TOPLINE:
Between 2011 and 2023, the US Food and Drug Administration (FDA) reported recalls of 334 cosmetic dermatology products in the United States, affecting over 77 million units, predominantly due to bacterial contamination.
METHODOLOGY:
- Researchers conducted a cross-sectional analysis of the FDA Enforcement Report database for cosmetic dermatology products from 2011 to 2023.
- Cosmetic products are any article “intended for body cleaning or beauty enhancement,” as defined by the FDA.
- Recalls were categorized by product type, reason for the recall, microbial contaminant, inorganic contaminant, distribution, and risk classification.
TAKEAWAY:
- During the study period, 334 voluntary and manufacturer-initiated recalls of cosmetic products were reported, affecting 77,135,700 units.
- A total of 297 recalls (88.9%) were categorized as Class II, indicating that they caused “medically reversible health consequences.” The median recall duration was 307 days.
- Hygiene and cleaning products accounted for most of the recalls (51.5%). Makeup gels, soaps, shampoos, tattoo ink, wipes, and lotions were the most recalled product categories. Nearly 51% of the products were distributed internationally.
- Microbial and inorganic contamination accounted for 76.8% and 10.2% of the recalls (the two most common reasons for the recall), respectively, with bacteria (80%) the most common contaminating pathogen (primarily Pseudomonas and Burkholderia species).
IN PRACTICE:
With 77 million units recalled by the FDA over 12 years, cosmetic recalls have remained common, the authors concluded, adding that “dermatologists should be key voices in pharmacovigilance given scientific expertise and frontline experience managing products and associated concerns.” Dermatologists, they added, “should also be aware of FDA enforcement reports for recall updates given that average recall termination took approximately 1 year.”
SOURCE:
The study was led by Kaushik P. Venkatesh, MBA, MPH, Harvard Medical School, Boston, and was published online on October 29 in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study’s limitations include the potential underreporting of Class III recalls (products that are unlikely to cause any adverse health reaction but violate FDA labeling or manufacturing laws) and lack of complete information on contaminants.
DISCLOSURES:
No information on funding was provided in the study. No conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.