Frequently Asked Questions

Do owners and operators of facilities that only manufacture or process cosmetic ingredients need to register their facilities? Does a responsible person need to submit a product listing for cosmetic ingredients?

No, at this time, FDA only expects non-exempt facilities to register if they manufacture or process the final formulation of cosmetic ingredients (including a final formulation that includes a single ingredient). This includes final formulations that have not yet been packaged. FDA only expects non-exempt responsible persons to list cosmetic products that are marketed for users (e.g., consumers or professional use).

Can a company located outside of the U.S. be the “responsible person”?

“Responsible person,” as defined in section 604(4) of the FD&C Act, means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. A company located outside of the U.S. could be a “responsible person” so long as they are the manufacturer, packer, or distributor of the cosmetic product. However, under section 609(a) of the FD&C Act, each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may be a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product. The FDA recommends firms consider when selecting electronic contact information, such as an email address or a website (whether foreign or domestic), how they can best respond to these reports and meet maintenance, inspection, and reporting requirements under section 605 of the FD&C Act.

Does an importer need to register and/or list under 607 of the FD&C Act?

If an importer meets the definition of a facility and/or a responsible person in section 604 of the FD&C Act, and does not meet any exemption, then they must comply with any applicable registration or listing requirements. Otherwise, the importer is not required to register or list.

Does a laboratory that only performs testing on cosmetic products used for research and development need to register?

No. If a laboratory tests cosmetic products that are solely for use in research, development, or evaluation, and that are not offered for retail sale, it does not need to register.

Does a laboratory that performs cosmetic product batch release testing need to register?

Yes. Cosmetic product batch release testing is part of manufacturing and processing. Laboratories conducting this testing are considered facilities subject to the registration requirements.

My company owns 2 buildings with 2 addresses, and 1 of the buildings is for storage only. Do we need to register the building used only for storage?

No. An establishment that solely performs storage (holding) with respect to cosmetic products is not required to register under section 607 of the FD&C Act.

If a contract manufacturer of cosmetic products is located outside of the United States are they required to be registered with the FDA under section 607 of the FD&C Act? Is there an exemption from registration if the contract manufacturer follows ISO22716?

If a contract manufacturer manufactures or processes cosmetic product(s) distributed in the United States, then the contract manufacturing facility must be registered with the FDA, even if the contract manufacturer is located outside of the United States. There is not an exemption from registration for following ISO22716.

Do hair coloring preparations (including hair dyes) need to be listed?

Yes. Hair coloring preparations, including hair dyes, are cosmetic products and therefore need to be listed, unless an exemption applies.

Do hairbrushes and wigs need to be listed?

No. Hairbrushes and wigs are not expected to be listed.

The cosmetic establishment registration is to be renewed biennially. Does this mean the biennial renewal has to be done every two years from the date of initial registration?

Yes, a cosmetic product facility needs to renew its registration every two years from the date of initial registration.