this highly dynamic period of childhood need continued follow-up to school age to give indications of any lasting health effects,” and the researchers plan to follow the current study population at 7 years of age.

Findings reinforce need for better nutrition

Previous research documents concern for childhood obesity associated with higher intake of protein, fats and overall calories in infancy, said Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview. “The inclusion of high-calorie, high-fat foods contributes to obesity in all children, so focusing on intake of fruits and vegetables is extremely important early in life,” she said.

A key barrier to the widespread use of a Nordic-type diet is that and vegetables tend to be more expensive than other foods and may not be readily available to all families, especially lower income families, Dr. Haut added.

However, for primary care clinicians, the current study reinforces the need to encourage the intake of fruits and vegetables at all ages, beginning in infancy, she said.

Looking ahead, “there is still limited information in the literature about the ideal recommended daily protein, except for increased amounts needed for preterm infants, early infancy, and during periods of healing,” Dr. Haut emphasized. “Some controls for this study were not included in the abstract, such as monitoring what foods were given to the infants in the conventional group. Parent and caregiver interpretation of recommendations can be highly variable,” she noted. Also, “The activity levels of late infancy and toddlers can vary in terms of energy usage, especially when crawling, walking, running and other exercise-related activities begin. These factors were not readily available in the abstract/study,” she said.  

The OTIS trial was sponsored by Semper. Dr. Johansson had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News.

Infants who were introduced to a low-protein diet – high in fruit, vegetables, and roots – ate more fruits and vegetables at 12 and 18 months of age, compared with those who ate a conventional diet, in a new study.

The “Nordic diet” has shown health benefits in children and adults, but has not been studied in infants, said Ulrica Johansson, MD, of Umeå (Sweden) University, in a presentation on the study at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition.

A healthy and sustainable diet early in life could have a significant impact on future health, Dr. Johansson said in an interview.

Dr. Johansson and colleagues aimed to investigate the effect of a Nordic diet in infants aged 4-18 months in the OTIS trial. All infants were breastfed or formula-fed at baseline.
 

Study methods and results

A total of 250 infants aged 4-6 months were randomized to consuming a Nordic diet or a conventional diet. Those in the Nordic group received exposures to Nordic foods and flavors, including Nordic fruit, berries, vegetables, and roots. Those in the conventional group received baby food products that followed the current Swedish dietary recommendations for infants. The researchers collected data on dietary intake, biomarkers, and growth from baseline up to 18 months of age.

Notably, acceptance of all the flavors in the Nordic diet was high, including those with sour or bitter taste, such as cranberry and white radish, Dr. Johansson said in her presentation. Food refusals were few, and did not differ among the Nordic food offerings.

At both 12- and 18-month follow-ups, infants in the Nordic group consumed 42%-45% more fruits and vegetables compared with those in the conventional group (P < .001). Plasma folate levels also were significantly higher in the Nordic group compared with in the conventional group, at both 12 months and 18 months (P < .001 and P < .003, respectively).

The daily mean protein intake ranged from 17% to 29% lower in the Nordic group compared with in the conventional group, at both 12 months and 18 months. The intake of protein in terms of g/kg of body weight was significantly lower in the Nordic group, at both time points. Lower protein intake was confirmed by blood urea nitrogen measurements.

The protein intake in the Nordic group still fell within the safe level recommended for healthy growth in young children by the World Health Organization, noted Dr. Johansson, and no significant differences were observed in growth between the groups. Total energy intake, iron status, and duration of breastfeeding also remained similar between the groups throughout the study period.

Parents received support from research nurses via social media and monthly clinic visits, which she believes contributed to the success of the intervention, she said.
 

Nordic diet offers feasible encouragement of healthy eating

The key message for clinicians, and for parents of young children, is that “the protein-reduced, Nordic diet is both feasible and safe for infants’ growth, nutritional requirements, and development during the complementary feeding period,” Dr. Johansson said in an interview. “Thus, it may serve as a healthy and environmentally sustainable diet alternative for infants and their parents in the future.”

“Nordic foods are feasible to use when exposing infants to a variety of flavors so that healthy food preferences can be established early in life; Nordic berries and some root vegetables are preferable when introducing bitter and sour tastes during the sensitive period,” she added.

“Multicomponent interventions with long-term follow-up are required to advance the field of child nutrition research,” Dr. Johansson emphasized. Home-based interventions are lacking, and “more studies are needed to bridge the gap in research between the transfer period from baby food to family food at 1-2 years of age.”

Large, randomized controlled studies of Nordic diet during infancy and later childhood are needed as well, said Dr. Johansson. “The long-term effects of the Nordic diet during this highly dynamic period of childhood need continued follow-up to school age to give indications of any lasting health effects,” and the researchers plan to follow the current study population at 7 years of age.

Findings reinforce need for better nutrition

Previous research documents concern for childhood obesity associated with higher intake of protein, fats and overall calories in infancy, said Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview. “The inclusion of high-calorie, high-fat foods contributes to obesity in all children, so focusing on intake of fruits and vegetables is extremely important early in life,” she said.

A key barrier to the widespread use of a Nordic-type diet is that and vegetables tend to be more expensive than other foods and may not be readily available to all families, especially lower income families, Dr. Haut added.

However, for primary care clinicians, the current study reinforces the need to encourage the intake of fruits and vegetables at all ages, beginning in infancy, she said.

Looking ahead, “there is still limited information in the literature about the ideal recommended daily protein, except for increased amounts needed for preterm infants, early infancy, and during periods of healing,” Dr. Haut emphasized. “Some controls for this study were not included in the abstract, such as monitoring what foods were given to the infants in the conventional group. Parent and caregiver interpretation of recommendations can be highly variable,” she noted. Also, “The activity levels of late infancy and toddlers can vary in terms of energy usage, especially when crawling, walking, running and other exercise-related activities begin. These factors were not readily available in the abstract/study,” she said.  

The OTIS trial was sponsored by Semper. Dr. Johansson had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News.

Infants who were introduced to a low-protein diet – high in fruit, vegetables, and roots – ate more fruits and vegetables at 12 and 18 months of age, compared with those who ate a conventional diet, in a new study.

The “Nordic diet” has shown health benefits in children and adults, but has not been studied in infants, said Ulrica Johansson, MD, of Umeå (Sweden) University, in a presentation on the study at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition.

A healthy and sustainable diet early in life could have a significant impact on future health, Dr. Johansson said in an interview.

Dr. Johansson and colleagues aimed to investigate the effect of a Nordic diet in infants aged 4-18 months in the OTIS trial. All infants were breastfed or formula-fed at baseline.
 

Study methods and results

A total of 250 infants aged 4-6 months were randomized to consuming a Nordic diet or a conventional diet. Those in the Nordic group received exposures to Nordic foods and flavors, including Nordic fruit, berries, vegetables, and roots. Those in the conventional group received baby food products that followed the current Swedish dietary recommendations for infants. The researchers collected data on dietary intake, biomarkers, and growth from baseline up to 18 months of age.

Notably, acceptance of all the flavors in the Nordic diet was high, including those with sour or bitter taste, such as cranberry and white radish, Dr. Johansson said in her presentation. Food refusals were few, and did not differ among the Nordic food offerings.

At both 12- and 18-month follow-ups, infants in the Nordic group consumed 42%-45% more fruits and vegetables compared with those in the conventional group (P < .001). Plasma folate levels also were significantly higher in the Nordic group compared with in the conventional group, at both 12 months and 18 months (P < .001 and P < .003, respectively).

The daily mean protein intake ranged from 17% to 29% lower in the Nordic group compared with in the conventional group, at both 12 months and 18 months. The intake of protein in terms of g/kg of body weight was significantly lower in the Nordic group, at both time points. Lower protein intake was confirmed by blood urea nitrogen measurements.

