On the 29th December 2022, President Joe Biden signed the Modernization of Cosmetics Regulation Act 2022 (MoCRA) into US law. This is the largest overhaul of how the sale, manufacture and distribution of cosmetics are regulated on the US market since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. The FDA will still remain as the
authority to regulate cosmetic products in the US. MoCRA requirements will become effective from 29th December 2023, except the requirements pertaining to labelling requirements which will become effective from 29th December 2024.
There are 2 key roles and their definitions under MoCRA which will directly affect brands and manufacturers:
● Facility
● Responsible Person
A ‘facility’ is defined as any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the US. Therefore, any facility which is involved in the manufacturing or processing of the formulation will be defined as a facility.
Facilities exclude beauty salons, cosmetic product retailers, pharmacies, direct sellers, retail distribution facilities, hospital/healthcare clinics, public health agencies, complimentary providers of cosmetics products e.g. hotels, trade show and other venues that provide product samples, research and development facilities, establishments that perform labelling, relabelling, packaging, repackaging, holding or distribution of the product.
A ‘Responsible Person’ is defined as —
The manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of MoCRA or section 4(a) of the Fair Packaging & Labelling Act.
This means that the US Responsible Person does not need to be located within the US. If the address on the label is a non-US address, as long as the address is that of the manufacturer, packer or distributor, it will be understood that is the US Responsible Person under MoCRA.
There are 9 key elements of MoCRA:
1. Facility Registration
2. Product Listing
3. Cosmetic Labelling & Fragrance Allergens
4. Safety Substantiation
5. Adverse Events Reports & Serious Adverse Events Reporting
6. GMP
7. FDA Enforcement Authorities
8. Talc Rule & PFAs Report
9. Small Business Exemption
1. Facility Registration
Owners or operators of a “facility” (as defined above) that manufactures or processes cosmetic products for US distribution must register the facility with the FDA unless an
exemption applies. Facilities that manufacture or process cosmetic products on behalf of one or more brands, are only required to register once. The brands a facility manufactures on
behalf of will not be publicly disclosed information.
Non-US based facilities are required to appoint a local US agent to complete the facility registration. The deadline for facility registration via the FDA Cosmetics Direct platform is 29th December 2023 & all facility registrations must be renewed bi-annually. There are exemptions for small businesses detailed within section 9.
2. Product Listing
The US Responsible Person must submit a product listing via the FDA Cosmetics Direct portal for each cosmetic product marketed for sale in the US. Product listings can also be submitted via a paper form although electronic submissions are preferred by the FDA. Any registrations submitted via the Voluntary Cosmetic Registration Program (VCRP) listings will not be carried across to the new system. These registrations will need to be re-completed on FDA Cosmetics Direct.
The deadline for all product listings to be completed for products currently sold on the US
market is 29th December 2023.New products after this deadline must be submitted within 120 days of marketing the product
in the US and updates are to be submitted annually.
There are exemptions for small businesses detailed within section 9.
3. Cosmetic Labelling & Fragrance Allergens
The majority of the existing cosmetic labelling rules are to remain the same, reducing the need for any immediate label updates before 29th December 2023. Brands must ensure the address, telephone number, email address or website of the US Responsible Person is on the label. As a reminder, a US Responsible Person is the distributor, packer or manufacturer of the cosmetic product.
Products which are for professional use only must bear specific labelling from 29th December 2023. There will also be a requirement to label fragrance allergens, similar to the existing rules
within the UK & EU. The FDA are to publish the final rule on this requirement in June 2024 with deadlines for compliance expected to be 29th December 2024. It is not yet known whether the MoCRA will add provisions for the existing 26 allergens or the extended allergens list.
