FDA recently began to crack down on compliance with the recently passed MoCRA (Modernization of Cosmetic Regulation Act) on cosmetic companies. Cosmetic companies that have evaded FDA regulations for cosmetic products may now find themselves in hot waters. Urgency to comply with FDA MoCRA regulations can trigger a sense of fear and uncertainty for many.
For the longest time, FDA has not enforced regulations for FDA required products and many have imported and sold products such as eye cosmetic products, hair and nail products. Companies are neither aware, nor find any urgency to address the FDA's newest MoCRA regulation. Due to the significant number of imported products that are not regulated by the FDA, FDA passed MoCRA on July 1, 2024. MoCRA requires cosmetic companies to meet certain requirements such as:
Facility Registration: Manufacturers and processors must register their facilities and renew every 2 years.
Product Listing: Each cosmetic product ingredient marked with the FDA must be listed by the "Responsible Person."
Responsible Person: Cosmetic manufacturer, packer, or distributor name is required to be listed on the product label.
Adverse Event Reporting: Serious adverse events must be reported by the "Responsible Person."
Recently, on June 12, 2024, FDA posted a warning letter to Landy International, a drug manufacturing facility. This warning letter from the FDA highlights "significant violations of Current Good Manufacturing Practice (CGMP) regulations) for their products (Read Full Letter Here). FDA placed the firm on "Import Alert 66-40," and Landy International must address all violations or FDA may "withhold approval of new applications or supplements to list their firm as a drug manufacturer."
FDA began investigations to ensure that cosmetic companies follow their regulations. This is not to create extra work for the cosmetic industry, but to ensure that products are safe for consumers to use. It has been long established that products manufactured overseas are not regulated and may prove to be unsafe for use.
Are you prepared for the worst? Do you know if your company requires MoCRA compliance? We can help! Let us help you navigate through the deep waters of FDA and MoCRA.
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