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Prepare now to meet new US FDA requirements for cosmetic companies.
The United States recently enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), expanding the U.S. Food and Drug Administration’s (FDA’s) regulatory authority over the cosmetics industry. MoCRA requires FDA to establish extensive new regulations for companies manufacturing and distributing cosmetics in the USA.
Many regulations go into effect as early as 2023.
Not sure where to start? Registrar Corp makes cosmetic compliance quick and easy.
We will:
- Properly register facilities with FDA as soon as possible
- Act as a U.S. Agent for cosmetic facilities outside the U.S.
- Submit and manage cosmetic product listings
- Provide updates as FDA implements additional MoCRA guidelines
What does MoCRA mean for cosmetic companies?
Under MoCRA, FDA will establish regulations that affect the entire lifecycle of your cosmetic products, from manufacturing to marketing. New requirements include:
- Mandatory FDA Registration for cosmetics facilities
- Mandatory Product Listings for each cosmetic product marketed in the USA
- Adverse Event Reporting
- Adherence to FDA-issued Good Manufacturing Practices (GMPs)
- Record Keeping, including adverse event and safety substantiation records
- Mandatory Recalls
- Declaration of Fragrance Allergens
Although FDA has not yet established regulations for these requirements, the law provides general insight, so that cosmetic companies can start preparing for the new FDA Requirements.
Frequently Asked Questions
MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States in 84 years and establishes many new requirements, such as:
- Facility Registration
- Product Listings
- Good Manufacturing Practices (GMPs)
- Safety Substantiation
- New labeling requirements
- Adverse Event Reporting
- Record Keeping
Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic products distributed in the United States. Facilities will need to register and comply with GMPs issued by FDA.
The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
The “responsible person” will be responsible for:
- Cosmetic product listing
- Adverse events
- Safety substantiation
- Labeling
- Fragrance allergen disclosures and records
Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:
- Come into contact with eyes,
- Are injected,
- Are intended for internal use,
- Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.
For existing facilities, facility registration and product listings are due by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later.
MoCRA allows “flexible listings.“ For flexible listings, companies can submit a single listing for cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
Contact Registrar Corp to determine which responsibilities your company will need to complete to be compliant.
- A U.S. address,
- A U.S. phone number, or
- Electronic contact information in which a responsible person can receive adverse event reports.
Cosmetic products that contain fragrance allergens must update their label to list those allergens. For professional cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used only by licensed professionals and is in conformity with the existing cosmetic labeling requirements.
Within 1 year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.
Within 2 years: Labels must include responsible person’s contact information for adverse reporting and must identify fragrance allergens determined by FDA.
