For the first time since the passage of the Food, Drug and Cosmetic Act in 1938, the Federal cosmetics law has been substantially updated with the passage of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”). Although large portions of the Act are still to be defined by forthcoming FDA Guidance and findings, broadly speaking, MOCRA requires additional reporting and labeling requirements from cosmetic manufacturers. Specifically, the Act requires:

1. Mandatory reporting by manufacturers of serious adverse health events caused by cosmetic products within 15 days of notification. (An adverse health event is defined as: death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement or an event requiring medical intervention to prevent the health outcomes listed above);
2. Cosmetic facilities to register with the FDA, and provide a list of products and product ingredients, including ingredients in fragrance and flavors;
3. Manufacturers to keep records showing safety substantiation of a product; and
4. Labeling of fragrance allergens for all cosmetics and labeling of ingredients in professional use-only products used by salon workers.

MOCRA also tasks FDA with providing additional standards and protocols for manufacturers. Specifically, the FDA is to:

• Establish Good Manufacturing Practices that all manufacturers will be required to follow (within 2 years from MOCRA passage);
• Establish a standardized testing method for detecting asbestos in talc-containing products (within 1 year from MOCRA passage); and
• Assess the use and safety of PFAS chemicals in cosmetics (report of assessment to be published within 3 years of MOCRA passage).

MOCRA also allows FDA to request records related to a product’s safety substantiation and ingredients and request a mandatory recall of products that are misbranded and/or adulterated.

MOCRA also preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting or safety substantiation.

Lastly, small business are exempt from MOCRA provided that their average gross annual sales for the previous three-year period is less than $1 million and they do not make cosmetics that come in contact with eye mucus membranes; are injected; intended for internal use; or alter the appearance for more than 24 hours.

MOCRA’s provisions bring the regulation of cosmetics more in line with the FDA’s oversight of medical products such as pharmaceuticals, biologics and medical devices. In light of these sweeping changes to FDA’s regulatory framework for cosmetics, manufacturers must take immediate steps to implement or update their adverse event protocols, policies and procedures and ensure the safety of their cosmetics are adequately substantiated, as both requirements come into effect at the end of 2023.