Private Label Cosmetics: Who Files With the FDA, You or the Factory?
If your brand name is on the label of a private label cosmetics line, the FDA treats you as the responsible person for those products — and the product listing is your filing, not your manufacturer’s. Your factory registers the facility; you list each product you market, with its ingredients. On September 9 the agency added a point that catches brand owners out: it will not issue either of you a certificate proving any of it was done.
Two filings, two different parties
Under section 607 of the Federal Food, Drug, and Cosmetic Act, as amended by the Modernization of Cosmetics Regulation Act of 2022, the duties split in a way that surprises new founders.
The owner or operator of a facility that manufactures or processes cosmetics for US distribution registers that facility, updates the registration within 60 days of any change, and renews it every two years. Separately, the responsible person — the manufacturer, packer or distributor whose name appears on the label — must list each marketed product with the FDA, including its full ingredient list, and update that listing annually.
In a private label or custom formulation arrangement, the label almost always carries the brand’s name, not the factory’s. That makes the brand the responsible person. The FDA’s registration and listing guidance also notes that a product listing must carry the facility registration number for every facility where the product is manufactured or processed, so the brand has to get that number from its manufacturer before it can file. A factory that cannot produce its registration number on request is a problem you want to discover before the first production run, not after.
The FDA will not send you a certificate
The agency said on September 9, 2026 that it had received a rising number of requests for proof-of-registration paperwork, and that no such paperwork exists. There is no certificate of facility registration, no verification letter or email stating that a facility is registered or a product is listed, and no document confirming that a company is exempt from registering.
The agency was equally direct about what the numbers mean: registration and listing are “neither a cosmetic approval program nor a promotional tool”, and being assigned a facility registration number or a product listing number does not indicate that the FDA has approved the facility or the products made in it. There is no approval pathway for cosmetics to be granted in the first place.
This matters commercially, not just legally. Retailers and marketplaces increasingly ask new brands for an “FDA registration certificate” during onboarding. The correct response is to explain that no such document is issued, and to supply the facility registration number and your own submission confirmation records instead. A supplier offering to sell you a certificate is selling something the FDA has now said does not exist.
2026 is the first full renewal wave
Because renewal runs two years from initial registration, facilities that registered during the first compliance push are now cycling through their second or third renewal. The FDA updated the Cosmetics Direct portal in February to show each facility’s registration status and renewal date, and to send automated reminders to facility and account contacts. Renewals come in two forms: a biennial renewal where details have changed, and an abbreviated renewal certifying nothing has changed since the last submission.
The practical risk for a brand is a lapsed registration upstream. Your listing points at your manufacturer’s facility number; if that registration goes stale, your filing is describing a facility whose record is no longer current. Registration and listing carry no FDA fee, so a supplier treating renewal as an expense to defer is telling you something about how it runs its quality system.
What to ask before you sign
- Ask for the facility’s registration number in writing, and the date it was last renewed.
- Confirm who is filing the product listing. If your name is on the label, assume it is you.
- Ask what ingredient disclosure you will receive, in listing-ready form, for every SKU.
- Check whether a small-business exemption genuinely applies. It does not cover products that routinely contact the mucous membrane of the eye, are injected, are intended for internal use, or are meant to alter appearance for more than 24 hours without consumer removal.
- Ask for the certificates that do exist — ISO 22716 cosmetics GMP, for instance — and verify them with the issuing body rather than accepting a logo.
- Treat any offer of an FDA compliance certificate as a reason to walk away.
Where this leaves a new brand
Private label cosmetics remain one of the fastest routes to a sellable product, and none of the above changes that. What has changed is that the paperwork is explicit, annual, and attached to your name rather than your factory’s. Brands that understand which filing belongs to whom spend ten minutes a year on it; brands that assume the manufacturer handles everything find out during a retailer audit.
Moe’s Group manufactures skincare, hair care and body care at a registered facility in Chatsworth, California, with ready-made formulas from 200 units and custom formulation from 1,000 units. Our ISO certificates and FDA establishment identifier are published and independently verifiable on our certifications page. If you are planning a launch and want the filing responsibilities mapped out first, send us your project details.
— Moe’s Group Newsroom
