Tools and directories

Who regulates you, and when

Updated October 2026

On this page5

One agency, two doors On the cosmetic side On the drug side Everyone else References

A short map, because people arrive expecting a local inspector and the answer is federal.

One agency, two doors

FDA regulates both cosmetics and OTC drugs, through different centers and completely different requirements.

There is no license to obtain in either case and no inspection to pass before selling. The obligations are continuous rather than gated, which is why they are so easy to be unaware of.

On the cosmetic side

Labeling under the cosmetic rules and FPLA, with ingredients by INCI.

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

Safety substantiation, with no small-business exemption.

Adverse event reporting obligations, which arrived with MoCRA and which small makers most often do not know about.

On the drug side

Establishment registration, an NDC labeler code and drug listing, renewed annually between 1 October and 31 December.

Drug Facts labeling under 201.66, and the monograph conditions in 21 CFR 347 or, for sunscreen, OTC Monograph M020.

cGMP under 21 CFR Parts 210 and 211.

No small-business exemption anywhere in that list.

Everyone else

Your state and city for business registration, sales tax and any local license.

Your state again for cosmetic ingredient disclosure programs where they exist, which attach to selling into the state rather than to being based there.

Markets and retailers, who set their own conditions and in practice ask more questions than any regulator will.

And your insurer, whose exclusions are the fastest way to discover which side of the line your product is on.

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

FDA, OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, the deemed final administrative order carrying forward the 1999 21 CFR part 352 conditions, amended by administrative order under the CARES Act rather than by rulemaking. fda.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.