Modernization of Cosmetics Regulation Act of 2022
Background on Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Most American consumers use cosmetic products every day. On average people use six to 12 cosmetics products daily. Examples of some of these products include makeup, nail polishes, shaving cream and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.
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. This new law will help ensure the safety of cosmetic products many consumers use daily.
MoCRA provides new authorities to the FDA including:
Records Access: If certain conditions are met, the FDA can access and copy certain records related to a cosmetic product, including safety records.
Mandatory Recall Authority: If the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, the FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.
MoCRA establishes the following new requirements for industry:
- Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to the FDA within 15 business days after receiving the report and certain additional information, such as new medical information, within one year of the initial report. The FDA will also have access to adverse event reports during an inspection.
- Facility Registration: 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 U.S. has a reasonable probability of causing serious adverse health consequences or death to humans, and 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 a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the U.S. cosmetic products from the facility.
- Product Listing: A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
- Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.
MoCRA also requires that industry comply with regulations that will be established by the FDA for:
- Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products.
- Fragrance allergen labeling requirements.
- Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
Exemptions
MoCRA exempts certain small businesses from GMP, registration, and product listing requirements.
However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
Voluntary Cosmetic Registration Program (VCRP)
We stopped accepting and processing submissions to the voluntary registration program for cosmetics establishments and products. The FDA is developing a program for submission of the facility registrations and product listings mandated by MoCRA and will provide further updates on its forthcoming availability.
MoCRA Webinar
FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions in April 2023. This stakeholder webinar provides an overview of the Modernization of Cosmetics Regulation Act of 2022. It outlines the requirements mandated by the act and the current steps FDA is taking to implement the requirements, including an update on the Voluntary Cosmetic Reporting Program, and information about an upcoming public listening session on good manufacturing practices (GMPs).
Meetings
Inquiries about MoCRA can be directed to [email protected].
Responsible person means 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 the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.