It’s time to review where things stand with MoCRA.
As was the case in the last MoCRA update I posted in July 2024, Most of the requirements of MoCRA are fully in effect:
- Safety substantiation
- Severe adverse event reporting
- Labeling of items for professional use
- Facility registration
- Product listing
- Additional FDA authority
There are only two sections not yet in effect, and both of those are waiting for FDA action to propose regulations:
— Fragrance Allergens
The proposed regulations to include some to-be-identified fragrance allergens on cosmetic labels were supposed to be issued by June 29, 2024. Didn’t happen.
The Biden Administration’s plan for upcoming regulatory action had the regulation proposal slated to be issued in October. Didn’t happen.
— Good Manufacturing Practices
The deadline for issuing the proposed regulations for Cosmetic GMP is December 29, 2024. We’ll see on that one.
What to expect now
Obviously, having missed two deadlines already, the FDA is running behind. How far behind they will be is anyone’s guess at this point.
A December 2023 report by the GAO (Government Accountability Office) on the FDA’s implementation of MoCRA found that the FDA hadn’t really developed a full implementation plan to get MoCRA into place or worked out a strategic worforce plan to make sure they had the necessary trained staff. So there’s that.
However, FDA has started the process of implementing a new organizational structure. Part of that was moving the Office of Cosmetics and Colors out of the Center for Food Safety and Applied Nutrition and into the Office of the Chief Scientist. The Chief Scientist was designated as the leader for MoCRA implementation.
Incoming Administration
The FDA is part of the Executive Branch of the federal government. As such, it is likely to be affected by changes in policy agendas and priorities by the incoming adminsitration. I haven’t heard any specific mention of cosmetics or MoCRA, but there has been a great deal of discussion about potential changes in other parts of the FDA. How that will affect cosmetics and the implementation of the final steps of MoCRA is unknown. But if there is a big shift in priorities, it’s very possible that once again cosmetics will fall to the bottom of the pile when it comes to allocating staff, resources, and funding. And that would certainly delay issuance of the rest of the MoCRA regulations as well as the enforcement of all aspects of it.
There has also been talk (I don’t know if it’s true or not) that the incoming administration may issue a 100-day moratorium on all new regulations. If that’s true, it could be a factor in if/when/how the remaining MoCRA regulations will be issued.
It’s possible the FDA will try to push things through before the new administration takes office — or maybe they will delay everything until after, in order to see how things fall out.
I’ll keep you posted!
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