The protein intake in the Nordic group still fell within the safe level recommended for healthy growth in young children by the World Health Organization, noted Dr. Johansson, and no significant differences were observed in growth between the groups. Total energy intake, iron status, and duration of breastfeeding also remained similar between the groups throughout the study period.

Parents received support from research nurses via social media and monthly clinic visits, which she believes contributed to the success of the intervention, she said.
 

Nordic diet offers feasible encouragement of healthy eating

The key message for clinicians, and for parents of young children, is that “the protein-reduced, Nordic diet is both feasible and safe for infants’ growth, nutritional requirements, and development during the complementary feeding period,” Dr. Johansson said in an interview. “Thus, it may serve as a healthy and environmentally sustainable diet alternative for infants and their parents in the future.”

“Nordic foods are feasible to use when exposing infants to a variety of flavors so that healthy food preferences can be established early in life; Nordic berries and some root vegetables are preferable when introducing bitter and sour tastes during the sensitive period,” she added.

“Multicomponent interventions with long-term follow-up are required to advance the field of child nutrition research,” Dr. Johansson emphasized. Home-based interventions are lacking, and “more studies are needed to bridge the gap in research between the transfer period from baby food to family food at 1-2 years of age.”

Large, randomized controlled studies of Nordic diet during infancy and later childhood are needed as well, said Dr. Johansson. “The long-term effects of the Nordic diet during this highly dynamic period of childhood need continued follow-up to school age to give indications of any lasting health effects,” and the researchers plan to follow the current study population at 7 years of age.

Findings reinforce need for better nutrition

Previous research documents concern for childhood obesity associated with higher intake of protein, fats and overall calories in infancy, said Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview. “The inclusion of high-calorie, high-fat foods contributes to obesity in all children, so focusing on intake of fruits and vegetables is extremely important early in life,” she said.

A key barrier to the widespread use of a Nordic-type diet is that and vegetables tend to be more expensive than other foods and may not be readily available to all families, especially lower income families, Dr. Haut added.

However, for primary care clinicians, the current study reinforces the need to encourage the intake of fruits and vegetables at all ages, beginning in infancy, she said.

Looking ahead, “there is still limited information in the literature about the ideal recommended daily protein, except for increased amounts needed for preterm infants, early infancy, and during periods of healing,” Dr. Haut emphasized. “Some controls for this study were not included in the abstract, such as monitoring what foods were given to the infants in the conventional group. Parent and caregiver interpretation of recommendations can be highly variable,” she noted. Also, “The activity levels of late infancy and toddlers can vary in terms of energy usage, especially when crawling, walking, running and other exercise-related activities begin. These factors were not readily available in the abstract/study,” she said.  

The OTIS trial was sponsored by Semper. Dr. Johansson had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News.

Although in many cases, food-allergen tolerance can be achieved with oral immunotherapy, primary prevention of food allergies remains crucial, according to the French Society of Allergology. In new recommendations that were presented at a session of the Congress of French Pediatric Societies, the academic society advocated early introduction of allergens for all children, starting at 4 months of age.

The latest prevention data from two major studies, LEAP and EAT, have prompted European and French experts to rethink their stance on food diversification. The new French proposals were recently published under the coordination of Dominique Sabouraud-Leclerc, MD, pediatrics department, Reims (France) University Hospital, on behalf of the Food Allergy Working Group of the French Society of Allergology.

For all newborns, regardless of whether they have a history of atopic or nonatopic dermatitis, food diversification is now recommended from 4 months of age instead of 6 months, as was previously recommended. If the child does not develop atopic dermatitis or develops only a mild form, peanuts, eggs, and nuts may be introduced at home.

However, if the child experiences severe atopic dermatitis, an allergy testing panel for peanuts, nuts, eggs, and cow’s milk proteins should be performed. An oral food challenge may be conducted at the allergist’s discretion.

Regarding peanuts, the working group proposed introducing a purée in the form of either a mixture of peanuts/hazelnuts/cashew nuts (1 level teaspoon five times a week; 2 g of protein/food per week) or a 100% peanut paste (1 scant teaspoon four times a week; 2 g of peanut protein/week). If the family is worried, the allergist can suggest monitoring the child in the clinic waiting room for 30 minutes after the first dose.

“We shouldn’t delay the introduction of the primary allergens anymore, regardless of whether children are at risk for a food allergy, and particularly a peanut allergy,” explained Stéphanie Lejeune, MD, pediatric pulmonologist and allergist at Lille (France) Regional University Hospital, who presented these new findings at the congress. “In fact, if we only target at-risk children, we overlook children with no family history who will nevertheless develop food allergies. The idea is to introduce everything, especially peanuts, between 4 and 6 months of age and to no longer do so gradually, one food after another, as was being done until now, beginning at 6 months and over. We must give priority to regularity over quantity.”

Although this approach is based on clinical trials, no real-life data are currently available.
 

LEAP and EAT studies support early introduction of peanuts

A study from 2021 summed up the risk factors for peanut allergy. About 61% of infants (4-11 months) had atopic dermatitis, 18% had a food allergy, 62% had a first-degree relative with a peanut allergy, and 11% had a confirmed peanut allergy. The risk of peanut allergy increased with age and severe eczema.

In 2015, the LEAP study, which was conducted in the United Kingdom with 640 infants aged 4-11 months who had risk factors for peanut allergy, revolutionized peanut-allergy primary prevention. Regardless of whether the children were sensitized or not, the number of children who developed a peanut allergy was systematically lower in the group that ingested the allergen in comparison with the “avoidance” group.

Additionally, the LEAP-ON study showed that protection against peanut allergy persisted for 12 months after cessation of consumption between ages 5 and 6 years among children who had consumed peanuts previously.

Early diversification in the general population was investigated in the EAT study, which involved 1303 breastfed infants. Of these infants, 24% had atopic dermatitis (median SCORAD score, 7.5). They were divided into two arms: avoidance and breast feeding until 6 months (standard introduction) or early introduction at 3 months (boiled egg, milk, peanuts, sesame, white fish, wheat, 2 g of protein twice a week). In the per-protocol analysis, there were 13 cases of peanut allergy in the standard introduction group; there were no cases in the early introduction group.

A version of this article first appeared on Medscape.com.

Although in many cases, food-allergen tolerance can be achieved with oral immunotherapy, primary prevention of food allergies remains crucial, according to the French Society of Allergology. In new recommendations that were presented at a session of the Congress of French Pediatric Societies, the academic society advocated early introduction of allergens for all children, starting at 4 months of age.

The latest prevention data from two major studies, LEAP and EAT, have prompted European and French experts to rethink their stance on food diversification. The new French proposals were recently published under the coordination of Dominique Sabouraud-Leclerc, MD, pediatrics department, Reims (France) University Hospital, on behalf of the Food Allergy Working Group of the French Society of Allergology.

For all newborns, regardless of whether they have a history of atopic or nonatopic dermatitis, food diversification is now recommended from 4 months of age instead of 6 months, as was previously recommended. If the child does not develop atopic dermatitis or develops only a mild form, peanuts, eggs, and nuts may be introduced at home.

However, if the child experiences severe atopic dermatitis, an allergy testing panel for peanuts, nuts, eggs, and cow’s milk proteins should be performed. An oral food challenge may be conducted at the allergist’s discretion.

Regarding peanuts, the working group proposed introducing a purée in the form of either a mixture of peanuts/hazelnuts/cashew nuts (1 level teaspoon five times a week; 2 g of protein/food per week) or a 100% peanut paste (1 scant teaspoon four times a week; 2 g of peanut protein/week). If the family is worried, the allergist can suggest monitoring the child in the clinic waiting room for 30 minutes after the first dose.

