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MoCRA - any further updates?
What is happening with MoCRA? Has the act been abandoned or has further implementation been delayed? I haven’t found any updates for a while.
We are not based in America, but we selling product there; and, trying to comply when you have no idea of what is happening is a bit hard.
Does anyone have any insight?
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4 Replies
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Yes it is happening. Some of the stuff has already been implemented.
What’s in Effect (and has been actively happening):
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Adverse Event Reporting: Companies have been required to report serious adverse events associated with their cosmetic products to the FDA since December 29, 2023.
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Facility Registration and Product Listing: Cosmetic manufacturing facilities were generally required to register with the FDA by July 1, 2024. Companies also had to list their cosmetic products, including ingredients, with the FDA by December 29, 2023, for existing products. The FDA has reported a significant increase in registrations and listings compared to the previous voluntary program, indicating widespread industry compliance with these mandatory requirements.
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Safety Substantiation: Companies must have records to support the safety of their cosmetic products.
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Mandatory Recall Authority: The FDA now has the authority to issue mandatory recalls for unsafe cosmetic products.
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Professional Use Labeling: Specific labeling requirements for cosmetic products intended for professional use became effective.
And some of the stuff has been delayed…
Where There Are Delays (and the FDA is behind schedule):
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Good Manufacturing Practices (GMPs): The FDA is mandated to establish federal regulations for GMPs for cosmetic facilities. A proposed rule for GMPs is now anticipated by October 2025, which is later than originally envisioned.
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Fragrance Allergen Labeling: Rules requiring the disclosure of certain fragrance allergens on cosmetic labels are still in development, with a proposed rule expected by January 2025 (a pushed-back timeline).
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Talc Testing for Asbestos: The FDA is mandated to establish standardized testing methods for detecting asbestos in talc-containing cosmetic products. A proposed rule for this is anticipated by December 2024, also a revised timeline.
In summary, MoCRA is very much happening, and companies are complying with the implemented requirements. However, the FDA is behind schedule on developing some of the more detailed new regulations mandated by the Act. The “DOGE cuts” and broader efforts to reduce federal staffing and regulations are likely contributing factors to these delays, as they impact the FDA’s capacity and prioritization of its many responsibilities.
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Thanks for that - it is the same as I had found. Because fragrance allergen was supposed to be next to be published - and that is now 7 months behind schedule, I was beginning to wonder if the act had been repealed; or just further delays.
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Now that our FDA has been substantially eviscerated, expect little in the way of reporting or compliance monitoring. I am RP for two brands currently and am in no hurry to update their MoCRA registrations. I would be genuinely surprised if I were contacted by anyone at FDA the next three years, even if a product was found to contain mercury or lead. My response would likely be something like “How are you, inspector? Are you OK? It’s good to know someone there is still at the office and practicing vigilance these days.”
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Thanks for your comments. It is pretty much what I suspected.
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