FDA Issues First MoCRA Warning Letter

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 represents a significant shift in how cosmetics are regulated in the United States. On June 12, 2024, the FDA issued a warning letter to Landy International, a pharmaceutical manufacturer with products that fall under the cosmetics category. The letter highlighted violations of Current Good Manufacturing Practice (CGMP) regulations and emphasized that MoCRA applies to Landy International’s cosmetic products. This incident serves as an important reminder for the entire cosmetics industry about the critical need to comply with MoCRA.

The FDA Warning letter, which essentially addresses CGMP violations related to Landy International's drug manufacturing, mentions MoCRA, which is particularly significant. It highlights the fact that even companies not exclusively focused on cosmetics must understand MoCRA's regulations if their products qualify as "cosmetic products" under FDA’s definition. The definition, found in 21 U.S.C. § 364(2) , defines a cosmetic product as "a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product". The definition covers a wide array of products, such as makeup, skincare, lotions, and shampoos, commonly found in the health and beauty sections.

Consequently, the Landy case serves as a warning for the cosmetics industry, emphasizing the need for proactive compliance with MoCRA to prevent regulatory issues, which may end up with a Warning Letter. MoCRA introduces a new phase in cosmetics regulation. By staying informed and ensuring compliance, companies can better secure their success in the constantly changing beauty market.

How Quantum Can Help

Since 1992 Quantum Analytics Group has been supporting cosmetics, beauty, and personal care product manufactures with testing and consulting services. Our services include consulting on cGMP standards and practices, product testing services to support quality and release testing, label reviews, quality audit support, and more.

Quantum provides comprehensive analytical testing in support of personal care products, cosmetics, beauty products, and consumer products. These include the testing of ingredients,raw materials, in-process samples and finished products.

Read the FDA Warning Letter

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