Major Cosmetic Regulation Update
March 27, 2023 – FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program
FDA issued an update today stating that they are no longer accepting voluntary cosmetic establishment registration and that information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.
Original Post
Most Americans know that Congress passed and the President signed a huge appropriations bill at the end of 2022. The law includes sections affecting departments, agencies, and functions such as Homeland Security, EPA, the military, Departments of State, Labor, Education, Transportation, and more. Part of the ‘and more’ is Section E that modernizes cosmetic regulations (contact us for a PDF of section E).
For decades, FDA Cosmetic Regulations required minimal labeling, warning statements for a handful of products, and included prohibitions on the use of a few ingredients and sections on the voluntary registration of cosmetic facilities and voluntary filing of cosmetic ingredient statements. (21 CFR 700, 701, 710, 720 and 740). Section E of the Consolidated Appropriations Act, 2023, includes many new requirements for the cosmetic industry. Many of these provisions require FDA to write new regulations and most become effective December 29, 2023, as summarized in the table below.
Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
| Regulatory Requirement | Comments | Effective Date |
|---|---|---|
| Serious Adverse Event Reporting | New for cosmetics; perhaps FDA will make use of the system used for dietary supplement due to the short timeline for implementation. | December 29, 2023 |
| Good Manufacturing Practices | Rules must be proposed by FDA within 2 years | December 29, 2025 |
| Facility Registration | New requirement although a voluntary system was initiated in 1974. | December 29, 2023 |
| Product Listing | New requirement that includes listing of ingredients. A voluntary system was initiated in 1974. | December 29, 2023 |
| Safety Substantiation | While regulations have always required that products introduced be safe, this is a major change. Compliance will likely be difficult for many companies. | December 29, 2023 |
| Labeling to include a way to report adverse events | A domestic address, domestic phone number, or electronic contact information, for reporting a cosmetic adverse event must be on the product label. | December 29, 2024 |
| Labeling of Fragrance Allergens | FDA must propose rules for public comment by June 29, 2024. The law requires consideration of similar programs and specifically notes “the substance and format of requirements in the European Union”. | Rules must be finalized 180 days after the public comment period ends. |
| Mandatory Recall Authority | FDA will be able to require market removal of cosmetics that have a reasonable probability of causing serious adverse health consequences or death. |
December 29, 2023 |
Talc and PFAS
The new regulations also require FDA to propose regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Similarly, FDA must assess the use of perfluoroalkyl and polyfluoroalkyl (PFAS) substances in cosmetic products as well as the scientific evidence regarding the safety and risks associated with such use. FDA’s PFAS report is due by December 29, 2025.
Animal Testing
Interestingly, the law includes this statement, “It is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances”.
Some Curious Inclusions
There are some fascinating tidbits in a section of the law on small business exemption. Small business 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 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 appearance for more than 24 hours that do not require the consumer to remove them under usual and customary conditions of use.
In my opinion, the list above indicates a bit of ignorance on the part of those that drafted the legislation, since products used in direct contact with the eye’s mucus membranes, or that are injected or intended for internal use are either medical devices or drugs and not cosmetics.
Funding
The law also authorizes appropriations to support its required implementation and enforcement:
- $14,200,000 for fiscal year 2023
- $25,960,000 for fiscal year 2024
- $41,890,000 for fiscal years 2025 – 2027
Next Steps
It is imperative that cosmetic companies start now with a few important steps:
- Evaluate their manufacturing practices. This FDA checklist is a great place to start.
- Evaluate the safety information they have on their ingredients and cosmetics. Consider assessing the potential risks of various ingredients in order to prioritize the project. A few guidelines may be found here and in 21 CFR 700.
- Review FDA’s voluntary program for cosmetic registration and listing.
- Contact the team at FDA Compliance Simplified for help.
