The beauty industry is experiencing rapid regulatory changes. The first Modernization of Cosmetics Regulation Act (MoCRA) deadline has already passed, and the next one is right around the corner. The opening of the FDA MoCRA portal late last year has presented a slew of registration challenges for beauty brands. The Cosmetics Convergence 2024 Spring Symposium, hosted by the Independent Beauty Association (IBA), addressed these issues in a session on MoCRA status updates and practical learnings. The symposium offered valuable insights and resources to assist beauty brands in navigating the complexities of the MoCRA rollout. In case you missed it, here are a few of the most important takeaways from the sessions on MoCRA updates, upcoming deadlines, and compliance FAQs to keep you well-informed.
MoCRA Deadlines
The December 29, 2023, deadline put into action many provisions of MoCRA, including adverse event tracking, serious adverse event reporting, professional use labeling, facility registration, product labeling, mandatory recall authority, records access, and test methods for asbestos. However, an enforcement delay was granted until July 1, 2024, specifically for facility registration and product labeling submissions to the portal.
“With the delay of facility registration and product labeling, we heard that many people assumed that everything was delayed until July 1, and that’s not the case,” says Don Frey, President and CEO at IBA. “If you haven’t started putting together your documentation for things like safety assessments or processes for adverse event reporting, you should start right away. It’s never too late.”
On June 29, 2024, IBA says to expect to see a proposed rule for the labeling of fragrance allergens. IBA didn’t give any indication as to what could be on that list, but it did say the FDA is very aware of the original European Union (EU) list and the extended allergen list that the industry is currently working to implement.
On the state regulation front, California’s Department of Health has added the extended EU allergen list to its reporting obligations. Products with those extended allergens need to be reported. The Department of Health has recently indicated that the timeline for reporting is the same as the timelines required under the EU law, i.e., 2026 or 2028. Originally, the proposed timeline was six months, but fragrance creators pushed back and were able to achieve a more favorable timeline.
“We’re not always able to affect timing or regulations, but when there is a concerted effort, we can frequently influence these things,” says Frey. “That’s a great example of IBA working alongside fragrance creators and PCPC [The Personal Care Products Council] to help get that timing changed by the California Department of Health. That was a great win for the industry. A big thanks to fragrance creators who led that effort."
The next major MoCRA deadline is July 1, 2024, which is the enforcement delay for facility registration and product listings. “The banner headline is do not delay!” says Meredith Petillo, VP of Technical & Regulatory Affairs at IBA. “There’s a tendency to see the headline and breathe a sigh of relief and worry about that later. Please get your information gathered and start handling it now rather than later. July will be here before you know it.”
Under the current MoCRA statutes, the FDA is required to put forth a proposed rule for good manufacturing processes (GMP) by December 29, 2024, and then the FDA has another year to publish a final rule by December 29, 2025. Also by December 2025, the FDA is required to issue a report summarizing the results of an assessment of the use of PFAS in cosmetics.
“This is one of those things where we are continuing to talk to the FDA as they’re developing these guidelines,” says Frey. “Whatever the FDA comes up with [should] work well with the guidelines that are used around the world, especially in the EU, so people can continue to make one batch of product and be able to use that batch both domestically and internationally. We’ve been making sure that the FDA is aware of that. Hopefully, we can get to a place that doesn’t require a separate set of books for international and domestic products. That’s our goal.”
MoCRA Portal Learnings
One of the most common issues Petillo sees brands face as they pursue MoCRA compliance is a facility registration bottleneck. Many facilities in the pipeline haven’t registered yet, and under current submission guidelines, the facility registration must precede the product listing. Brands cannot submit product listings if their facility is not registered. Petillo advised that brands highly encourage their facility’s submission because there is a massive volume of product listings that follow facility registrations.
“This is very critical for [brands] to know,” she says. “You cannot submit your product listing if the facility is not registered. There are two parts of facility registration: one is to get the FEI [FDA Establishment Identifier] number and the second is actually to register as a cosmetic facility.”
