January 25, 2023
On December 29, 2022, The president signed a new law: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA will issue related guidance and final rules on specific compliance dates.
Under the new FDA Cosmetic Regulations MoCRA, it requires the labeling to include warning statements for products, prohibitions for use pertaining to specific ingredients and the responsible person's contact information.
Regulatory Requirement | Effective Date |
Serious Adverse Event Reporting | December 29, 2023 |
Good Manufacturing Practices | December 29, 2025 |
Facility Registration | December 29, 2023 |
Product Listing | December 29, 2023 |
Safety Substantiation | December 29, 2023 |
Labeling to include a way to report adverse events | December 29, 2024 |
Labeling of Fragrance Allergens | Rules must be finalized 180 days after the public comment period ends. |
Mandatory Recall Authority | December 29, 2023 |
MoCRA Requirements
- Facility Registration: Mandatory Facility Registration must be renewed biennially. New facilities must register with the FDA within 60 days of initiating manufacturing or processing operations.
** Note: Foreign Facility must have a U.S. Agent.
- Product Listing: The cosmetic manufacturer, packer, or distributor must submit the product listing within 120 days of marketing and must update product listing information annually.
- Safety Substantiation: Must ensure and maintain records or evidence or information of adequate substantiation of safety. (tests or studies, research, analyses, etc)
- Labeling: Must include a domestic address, domestic phone number, or electronic contact information, for reporting a cosmetic adverse event must be on the product label.
- Adverse Event Reporting: Must submit a copy of the label or retail packaging of the cosmetic product and serious adverse event report to the FDA within 15 business days after it is received.
FDA Enforcement Authorities
- GMP (Good Manufacturing Practices): The new regulations will require to maintain records of any health-related adverse events for 3 years of using products.
- Recall: if the FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded, and that it may cause serious adverse health consequences or death, the FDA may provide the responsible person with an opportunity to voluntarily recall the cosmetic.
- Small business Exemptions:
Small businesses with less than one million dollars in sales over the previous three years are exempt from the regulations unless they manufacture:
Cosmetic products that regularly come into contact with the mucus membrane of the eye under customary or usual use.
Cosmetic products that are injected.
Cosmetic products that are intended for internal use.
Cosmetic products that are intended to alter the appearance for more than 24 hours do not require the consumer to remove them under usual and customary conditions of use.
Others
- Talc and PFAS: the FDA will issue a standardized test method for detecting asbestos in talc-containing products.
- Animal Testing: the FDA will not adopt specific requirements for animal testing. However, Animal testing should not be used for the purpose of safety testing on cosmetic products.
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