US MoCRA

Cosmetics Section

Regulatory Background

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). According to MoCRA, all cosmetics exported to the United States must comply with facility registration and product listing obligations.

*Note: "Facility registration" refers to the registration of manufacturing sites (factories). This term will be used interchangeably in the following sections.

Compliance Process

Exemptions

• Small Business Exemption: Companies with average annual cosmetics sales of less than $1 million in the U.S. market over the past three years may qualify as small businesses.
  Exception: This exemption does not apply if the company manufactures certain higher-risk products, such as cosmetics intended for use near the eye mucosa.

• Drug/Medical Device Overlap: Facilities that produce products also regulated as drugs or medical devices are exempt from cosmetic facility registration.

• Product Listing Exemption: Small businesses (as defined above) are exempt from product listing requirements, provided their products are not classified as higher-risk.

• Drug/Medical Device Products: Products that also meet the definition of drugs or medical devices do not require cosmetic product listing.

Registration/Listing Timelines

• Facility Registration

• Existing facilities must register by July 1, 2024.

• New facilities must register within 60 days of commencing operations.

• Registration must be renewed every two years.

• Product Listing

• Products already on the market must be listed by July 1, 2024.

• New products must be listed within 120 days of entering interstate commerce.

• Listings must be updated annually.

Note: FDA does not charge fees for cosmetic facility registration or product listing.

OTC Monograph Product Section

OTC Product Listing Requirements

OTC (Over-the-Counter) drugs are non-prescription products available directly to consumers. Regulated by the FDA, they must meet standards for safety, efficacy, and quality.

Cosmetic products containing active ingredients that comply with an OTC monograph and meet corresponding labeling and safety requirements are classified as OTC drugs. These products require facility registration and product listing but do not need pre-market FDA approval.

Compliance Process

Business Registration

• Timeline: Must be completed within 5 days of market entry. Registration is valid for one year and must be renewed annually between October 1 and December 31.

• Fees:

• OTC Monograph Drug Enterprise (manufacturer): $37,556/year

• Contract Manufacturer: $25,037/year

Product Listing

• Initial listing must be submitted within 3 days of business registration. New products must be listed before market entry.

• Product updates must be submitted by June or December each year. A "No Change Notice" is required between October 1 and December 31 if no updates occur.

• No FDA fees apply for product listing.