Introduction
The U.S. Food and Drug Administration (FDA) recently issued a Federal Register notice1(the notice) that the FDA intends to conduct a web-based survey for a "more current understanding of the prevalence of adverse reactions to cosmetics."2The FDA states that evidence "indicates that the prevalence of allergies in the U.S. population is increasing…"3At the same time, the FDA notes that "no publicly available data has been collected on the prevalence of adverse reactions to cosmetic products since 1975…"4
The increased prevalence of allergies and lack of current publicly available data for adverse reactions to cosmetics, coupled with an increasing number and diversity of cosmetic ingredients, as well as the observation that "multiple cosmetic products…are used daily by nearly everyone in the United States, including infants, children, adults, geriatric populations, healthy people, and individuals with medical conditions,"5are the factors prompting the FDA to propose its consumer survey.
FDA's Proposed Survey
The proposed survey will be web based and will attempt to understand the prevalence and frequency of allergic reactions, consumer awareness of the problem, and any actions taken to avoid allergens.6The survey is intended to be completed in 20 minutes and is targeting 1,000 English language speaking adults. Selected participants will be invited to participate through an email, which will contain a link to access the survey. The survey is intended to be representative of the U.S. adult population, and the FDA intends to pretest the survey on 100 respondents.7
Our Recommendations
The notice maintains that the survey is "part of the agency's continuing effort to understand the impact of allergens on cosmetics."8Thus, cosmetics manufacturers should continue ongoing efforts to monitor for allergies to individual cosmetics and ingredients therein. Should a specific ingredient appear to become associated with a higher prevalence of allergies, cosmetics manufacturers may wish to consider if the ingredient can be substituted with a different ingredient, or eliminated, and any downstream effects that could result from these action (e.g., on patent claims, in supply chains, on ingredient purchasing contracts, for formulation logistics, on toxicity testing, as a perceived admission in a future litigation). Also, cosmetics manufacturers should be prepared for possible labeling changes that could be required by the FDA. Finally, with the comments period still open, cosmetics manufacturers should consider providing comments to the FDA.
Conclusion
For questions about the proposed survey, or any FDA-related matter, please contact David Hoffmeister or any member of Wilson Sonsini's FDA Regulatory, Healthcare, and Consumer Products practice.
