November 7, 2018

The U.S. Food and Drug Administration is announcing today the opportunity to provide comment on a proposed web-based consumer survey about allergens in cosmetics. Cosmetics are a broad category that includes items such as fragrances, hair products, makeup, nail products, and skin care products. The survey will be the first on consumer perceptions of cosmetics that the FDA has conducted since 1975. The purpose of the survey is to collect information that will improve the FDA’s current understanding of adverse events caused by allergens in cosmetics. In addition, the survey will help the agency better understand consumer perceptions and awareness as well as consumer behavior regarding allergens in cosmetics such as decisions to purchase specific products or to avoid certain ingredients, when to contact a health care provider, and when to report an adverse event. The people invited to participate in the survey will be selected to be representative of U.S. adults.

This survey is part of the FDA’s ongoing effort within recent years to learn more about allergens in cosmetics. In 2015-2016, the FDA contracted Integrated Laboratory Systems, Inc. (ILS) to conduct a comprehensive literature review of 26 fragrances that the European Union has identified as allergens. In 2016-2017, the FDA expanded the literature review to other cosmetic ingredients. Beginning in 2019, the FDA hopes to begin conducting a new consumer survey.

In order to do so, the FDA must obtain approval from the Office of Management and Budget to conduct the survey. As a first step toward obtaining that approval, tomorrow the FDA is publishing a notice in the Federal Register seeking public comment on the survey pursuant to the Paperwork Reduction Act. The survey will be included in the docket. Comments must be submitted on or before 60 days after date of publication in the Federal Register. FDA encourages the public to submit comments on the survey here: https://www.federalregister.gov/documents/2018/11/08/2018-24441/agency-information-collection-activities-proposed-collection-comment-request-web-based-pilot-survey. Written comments may also submitted to Docket Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

For Additional Information:
• FDA requests public input concerning a new consumer survey about allergens in cosmetics: https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm625264.htm?utm_campaign=CFSANCU%3A%20FDA%20Requests%20Comments%20on%20New%20Consumer%20Survey%20about%20Allergens%20in%20Cosmetics&utm_medium=email&utm_source=Eloqua

• Using Adverse Event Reports to Monitor Cosmetic Safety: https://www.fda.gov/Cosmetics/ComplianceEnforcement/AdverseEventReporting/ucm531634.htm?utm_campaign=CFSANCU%3A%20FDA%20Requests%20Comments%20on%20New%20Consumer%20Survey%20about%20Allergens%20in%20Cosmetics&utm_medium=email&utm_source=Eloqua

• How to Report a Cosmetic Related Complaint
https://www.fda.gov/Cosmetics/ComplianceEnforcement/AdverseEventReporting/default.htm?utm_campaign=CFSANCU%3A%20FDA%20Requests%20Comments%20on%20New%20Consumer%20Survey%20about%20Allergens%20in%20Cosmetics&utm_medium=email&utm_source=Eloqua

• CFSAN Adverse Event Reporting System (CAERS)
https://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm?utm_campaign=CFSANCU%3A%20FDA%20Requests%20Comments%20on%20New%20Consumer%20Survey%20about%20Allergens%20in%20Cosmetics&utm_medium=email&utm_source=Eloqua