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
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. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days. FDA will also have access to adverse event reports during an inspection.
FDA recommends that industry responsible persons submit serious adverse event reports for cosmetics by using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF). Please submit the completed form along with information to support the report, such as scans of labels and images of the serious adverse event to FDA via email at: CosmeticAERS@fda.hhs.gov or by mail to:
FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics.
Facility Registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years.
Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
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.
MoCRA also requires that industry comply with regulations that FDA will establish for:
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:
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
FDA hosted 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 a public listening session on good manufacturing practices (GMPs).
Inquiries about MoCRA can be directed to QuestionsAboutMoCRA@fda.hhs.gov.