“We shouldn’t delay the introduction of the primary allergens anymore, regardless of whether children are at risk for a food allergy, and particularly a peanut allergy,” explained Stéphanie Lejeune, MD, pediatric pulmonologist and allergist at Lille (France) Regional University Hospital, who presented these new findings at the congress. “In fact, if we only target at-risk children, we overlook children with no family history who will nevertheless develop food allergies. The idea is to introduce everything, especially peanuts, between 4 and 6 months of age and to no longer do so gradually, one food after another, as was being done until now, beginning at 6 months and over. We must give priority to regularity over quantity.”

Although this approach is based on clinical trials, no real-life data are currently available.
 

LEAP and EAT studies support early introduction of peanuts

A study from 2021 summed up the risk factors for peanut allergy. About 61% of infants (4-11 months) had atopic dermatitis, 18% had a food allergy, 62% had a first-degree relative with a peanut allergy, and 11% had a confirmed peanut allergy. The risk of peanut allergy increased with age and severe eczema.

In 2015, the LEAP study, which was conducted in the United Kingdom with 640 infants aged 4-11 months who had risk factors for peanut allergy, revolutionized peanut-allergy primary prevention. Regardless of whether the children were sensitized or not, the number of children who developed a peanut allergy was systematically lower in the group that ingested the allergen in comparison with the “avoidance” group.

Additionally, the LEAP-ON study showed that protection against peanut allergy persisted for 12 months after cessation of consumption between ages 5 and 6 years among children who had consumed peanuts previously.

Early diversification in the general population was investigated in the EAT study, which involved 1303 breastfed infants. Of these infants, 24% had atopic dermatitis (median SCORAD score, 7.5). They were divided into two arms: avoidance and breast feeding until 6 months (standard introduction) or early introduction at 3 months (boiled egg, milk, peanuts, sesame, white fish, wheat, 2 g of protein twice a week). In the per-protocol analysis, there were 13 cases of peanut allergy in the standard introduction group; there were no cases in the early introduction group.

A version of this article first appeared on Medscape.com.

Although in many cases, food-allergen tolerance can be achieved with oral immunotherapy, primary prevention of food allergies remains crucial, according to the French Society of Allergology. In new recommendations that were presented at a session of the Congress of French Pediatric Societies, the academic society advocated early introduction of allergens for all children, starting at 4 months of age.

The latest prevention data from two major studies, LEAP and EAT, have prompted European and French experts to rethink their stance on food diversification. The new French proposals were recently published under the coordination of Dominique Sabouraud-Leclerc, MD, pediatrics department, Reims (France) University Hospital, on behalf of the Food Allergy Working Group of the French Society of Allergology.

For all newborns, regardless of whether they have a history of atopic or nonatopic dermatitis, food diversification is now recommended from 4 months of age instead of 6 months, as was previously recommended. If the child does not develop atopic dermatitis or develops only a mild form, peanuts, eggs, and nuts may be introduced at home.

However, if the child experiences severe atopic dermatitis, an allergy testing panel for peanuts, nuts, eggs, and cow’s milk proteins should be performed. An oral food challenge may be conducted at the allergist’s discretion.

Regarding peanuts, the working group proposed introducing a purée in the form of either a mixture of peanuts/hazelnuts/cashew nuts (1 level teaspoon five times a week; 2 g of protein/food per week) or a 100% peanut paste (1 scant teaspoon four times a week; 2 g of peanut protein/week). If the family is worried, the allergist can suggest monitoring the child in the clinic waiting room for 30 minutes after the first dose.

“We shouldn’t delay the introduction of the primary allergens anymore, regardless of whether children are at risk for a food allergy, and particularly a peanut allergy,” explained Stéphanie Lejeune, MD, pediatric pulmonologist and allergist at Lille (France) Regional University Hospital, who presented these new findings at the congress. “In fact, if we only target at-risk children, we overlook children with no family history who will nevertheless develop food allergies. The idea is to introduce everything, especially peanuts, between 4 and 6 months of age and to no longer do so gradually, one food after another, as was being done until now, beginning at 6 months and over. We must give priority to regularity over quantity.”

Although this approach is based on clinical trials, no real-life data are currently available.
 

LEAP and EAT studies support early introduction of peanuts

A study from 2021 summed up the risk factors for peanut allergy. About 61% of infants (4-11 months) had atopic dermatitis, 18% had a food allergy, 62% had a first-degree relative with a peanut allergy, and 11% had a confirmed peanut allergy. The risk of peanut allergy increased with age and severe eczema.

In 2015, the LEAP study, which was conducted in the United Kingdom with 640 infants aged 4-11 months who had risk factors for peanut allergy, revolutionized peanut-allergy primary prevention. Regardless of whether the children were sensitized or not, the number of children who developed a peanut allergy was systematically lower in the group that ingested the allergen in comparison with the “avoidance” group.

Additionally, the LEAP-ON study showed that protection against peanut allergy persisted for 12 months after cessation of consumption between ages 5 and 6 years among children who had consumed peanuts previously.

Early diversification in the general population was investigated in the EAT study, which involved 1303 breastfed infants. Of these infants, 24% had atopic dermatitis (median SCORAD score, 7.5). They were divided into two arms: avoidance and breast feeding until 6 months (standard introduction) or early introduction at 3 months (boiled egg, milk, peanuts, sesame, white fish, wheat, 2 g of protein twice a week). In the per-protocol analysis, there were 13 cases of peanut allergy in the standard introduction group; there were no cases in the early introduction group.

A version of this article first appeared on Medscape.com.

According to a consensus study, many infants in some countries are misdiagnosed with allergy to cow, sheep, or goat milk, and they’re prescribed specialized formulas they don’t need.

“Milk allergy overdiagnosis is common in some regions and can potentially harm mothers and infants,” the authors write in Clinical & Experimental Allergy. “These new consensus recommendations on the safe detection and management of milk allergy in children under 2 years aim to reduce harms associated with milk allergy overdiagnosis.”

“This guidance, developed by experts without commercial ties to the formula industry, aims to reduce milk allergy overdiagnosis and [to] support ... breastfeeding and less use of specialized formula, compared with current guidelines,” they add.

Up to 1% of European infants 2 years of age and younger are considered allergic to cow’s milk. Prescriptions for specialized formula for bottle-fed infants allergic to cow’s milk in Australia, England, and Norway have grown to over 10 times the expected volumes.

Lead study author Hilary I. Allen, National Heart and Lung Institute, Imperial College London, and her colleagues on several continents developed practical guidance for providers on safely detecting and managing milk allergy in infants.

Due to lack of high-certainty research evidence in this area, they used the Delphi consensus method.

The study involved two rounds of anonymous consensus-building surveys and one formal meeting in 2021.

The team identified experts from diverse geographic and cultural settings by searching medical databases for the term “milk hypersensitivity.” They asked those experts to recommend colleagues. The researchers also contacted experts with ties to international professional organizations, such as the International Board of Lactation Consultant Examiners, as well as societies associated with the World Allergy Organization.

The 17 study participants included clinicians and researchers in general practice, health visiting, lactation support, midwifery, nutrition, and relevant areas of pediatrics from Africa, Asia, Australia, Europe, the Middle East, and North America. Experts with recent conflicts of interest with the breastmilk substitute (formula) industry were excluded from the study. Five authors of earlier milk allergy guidelines and seven parents contributed feedback.

In each survey round, participants used a nine-point scale to rank the importance of each proposed statement that addressed prevention of overdiagnosis or underdiagnosis, support of breastfeeding women, and the role of specialized formula products.

Based on the number of total points participants assigned, each statement was classified as “essential,” “recommended,” “no consensus,” or “excluded” due to lack of relevance.

