The FDA will adopt rules under MoCRA that impact every stage of the production and marketing of your cosmetic items. New specifications include:

• Required FDA registration of establishments for cosmetics
• Required Product Listings for all cosmetics sold in the USA
• Adherence to Good Manufacturing Practices (GMPs) mandated by the FDA for the Reporting of Adverse Events
• Keeping records, including those of adverse events and safety justifications
• Required Recalls
• Allergen Statement for Fragrances

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:

• Cosmetic product listing
• Adverse events
• Safety substantiation and regulatory expertise
• Labeling
• Fragrance allergen disclosures and records
• Based in the U.S.A.
  • Single point of contact for authorities
  • Registrations: product listing, facility registration

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:

• 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.

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.

• A U.S. address,
• A U.S. phone number, or
• Electronic contact information for receiving adverse event reports

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