Last month FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions. The purpose of the program was to provide an overview of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”). The Act imposes new reporting and registration requirements on cosmetic manufacturers. In addition, under MOCRA, cosmetic manufacturing facilities will be required to implement Good Manufacturing Practices (GMPs).
Under MOCRA, mandatory reporting will be required for serious adverse health events caused by cosmetic products. Responsible persons (i.e., manufacturers, packers, and distributors) will be required to report such events to FDA within 15 business days of learning about them. MOCRA defines serious adverse health events to include infections, incapacitation, significant disfigurement (e.g., serious rashes, second or third-degree burns, significant hair loss, or alternation of appearance), or any condition of severity that requires professional medical attention. Reports of adverse events must be accompanied by a copy of the label of the product at issue. Records related to adverse events must be maintained for six years. Responsible persons shall make these records to “authorized persons’ during inspections. FDA claims the new requirement aims to help FDA identify potential safety concerns with cosmetic products more quickly and take appropriate action to protect the public.
Cosmetic manufacturing facilities will now be required to register with FDA; existing facilities must register within one year of enactment of the Act, and new facilities must register within 60 days of first beginning cosmetics manufacture. Facilities must renew their registration biennially. Registration requirements include providing all brand names under which cosmetic products manufactured or processed in the facility are sold, a list of all cosmetic products manufactured at the facility, and for each product listed, product ingredients, including ingredients in fragrances and flavors. Manufacturers must also keep records documenting ‘adequate substantiation of safety’ providing competent and reliable evidence that products are safe for use. Further, the Act tasks FDA with establishing Good Manufacturing Practices within 2 years of MOCRA’s passage.
MOCRA also mandates the labeling of fragrance allergens for all cosmetics and ingredient labeling for professional use-only products used by salon workers. Additionally, FDA is to establish a standardized testing method for detecting asbestos in talc-containing products within 1 year of MOCRA’s enactment. MOCRA also requires the FDA to assess the use and safety of PFAS in cosmetics and to publish a report of the assessment to be by December 2025.
In addition, MOCRA 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 includes a small business exemption for businesses reporting average gross annual sales for the previous three-year period is less than $1 million. The exemption is limited to small businesses that 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. Qualifying businesses are exempt from the core provisions of MOCRA, including facility registration (Section 607) and good manufacturing practice or GMP (Section 606).
MOCRA preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. This means that cosmetic manufacturers will be subject to a uniform set of regulations across the country.