The experts agreed on 38 essential statements in several categories, including:

• Maternal dietary restriction is often not necessary to manage milk allergy
• In infants with chronic symptoms who are exclusively breastfed, milk allergy diagnosis should be considered only in specific, rare circumstances
• Milk allergy diagnosis does not usually need to be considered for stool changes, aversive feeding, or occasional spots of blood in stool, if not related in time with milk protein ingestion

The consensus recommendations provide more restrictive criteria than earlier guidelines for detecting milk allergy, fewer maternal dietary exclusions, and less use of specialized formula.
 

During an infant formula shortage in the U.S., a timely study

Jodi A. Shroba, MSN, APRN, CPNP, coordinator for the Food Allergy Program, Children’s Mercy Kansas City, Missouri, welcomed the study’s engagement of specialists in various fields and avoidance of bias from formula companies.

“Food allergies have received a lot of attention, especially through websites and social media,” Ms. Shroba, who was not involved in the study, told this news organization in an email. “Unfortunately, a lot of that information is incorrect and can lead to misunderstanding and misdiagnosis.”

“This article helps guide practitioners through identifying the concerning symptoms of milk allergy versus normal infant symptoms,” she said. “It can help providers discern when testing, elimination diets, and changes in formula are warranted.

“This guidance emphasizes the reproducibility and specificity of symptoms, which are key elements of a food allergy diagnosis,” she explained. “By eliminating unnecessary milk allergy labeling, we can keep infants on appropriate diets for their age, such as breastfeeding or milk-based formulas. Proper diagnosis can also reduce unnecessary financial strain of specialty formulas, stress to the family regarding feedings, and a restrictive diet for the breastfeeding mother.”

The study will be useful to a wide range of health care providers, Jennifer Anne Dantzer, MD, assistant professor of pediatrics, Johns Hopkins Medicine, Baltimore, said in an email.

“With the current formula shortage, there has perhaps never been a more important time to do this study and provide additional guidance on who does or does not need special formula,” noted Dr. Dantzer, who also was not involved in the study. “A milk allergy diagnosis impacts the child and the family, so it is very important to avoid overdiagnosis and to support the breastfeeding mother.”

“These findings should provide reassurance that dietary exclusions for the breastfeeding mother are not needed for most children with milk allergy,” she said. “If a milk allergy is suspected, the child should be referred to an allergist.”

The authors recommend further related research into the safety and effectiveness of using the guidance in practice.

One coauthor reports financial relationships with a biotech company. Ms. Allen and her remaining coauthors, as well as Ms. Shroba and Dr. Dantzer, report no relevant financial relationships. The study was funded through fellowships.

A version of this article first appeared on Medscape.com.

According to a consensus study, many infants in some countries are misdiagnosed with allergy to cow, sheep, or goat milk, and they’re prescribed specialized formulas they don’t need.

“Milk allergy overdiagnosis is common in some regions and can potentially harm mothers and infants,” the authors write in Clinical & Experimental Allergy. “These new consensus recommendations on the safe detection and management of milk allergy in children under 2 years aim to reduce harms associated with milk allergy overdiagnosis.”

“This guidance, developed by experts without commercial ties to the formula industry, aims to reduce milk allergy overdiagnosis and [to] support ... breastfeeding and less use of specialized formula, compared with current guidelines,” they add.

Up to 1% of European infants 2 years of age and younger are considered allergic to cow’s milk. Prescriptions for specialized formula for bottle-fed infants allergic to cow’s milk in Australia, England, and Norway have grown to over 10 times the expected volumes.

Lead study author Hilary I. Allen, National Heart and Lung Institute, Imperial College London, and her colleagues on several continents developed practical guidance for providers on safely detecting and managing milk allergy in infants.

Due to lack of high-certainty research evidence in this area, they used the Delphi consensus method.

The study involved two rounds of anonymous consensus-building surveys and one formal meeting in 2021.

The team identified experts from diverse geographic and cultural settings by searching medical databases for the term “milk hypersensitivity.” They asked those experts to recommend colleagues. The researchers also contacted experts with ties to international professional organizations, such as the International Board of Lactation Consultant Examiners, as well as societies associated with the World Allergy Organization.

The 17 study participants included clinicians and researchers in general practice, health visiting, lactation support, midwifery, nutrition, and relevant areas of pediatrics from Africa, Asia, Australia, Europe, the Middle East, and North America. Experts with recent conflicts of interest with the breastmilk substitute (formula) industry were excluded from the study. Five authors of earlier milk allergy guidelines and seven parents contributed feedback.

In each survey round, participants used a nine-point scale to rank the importance of each proposed statement that addressed prevention of overdiagnosis or underdiagnosis, support of breastfeeding women, and the role of specialized formula products.

Based on the number of total points participants assigned, each statement was classified as “essential,” “recommended,” “no consensus,” or “excluded” due to lack of relevance.

The experts agreed on 38 essential statements in several categories, including:

• Maternal dietary restriction is often not necessary to manage milk allergy
• In infants with chronic symptoms who are exclusively breastfed, milk allergy diagnosis should be considered only in specific, rare circumstances
• Milk allergy diagnosis does not usually need to be considered for stool changes, aversive feeding, or occasional spots of blood in stool, if not related in time with milk protein ingestion

The consensus recommendations provide more restrictive criteria than earlier guidelines for detecting milk allergy, fewer maternal dietary exclusions, and less use of specialized formula.
 

During an infant formula shortage in the U.S., a timely study

Jodi A. Shroba, MSN, APRN, CPNP, coordinator for the Food Allergy Program, Children’s Mercy Kansas City, Missouri, welcomed the study’s engagement of specialists in various fields and avoidance of bias from formula companies.

“Food allergies have received a lot of attention, especially through websites and social media,” Ms. Shroba, who was not involved in the study, told this news organization in an email. “Unfortunately, a lot of that information is incorrect and can lead to misunderstanding and misdiagnosis.”

“This article helps guide practitioners through identifying the concerning symptoms of milk allergy versus normal infant symptoms,” she said. “It can help providers discern when testing, elimination diets, and changes in formula are warranted.

“This guidance emphasizes the reproducibility and specificity of symptoms, which are key elements of a food allergy diagnosis,” she explained. “By eliminating unnecessary milk allergy labeling, we can keep infants on appropriate diets for their age, such as breastfeeding or milk-based formulas. Proper diagnosis can also reduce unnecessary financial strain of specialty formulas, stress to the family regarding feedings, and a restrictive diet for the breastfeeding mother.”

The study will be useful to a wide range of health care providers, Jennifer Anne Dantzer, MD, assistant professor of pediatrics, Johns Hopkins Medicine, Baltimore, said in an email.

“With the current formula shortage, there has perhaps never been a more important time to do this study and provide additional guidance on who does or does not need special formula,” noted Dr. Dantzer, who also was not involved in the study. “A milk allergy diagnosis impacts the child and the family, so it is very important to avoid overdiagnosis and to support the breastfeeding mother.”

“These findings should provide reassurance that dietary exclusions for the breastfeeding mother are not needed for most children with milk allergy,” she said. “If a milk allergy is suspected, the child should be referred to an allergist.”

The authors recommend further related research into the safety and effectiveness of using the guidance in practice.

One coauthor reports financial relationships with a biotech company. Ms. Allen and her remaining coauthors, as well as Ms. Shroba and Dr. Dantzer, report no relevant financial relationships. The study was funded through fellowships.

A version of this article first appeared on Medscape.com.

According to a consensus study, many infants in some countries are misdiagnosed with allergy to cow, sheep, or goat milk, and they’re prescribed specialized formulas they don’t need.

“Milk allergy overdiagnosis is common in some regions and can potentially harm mothers and infants,” the authors write in Clinical & Experimental Allergy. “These new consensus recommendations on the safe detection and management of milk allergy in children under 2 years aim to reduce harms associated with milk allergy overdiagnosis.”

“This guidance, developed by experts without commercial ties to the formula industry, aims to reduce milk allergy overdiagnosis and [to] support ... breastfeeding and less use of specialized formula, compared with current guidelines,” they add.

