FDA Announces Listening Session Regarding Good Manufacturing Practices for Cosmetic Products

As part of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), Congress directed FDA to develop good manufacturing practice regulations (“GMPs”) in consultation with the cosmetics industry and other stakeholders. In a recorded webinar on MoCRA published on April 12, 2023, FDA announced that it will host a June 1, 2023 public listening session on GMPs for cosmetic products to gather industry feedback as part of its rulemaking efforts. Yesterday FDA published a Federal Register Notice providing the logistics for the session.

The June 1, 2023 virtual session will be held from 10:00 a.m. to 1:00 p.m. ET, or until the last commenter has spoken. Stakeholders can register to attend at any time before the session ends, but anyone who wishes to speak at the meeting must register by 6:00 p.m. ET on May 18, 2023 and must submit all presentation materials to FDA by May 22, 2023. As part of the listening session, the public can submit comments through July 3, 2023.                        

Background on Good Manufacturing Practices for Cosmetic Products

MoCRA added section 606 of the Federal Food, Drug, and Cosmetic Act, which directs FDA to establish good manufacturing practice regulations for cosmetics. The regulations will be designed to ensure that cosmetic products are not adulterated and may include provisions that allow FDA to inspect records necessary to demonstrate GMP compliance. FDA previously issued draft guidance regarding cosmetic GMPs, but announced in the Federal Register notice that it intends to withdraw or revise this draft guidance based on its GMP rulemaking.

Topics for Comment

FDA provided a list of six topics on which it would like comment as part of the listening session:

GMP Topics

1. Identify any national or international standard (e.g., International Organization for Standardization (ISO) standard 22716:2007) and the extent to which it would be practicable for good manufacturing practice regulations for cosmetic products to be consistent with such standard. Please include whether there are specific items in the standard which are perceived to be burdensome or for which a less burdensome alternative exists that would protect the public health and ensure that cosmetic products are not adulterated. 
2. Describe what constitutes sufficient flexibility within good manufacturing practices for cosmetic products to ensure regulations are practicable for all sizes and types of facilities to which such practices may apply. Please take into account the size and scope of the businesses engaged in the manufacture of cosmetic products and the risks to public health posed by cosmetic products. 
3. Describe what constitutes simplified good manufacturing practices requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship. 
4. Describe appropriate compliance times for good manufacturing practices regulations.

Economic Impact Topics

1. To what extent are manufacturers of cosmetic products already following a national or international standard for good manufacturing practices? For manufacturers of cosmetic products that are not currently following such a national or international standard, what would it cost to implement good manufacturing practices consistent with such a standard? 
2. Please provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing good manufacturing practices impact the likelihood of a recall of cosmetics products? How would implementing good manufacturing practices impact the likelihood of consumers experiencing adverse events from the use of cosmetics products? How would these impacts differ by type of cosmetic product?

Joining the Listening Session and Submitting Comments

The listening session is free and open to the public. Stakeholders can register to attend a Zoom webcast of the event here. After the session, FDA will make a transcript of the session available on regulations.gov.

Companies can submit public comments on cosmetic GMPs electronically via regulations.gov (Docket No. FDA-2023-N-1466). 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.

Stakeholders can also present during the listening session with each presentation likely limited to three minutes. To be considered, stakeholders must submit requests to present before 6:00 p.m. on May 18, 2023 ET. Further instructions are in the Federal Register notice.

• May 18, 2023 (6:00 pm ET): Deadline to register if you wish to speak at the meeting.
• May 22, 2023: Deadline to submit all presentation materials for persons selected to speak at the meeting. 
• June 1, 2023: Deadline to register to attend the listening session.
• July 3, 2023: Deadline to submit comments to Docket No. FDA-2023-N-1466.

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drug, and Device practice: Wade Ackerman, Jessica O'Connell, Jeannie Perron, Peter Hutt, James Holloway.