The Modernization of Cosmetics Regulatory Act (MoCRA), which was widely anticipated, was signed into law on December 29, 2022, ushering in increased regulatory monitoring of cosmetic facilities and products. The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 established the existing regulatory framework for cosmetics, although MoCRA makes substantial revisions to that structure.
MoCRA’s key provisions are as follows:
1. Facility Registration
A new facility must register with the US FDA within 60 days of marketing a product or 60 days after the registration deadline, whichever is later, and all currently operating facilities that manufacture cosmetics must do so no later than one year (01) after the enactment of MoCRA, or on December 29th, 2023. Every two (02) years, facility registrations must be renewed.
2. Product Listing
By December 29th, 2023, each cosmetic product, together with its contents, must be registered with the US FDA by a "responsible person (RP)" (the producer, packer, or distributor whose name is on the label).
Once a product is marketed after MoCRA is in effect, a Responsible Person (RP) has 120 days to submit the product listing. Also, the RP must yearly update the information on the product listings.
3. Cosmetic Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMPs) that are compliant with national, and international standards will be enforced at facilities. GMP aims to safeguard the public health and guarantee that cosmetic items aren't adulterated. The US FDA will be able to examine facilities and have access to information as needed to confirm compliance with GMP set by the FDA. Currently, the FDA has two (02) years from the enactment, to publish a Notice of Proposed Rulemaking for the Cosmetic GMP, with the final ruling not later than three (03) years after enactment.
A domestic address, domestic phone number, or electronic contact details where an RP may receive the adverse event reports are now required.
The MoCRA also requires that fragrance allergens be labelled. The US FDA is required to publish the list of fragrance allergens within 18 months of the law's enactment, and the final decision must be made no later than 180 days after the public comment period has ended.
Professionally used cosmetics must be labeled to indicate a clear and prominent statement that the product is administered or used only by licensed professionals and conforms with the existing cosmetic labeling requirements.
5. Adverse Event Reporting
Any "serious adverse event" connected to the use of a cosmetic product must be reported by an RP to the US FDA within 15 business days of receiving it. Moreover, for a period of one (01) year following the original submission, the RP is required to send to the FDA any new significant medical information pertaining to the initial report within 15 business days of receiving it.
For a period of six (06) years, the RP is required to maintain record of each report of an adverse event connected to the domestic use of a cosmetic product. Only certain small businesses must maintain such records for a period of three (03) years.
6. Safety Substantiation
The RP should ensure the ingredients and the intended use of the product is safe. It is the responsibility of the RP to keep adequate safety substantiation of their products, or to evaluate the product safety by a qualified expert.
Products with no safety substantiation would be considered as misbranded and adulterated products.
The US FDA now has the authority to in-person audit all kinds of records related to the product if they believe the product or ingredients used in it would pose any serious health issues or adverse events.
8. Mandatory Recall Authority
If the US FDA determines that there is a reasonable probability that the cosmetic is adulterated or misbranded and or in case of serious adverse health consequences or death, the US FDA will order the RP to voluntarily cease its distribution, or they will recall it.
9. Small Businesses
Any business whose average gross annual sales of cosmetic products for the previous three years period is less than $ 1 Million, in the US, adjusted for inflation, and who does not engage in the manufacturing or processing of the cosmetic products described below, shall be considered small businesses and they are exempted from GMP, Facility Registration, and Product Listing.
- Cosmetic products that regularly come in contact with the mucus membrane of the eye under conditions of use that are customary or usual
- 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 under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual
10. Talc Containing Cosmetics
The US FDA must issue the proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products before one (01) year of enactment, no later than 180 days after the date on which the public comment period on the proposed regulations closes.
11. PFAS in Cosmetics
The US FDA must assess and provide scientific evidence on the safety and use of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) in cosmetic products not later than three (03) years after the enactment of this act.
With the changing regulations, it can be challenging for the manufacturer to comply with the regulations. Consult a Regulatory partner like Freyr for Region specific cosmetic Regulatory support.