On November 7, the FDA announced that it is seeking approval for a web-based pilot survey about allergens in cosmetics, including fragrances, hair products, makeup, nail products and skin care products. The federal register notice was published on Nov. 8, 2018.
The survey is part of FDA’s efforts to learn more about allergens in cosmetics. Although FDA receives information about adverse reactions to cosmetics via the voluntary reporting to Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS), the Agency believes these reports are an underestimate of the incidence of allergic and other reactions to cosmetics. The objective of the proposed survey is to collect information needed for a more current understanding of the prevalence of adverse reactions to cosmetics, consumer awareness of the problem, and actions (if any) consumers take to avoid allergens, e.g., purchasing hypoallergenic cosmetics, avoidance of cosmetics containing fragrances. The survey is a pilot scheduled to cover 1000 adult consumers. The proposed survey is available in the docket. FDA requests feedback on four topics:
- whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
- the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
- ways to enhance the quality, utility, and clarity of the information to be collected;
- ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Comments must be submitted by Jan. 7, 2019.