The FDA regulation of cosmetic products is designed to protect public health and ensure that consumers have access to safe and accurately labeled cosmetic products. In December 2022, Congress passed the Modernization of Cosmetic Regulation Act (MoCRA). MoCRA is the first significant expansion of the FDA’s authority to regulate cosmetics since the establishment of its regulatory framework in 1938 through the Federal Food, Drug, and Cosmetic (FD&C) Act.
Who Does MoCRA Impact?
MoCRA establishes new FDA enforcement authority and new requirements which apply to cosmetic companies, manufacturers, distributors of finished products, and others in the distribution chain.
What Are the New Federal Requirements Under MoCRA?
MoCRA imposes new federal requirements regarding product safety, reporting, and documentation. These include new provisions in MoCRA such as:
- New Requirements for Cosmetics
- Section 605: Adverse Event Recordkeeping and Mandatory Serious Adverse Event Reporting:
Manufacturers must track and report adverse events and serious adverse events associated with cosmetic products
- Section 607: Facility Registration and Product/Ingredient Listing:
Every facility that engages in the manufacturing or processing of cosmetics for sale in the U.S. must be registered with the FDA.
- Section 608: Safety Substantiation:
Manufacturers are required to demonstrate adequate substantiation of the safety of a cosmetic product by way of evidence provided by research, analyses, or other scientific evidence
- Section 609: Cosmetic Labeling and Fragrance Allergen Transparency:
Manufacturers, processors, or distributors of cosmetic products must provide their domestic address, phone number, or the electronic contact information of the person responsible for the product. In addition, there are other labeling requirements for fragrance allergens and cosmetic products for professional use.
- New FDA Enforcement Authority
- Section 606: Good Manufacturing Practices (GMP) requirements:
Manufacturers of cosmetics will be required to be compliant with Good Manufacturing Practices (GMPs) with exemptions for some small businesses. Failure to meet these requirements can result in your product being deemed adulterated.
- Section 607: Facility Suspension:
Manufacturers of cosmetics will be required to be compliant with Section 607 (facility registration and product) listing with exemptions for some small businesses. Failure to meet these requirements can result in suspension of the registration of the facility.
- Section 610: Records Access:
The FDA will have the authority to access and inspect records related to a cosmetic product, should they have reason to believe a product is adulterated or present a threat of serious adverse health consequences.
- Section 611: Mandatory Recall Authority:
The FDA will have the authority to recall a cosmetic product, should they have reason to believe a product is adulterated or presents a threat of serious adverse health consequences.
- Section 612 and 613: Exemptions:
- 612: Small businesses whose average gross annual sales in the U.S. is less than $1 million over a previous 3-year period, shall be exempt from Section 606 and Section 607 (facility registration and product listing). However, this exemption for small businesses only applies based on the intended use of cosmetic products and specific conditions.
- 613: Products that are regulated as both drugs and cosmetics fall under the jurisdiction of the Food and Drug Act, except where fragrance allergen requirements are applicable
- Section 614: Preemption:
State or local governments cannot establish requirements for cosmetics that are different from the federal requirements applicable under MoCRA. However, States can prohibit or limit the use of an ingredient in a cosmetic.
MoCRA has not amended the product type classification. Any product with an intended use outside of cosmetics (previously listed non-cosmetics) or any over-the-counter (OTC) drugs that make cosmetic claims are not regulated under MoCRA, except for new cosmetic labeling requirements.
What Does This Mean for Industry?
The act comes into force as early as December 29, 2023. We recommend that all cosmetic facilities consider becoming compliant with MoCRA without delay, as the existing product listings and facilities must be registered by the above date.
The MoCRA will require significant additional procedures to be followed by affected industrial entities. Our cosmetic experts continuously monitor regulatory changes and can collaborate with you to ensure compliance with the new MoCRA regime.
Contact dicentra today to learn more about the FDA’s Modernized Cosmetic Regulations Act (MoCRA).