Dear Valerie: The passing of the Modernization of Cosmetics Regulation Act (MoCRA) was such a big deal last year; it’s all we heard about from trade associations, industry consultants and trade press. I haven’t heard much about it, however, in the past few months. Is all this worry about MoCRA still a thing?

              —Randy Regulations

Dear Randy:

You’re right! Since MoCRA’s enactment, our inboxes were stuffed with newsletters and webinars related to making sure you knew everything you needed to know about MoCRA and ensuring your company was MoCRA-ready. Occasionally, I still receive a MoCRA webinar offering in my inbox, but I actually forgot MoCRA was even a burden until your email arrived.

The biggest to-do with MoCRA (Modernization of Cosmetics Regulation Act) was the enactment of a registration system that provided transparency to the FDA about who is manufacturing what, and for whom. Additionally, brands are required to report which specific products their manufacturer is producing, along with an INCI list and fragrance details (if any). If all the information lines up, the submission into the portal is good to go. 

While we had to wait a significant amount of time for the portal’s creation (along with a brief extension past the initial deadline), the portal is live. 

You may be pleased to know your tax dollars are hard at work, as the FDA has even provided some modifications to the portal since its launch. FDA must be listening to our feedback! 

As an aside, all MoCRA-required reporting is confidential and protected, so consumers can’t request this information through the Freedom of Information Act (FOIA). 

Also checked off the FDA’s daunting to-do list was the finalization of the Talc Testing Rule, as well as mandating of safety substantiation, adverse event reporting and professional product labeling. 

There still are a few big-ticket items that need to be addressed for MoCRA. The FDA is diligently working on a proposed allergen labeling rule, which was due in June 2024. As of this publication, we’re still waiting for the FDA’s initial proposal, upon which the industry will have time to remit feedback. Perhaps it’s clairvoyance or wishful thinking, but the overall industry sentiment is the FDA should mirror the EU’s regulations on fragrance allergens to make it a little easier on all of us.

Speaking of intransigent regulatory bodies—if you sell product into California, you need to follow the allergen reporting rules as part of the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020, which California also calls CFFIRKA—which is not much easier to say. It’s my hope the FDA’s proposed allergen labeling will align with what the state of California has dictated to report, which is essentially the European Union regulations, plus a bit more. If your brand isn’t registered in compliance with CFFIRKA in the California Safe Cosmetics Program database, please contact me and I can walk you through the steps.

Lastly, we’re still waiting for GMP guidance from the FDA (which is due December 2024), enforcement of new labeling requirements (also due December 2024), and ruling on PFAs (due December 2025). We’re not out of the woods yet in terms of never-ending-MoCRA news, but we’ve come a long way! And, if you’re not aware of anything I wrote about is in this column, please find one of those old MoCRA webinar emails in your inbox and register for it!

Valerie George

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Valerie George is a cosmetic chemist, science communicator, educator, leader, and avid proponent of transparency in the beauty industry. She works on the latest research in hair color and hair care at her company, Simply Formulas, and is the co-host of The Beauty Brains podcast. You can find her on Instagram at @cosmetic_chemist or showcasing her favorite ingredients to small brands and home formulators at simply-ingredients.com