Navigating FDA MoCRA Compliance for Cosmetic Businesses

Understanding MoCRA and Its Impact
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, marks the most significant update to U.S. cosmetic regulations since 1938. With MoCRA, the Food and Drug Administration (FDA) now has expanded authority over cosmetic manufacturers, importers, and distributors. The act introduces stricter requirements for product safety, facility registration, and ingredient transparency. For businesses in the cosmetics industry, compliance with MoCRA is not optional—it is a legal obligation that ensures consumer trust and product credibility in a rapidly growing global market.

Facility Registration and Product Listing
One of the primary elements of MoCRA is the requirement for all cosmetic manufacturing facilities to register with the FDA. In addition, companies must list each cosmetic product they market, including details about ingredients and responsible persons. This new system of accountability ensures that the FDA can monitor products more effectively and respond quickly to safety concerns. Businesses that fail to register or maintain accurate product listings risk penalties and potential removal of products from the market, highlighting the importance of proper compliance planning.

Safety Substantiation and Adverse Event Reporting
Under MoCRA, companies must ensure that their cosmetic products are safe for consumer use when applied under normal or customary conditions. This requires maintaining safety substantiation records based on scientific evidence, testing, or reliable expert FDA MoCRA compliance evaluations. Moreover, the act mandates that companies report serious adverse events associated with their products within 15 business days. These measures are designed to enhance consumer safety while holding companies accountable for the quality and safety of their formulations.

Labeling and Ingredient Transparency
Transparency is a cornerstone of MoCRA, particularly regarding labeling requirements. Products must display clear ingredient lists, warnings, and contact details for consumers to report issues. Certain allergens and fragrance ingredients must also be disclosed, reducing the risk of consumer harm. This emphasis on transparency not only benefits consumers but also enhances brand reputation, as customers are increasingly drawn to companies that prioritize honesty and safety in their product labeling practices.

Steps Toward Effective Compliance
To achieve full compliance with MoCRA, businesses should begin with a thorough review of their current manufacturing practices, product safety documentation, and labeling processes. Partnering with regulatory consultants or legal advisors may be necessary to navigate complex requirements. Implementing robust internal systems for safety testing, adverse event tracking, and ingredient disclosure will also ensure smooth alignment with the new regulations. Ultimately, MoCRA compliance provides more than just regulatory approval—it builds consumer confidence and strengthens long-term market presence.