On the 29th December 2022, President Joe Biden signed the Modernisation of CosmeticsRegulation 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 FederalFood, Drug, and Cosmetic (FD&C) Act was passed in 1938.There have been various interpretations of MoCRA as the FDA tries to clarify the requirements and application. This article will go through some common MoCRA misinformation which has been circulating to help cosmetic manufacturers, suppliers and brands focus on correctly complying ahead of the 29th December 2023 deadline.
Myth 1
Cosmetic product labels do not need to be updated by 29th December 2023 to show a USResponsible Person before they can be sold and distributed on the US market. The definition of a Responsible Person in MoCRA is ‘he 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) or the Fair Packaging & Labelling Act.’ The definition does not state that the Responsible Person needs to be based in the US. The name & address on the label will be understood to be the ‘Responsible Person’ as long as it is a manufacturer, packer or distributor.
Myth 2
To fall within the scope of a small business under MoCRA a business must meet the following definition: ‘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 do not engage in the manufacturing or processing of cosmetic products.
MoCRA has 3 main provisions small businesses do not need to comply with. These are product listing, facility registration and future GMP requirements. Small businesses must still comply with other elements of MoCRA such as compliant cosmetic product labelling, adequate safety substantiation and having a process for monitoring and reporting adverse and serious adverse events.
Myth 3
MoCRA does not specify that the UK & EU Cosmetic Product Safety Report (CPSR) is also required in the US. However, industry thinking is that the following will be sufficient:
Myth 4
All cosmetic products currently sold on the US market must complete their product listing by 29th December 2023 on the FDA Cosmetics Direct portal. Any new cosmetic products sold on the US market after this date have 120 days to complete their product listing.
Myth 5
All facilities will need to register on the FDA Cosmetics Direct portal by 29th December 2023 if they manufacture or process cosmetic products for distribution and sale in the US. Prior to this they will need to obtain an FEI FDA Establishment Identifier) which will be required to be entered when completing the facility registration within FDA Cosmetics Direct. The FEI can be obtained from http://www.access data.fda.gov/scripts/FEI portal/index.cam?action=portal.login
Myth 6
The definition of a Responsible Person in MoCRA is "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) or the Fair Packaging & Labelling Act." The definition does not state that the Responsible Person needs to be based in the US.The name & address on the label will be understood to be the "Responsible Person" as long as it is a manufacturer, packer or distributor.
Myth 7
Non-US based facilities who manufacture or process cosmetic products which are sold and distributed on the US market must complete a facility registration. Non-US based facilities will need to appoint a US Agent to help with the registration. All facilities, US and non-US based will be subject to FDA inspections and enforcements if they are manufacturing and processing cosmetic products sold and distributed in the US.
Myth 8
The product listing can only be completed once and this can only be completed by the Responsible Person.Facilities who manufacture or process cosmetic products which are sold and distributed on the US market must indicate the brands and categories of products they manufacture and/or process. However, this does not constitute a product listing and would not fulfil the requirements laid out in MoCRA. If a facility is also a brand’s Responsible Person, they will be able to complete product listings by going through the product listing process within FDA Cosmetics Direct.
Myth 9
Cosmetic products currently sold in the US do not require allergens to be listed on the ingredients list. Allergens are also not required to be listed on the ingredients list from 29th December 2023.In June 2024, the FDA will issue a notice of proposed rule making regarding the inclusion of fragrance allergens on cosmetic product labels. It is not yet known whether this will include the extended fragrance allergens, an EU regulatory update which was published in July2023. Compliant labels including the FDA’s requirements on fragrance allergen listing will need to be in place from 29th December 2024.
Myth 10
The FDA stopped accepting and processing electronic and paper submissions to the Voluntary Cosmetic Registration Program (VCRP) for cosmetic facilities and products on 27th March 2023. Registrations submitted on VCRP will not be transferred over to the new portal, FDA Cosmetics Direct. All existing cosmetic products will need to be re-listed on the new FDA Cosmetics Direct portal by 29th December 2023.
Myth 11
FDA Cosmetics Direct only requires the INCI list to be submitted, with no quantitative information shared. FDA Cosmetics Direct will also ask if the product contains a fragrance, flavour or both but it will not ask for the exact percentage concentration. This is unlike the UK and EU where exact percentage concentrations must be submitted for certain ingredients.
Myth 12
Product listings will not be publicly available. Nor will the brands a facility manufactures or process cosmetic products on behalf of. The FDA intends to make relevant Information from cosmetic product facility registration and listings available to the public to the extent permitted by the law. It is not known yet exactly which part of the facility registration or product listing will be made publicly available, how to access this information or who can access this information.
Myth 13
Submitting serious adverse events information and product labels to the FDA is the responsibility of the Responsible Person under MoCRA. There is no requirement in MoCRA for a brand or facility to employ a medical doctor to perform the duties of a Responsible Person.
Myth 14
A cosmetic that is also a drug, e.g. an OTC product is not subject to product listing on FDA Cosmetics Direct.
A facility which manufactures cosmetic products that are also drugs are not subject to facility registration on FDA Cosmetics Direct. For example, a manufacturer who only produces SPF products will not be subject to facility registration under MoCRA. However, if that facility also manufactures and processes cosmetic products which are not also drugs, that facility will besubject to facility registration for example, the facility manufactures SPF products and regular cosmetic moisturiser.
