Q&A: MoCRA tames the ‘wild, wild West’ of cosmetics with impending deadline
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Key takeaways:
- The MoCRA of 2022 imposed a 2-year deadline for manufacturers to list contact information for adverse event reporting.
- Jaclyn Bellomo, MS, MBA, spoke with Healio on the importance of this topic.
The cosmetic industry is preparing for yet another rapidly approaching deadline imposed by the Modernization of Cosmetics Registration Act of 2022.
On Dec. 29, 2022, in what has been called the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938, the Consolidated Appropriations Act of 2023 was signed into law, which encompassed the Modernization of Cosmetics Registration Act of 2022 (MoCRA).
According to the Federal Register, MoCRA requires manufacturers of cosmetic products to label products intended for use only by licensed professionals and products intended for use by consumers.
MoCRA also added the requirement for cosmetic product labels to include contact information through which adverse events can be reported to the responsible person, which is defined as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label. The 2-year deadline for manufacturers to add this contact information to their products is approaching, leaving dermatologists wondering how this will affect the cosmetic landscape in the U.S.
Healio spoke with Jaclyn Bellomo, MS, MBA, director of cosmetic science and regulatory affairs at Registrar Corp, about the details and importance of MoCRA.
Healio: What is the value in MoCRA?
Bellomo: Cosmetics has been left behind in terms of regulations compared with other industries, such as food, drugs and medical devices. There hasn’t been a significant update to the regulation in over 85 years. There’s been some updates around color additives and cosmetic ingredient reviews, but nothing as dramatic and stringent as this new MoCRA regulation that has come into effect, and it’s long overdue.
It was kind of the wild, wild West for cosmetics in the U.S. for a very long time. There was never any transparency into where the products were coming from, who was responsible for them and safety requirements around any of the products until MoCRA. Now, this is in effect.
Healio: Why did the FDA decide to regulate the cosmetics field?
Bellomo: Cosmetics is a huge industry totaling about $500 billion. The U.S. is actually known for being one of the largest cosmetic markets, which is really heavily influenced by how many brands sell in the U.S. and launch in the U.S. in addition to the fact that the U.S. has a wide range of products.
For some time there has been a huge need for regulations around cosmetics in the U.S. Many states started to regulate cosmetics on their own which left too many states developing these processes, ranges and requirements. It pretty much left the FDA behind, leaving states to take on the job of the FDA. So, this is really a push to start regulating a huge industry in the U.S., ensuring the products that are being put on the shelves and used by consumers are safe.
Healio: What types of products potentially need the most regulation?
Bellomo: I think there’s a lot that happens in skin care. There are a lot of skincare products out there that promise to do a lot and might not have the necessary safety information or safety testing behind them to make sure they’re safe to use for all consumers.
People want to see results, so a lot of brands have pushed types of active ingredients in cosmetic products to their limits without 100% understanding how they would work in a post-market world where there’s millions of people using it.
We have so many beauty products from Korea, Japan and Australia, and these foreign countries that want to bring their skin care here do so without really understanding the safety requirements or the type of products they can bring into the U.S. Because of this, I think skin care is really going to have an eye-opening experience.
Healio: How are brands expected to handle the reports they will receive?
Bellomo: We have been helping a lot of brands set up processes and what we’re finding is a lot of the regulatory quality departments really don’t have that background to know exactly what they should be doing. So, there’s a lot of training, a lot of education that’s going to still have to happen.
Taking in reports of health-related events is a very niche type of skill and there’s not that many people out there that do it in cosmetics because it’s never been needed. So, there’s definitely going to be teams that are going to have to get trained.
Thankfully, cosmetics was very lucky as it is the only industry they have allowed an electronic contact for adverse events. Every other industry must have a domestic physical address or domestic phone number, which you can also have as a cosmetic company, but I’m not really sure people are writing letters and mailing letters about an adverse event.
Consumers can also call as a phone number will be manned 24/7; however, a phone call leaves it up to the consumer to disclose whatever information they want which may not be helpful. So, the electronic contact really provides a quick way to get reports that, if done right, will guide the consumer toward providing the right information.
Healio: How will this new reporting requirement help consumers?
Bellomo: I think it brings a level of confidence to the products that are sold in the U.S. Believe it or not, the U.S. is probably the highest cosmetic counterfeit country outside of China.
Think about Kylie Jenner’s line. When she launched her whole cosmetic brand, it was the No. 1 counterfeited lip kit ever in the U.S. with close to $50 million worth of goods being confiscated from one company.
Same goes for perfumes. Perfumes are very expensive, so a lot of people knock off perfumes and bring them here. However, it’s very dangerous to counterfeit perfume because allergens come into play. But now, perfumes are going to be heavily regulated under MoCRA.
So, overall, I think this new requirement builds a confidence that the products that are here have gone through the right process. And if consumers do experience a reaction or issue, they now know who to go to and how to handle it, whereas before, it was very confusing and consumers did not know what to do.
Healio: What role, if any, can dermatologists play in reporting adverse events on behalf of patients?
Bellomo: I would definitely recommend that they say something if they see trends or any type of incidental rates in patients using a certain brand or certain product over and over again. Dermatologists are the best people to advise the cosmetic industry of what to be looking out for so that we can understand a little bit more about that type of product and how it’s currently used on the market.
Reference:
- Agency information collection activities; Proposed collection; Comment request; Cosmetic labeling requirements and facility registration and cosmetic product listing program. https://www.federalregister.gov/documents/2023/05/01/2023-09178/agency-information-collection-activities-proposed-collection-comment-request-cosmetic-labeling. Published May 1, 2023. Accessed Sept. 3, 2024.
- BILLS-117hr2617enr. https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf. Updated Dec. 29, 2022. Accessed Sept. 4, 2024.
- Cosmetics & U.S. Law. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law. Updated May 2, 2024. Accessed Sept. 3, 2024.
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA). https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra. Updated Dec. 18, 2023. Accessed Sept. 3, 2024.
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