Up to 1% of European infants 2 years of age and younger are considered allergic to cow’s milk. Prescriptions for specialized formula for bottle-fed infants allergic to cow’s milk in Australia, England, and Norway have grown to over 10 times the expected volumes.

Lead study author Hilary I. Allen, National Heart and Lung Institute, Imperial College London, and her colleagues on several continents developed practical guidance for providers on safely detecting and managing milk allergy in infants.

Due to lack of high-certainty research evidence in this area, they used the Delphi consensus method.

The study involved two rounds of anonymous consensus-building surveys and one formal meeting in 2021.

The team identified experts from diverse geographic and cultural settings by searching medical databases for the term “milk hypersensitivity.” They asked those experts to recommend colleagues. The researchers also contacted experts with ties to international professional organizations, such as the International Board of Lactation Consultant Examiners, as well as societies associated with the World Allergy Organization.

The 17 study participants included clinicians and researchers in general practice, health visiting, lactation support, midwifery, nutrition, and relevant areas of pediatrics from Africa, Asia, Australia, Europe, the Middle East, and North America. Experts with recent conflicts of interest with the breastmilk substitute (formula) industry were excluded from the study. Five authors of earlier milk allergy guidelines and seven parents contributed feedback.

In each survey round, participants used a nine-point scale to rank the importance of each proposed statement that addressed prevention of overdiagnosis or underdiagnosis, support of breastfeeding women, and the role of specialized formula products.

Based on the number of total points participants assigned, each statement was classified as “essential,” “recommended,” “no consensus,” or “excluded” due to lack of relevance.

The experts agreed on 38 essential statements in several categories, including:

• Maternal dietary restriction is often not necessary to manage milk allergy
• In infants with chronic symptoms who are exclusively breastfed, milk allergy diagnosis should be considered only in specific, rare circumstances
• Milk allergy diagnosis does not usually need to be considered for stool changes, aversive feeding, or occasional spots of blood in stool, if not related in time with milk protein ingestion

The consensus recommendations provide more restrictive criteria than earlier guidelines for detecting milk allergy, fewer maternal dietary exclusions, and less use of specialized formula.
 

During an infant formula shortage in the U.S., a timely study

Jodi A. Shroba, MSN, APRN, CPNP, coordinator for the Food Allergy Program, Children’s Mercy Kansas City, Missouri, welcomed the study’s engagement of specialists in various fields and avoidance of bias from formula companies.

“Food allergies have received a lot of attention, especially through websites and social media,” Ms. Shroba, who was not involved in the study, told this news organization in an email. “Unfortunately, a lot of that information is incorrect and can lead to misunderstanding and misdiagnosis.”

“This article helps guide practitioners through identifying the concerning symptoms of milk allergy versus normal infant symptoms,” she said. “It can help providers discern when testing, elimination diets, and changes in formula are warranted.

“This guidance emphasizes the reproducibility and specificity of symptoms, which are key elements of a food allergy diagnosis,” she explained. “By eliminating unnecessary milk allergy labeling, we can keep infants on appropriate diets for their age, such as breastfeeding or milk-based formulas. Proper diagnosis can also reduce unnecessary financial strain of specialty formulas, stress to the family regarding feedings, and a restrictive diet for the breastfeeding mother.”

The study will be useful to a wide range of health care providers, Jennifer Anne Dantzer, MD, assistant professor of pediatrics, Johns Hopkins Medicine, Baltimore, said in an email.

“With the current formula shortage, there has perhaps never been a more important time to do this study and provide additional guidance on who does or does not need special formula,” noted Dr. Dantzer, who also was not involved in the study. “A milk allergy diagnosis impacts the child and the family, so it is very important to avoid overdiagnosis and to support the breastfeeding mother.”

“These findings should provide reassurance that dietary exclusions for the breastfeeding mother are not needed for most children with milk allergy,” she said. “If a milk allergy is suspected, the child should be referred to an allergist.”

The authors recommend further related research into the safety and effectiveness of using the guidance in practice.

One coauthor reports financial relationships with a biotech company. Ms. Allen and her remaining coauthors, as well as Ms. Shroba and Dr. Dantzer, report no relevant financial relationships. The study was funded through fellowships.

A version of this article first appeared on Medscape.com.

What would you do if you believed you had a serious health issue, but the best way to find out for sure might kill you?

That’s the reality for patients who wish to confirm or rule out a food allergy, says Sindy Tang, PhD, an associate professor of mechanical engineering at Stanford (Calif.) University.

And it’s the reason Dr. Tang and her colleagues are developing a food allergy test that’s not only safer, but also more reliable than today’s tests. In a paper in the journal Lab on a Chip, Dr. Tang and her colleagues outline the basis for this future test, which isolates a food allergy marker from the blood using a magnetic field.
 

How today’s food allergy tests fall short

The gold standard for food allergy diagnosis is something called the oral food challenge. That’s when the patient eats gradually increasing amounts of a problem food – say, peanuts – every 15 to 30 minutes to see if symptoms occur. This means highly allergic patients may risk anaphylaxis, an allergic reaction that causes inflammation so severe that breathing becomes restricted and blood pressure drops. Because of that, a clinical team must be at the ready with treatments like oxygen, epinephrine, or albuterol.

“The test is very accurate, but it’s also potentially unsafe and even fatal in rare cases,” Dr. Tang says. “That’s led to many sham tests advertised online that claim to use hair samples for food tests, but those are inaccurate and potentially dangerous, since they may give someone a false sense of confidence about a food they should avoid.”

Less risky tests are available, such as skin-prick tests – those involve scratching a small amount of the food into a patient’s arm – as well as blood tests that measure allergen-specific antibodies.

“Unfortunately, both of those are not that accurate and have high false-positive rates,” Dr. Tang says. “The best method is the oral food challenge, which many patients are afraid to do, not surprisingly.”
 

The future of food allergy testing: faster, safer, more reliable

In their study, the Stanford researchers focused on a type of white blood cell known as basophils, which release histamine when triggered by allergens. By using magnetic nanoparticles that bind to some blood cells but not basophils, they were able to separate basophils from the blood with a magnetic field in just 10 minutes.

Once isolated, the basophils are exposed to potential allergens. If they react, that’s a sign of an allergy.

Basophils have been isolated in labs before but not nearly this quickly and efficiently, Dr. Tang says.

“For true basophil activation, you need the blood to be fresh, which is challenging when you have to send it to a lab,” Dr. Tang says. “Being able to do this kind of test within a clinic or an in-house lab would be a big step forward.”
 

Next steps

While this represents a breakthrough in basophil activation testing, more research is needed to fully develop the system for clinical use. It must be standardized, automated, and miniaturized, the researchers say.

That said, the results give hope to those with food allergies that tomorrow’s gold-standard test will require only a blood sample without an emergency team standing by.

A version of this article first appeared on WebMD.com.

What would you do if you believed you had a serious health issue, but the best way to find out for sure might kill you?

That’s the reality for patients who wish to confirm or rule out a food allergy, says Sindy Tang, PhD, an associate professor of mechanical engineering at Stanford (Calif.) University.

And it’s the reason Dr. Tang and her colleagues are developing a food allergy test that’s not only safer, but also more reliable than today’s tests. In a paper in the journal Lab on a Chip, Dr. Tang and her colleagues outline the basis for this future test, which isolates a food allergy marker from the blood using a magnetic field.
 

How today’s food allergy tests fall short

The gold standard for food allergy diagnosis is something called the oral food challenge. That’s when the patient eats gradually increasing amounts of a problem food – say, peanuts – every 15 to 30 minutes to see if symptoms occur. This means highly allergic patients may risk anaphylaxis, an allergic reaction that causes inflammation so severe that breathing becomes restricted and blood pressure drops. Because of that, a clinical team must be at the ready with treatments like oxygen, epinephrine, or albuterol.

