The short answer
When a brand has its products made by someone else, U.S. rules split the duties:
- The factory that makes the product registers as the facility — food, cosmetic, drug or device.
- The brand owner is usually the name on the label, and for cosmetics, supplements and drugs it carries its own duties too (product listing, safety, adverse events).
- The label must show who the named company is to the product, with a phrase like “Manufactured for” or “Distributed by” when it did not make it.
Who does what, by product type
| Product | Contract manufacturer (factory) | Brand owner |
|---|---|---|
| Food | Food facility registration; preventive controls | No registration unless it also makes, packs or holds food; its name on the label with “Distributed by” |
| Dietary supplements | Food facility registration; 21 CFR part 111 CGMP | Responsible for the product meeting part 111, label claims, and serious adverse event reports if its name is on the label |
| Cosmetics (MoCRA) | Cosmetic facility registration | As the responsible person: product listing, safety substantiation, adverse event reporting |
| OTC drugs | Drug establishment registration and drug listing; drug CGMP | Private label distributors may get their own labeler code and NDC; the product must be listed |
| Medical devices | Contract manufacturers register and list | The specification developer also registers; premarket clearance where required |
The label: name and place of business
Under 21 CFR 101.5, a food label must show the name and place of business of the manufacturer, packer or distributor. If the name shown is not the manufacturer, it must be qualified by a phrase that shows the connection — “Manufactured for ___” or “Distributed by ___”. A street address can be left off only if it is in a current city or telephone directory; the city, state (or country) and ZIP code are still needed.
Contract checklist for brand owners
- 1Check the factory’s registrationsAsk for the FDA registration number (and FEI for cosmetics) and confirm it is current. See does FDA issue certificates?
- 2Agree who files whatProduct listing, NDC, Prior Notice, adverse event reports — put it in the contract.
- 3Approve specifications and releaseEspecially for supplements, where FDA expects the brand to ensure specifications are met.
- 4Control the labelThe brand usually owns the artwork, so it owns the label errors.
- 5Set up complaints and recallsWho receives complaints, who investigates, who reports to FDA. See recalls.
Example: a UK brand with factories in Italy and South Korea
A UK wellness brand sells pasta sauce made by an Italian factory and a face serum made by a Korean factory. The Italian factory holds the FDA food facility registration; the sauce label reads “Manufactured for [UK brand], London, UK”. The Korean factory registers under MoCRA, while the UK brand, as the responsible person, lists the serum, keeps its safety file and adds a U.S. contact for adverse events to the label.
Food facility registration with U.S. Agent from $300. Cosmetic product listing $150 per product. Basic food label review $250; cosmetics label review $250.
Frequently asked questions
Does a private label food brand need FDA registration?
Not if it does not manufacture, process, pack or hold food itself. The factory registers.
What does “Manufactured for” mean on a US label?
It shows that the company named did not make the product but has it made. FDA requires a qualifying phrase like this when the name on the label is not the manufacturer.
Who lists a private label cosmetic under MoCRA?
The responsible person — usually the brand whose name is on the label. The factory registers the facility.
Is a supplement brand responsible for its contract manufacturer’s GMP?
FDA holds firms that sell supplements under their own label responsible for ensuring the product meets part 111 requirements, even when another company makes it.
Sources
- 21 CFR 101.5 — Name and place of business of manufacturer, packer or distributor
- FDA — Questions and answers regarding food facility registration (seventh edition)
- 21 U.S.C. 364 — MoCRA definitions (responsible person)
Requirements checked on November 12, 2026. This article is general information, not legal advice.