The Modernization of Cosmetics Regulation Act: A New Era of Safety and Compliance
Mar 07 2024 EXP LegalIntroduction
In today's world, where the average American uses between six to twelve cosmetic products daily - from makeup and perfumes to skincare and haircare products - the safety of these items is more crucial than ever.
Recognizing this, the MoCRA - Modernization of Cosmetics Regulation Act of 2022 (entered into force last December 29, 2023) marks a monumental step forward, representing the most significant expansion of the Food and Drug Administration's (FDA) authority over cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938.
MoCRA's introduction is a response to growing concerns over the safety of cosmetic products that are an integral part of daily life for millions. It establishes a new framework aimed at ensuring the well-being of consumers through enhanced regulatory measures, mandatory reporting, and adherence to Good Manufacturing Practices (GMP).
Key Provisions and What They Mean for Consumers and Industry
Enhanced FDA Authority: under MoCRA, the FDA gains new powers, including access to records related to a cosmetic product's safety and the authority to mandate recalls if a product is found to be adulterated or misbranded, posing serious health risks.
Mandatory Adverse Event Reporting: manufacturers, packers, or distributors - termed as "responsible persons" - are now required to report serious adverse events to the FDA within 15 business days. This includes providing product labels and any new medical information about the event within a year of the initial report. This measure aims to ensure swift action to prevent harmful products from affecting more consumers.
Facility Registration and Product Listing: facilities that manufacture or process cosmetics for distribution in the U.S. must register with the FDA and renew every two years. Responsible persons are also required to list each marketed cosmetic product, including ingredients, ensuring the FDA has a comprehensive database to monitor and regulate the market effectively.
Safety Substantiation: companies must demonstrate the safety of their products, maintaining records that support their safety claims. While specific tests are not mandated, the data used must be derived from scientifically robust methods, ensuring consumer safety is not compromised.
Good Manufacturing Practice (GMP) Requirements: MoCRA will see the introduction of GMP requirements for cosmetic product facilities, a move aimed at standardizing the quality and safety of cosmetic products. This aligns with practices across other sectors regulated by the FDA, ensuring that cosmetics are produced under conditions that prevent contamination and ensure consistency.
Exemptions for Small Businesses: recognizing the potential burden on small businesses, MoCRA includes exemptions from GMP, registration, and product listing requirements for certain small business operations. However, this exemption does not apply to products with higher risk profiles, such as those intended for internal use or that come into contact with the eye's mucus membranes.
Implications and Moving Forward
The enactment of MoCRA is a significant milestone in consumer protection and industry regulation.
For consumers, it brings the assurance that the cosmetic products they use daily are subjected to stringent safety standards and monitoring. For the industry, while it introduces new compliance requirements, it also offers a framework for ensuring product safety and quality, potentially increasing consumer trust and market stability.
Companies in the cosmetic industry must now adapt to these new regulations, ensuring their products meet the FDA's safety and reporting standards.
As these changes take effect, our law firm is here to help businesses navigate the complexities of compliance, ensuring they meet their obligations under MoCRA while continuing to innovate and serve consumers safely.
In conclusion, MoCRA represents a significant step forward in the regulation of cosmetic products, offering enhanced protection for consumers and a clear framework for industry compliance. As we move into this new era of cosmetic regulation, the emphasis on safety, transparency, and responsibility has never been more important.
For more information on MoCRA compliance and how it may affect your business, feel free to contact our legal team specialized in FDA regulatory affairs.
