Cosmetic Manufacturer

What is MoCRA?

The cosmetics industry has been experiencing tremendous growth over the years, with new products and trends emerging every day. However, the regulation of cosmetics has not kept up with the pace of innovation, leading to potential health hazards and concerns. To combat this, the Modernization of Cosmetics Regulation Act of 2022 was passed to expand the FDA’s authority of regulating cosmetic products.

The Modernization of Cosmetics Regulation Act 2022 (MoCRA) is a bill introduced in Congress aimed at modernizing the regulation of cosmetics in the United States. The bill seeks to improve the safety of cosmetics by requiring manufacturers to provide the Food and Drug Administration (FDA) with more information about the ingredients they use.

Under the proposed law, MoCRA requires the following:
• Mandatory Recalls
• Adverse Event Reporting
• Facility Registration
• Product Listing
• Record-Keeping (Adverse Events and Safety Substantiation)
•Good Manufacturing Practices
• Allergen Declarations

The Modernization of Cosmetics Regulation Act 2022 would have a significant impact on the cosmetics industry. By requiring manufacturers to provide more information about their products, the bill increases transparency and accountability, ensuring that consumers have access to safe and reliable cosmetics.

The FDA, however, is making some exemptions for small businesses from GMP, facility registration, and product listing requirements. A small business is defined by the FDA as a business that has averaged less than $1,000,000 in annual gross sales in the previous three years. According to FDA’s website, exemptions do not apply to manufacturers and facilities that manufacture products that:

• frequently make contact with the eyes
• are injected
• are intended for internal use
• are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

The FDA has created a Voluntary Cosmetic Registration Program for cosmetic products but has recently closed submissions. The FDA has not yet provided the final regulations for all the requirements listed above, but MoCRA provides enough general information that should allow companies to begin the process of accustoming their operations to the new requirements.