Many facilities already have an FEI number because they were manufacturing sunscreens or other over-the-counter products. However, the facility still needs to go into the cosmetic portal and register its facility.
“That’s a key step that many facilities are missing,” says Frey. “It will block you from doing your product listing if they’re not registered or if you don't have a registration number for the facility. It’s very important to get in front of this so that your facility has an FEI number and is registered as a cosmetic facility.”
MoCRA FAQ’s
Are Unique Ingredient Identifier (UNII) codes optional?
Yes! UNII codes are optional in the product listing. Petillo notes that the portal has been challenging in that it’s been guiding users to input UNII codes, but she emphasizes that brands are not obligated to include them. If you’re having trouble submitting your products without UNII codes, she suggests reaching out directly to the FDA. They have an inbox that deals with errors in the portal.
“For people who are trying to upload formulas in the product listing using a spreadsheet, the portal is still not allowing that to go through if you do not include UNII codes,” says Frey. “Please reach out to the FDA if you’re experiencing that issue. Officially, they cannot require UNII codes. The more you let the FDA know that that’s an obstacle, the more likely they’ll fix it.”
If my brand sells a kit, does the kit need to be registered as a product listing?
No. The kit itself does not count as a product, but each individual product in the kit does and needs to be registered, even if the brand doesn’t sell the individual product as a standalone SKU and it’s only available as part of the kit. All components will need to be registered, but the kit itself does not need a separate product listing. The same goes for products that are sold in various sizes, such as jumbo or mini sizes.
If I sell the same product in different shades, does each shade need to be registered?
Yes, the FDA has a cloning feature in the portal to make this process easier. For products that truly differ only in color or fragrance, once you’ve successfully submitted a product listing, the recommended course of action is to use the cloning feature to replicate the listing for any additional shades that are identical other than color or fragrance.
I qualify as a small business under MoCRA. What regulations am I exempt from?
Small businesses are not exempt from all MoCRA provisions, but they are exempt from product listings, facility registration, and GMP. However, there are caveats to the small business exemptions. Brands that make products that regularly come into contact with the mucus membrane of the eye (i.e., eye makeup remover, liquid or mucosal eyeliner, false eyelash adhesive) or products that are intended to alter the appearance for more than 24 hours (i.e., nail polishes, some hair products, and some eyebrow dyes) don’t qualify for the small business exemptions, even if they earn less than $1 million over three years.
Will I have to prove that I meet the small business exemption criteria to the FDA?
The FDA is not asking for companies to submit or provide a certification that they meet the exemption criteria. However, you should still have your rationale or substantiation ready and up to date. “It’s very important to have a point person in your organization to make sure to update that,” says Petillo. “A product can go viral, and your revenue can go beyond the $1 million mark quickly, and it's best to be proactive rather than reactive. Having someone continue to monitor your organization’s status would be very prudent.”
MOCRA Help Desk Contacts
According to Petillo, the FDA has been fairly quick to respond to inquiries, often replying within one to two days, as long as they are sent to the right inbox. Here’s a list of help desk contacts to keep handy as you’re working your way through the submission requirements:
If you have questions about what’s required under MoCRA, both Frey and Petillo recommend revisiting the MoCRA text for answers.
“I can’t emphasize enough that this law is relatively unique in that it’s written in English—not lawyer,” says Frey. “The text of the law is a great resource for people to go through and read because it’s pretty understandable. It can help you know exactly what you need to do and what you don't need to do. There’s a good chance you can self-serve some of your questions with the user guides, tools, and guidance docs. Spend some time with those if you’re having issues because chances are the answers are in there.”
What’s Next?
The July 1, 2024, deadline for facility registration and product listing is approaching quickly and should be the first priority for brands. Whether brands are doing it internally or working with a third party, make sure your facility is registered and your product listings are in progress. If you have any new launches between now and then or anything in your new product development pipeline, don’t forget to have it accounted for by July 1, 2024.
