Modernization of the Cosmetic Regulation Act of 2022 (MOCRA) has been signed into law as part of the inclusion of the Consolidated Appropriation Act by President Biden on 29 December 2022.
This is the most significant update of the US Federal Food, Drug and Cosmetic Act (FDCA) since its introduction in 1938.
MOCRA includes new provisions for cosmetic products. It enhances the Food and Drug Administration (FDA) regulatory jurisdiction and enforcement of cosmetics by granting the FDA authority to order a mandatory recall of a cosmetic product, and access to company and cosmetic product dossiers.
Our regulatory experts have reviewed this new law, and we present below the main anticipated changes and upcoming deadlines!
MOCRA’S KEY PROVISIONS
MOCRA introduces new provisions, including for cosmetic company registration, product listing, record keeping, adverse events reporting, safety substantiation, Good Manufacturing Practices (GMP), and recalls. All of these changes are set out in sections 605-611 of this law.
- Section 605 – Serious Adverse Event Reporting and Record keeping
Manufacturers need to submit a report to the FDA within 15 days in the case of a “serious adverse event”. Additionally, for one year after the initial submission, the responsible person must submit to FDA within 15 business days of receipt any new and material medical information related to the initial report.
The responsible person must maintain records related to each report of an adverse event associated with the domestic use of a cosmetic product for six years. Certain small businesses only have to maintain such records for a period of three years.
- Section 606 – Good Manufacturing Practices (GMP)
MOCRA requires the FDA to establish GMP’s to protect public health and ensure that cosmetic products are not adulterated. The FDA is required to promulgate a proposed rule for GMP’s for cosmetic manufacturing and processing facilities by December 2024. By December 2025, the final rule for GMP’s will be published, including simplified GMP requirements or longer compliance timelines for small businesses.
Furthermore, the FDA may promulgate regulations that would allow the Agency to inspect records necessary to demonstrate compliance with GMP.
- Section 607 – Facility Registration and Product Listing
MOCRA requires the registration of existing facilities that manufacture or process cosmetics for distribution in the United States by 29 December 2023. For new facilities, registration is mandatory within 60 days of the start of the activity.
Facilities that solely perform labelling, relabelling, packaging, or repackaging of cosmetic products are not required to register with the FDA. The same applies for facilities that only manufacture ingredients and not finished products, and facilities with the sole purpose of carrying out research and development activities.
The responsible person must also list each cosmetic product, including its ingredients, with the FDA no later than December 29, 2023. A flexible system must allow for the grouping of different versions of the same product in a single submission.
For products placed on the market after 29 December 2023, the responsible person must submit the product listing within 120 days of the market placement. Additionally, the responsible person must update product listing information annually.
- Section 608 – Safety Substantiation
A responsible person must ensure and maintain records supporting that there is adequate substantiation of safety of the cosmetic product.
- Section 609 – Labelling Requirements
Cosmetic product labels must include a national address and national telephone number or electronic contact details (which may include a website), through which the responsible person can receive an adverse event report concerning a cosmetic product.
The labelling of cosmetic products for professional use must include a clear and visible statement indicating that the product is administered or used only by authorised professionals and complies with existing labelling requirements for cosmetic products.
Fragrance allergens, based on the list that will be proposed by the FDA no later than June 2024, will also have to appear on the label according to their application type criteria and concentration level in the finished product. We expect the allergen labelling rules to be the same as those applicable in Europe.
- Section 610 – Cosmetic Products Dossiers
If the FDA determines with reasonable probability, that a cosmetic is adulterated or misbranded, it can access the cosmetic product dossier.
- Section 611 – Mandatory Recall
MOCRA grants the FDA the authority to request a voluntary recall of a cosmetic product if the Agency determines that there is a reasonable probability that the product is adulterated or misbranded, and the use of, or exposure to the product, will cause serious adverse health consequences or death. If the responsible person does not comply with the FDA’s request, the FDA can order a mandatory recall after providing the responsible person an opportunity for an informal hearing.
GET READY FOR THE NEXT DEADLINES !
MOCRA is the culmination of more than a decade of negotiations and effort. The passage of MOCRA will help to ensure the safety of cosmetic products and increase consumer trust in products that are a part of daily life.
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