FDA Announces Opportunity to Comment on Cosmetic Labeling, Facility Registration, and Product Listing Requirements

FDA Announces Opportunity to Comment on Cosmetic Labeling, Facility Registration, and Product Listing Requirements

May 10, 2023, Covington Alert

On May 1, 2023, FDA announced that it is accepting comments with respect to the information collection provisions to support FDA’s longstanding cosmetic labeling regulations as well as the new statutory provisions for cosmetic labeling, facility registration, and product listing under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). To be considered timely, comments must be submitted by June 30, 2023.

Request for Comment

MoCRA amended the Federal Food, Drug, and Cosmetic Act to establish requirements for cosmetics facilities registration, product listing, and the inclusion on cosmetic product labels of contact information through which the responsible person can receive adverse event reports, among other requirements.

FDA is now seeking information to support its longstanding cosmetic labeling regulations and these new statutory provisions. Specifically, FDA is inviting comments on:

1. whether its proposed information collection is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
2. the accuracy of the agency’s estimate of the burden imposed by the proposed information collection, including the validity of the methodology and assumptions used;
3. ways to enhance the quality, utility, and clarity of the information to be collected; and
4. 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.

FDA is hoping to receive comments from cosmetic manufacturers and processors.

How to Submit Comments

Companies can submit public comments electronically via regulations.gov (Docket No. FDA–2023–N–1029). If a company wants to submit confidential information in its comments, it must send in paper submissions by mail or hand delivery to FDA and indicate which information is confidential. FDA will accept electronic comments until 11:59 p.m. ET on June 30, 2023, and will consider written comments timely if they are received on or before that date. Further instructions are in the Federal Register notice.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.