Makeup Distributor Companies Cannot Give You an FDA Number
Brand founders searching for makeup distributor companies are usually solving two problems at once: who makes the product, and who moves it. Those are different suppliers with different legal footprints, and the distinction now has a paperwork consequence. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the brand whose name is on the label must file a cosmetic product listing with the FDA, and that listing has to carry the registration number of every facility where the product was manufactured or processed. A company that only distributes does not have one, because distribution-only establishments sit outside FDA’s definition of a facility.
What the FDA means by “facility” and “responsible person”
MoCRA defines a facility as any establishment, including an importer’s, that manufactures or processes cosmetic products distributed in the United States. It defines the responsible person as the manufacturer, packer or distributor whose name appears on the label.
For most new brands, that second definition lands on them. If the jar says your brand, you are the responsible person, and the duties that follow are yours: the product listing, annual updates to it, serious adverse event reporting, and records substantiating the product’s safety. They do not transfer to the factory because it mixed the batch, or to a distributor because it warehoused the result.
The statute also carves establishments out of the facility definition, including any that solely performs labeling, relabeling, packaging, repackaging, holding or distributing. One detail matters when comparing suppliers: packaging and repackaging there do not include filling a product container with a cosmetic product. A contract filler is manufacturing or processing and registers. A warehouse that receives sealed units and ships them does not.
Why the listing form is where this gets expensive
The crunch arrives on Form FDA 5067, the cosmetic product listing. Section II asks for the responsible person’s name as it appears on the label. Section III asks for the FDA Establishment Identifier (FEI) of each facility where the product is manufactured or processed. The FEI is the number FDA uses as the facility registration number, and a facility’s owner or operator must obtain it before registering at all.
FDA’s guidance for industry is explicit that the responsible person needs those numbers, because the listing cannot be completed without them. There is a fallback where a facility is exempt from registration and has no number, in which case its name and address can be supplied instead — a fallback for exempt facilities, not for suppliers who would rather not say where the product was made.
So the question to put to a supplier is not whether they are “FDA compliant”. It is narrower and harder to dodge: which facility manufactures this, and will you give me its FEI for my listing?
There is no certificate to ask for
Brands frequently ask a supplier to email an FDA registration certificate, and suppliers sometimes produce something that looks like one. FDA’s registration and listing hub states that it does not issue certificates or verification documents for facility registration or product listing, and that assignment of a registration or listing number does not indicate FDA approval of the facility or its products. Registration is not an approval program and not a promotional tool.
Two timing points belong in your own calendar rather than a supplier’s. Facility registrations renew every two years from the date of initial registration. Product listings update annually, including to notify FDA that a product has been discontinued. The renewal clock belongs to the facility; the annual listing clock belongs to you.
Where a distributor still earns its place
None of this makes distributors redundant. A distributor that holds inventory and services retail accounts does work a manufacturer generally does not. The failure mode is treating one supplier as if it covers both roles, then discovering at listing time that nobody will name the manufacturing site.
One note on sequencing: FDA’s guidance lets a responsible person submit the facility registration for a contract manufacturing facility, in which case the contract manufacturer does not separately register it. A legitimate route, but the registration duty has then moved onto the brand, so make it a decision rather than an accident.
What to ask before you sign
- Does this supplier manufacture, process or fill, or does it only label, hold and ship? Filling counts as manufacturing or processing.
- Which specific facility makes my product, and will you supply its FEI for Section III of my listing?
- If more than one site is involved, can I have the number for each? The listing asks for every facility.
- When was that registration last renewed, and when is it next due? The cycle is two years from initial registration.
- Who is named as responsible person on my label, and who files the listing? Get it in writing.
- Do not accept a “registration certificate” as evidence. FDA does not issue one.
MoCRA does provide a small-business exemption from GMP, registration and listing, but with carve-outs for categories including products that regularly contact the mucus membrane of the eye, injected products and products intended to alter appearance for more than 24 hours. If a supplier claims the exemption, check your product category against those carve-outs first.
Moe’s Group is an FDA-registered contract manufacturer in Chatsworth, California, where formulation, filling and labeling happen in the same facility — existing formulas from 200 units, custom formulations from 1,000. To know which facility would appear on your product listing before you commit, ask us at moesgroup.com/product-inquiry.
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