Science in the News
An In-Press Research Letter Reports on an Analysis of the FDA Adverse Event Database for Cosmetic and Personal Care Products
July 05, 2017
Researchers at Northwestern University Feinberg School of Medicine conducted an analysis of the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) in order to categorize the numbers and types of adverse events voluntarily reported to the Agency according to cosmetic or personal care product type.1 Public access to the dataset, which began taking reports in 2004, was made available in 2016, with the hopes of increasing reporting to the voluntary system, and also to increase transparency. According to the investigators’ analysis, over 5,100 adverse events were submitted to the system from 2004 to 2016; this was an average of approximately 400 reported events per year. The 3 product types most commonly implicated in adverse event reports were hair care (n = 1,805), skin care (n = 1,148), and tattoos (n = 388). Classes of products with significantly higher than average (35.0%) reports of serious adverse events were baby products (51.8%; 95% confidence interval [CI]: 44.2, 59.3), unclassified (50.2%; 95% CI: 44.1, 56.3), personal cleanliness (47.1%; 95% CI: 41.2, 53.2), hair care (43.9%; 95% CI: 41.7, 46.2), and hair coloring products (40.5%; 95% CI: 35.0, 46.1). Reports of serious adverse events for products classified as oral hygiene did not differ statistically from the mean across all product classes at approximately less than 30% (as estimated from Figure 2 in the paper).
The authors identified several limitations of the CAERS dataset, including limited demographic data, no data on coincident disease or concomitant product use, inability to establish causality, and the inability to determine if the reporting person is a consumer or health-care professional. Also, because reporting to CFSAN’s system is voluntary, the numbers of adverse events reported are likely underestimated. An associated editorial by Califf et al.2 points out that when events are reported via passive surveillance, “there is no credible way to calculate a valid denominator or understand how many events were not reported,” and that “…absence of evidence in this context should not be confused with evidence of absence (of adverse events).”
For both the general public and for specific populations (e.g., those with limited dexterity), there is a need to identify oral care products to help achieve adequate oral hygiene.3 The ADA Seal of Acceptance Program, established in 1931, evaluates the safety and efficacy of over-the-counter dental products. It is a resource to help the public gauge whether products will do what they claim; and serves as a resource for dentists to identify products to recommend to patients, as well as a resource for manufacturers about the quality standards that are needed to earn the Seal of Acceptance.4 Products with the Seal of Acceptance have been evaluated for both safety and efficacy by an independent body of scientific experts, under the auspices of the ADA Council on Scientific Affairs.
- Kwa M, Welty LJ, Xu S. Adverse events reported to the US Food and Drug Administration for cosmetics and personal care products. JAMA Intern Med. 2017. http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2633256. Accessed June 29, 2017.
- Califf RM, McCall J, Mark DB. Cosmetics, regulations, and the public health: Understanding the safety of medical and other products. JAMA Intern Med. 2017. http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2633254. Accessed June 29, 2017.
- Hitz Lindenmuller I, Lambrecht JT. Oral care. Curr Probl Dermatol 2011;40:107-15.
- Meyer DM. Voluntary programs: ADA Seal program and international implications. Ann Periodontol 1997;2(1):31-41.
Prepared by: Center for Scientific Information, ADA Science Institute
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