“The test is very accurate, but it’s also potentially unsafe and even fatal in rare cases,” Dr. Tang says. “That’s led to many sham tests advertised online that claim to use hair samples for food tests, but those are inaccurate and potentially dangerous, since they may give someone a false sense of confidence about a food they should avoid.”

Less risky tests are available, such as skin-prick tests – those involve scratching a small amount of the food into a patient’s arm – as well as blood tests that measure allergen-specific antibodies.

“Unfortunately, both of those are not that accurate and have high false-positive rates,” Dr. Tang says. “The best method is the oral food challenge, which many patients are afraid to do, not surprisingly.”
 

The future of food allergy testing: faster, safer, more reliable

In their study, the Stanford researchers focused on a type of white blood cell known as basophils, which release histamine when triggered by allergens. By using magnetic nanoparticles that bind to some blood cells but not basophils, they were able to separate basophils from the blood with a magnetic field in just 10 minutes.

Once isolated, the basophils are exposed to potential allergens. If they react, that’s a sign of an allergy.

Basophils have been isolated in labs before but not nearly this quickly and efficiently, Dr. Tang says.

“For true basophil activation, you need the blood to be fresh, which is challenging when you have to send it to a lab,” Dr. Tang says. “Being able to do this kind of test within a clinic or an in-house lab would be a big step forward.”
 

Next steps

While this represents a breakthrough in basophil activation testing, more research is needed to fully develop the system for clinical use. It must be standardized, automated, and miniaturized, the researchers say.

That said, the results give hope to those with food allergies that tomorrow’s gold-standard test will require only a blood sample without an emergency team standing by.

A version of this article first appeared on WebMD.com.

What would you do if you believed you had a serious health issue, but the best way to find out for sure might kill you?

That’s the reality for patients who wish to confirm or rule out a food allergy, says Sindy Tang, PhD, an associate professor of mechanical engineering at Stanford (Calif.) University.

And it’s the reason Dr. Tang and her colleagues are developing a food allergy test that’s not only safer, but also more reliable than today’s tests. In a paper in the journal Lab on a Chip, Dr. Tang and her colleagues outline the basis for this future test, which isolates a food allergy marker from the blood using a magnetic field.
 

How today’s food allergy tests fall short

The gold standard for food allergy diagnosis is something called the oral food challenge. That’s when the patient eats gradually increasing amounts of a problem food – say, peanuts – every 15 to 30 minutes to see if symptoms occur. This means highly allergic patients may risk anaphylaxis, an allergic reaction that causes inflammation so severe that breathing becomes restricted and blood pressure drops. Because of that, a clinical team must be at the ready with treatments like oxygen, epinephrine, or albuterol.

“The test is very accurate, but it’s also potentially unsafe and even fatal in rare cases,” Dr. Tang says. “That’s led to many sham tests advertised online that claim to use hair samples for food tests, but those are inaccurate and potentially dangerous, since they may give someone a false sense of confidence about a food they should avoid.”

Less risky tests are available, such as skin-prick tests – those involve scratching a small amount of the food into a patient’s arm – as well as blood tests that measure allergen-specific antibodies.

“Unfortunately, both of those are not that accurate and have high false-positive rates,” Dr. Tang says. “The best method is the oral food challenge, which many patients are afraid to do, not surprisingly.”
 

The future of food allergy testing: faster, safer, more reliable

In their study, the Stanford researchers focused on a type of white blood cell known as basophils, which release histamine when triggered by allergens. By using magnetic nanoparticles that bind to some blood cells but not basophils, they were able to separate basophils from the blood with a magnetic field in just 10 minutes.

Once isolated, the basophils are exposed to potential allergens. If they react, that’s a sign of an allergy.

Basophils have been isolated in labs before but not nearly this quickly and efficiently, Dr. Tang says.

“For true basophil activation, you need the blood to be fresh, which is challenging when you have to send it to a lab,” Dr. Tang says. “Being able to do this kind of test within a clinic or an in-house lab would be a big step forward.”
 

Next steps

While this represents a breakthrough in basophil activation testing, more research is needed to fully develop the system for clinical use. It must be standardized, automated, and miniaturized, the researchers say.

That said, the results give hope to those with food allergies that tomorrow’s gold-standard test will require only a blood sample without an emergency team standing by.

A version of this article first appeared on WebMD.com.

I have become obsessed with the reality that the unprecedented national shortage of formula is keeping some families from adequately feeding their infants and young children. I am deeply concerned, both as a family medicine physician and a new mother, about the heartbreaking stories that I’ve heard from parents of all socioeconomic backgrounds. New mothers, unable to breastfeed for a multitude of reasons, find themselves standing in front of empty store shelves, in tears.

In recent months, many health care providers have had patients disclose that they are diluting ready-to-feed formula or mixing powdered formula with more water than instructed to make it go further. Some parents are giving cow’s milk to their children at too young an age because they can’t find formula. Others are foregoing milk altogether and feeding their children beverages such as juice or soda. All of these practices can threaten a child’s life, growth, and development.
 

When breastfeeding isn’t possible

We all know that human milk is the optimal, most nutritionally complete food source for newborn babies and infants. It can improve dental health and neurodevelopmental outcomes, as well as reduce the risk for asthma, eczema, diabetes, and obesity. An added benefit during the COVID-19 pandemic has been providing newborn infants with a boost of immunity before they are able to be vaccinated against SARS-CoV-2 infection.

But lactation and breastfeeding aren’t possible for everyone. Earlier this year, when my daughter was born more than a month prematurely, I worried that I would be unable to breastfeed her. The complications of prematurity can interfere with establishing lactation, and my daughter spent some time in the neonatal intensive care unit (NICU), requiring frequent feedings to treat hypoglycemia. She also lacked the muscle strength or coordination to latch on to the breast, so she was fed my colostrum and donor breast milk by bottle.

Not knowing when my mature milk would come in, my family scoured the retail stores for formula while I was still recovering from delivery. My daughter needed a specific type of high-calorie formula for premature infants. Eventually, my mother found one can of this powdered formula. The hospital also sent us home with 16 oz of ready-to-feed samples and enough donor breastmilk to last 24 hours at home. We considered ourselves lucky. The fear and anxiety about being able to feed my baby still stands out in my mind.
 

Pumping and sharing

Over the next few months, out of necessity, I became an “exclusively pumping” mother. My daughter, unable to latch, drank my pumped milk from a bottle. My body started to produce more milk than she needed in a day. In an effort to pay it forward and to put my extra milk to use, I became a human-milk donor. I underwent rigorous screening, including testing for infectious diseases such as HIV and hepatitis C. I was approved to donate to our local hospital’s milk bank, helping other families in the NICU feed their babies. Through informal connections on the internet, I also provide expressed milk to another mother in the community who is unable to lactate. To date, I’ve donated more than 1,500 oz of human milk (and counting).

The practice of human-milk donation dates back millennia with wet-nursing, when children were breastfed by someone other than their biological mothers: relatives, friends, or even strangers. The first milk bank in the United States opened in Boston in the early 20th century. In 1980, the World Health Organization and the United Nations Children’s Fund released a joint statement supporting the use of human-donor milk as the first alternative if the biological mother is unable to breastfeed. Donor milk is a safe option for families who cannot provide their own human milk to their children.
 

Human-milk banks

More than 30 nonprofit milk banks now operate in the United States. Because their mission is primarily to meet the needs of sick and hospitalized children rather than the general public, these milk banks are an impractical solution to the national formula shortage. Although families with healthy children can purchase donor milk with a prescription, supplies are scarce, and insurance doesn’t cover the cost.

