The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant expansion of FDA’s authority to regulate cosmetics to help ensure the safety of cosmetic products.
This expansion will include the registration of any facility that manufactures or processes cosmetic products distributed in the United States. This registration must occur every two (2) years and gives the FDA authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences.
Additionally, this will allow the FDA to access certain records related to a cosmetic product, including safety records, and exercise recall authority in some circumstances.
The FDA hosted a webinar on MoCRA for stakeholders that is now available on YouTube. The deadline for facility registration is December 31st, 2023. Additionally, the FDA has issued a “Draft Guidance on the registration and listing of cosmetic product facilities and products.”
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