The FDA explains in this article the backgrounds and impacts of MoCRA:
Background on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Most American consumers use cosmetic products every day. On average people use 6 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 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.
Adverse Event: any health-related event associated with the use of a cosmetic product that is adverse
Facility: any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States
Responsible Person: 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
Serious Adverse Event: an adverse event that
- (A) results in:
- a life-threatening experience;
- inpatient hospitalization;
- a persistent or significant disability or incapacity;
- a congenital anomaly or birth defect;
- an infection; or
- significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or
- (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.
MoCRA provides new authorities to FDA including:
Records Access: If certain conditions are met, 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, 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 United States to FDA within 15 business days, along with a copy of the label on or within the retail packaging of such cosmetic product, after receiving the report and certain additional information, such as new medical information, within 1 year of the initial report. FDA will also have access to adverse event reports during an inspection.
FDA is developing a process for submitting mandatory adverse event reports for cosmetics. Currently, we encourage electronic reporting through the Safety Reporting Portal (SRP). To access the portal, please request an SRP account by emailing email@example.com. (See FDA Adverse Event Reporting System (FAERS) Electronic Submissions for additional details).
Facility Registration: Manufacturers and processors must register their facilities with 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 United States 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 United States cosmetic products from the facility.
Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
FDA issued draft guidance below on cosmetic product facility registrations and product listings, as mandated by MoCRA. When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA.
- Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
- FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.
- A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is 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 data used to support the safety are derived from scientifically robust methods.
- For more resources on cosmetics safety substantiation, please visit Product Testing of Cosmetics.
MoCRA also requires that industry comply with regulations that FDA will establish for:
- Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products. For more information, please visit:
- Fragrance allergen labeling requirements.
- Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products
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.