4. Safety Substantiation
There is a new legal requirement under MoCRA requiring the Responsible Person to ensure and maintain records supporting the “adequate substantiation” that a cosmetic product is ‘safe.’ MoCRA does not detail how to meet this requirements but is is expected the following will satisfy the requirements:
● CPSR (Cosmetic Product Safety Report) - currently required under UK & EU Regulations
● Preservative Efficacy Test Report
● Repeat Insult Patch Tests
● Ocular Irritation Tests for products specifically designed for use around the eye area
The deadline for ensuring safety substantiation under MoCRA is 29th December 2023.
5. Adverse Events & Serious Adverse Events Reporting
Under MoCRA, the Responsible Person must have a process for monitoring and handling adverse & serious adverse events. An adverse event is defined as ‘any health-related event associated with the use of a cosmetic product that is adverse.’ A serious adverse event is defined as ‘an adverse event that results in, or requires medical intervention to prevent death, a life-threatening experience, hospitalisation, a persistent or significant disability or incapacity.’ If a serious adverse event is reported, the Responsible Person must submit a serious adverse event, along with a copy of the label to FDA within 15 business days after a report is received.
Each serious adverse event report should be kept for 6 years & 3 years for small businesses as defined in section 9.
The deadline for compliance under MoCRA is 29th December 2023.
6. GMP (Good Manufacturing Practice)
MoCRA requires that industry comply with regulations that will be established by the FDA for GMP requirements for facilities that manufacture and process cosmetic products as per the definition above. The FDA are yet to establish what the acceptable GMP requirements will be.
It has not yet been confirmed whether ISO 22716 will be sufficient but it is expected that MoCRA will be consistent with international standards.
Products which have not been manufactured under GMP standards will be deemed adulterated.
The FDA are expected to issue the GMP requirements proposal by 29th December 2024 with the final regulation due to be published by 29th December 2025. There are exemptions for small businesses detailed within section 9.
7. FDA Enforcement Authorities
Under MoCRA, the FDA have increased enforcement authorities to ensure the safety of cosmetic products sold in the US.
The FDA can suspend the registration of a facility if they believe products manufactured at that facility have a reasonable probability of causing serious adverse health consequences and other products at the same facility may be affected. These facilities cannot introduce any cosmetic products to the market until its registration is reinstated.
The FDA have the authority to access records and documents relating to a cosmetic product if they reasonably believe that product or its ingredients are adulterated and present a threat of serious adverse health consequences.
However, this does not permit the FDA access to confidential formulation information, financial documents, pricing or sales data, research data. The FDA can request safety information the ingredients in fragrances and/or flavours in cosmetic products if they reasonably believe the fragrance and/or flavour contributed to a serious adverse event.
The FDA has the authority to recall a product if there is a reasonable probability that it is adulterated or misbranded and exposure to the product will cause serious adverse health consequences or death.
All brands will need to ensure a recall process is in place as well as an internal process for handling FDA inspections and how information is managed during an inspection. The FDA are able to exercise the above from 29th December 2023.
8. Talc Rule & PFAS Report
Section 3505 of MoCRA mandates the FDA to issue regulations to establish standardised testing methods for detecting asbestos in talc-containing cosmetics. This is a result of various class action lawsuits in the US regarding asbestos containing talc and ensuring the safety of cosmetic products which contain talc. The FDA are expected to issue their standardised testing method proposal by 29th
December 2023 with the final regulation due to be published by June 2024.
Section 3506 of MoCRA mandates the FDA to assess the use of per- and polygluoralkyl substances (PFAS) in cosmetic products and the scientific evidence regarding the safety of their use in cosmetics.
The FDA are expected to publish their final report by December 2025.
9. Small Business Exemption
A small business under MoCRA is defined as ‘Responsible Persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1m, adjusted for inflation, and who do not engage in the manufacturing or processing of cosmetic products.’ If a brand or facility falls within the exemption they are not required to:
● Complete a facility registration
● Complete product listings
● Comply with future GMP requirements
However, all brands and facilities must still comply with the following provisions:
● Cosmetic labelling & fragrance allergen labelling
● Safety substantiation
● Adverse events & serious adverse events process & reporting
● FDA enforcement authorities
● Future standardised testing for talc-containing products