Milk provided by formal human-milk banks is considered safe. Certain infections such as HIV and hepatitis can be transmitted through human milk. However, milk banks screen their donors and safely pasteurize and store donated breastmilk, following standard protocols. The risk of contracting an illness from banked donor milk is very low. The American Academy of Pediatrics recommends accepting donor milk only from a milk bank.
 

Informal human-milk donation

An increasingly popular alternative to formal human-milk banks is informal human-milk sharing. But many people, including health care professionals, hold misconceptions about how informal milk donation works. Today’s informal milk donation looks very different from age-old wet-nursing: Moms in support groups, often via social media, are requesting pumped milk from one another. (Note that this definition of “informal human-milk donation” does not include selling or purchasing human milk.)

Although the safety of sharing pumped human milk this way cannot be guaranteed, a harm-reduction approach is warranted, especially in view of the current formula scarcity.

I believe that medical professionals have a responsibility to raise awareness and dispel myths about donor breast milk. Many physicians acknowledge that informal milk sharing is common but rarely recommend it to patients. Whether they are donors or recipients, families who choose to participate need to be educated about how to go about the process as safely as possible.

Patients who are considering accepting informally donated human milk should ask key questions of the donor to gauge the risk of pathogens or other harmful substances being passed to their babies:

• What medications do you take?
• What supplements do you take?
• What recreational drugs do you take?
• Any recent travel?
• Any tattoos and if so, how recent?
• How much alcohol do you drink and how often?
• Have you been diagnosed with any infections?
• Any recent illness?
• How do you pump your breast milk?
• How do you store your breast milk?
• When was the available milk pumped?

We can help families by offering our medical expertise, allowing them to make an informed decision about whether to accept donated human milk. Clinicians can encourage patients and their families to use resources like the Infant Risk Center, which provides evidence-based information about medication safety and breast milk.

If your lactating patient is considering donating milk through informal channels to a family in need, encourage them to be open and honest about their medical history and lifestyle habits. If they cannot be transparent, they should not donate. A mutual level of respect and honesty can ensure the safety of those they hope to help. It is also important to counsel prospective milk donors to notify their milk recipients of any new illnesses, substance use, medications, travel, tattoos, or changes to their medical history.

Finally, encourage lactating patients who are able to do so to donate their extra milk to local nonprofit milk banks to increase the availability of screened, pasteurized breast milk in the community.

As a physician and mother, I hope that U.S. families will be less vulnerable to future formula shortages. Human milk is an ideal food source, but not everyone can lactate. Though not perfect, human milk donated outside of formal milk banks offers a safer alternative to diluting formula or feeding other unsuitable beverages to infants and children. As health care professionals, we need to counsel our patients about how to engage in this practice safely.

Dr. Mieses Malchuk is assistant professor in the department of family medicine at the University of North Carolina at Chapel Hill and a board-certified family physician and attending physician at UNC Health in Chapel Hill. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

I have become obsessed with the reality that the unprecedented national shortage of formula is keeping some families from adequately feeding their infants and young children. I am deeply concerned, both as a family medicine physician and a new mother, about the heartbreaking stories that I’ve heard from parents of all socioeconomic backgrounds. New mothers, unable to breastfeed for a multitude of reasons, find themselves standing in front of empty store shelves, in tears.

In recent months, many health care providers have had patients disclose that they are diluting ready-to-feed formula or mixing powdered formula with more water than instructed to make it go further. Some parents are giving cow’s milk to their children at too young an age because they can’t find formula. Others are foregoing milk altogether and feeding their children beverages such as juice or soda. All of these practices can threaten a child’s life, growth, and development.
 

When breastfeeding isn’t possible

We all know that human milk is the optimal, most nutritionally complete food source for newborn babies and infants. It can improve dental health and neurodevelopmental outcomes, as well as reduce the risk for asthma, eczema, diabetes, and obesity. An added benefit during the COVID-19 pandemic has been providing newborn infants with a boost of immunity before they are able to be vaccinated against SARS-CoV-2 infection.

But lactation and breastfeeding aren’t possible for everyone. Earlier this year, when my daughter was born more than a month prematurely, I worried that I would be unable to breastfeed her. The complications of prematurity can interfere with establishing lactation, and my daughter spent some time in the neonatal intensive care unit (NICU), requiring frequent feedings to treat hypoglycemia. She also lacked the muscle strength or coordination to latch on to the breast, so she was fed my colostrum and donor breast milk by bottle.

Not knowing when my mature milk would come in, my family scoured the retail stores for formula while I was still recovering from delivery. My daughter needed a specific type of high-calorie formula for premature infants. Eventually, my mother found one can of this powdered formula. The hospital also sent us home with 16 oz of ready-to-feed samples and enough donor breastmilk to last 24 hours at home. We considered ourselves lucky. The fear and anxiety about being able to feed my baby still stands out in my mind.
 

Pumping and sharing

Over the next few months, out of necessity, I became an “exclusively pumping” mother. My daughter, unable to latch, drank my pumped milk from a bottle. My body started to produce more milk than she needed in a day. In an effort to pay it forward and to put my extra milk to use, I became a human-milk donor. I underwent rigorous screening, including testing for infectious diseases such as HIV and hepatitis C. I was approved to donate to our local hospital’s milk bank, helping other families in the NICU feed their babies. Through informal connections on the internet, I also provide expressed milk to another mother in the community who is unable to lactate. To date, I’ve donated more than 1,500 oz of human milk (and counting).

The practice of human-milk donation dates back millennia with wet-nursing, when children were breastfed by someone other than their biological mothers: relatives, friends, or even strangers. The first milk bank in the United States opened in Boston in the early 20th century. In 1980, the World Health Organization and the United Nations Children’s Fund released a joint statement supporting the use of human-donor milk as the first alternative if the biological mother is unable to breastfeed. Donor milk is a safe option for families who cannot provide their own human milk to their children.
 

Human-milk banks

More than 30 nonprofit milk banks now operate in the United States. Because their mission is primarily to meet the needs of sick and hospitalized children rather than the general public, these milk banks are an impractical solution to the national formula shortage. Although families with healthy children can purchase donor milk with a prescription, supplies are scarce, and insurance doesn’t cover the cost.

Milk provided by formal human-milk banks is considered safe. Certain infections such as HIV and hepatitis can be transmitted through human milk. However, milk banks screen their donors and safely pasteurize and store donated breastmilk, following standard protocols. The risk of contracting an illness from banked donor milk is very low. The American Academy of Pediatrics recommends accepting donor milk only from a milk bank.
 

Informal human-milk donation

An increasingly popular alternative to formal human-milk banks is informal human-milk sharing. But many people, including health care professionals, hold misconceptions about how informal milk donation works. Today’s informal milk donation looks very different from age-old wet-nursing: Moms in support groups, often via social media, are requesting pumped milk from one another. (Note that this definition of “informal human-milk donation” does not include selling or purchasing human milk.)

Although the safety of sharing pumped human milk this way cannot be guaranteed, a harm-reduction approach is warranted, especially in view of the current formula scarcity.

I believe that medical professionals have a responsibility to raise awareness and dispel myths about donor breast milk. Many physicians acknowledge that informal milk sharing is common but rarely recommend it to patients. Whether they are donors or recipients, families who choose to participate need to be educated about how to go about the process as safely as possible.

Patients who are considering accepting informally donated human milk should ask key questions of the donor to gauge the risk of pathogens or other harmful substances being passed to their babies:

• What medications do you take?
• What supplements do you take?
• What recreational drugs do you take?
• Any recent travel?
• Any tattoos and if so, how recent?
• How much alcohol do you drink and how often?
• Have you been diagnosed with any infections?
• Any recent illness?
• How do you pump your breast milk?
• How do you store your breast milk?
• When was the available milk pumped?

