FDA Requires Registration of Cosmetic Products by December 2023

Trade Update • October 20, 2023

he Food and Drug Administration (FDA) will require most cosmetics manufacturing and processing companies to register and list their products by December 29, 2023 to comply with the Modernization of Cosmetics Regulation Act (MoCRA).

Registration

MoCRA requires “every person that owns or operates a facility that engages manufacturing or processing of a cosmetic product for distribution in the United States to register each facility” with FDA with very limited exceptions.

• Cosmetic manufacturers and processors are directed to us the FDA Direct – Electronic Submissions Portal to register their facilities and list their products.

• Should you require guidance on registration, please refer to the Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products.

• FDA has developed instructions [with screen shots] on how to register here.

Responsible Person

As provided under section 607(a)(3) of the FD&C Act, if a facility manufactures or processes cosmetic products on behalf of a responsible person (i.e., a contract manufacturer), only a single registration is required for such facility even if the facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. A responsible person whose products are manufactured or processed at such facility may submit the facility registration for such facility. Under this approach, an owner or operator of a contract manufacturing facility would not register such facility if the responsible person submitted the facility registration.

What Does Not Qualify as a ‘Facility’?

Facility is as defined in section 604(3) of the FD&C Act, includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. This term does not include the following, which would be exempt:

(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location;

(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of the Internal Revenue Code of 1986), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location;

(iii) Hospitals, physicians’ offices, and health care clinics;

(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer;

(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services;

(vi) Trade shows and other venues where cosmetic product samples are provided free of charge;

(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale;

(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:

– Labeling

– Relabeling

– Packaging

– Repackaging

– Holding

– Distributing

Questions about whether your imports are affected? We are always here to help, contact us.