The Food and Drug Administration (FDA) will require most cosmetics manufacturing and processing companies to register and list their products by December 29th to comply with the Modernization of Cosmetics Regulation Act (MoCRA). 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.
The “Responsible Person” at a facility is required to submit the cosmetic product listing. The “Responsible Person” is the manufacturer, packer, or distributor whose name appears on the label of a cosmetic product.
The following are not included in the definition of “Facility:”
- Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location
- 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
- Hospitals, physicians’ offices, and health care clinics
- Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services
- Trade shows and other venues where cosmetic product samples are provided free of charge
- 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
- An establishment that solely performs one or more of the following with respect to cosmetic products:
How To Register and List?
FDA has created Guidance for Industry, which may be found here, to help answer any questions that parties involved in the Cosmetic field may have.