Today the FDA announced their first steps in creating cosmetic GMP regulations under the Modernization of Cosmetic Regulations Act of 2022 (MoCRA), starting with a Request for Comments, Listening Session/Public Meeting.
KEEP IN MIND: Regulations covering GMP for cosmetic manufacturing will only apply to busineses with more than $1 Million annual revenue from cosmetic sales.
Request for Comments
The FDA has laid out 6 topics that they would like comments on. They encourage commenters to include the specific rationale and basis for their comments, plus any available supporting data and information. Commenters don’t need to respond to every topic.
NOTE: If you belong to an trade organization or association for the industry (such as the Handcrafted Soap and Cosmetic Guild) before making your comment it would be a good idea to find out what actions they are taking on your behalf and if there are any coordinated actions they are encouraging.
The comment period closes July 3, 2023.
There will be a virtual public listening session on June 1st, 2023 from 10am to 1pm Eastern Time.
You can register to watch any time before or during the session.
The FDA is taking requests to present oral presentations; there is an option to do so when registering. Requests for make an oral presentations during the Listening Session must be submitted by May 18th. The FDA requests that individuals and organizations with common interests consolidate and coordinate their presentations.
What Comes After This?
This is the very first step. This is the period when the FDA gets input from all the stakeholders. THIS stage of data gathering ends with the close of the comment period on July 3 (unless it is extended, which it could be).
The next step will either be more data gathering or the FDA will start on the process of putting together the Proposed Rule.
Proposed rules are normally then available for comments for 30 – 90 days or so, although it can be extended if there seems to be a need. At the end of the comment period the FDA takes the comments on the Proposed Rule, makes any changes and publishes the Final Rule (which are the actual regulations). This whole process normally takes around a year or more.
The final regulations will specify the compliance date (the date by which everyone has to come into compliance with the new regulations). For something like this, it’s normally 1-2 years from the date the regulations are issued. There can be a longer time for small businesses.