Modified-risk tobacco products – such as e-cigarettes and tobacco lozenges that may reduce the health risks of using tobacco – could represent part of a comprehensive strategy to combat tobacco-related disease and death, but too little is known about whether they actually pose less risk than do traditional tobacco products, according to a report issued Dec. 14 by the Institute of Medicine.
Consequently, the Food and Drug Administration should require specific types of research on these modified-risk products before allowing tobacco companies to sell or advertise them as being capable of reducing the health effects of tobacco use, the IOM report recommended.
Photo courtesy timur1970/Fotolia.comCredit
The IOM report recommended that the FDA should require specific types of research on modified-risk products (such as the e-cigarette shown above) before allowing tobacco companies to sell or advertise them as safer than other tobacco products.
The research should determine whether the product really presents a lessened risk for a person who might use it, Dr. Jane Henney, committee chair and professor of medicine and public health sciences at the University of Cincinnati, said in an interview. The product "also should not negatively impact the general public, as in the case of secondhand smoke, and it shouldn’t raise the risk" for nonusers or former users to begin or resume using the product.
Few smokers – only about 6% each year – are able to successfully quit tobacco use. Because quitting is so difficult, many cigarette smokers would welcome products that allow them to continue smoking with less risk to their health. However, there’s no research showing that modified-risk tobacco products are safer; in fact, so-called "light" cigarettes actually turned out to be just as risky as regular cigarettes, the IOM report said.
The Family Smoking Prevention and Control Act of 2009 gave the FDA the authority to ensure that modified-risk tobacco products actually do reduce tobacco-related harm before they can be marketed. The 2009 law also directed the IOM to work with the FDA on the design and conduct of scientific studies of modified-risk tobacco products.
The 330-page report provides details on how such studies should be conducted.
The tobacco industry "is new to regulation, and has a past history that would lead one to believe it can’t be trustworthy," Dr. Henney said. "We speak to the governance tools that should be put in place to really open up this process."
In part because of this trust gap, companies and other sponsors who develop modified-risk tobacco products should consider using FDA-approved, independent third parties to oversee health and safety research on their product, the report recommended. Independent oversight would ensure that the data submitted to the FDA are reliable and credible, the report said, and it might help to lure institutions and scientists back into the field; currently, many refuse to conduct or publish research supported by the tobacco industry.
Tobacco makers currently lack the capacity and expertise to conduct valid scientific research on their own products, according to the IOM report.
The report recommends that studies on modified-risk tobacco products should examine the product’s composition and addiction potential, the amount of human exposure to harmful components, perceptions about the product’s effects and likelihood of addiction, and its effects on human health. Studies should be "generalizable" to the whole population, but also should include populations of special relevance, including current and former smokers, beginning smokers, adolescents, and populations at high risk for tobacco use.
IOM committee member Dr. Bonnie Halpern-Felsher, professor of pediatrics at the University of California, San Francisco, said in an interview that it’s especially critical to understand how these modified-risk products could impact adolescents.
"We do know that the majority of people who start smoking are adolescents," Dr. Halpern-Felsher said. "We need to make sure when these studies are done that they do include the adolescent population, and cover the health effects on adolescents and adolescents’ perceptions of the product and their likelihood of going on to use it."
No disclosures were reported.