1. Facility Registration + US Agent- 30% OFF
2. Product Listing + Label Review- 30% OFF
3. Both services together- 40% OFF
The official implementation of MoCRA is set for December 29, 2023. On this date, the majority of the new requirements will take effect, including facility registration, product listing, safety substantiation, adverse event reporting, and professional cosmetics labeling.
MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the most extensive cosmetic regulation reform in the United States in 84 years. It establishes many new requirements, such as:
The FDA will adopt rules under MoCRA that impact every stage of the production and marketing of your cosmetic items. New specifications include:
The bill offers general guidance so that cosmetic companies can begin planning for the new FDA Requirements, even though the FDA still needs to develop regulations.
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 under 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:
When choosing a local distributor, be sure to consider factors like data storage capacity, regulatory and scientific competence, experience working with authorities, and confidentiality of product/supplier information.
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:
Facility registration and product listings are due by December 29th, 2023, for existing facilities. 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 in colors, fragrances, flavors, or quantity of contents.
Cosmetic products containing fragrance allergens must update labels to list these allergens. Professional cosmetic products must prominently indicate that they are to be used solely by licensed professionals and are compliant with existing cosmetic labeling norms.
Within one year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.
Within two years: Labels must include the responsible person's contact information for adverse reporting and identify fragrance allergens determined by the FDA