We can help families by offering our medical expertise, allowing them to make an informed decision about whether to accept donated human milk. Clinicians can encourage patients and their families to use resources like the Infant Risk Center, which provides evidence-based information about medication safety and breast milk.

If your lactating patient is considering donating milk through informal channels to a family in need, encourage them to be open and honest about their medical history and lifestyle habits. If they cannot be transparent, they should not donate. A mutual level of respect and honesty can ensure the safety of those they hope to help. It is also important to counsel prospective milk donors to notify their milk recipients of any new illnesses, substance use, medications, travel, tattoos, or changes to their medical history.

Finally, encourage lactating patients who are able to do so to donate their extra milk to local nonprofit milk banks to increase the availability of screened, pasteurized breast milk in the community.

As a physician and mother, I hope that U.S. families will be less vulnerable to future formula shortages. Human milk is an ideal food source, but not everyone can lactate. Though not perfect, human milk donated outside of formal milk banks offers a safer alternative to diluting formula or feeding other unsuitable beverages to infants and children. As health care professionals, we need to counsel our patients about how to engage in this practice safely.

Dr. Mieses Malchuk is assistant professor in the department of family medicine at the University of North Carolina at Chapel Hill and a board-certified family physician and attending physician at UNC Health in Chapel Hill. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

I have become obsessed with the reality that the unprecedented national shortage of formula is keeping some families from adequately feeding their infants and young children. I am deeply concerned, both as a family medicine physician and a new mother, about the heartbreaking stories that I’ve heard from parents of all socioeconomic backgrounds. New mothers, unable to breastfeed for a multitude of reasons, find themselves standing in front of empty store shelves, in tears.

In recent months, many health care providers have had patients disclose that they are diluting ready-to-feed formula or mixing powdered formula with more water than instructed to make it go further. Some parents are giving cow’s milk to their children at too young an age because they can’t find formula. Others are foregoing milk altogether and feeding their children beverages such as juice or soda. All of these practices can threaten a child’s life, growth, and development.
 

When breastfeeding isn’t possible

We all know that human milk is the optimal, most nutritionally complete food source for newborn babies and infants. It can improve dental health and neurodevelopmental outcomes, as well as reduce the risk for asthma, eczema, diabetes, and obesity. An added benefit during the COVID-19 pandemic has been providing newborn infants with a boost of immunity before they are able to be vaccinated against SARS-CoV-2 infection.

But lactation and breastfeeding aren’t possible for everyone. Earlier this year, when my daughter was born more than a month prematurely, I worried that I would be unable to breastfeed her. The complications of prematurity can interfere with establishing lactation, and my daughter spent some time in the neonatal intensive care unit (NICU), requiring frequent feedings to treat hypoglycemia. She also lacked the muscle strength or coordination to latch on to the breast, so she was fed my colostrum and donor breast milk by bottle.

Not knowing when my mature milk would come in, my family scoured the retail stores for formula while I was still recovering from delivery. My daughter needed a specific type of high-calorie formula for premature infants. Eventually, my mother found one can of this powdered formula. The hospital also sent us home with 16 oz of ready-to-feed samples and enough donor breastmilk to last 24 hours at home. We considered ourselves lucky. The fear and anxiety about being able to feed my baby still stands out in my mind.
 

Pumping and sharing

Over the next few months, out of necessity, I became an “exclusively pumping” mother. My daughter, unable to latch, drank my pumped milk from a bottle. My body started to produce more milk than she needed in a day. In an effort to pay it forward and to put my extra milk to use, I became a human-milk donor. I underwent rigorous screening, including testing for infectious diseases such as HIV and hepatitis C. I was approved to donate to our local hospital’s milk bank, helping other families in the NICU feed their babies. Through informal connections on the internet, I also provide expressed milk to another mother in the community who is unable to lactate. To date, I’ve donated more than 1,500 oz of human milk (and counting).

The practice of human-milk donation dates back millennia with wet-nursing, when children were breastfed by someone other than their biological mothers: relatives, friends, or even strangers. The first milk bank in the United States opened in Boston in the early 20th century. In 1980, the World Health Organization and the United Nations Children’s Fund released a joint statement supporting the use of human-donor milk as the first alternative if the biological mother is unable to breastfeed. Donor milk is a safe option for families who cannot provide their own human milk to their children.
 

Human-milk banks

More than 30 nonprofit milk banks now operate in the United States. Because their mission is primarily to meet the needs of sick and hospitalized children rather than the general public, these milk banks are an impractical solution to the national formula shortage. Although families with healthy children can purchase donor milk with a prescription, supplies are scarce, and insurance doesn’t cover the cost.

Milk provided by formal human-milk banks is considered safe. Certain infections such as HIV and hepatitis can be transmitted through human milk. However, milk banks screen their donors and safely pasteurize and store donated breastmilk, following standard protocols. The risk of contracting an illness from banked donor milk is very low. The American Academy of Pediatrics recommends accepting donor milk only from a milk bank.
 

Informal human-milk donation

An increasingly popular alternative to formal human-milk banks is informal human-milk sharing. But many people, including health care professionals, hold misconceptions about how informal milk donation works. Today’s informal milk donation looks very different from age-old wet-nursing: Moms in support groups, often via social media, are requesting pumped milk from one another. (Note that this definition of “informal human-milk donation” does not include selling or purchasing human milk.)

Although the safety of sharing pumped human milk this way cannot be guaranteed, a harm-reduction approach is warranted, especially in view of the current formula scarcity.

I believe that medical professionals have a responsibility to raise awareness and dispel myths about donor breast milk. Many physicians acknowledge that informal milk sharing is common but rarely recommend it to patients. Whether they are donors or recipients, families who choose to participate need to be educated about how to go about the process as safely as possible.

Patients who are considering accepting informally donated human milk should ask key questions of the donor to gauge the risk of pathogens or other harmful substances being passed to their babies:

• What medications do you take?
• What supplements do you take?
• What recreational drugs do you take?
• Any recent travel?
• Any tattoos and if so, how recent?
• How much alcohol do you drink and how often?
• Have you been diagnosed with any infections?
• Any recent illness?
• How do you pump your breast milk?
• How do you store your breast milk?
• When was the available milk pumped?

We can help families by offering our medical expertise, allowing them to make an informed decision about whether to accept donated human milk. Clinicians can encourage patients and their families to use resources like the Infant Risk Center, which provides evidence-based information about medication safety and breast milk.

If your lactating patient is considering donating milk through informal channels to a family in need, encourage them to be open and honest about their medical history and lifestyle habits. If they cannot be transparent, they should not donate. A mutual level of respect and honesty can ensure the safety of those they hope to help. It is also important to counsel prospective milk donors to notify their milk recipients of any new illnesses, substance use, medications, travel, tattoos, or changes to their medical history.

Finally, encourage lactating patients who are able to do so to donate their extra milk to local nonprofit milk banks to increase the availability of screened, pasteurized breast milk in the community.

As a physician and mother, I hope that U.S. families will be less vulnerable to future formula shortages. Human milk is an ideal food source, but not everyone can lactate. Though not perfect, human milk donated outside of formal milk banks offers a safer alternative to diluting formula or feeding other unsuitable beverages to infants and children. As health care professionals, we need to counsel our patients about how to engage in this practice safely.

Dr. Mieses Malchuk is assistant professor in the department of family medicine at the University of North Carolina at Chapel Hill and a board-certified family physician and attending physician at UNC Health in Chapel Hill. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

A version of this article first appeared on WebMD.com.

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

A version of this article first appeared on WebMD.com.

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

A version of this article first appeared on WebMD.com.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

A version of this article first appeared on WebMd.com.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

A version of this article first appeared on WebMd.com.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

A version of this article first appeared on WebMd.com.

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

A version of this article first appeared on Medscape.com.

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

A version of this article first appeared on Medscape.com.

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

A version of this article first appeared on Medscape.com.