The Food and Drug Administration (FDA) is delaying the requirement for cosmetics manufacturing and processing companies to register and list their products until July 1, 2024 to comply with the Modernization of Cosmetics Regulation Act (MoCRA). MoCRA requirements were slated to take effect on December 29, 2023. The delay is in response to industry concerns that additional time is needed to collect the information needed to register. 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:
- Labeling
- Relabeling
- Packaging
- Repackaging
- Holding
- Distributing
How To Register and List?
Cosmetic manufacturers and processors may use FDA Direct to register their facilities and list their products. FDA has developed an overview of the registration process to those who must register.
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.