Cosmetic Manufacturer USA: Made in USA Is Not Automatic
Hiring a cosmetic manufacturer in the USA does not, on its own, entitle your product to an unqualified “Made in USA” label. The Federal Trade Commission’s Made in USA Labeling Rule requires three things at once: final assembly or processing in the United States, all significant processing in the United States, and all or virtually all ingredients and components made and sourced in the United States (16 C.F.R. Part 323). Domestic filling satisfies the first condition. Most new skincare brands fail the third one without ever checking.
The gap matters more this year than last. On March 13, 2026, the President signed Executive Order 14392, published in the Federal Register on March 18, directing the FTC Chairman to prioritize enforcement where a seller’s or manufacturer’s American-origin claim violates the law. The order also tells the FTC to consider rules under which an online marketplace that fails to verify country-of-origin claims could itself be committing an unfair or deceptive act. For a brand selling through a marketplace listing, that is a second party with a reason to ask where the bottle came from.
What the FTC actually tests
The “all or virtually all” standard is older than the rule, but the 2021 rule codified it for labels and made civil penalties available for unqualified claims, including claims in catalogs and online marketing. The FTC’s own business guidance explains how it is applied: final assembly or processing must happen in the US as a threshold matter, and then the Commission weighs the share of total manufacturing cost attributable to US parts and processing, how far removed any foreign content is from the finished product, and how important that foreign content is to the product’s form or function. There is no fixed percentage. The product should contain no more than negligible foreign content.
Apply that to a typical first launch. The formula is blended and filled in the United States. The airless pump is imported. The glass is imported. Two of the actives are imported in drum. The carton is printed domestically. Final assembly is clearly American; “all or virtually all” is clearly not. The guidance is also explicit that raw materials are neither automatically counted nor automatically excluded, so “it’s only the ingredients” is not a defense anyone should rely on.
Qualified claims are the usual honest answer
Brands tend to treat a qualified claim as a climbdown. It is not. The FTC expressly contemplates claims such as “Assembled in USA” or “Made in USA of US and imported parts”, provided they are truthful, substantiated, and the qualification is clear and prominent. A qualified claim that survives a complaint is worth considerably more than an unqualified one that invites a civil penalty. The guidance also warns against implying that a whole product line is domestic when only part of it is — a common failure mode for a brand that onshores one hero SKU and leaves the rest imported.
Whichever version you use, you need a reasonable basis before you print it: competent, reliable evidence held at the time the claim is made. In practice that means a bill of materials with country of origin against every line, kept current, with your manufacturer’s input where components are procured on your behalf.
While we’re correcting assumptions: FDA registration is not a certificate
The second thing buyers of US manufacturing routinely get wrong sits next door. In a Cosmetics Constituent Update dated September 9, 2026, the FDA said it does not issue certificates, letters or emails verifying compliance with cosmetic product facility registration or product listing, and that registration is “neither a cosmetic approval program nor a promotional tool”. A facility registration number does not indicate FDA approval of the facility or its products.
So if a supplier offers you a “registration certificate”, the document is not from the FDA. Separately, facility registration must be renewed every two years from the date of initial registration under section 607(a)(2) of the FD&C Act, a date that belongs to the facility and can be asked for directly (FDA registration and listing page). And under MoCRA the responsible person is the party whose name appears on the label — which is you, not your factory.
Practical takeaways
- Build a bill of materials with country of origin for every ingredient and every component, including pumps, closures and decoration, before you write any origin claim.
- Default to a qualified claim (“Assembled in USA”, “Made in USA of US and imported parts”) unless the BOM genuinely supports “all or virtually all”.
- Never apply an origin claim to a whole line when only one product qualifies.
- Ask your manufacturer for its facility registration renewal date rather than a certificate; the FDA does not issue one.
- Remember that the FDA listing obligation follows the name on the label, so it is the brand’s, not the factory’s.
- Keep your substantiation on file, dated, and update it when a component is re-sourced — which under current tariff conditions happens often.
Where a domestic factory does help
Domestic manufacturing does not hand you a label, but it does shorten the chain you have to document, and it puts the people who know the component origins in the same building as the people filling the bottle. Moe’s Group formulates, fills and labels skincare, hair care and body care in a single FDA registered facility in Chatsworth, California, with white label formulas from 200 units, custom formulations from 1,000 units, and capacity of up to 1,000,000 units per month. If you are working out which origin claim your formula and components can actually support, start a product inquiry and bring your component list.
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