Moving Towards MOCRA Implementation: FDA Announces Industry “Listening Session”
Since the late December 2022 seismic shift in the legal landscape for cosmetic companies – when Congress passed and President Biden signed the Modernization of Cosmetics Regulation Act, or MOCRA, into law (see our prior post here) – the Food and Drug Administration (FDA) has been relatively subdued in providing guidance to the affected industries regarding questions around “what happens next.” The most significant public announcements made by FDA since the law was passed are arguably that: (1) the voluntary cosmetic establishment registration program would be shuttered in favor of the yet-to-be-explained mandatory registration and listing system for cosmetic facilities; and (2) cosmetic manufacturers that want to report adverse events to the agency now should do so via the existing MedWatch program, which is currently used for drugs, biologics, and medical devices.
However, on April 26, 2023, the FDA announced that it would be convening a virtual “listening session” on June 1 to hear directly from stakeholders in order “to inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPs) for facilities that manufacture, or process cosmetic products distributed in the United States.” The agency is specifically calling for engagement by participants in the cosmetic and personal care industry who are small businesses and contract manufacturers, as well as consumer organizations. This kind of consultation with affected industries and other stakeholders was mandated by Congress in MOCRA, before FDA promulgates the proposed cosmetic GMP regulations (which are expected to be issued within two years of the law’s passage, by December 2024).
Registration in advance of the June 1 listening session is required and can be done on the FDA’s registration webpage. Attendees who wish to make a presentation or otherwise speak during the meeting must register by May 18 and submit their presentations by May 22. Non-presenting attendees can register at any time, and the deadline for submitting written comments to the docket (Docket No. FDA-2023-N-1466) in response to FDA’s requests for information is June 3, 2023.
FDA’s meeting notice and request for comments identifies several topics of interest to federal regulators, and seeks to focus stakeholder input on several different topics. While the majority of the topics relate to developing GMPs, others focus on the economic impact of GMPs and MOCRA. The topics include the following:
- “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.”
- “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.”
- “Describe what constitutes simplified good manufacturing practices requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship.”
- “Describe appropriate compliance times for good manufacturing practices regulations.”
- “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?”
- “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?”
The new MOCRA regulatory regime will impose significant additional requirements, processes, and procedures on affected entities. We therefore encourage everyone with relevant experiences or other information to share with the FDA to engage by presenting at the June 1st listening session and/or through written comments to the docket, which can be submitted as early as April 27. This listening session and the creation of an e-docket represent the first steps of a lengthy rulemaking process that will culminate in mandatory GMP regulations for this universally utilized class of consumer products.