FDA discusses MoCRA registration deadline and major authority expansion since 1938

01 Jul 2024 --- The US beauty sector sees a significant shift with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), marking the “most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug and Cosmetic (FD&C) Act was passed in 1938.” 

The legislation mandates new registration and listing requirements for cosmetic manufacturers, aiming to bolster consumer safety and product transparency across the industry. With the initial compliance deadline set and an extension granted last November, businesses are navigating steps to align with these stringent guidelines.

Personal Care Insights speaks with the FDA to learn how cosmetic companies can ensure compliance with MoCRA, given that businesses must now register with the agency.

What are the key requirements of the upcoming MoCRA registration and listing regulation that cosmetic businesses must comply with?
FDA: The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug and Cosmetic (FD&C) Act was passed in 1938. 

Manufacturers and processors must register their facilities with the FDA and renew their registration every two years. FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the US has a reasonable probability of causing serious adverse health consequences or death to humans. The agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is prohibited to distribute or sell (or otherwise introduce or deliver into commerce) US cosmetic products from the facility.

Regarding listing, a responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually. Responsible person means the manufacturer, packer or distributor of a cosmetic product whose name appears on the label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Cosmetic businesses must act swiftly to meet the extended compliance deadlines under MoCRA to avoid regulatory repercussions.MoCRA exempts certain small businesses from facility registration and product listing requirements. However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

• Products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer are not part of such conditions of use. 
• Exemptions also exist for certain products and facilities subject to drug and device requirements.

Can you describe the biggest modifications made by MoCRA in contrast to earlier rules?
FDA: MoCRA provides new authorities to the FDA, directs the FDA to issue certain regulations, and establishes new industry requirements. Before MoCRA:

• Under the law, manufacturers were not required to register their cosmetic establishments or file product formulations with the FDA.
• FDA did not have mandatory recall authority for cosmetics.
• FDA published recommendations in a draft guidance for cosmetic Good Manufacturing Practices (GMPs). Under MoCRA, the FDA will establish by regulation Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products. A final rule for GMPs will specify the date upon which the industry must comply with the rule.
• Adverse event reporting (including serious adverse events) was voluntary. 

For safety substantiation, under US law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is certain color additives, which must be approved for their intended use. Companies and individuals who market cosmetics are responsible for ensuring their products’ safety. MoCRA does not change this requirement, however, under MoCRA, a responsible person is now required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all the data used to support safety is derived from scientifically robust methods.

What steps should cosmetic businesses take now to meet the MoCRA registration and listing compliance deadline?
FDA: We do not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements. In addition, we do not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.

MoCRA introduces changes in regulating cosmetic products, emphasizing safety and accountability.FDA is using the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. Requests for issuance of FEI numbers associated with registration for cosmetic product facilities are typically processed in 7 to 10 business days. A facility previously assigned an FEI number in connection with other businesses with the FDA should use the same FEI number and not request a new FEI. 

If your entity does not have an FEI number assigned by the FDA, send a request to feiportal@fda.hhs.gov and provide the following information: 

• Legal firm name 
• Any alternate firm names, including those used for “doing business as” purposes 
• Physical address 
• Designated mailing address 
• Name and contact information of the designated contact person 
• A comprehensive list of activities conducted at this location (e.g., drug manufacturing, food packaging, etc.) 
• Any registration numbers associated with other FDA Center(s), if applicable 
• Any former names the firm was known by 
• Any previous addresses linked to the firm 

Are there any common pitfalls that businesses should be especially aware of?
FDA: On June 13, 2024, the FDA reminded the industry of the resources available to help firms comply with the new registration and listing requirements at the Deadline for Registration and Listing of Cosmetic Product Facilities and Products: What Does the Deadline Mean to You, and How is FDA Helping You Comply?

How will the FDA support cosmetic businesses in the transition to comply with MoCRA?
FDA: Businesses should follow our social media handle, @FDACosmetics on X (formerly Twitter) and subscribe to email updates at the Cosmetics News & Events | FDA Web page to stay up to date as we continue to make more announcements related to MoCRA.

By Venya Patel