Getting started

What you have to register, and with whom

Updated October 2026

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It depends on the answer to one question The cosmetic route The drug route Doing it in the right order References

Two completely different lists, and which one applies to you was decided the moment you wrote the label.

It depends on the answer to one question

Cosmetic or drug. Everything below forks on it, and there is no partial answer: a product is one or the other, or in the awkward case both, and both means both sets of obligations.

The cosmetic route

Facility registration and product listing under MoCRA, with small-business exemptions that some makers qualify for by revenue.

Safety substantiation, which has no small-business exemption. You must have adequate substantiation of safety, whatever your size.

Labeling under the cosmetic rules: identity, net quantity, ingredients under INCI, name and address.

Note also that the exemptions do not reach a product that is a drug. Being small does not make a medicated lip balm into a cosmetic.

The drug route

Establishment registration with FDA.

An NDC labeler code.

Drug listing for each product, renewed or certified annually between 1 October and 31 December.

cGMP under 21 CFR Parts 210 and 211.

Drug Facts labeling in the prescribed format.

None of that has a small-business exemption. This is the same list a large manufacturer works through.

Doing it in the right order

Decide the regime. Write the label to it. Then register to it.

The failure people fall into is registering as a cosmetic business, then writing "for chapped lips" on the tube, and now holding a registration for a product they are not actually selling.

References

US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.gov

US Food and Drug Administration. Small Businesses & Homemade Cosmetics: Fact Sheet. fda.gov

FDA drug establishment registration and drug listing: an NDC labeler code, product listing, and annual renewal between 1 October and 31 December, required of anyone manufacturing, repacking or relabeling an OTC drug product. fda.gov

21 CFR Parts 210 and 211, Current Good Manufacturing Practice for finished pharmaceuticals, which apply to OTC monograph drug products with no exemption based on the size of the business. ecfr.gov

Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.