Cosmetic or drug

What MoCRA added

On this page9

Facility registration Product listing Who the responsible person is Safety substantiation Adverse event reporting Good manufacturing practice The small business exemption, and its carve-out What this means for a kitchen operation References

The small business exemption is real, and it does not cover a product that contacts mucous membranes.

Facility registration

Facilities that manufacture or process cosmetics register with FDA, and the registration is renewed every two years.

Product listing

The responsible person lists each marketed cosmetic product, including its ingredients, and updates the listing annually.

Who the responsible person is

The manufacturer, packer or distributor whose name appears on the label. For a small maker selling their own product that is you, and it is the same name 21 CFR 701.12 requires with a street address.

Safety substantiation

Records supporting adequate safety substantiation, derived from scientifically robust methods, maintained and available. Animal testing is not required to meet this.

Adverse event reporting

Serious adverse events are reported to FDA within 15 business days, with a copy of the product label included in the initial report. New medical information received within a year of that report is submitted within a further 15 business days.

Good manufacturing practice

FDA is required to establish GMP regulations for cosmetics. Final rules are not yet published and draft guidance is available, so this is the part of MoCRA most likely to have moved since this page was written.

The small business exemption, and its carve-out

Certain small businesses are exempt from GMP, registration and listing. The exemption does not apply to products that contact mucous membranes, are injected, are intended for internal use, or alter appearance for more than 24 hours. An aftershave applied to a freshly shaved face is worth thinking about carefully against that first category.

What this means for a kitchen operation

Not that you cannot run one. FDA says plainly that manufacturing cosmetics at home is not against the law. It means the record keeping is part of the product rather than paperwork added afterwards.

References

FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Facility registration renewed every two years; product listing by the responsible person with annual updates; records supporting adequate safety substantiation derived from scientifically robust methods; serious adverse events reported within 15 business days, with new medical information received within one year reported within a further 15 business days. Certain small businesses are exempt from GMP, registration and listing, except for products that contact mucous membranes, are injected, are intended for internal use, or alter appearance for more than 24 hours. fda.gov

21 CFR 701.12, the name and place of business of the manufacturer, packer or distributor. FDA’s small business fact sheet states that a street address, city, state and ZIP are required and that a post office box or a website is not sufficient. law.cornell.edu

FDA, Small Businesses & Homemade Cosmetics: Fact Sheet. Cosmetics and their ingredients, other than color additives, do not need FDA approval before sale, and the manufacturer is "legally responsible for making sure your cosmetics are safe and properly labeled". Manufacturing at home is not against the law, but the product must not be adulterated by the conditions it is made in. fda.gov

Written from the FD&C Act and 21 CFR parts 701 and 740, and from the catalog as it stood on 17 October 2026. Whether a particular product is a cosmetic or a drug turns on its claims and its ingredients, and that determination has consequences; nothing here substitutes for getting it right for a specific formula and a specific label.