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First Warning Letter Mentioning MoCRA Has Been Issued


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The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 represents a significant shift in how cosmetics are regulated in the United States. Recently, the FDA issued a warning letter to Landy International, a drug manufacturer, citing violations of Current Good Manufacturing Practice (CGMP) regulations. Notably, the letter also highlights the applicability of MoCRA to some of Landy International's products. This incident serves as a crucial reminder for the entire cosmetics industry of the importance of MoCRA compliance.


The Significance of the First Warning Letter Mentioning MoCRA


While the FDA's warning letter primarily focuses on CGMP violations for Landy International's drug manufacturing, the mention of MoCRA carries significant weight. It underscores that even companies not solely focused on cosmetics need to be aware of MoCRA's regulations if their products fall under the definition of a "cosmetic product."

The FDA website defines a "cosmetic product" as "a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product" (21 U.S.C. § 364(2)). This broad definition encompasses a wide range of products typically found in the health and beauty section, from makeup and skincare to lotions and shampoos.

Therefore, the Landy case serves as a cautionary tale for the entire cosmetics industry. It emphasizes the need for proactive compliance with MoCRA to avoid potential regulatory issues.


MoCRA represents a new era for cosmetics regulation. By staying informed and taking proactive steps to comply, companies can ensure they are well-positioned for continued success in the evolving beauty landscape. Remember, prioritizing safety and consumer trust is not just a regulatory requirement, it's a core value that will ultimately benefit your business.


Provision Consulting Group: Your Partner in MoCRA Compliance

Provision Consulting Group offers end-to-end solutions for navigating MoCRA compliance.  From facility registration to label reviews and ensuring cGMP adherence, we provide A-Z comprehensive guidance for cosmetic companies. As a professional FDA regulatory consulting firm, we are your ideal partner for manufacturers producing both drugs and cosmetics, helping them navigate and comply with the distinct GMP standards for each.




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