Can You Put “Made in USA” on a Private Label Supplement or Skincare Product? The FTC’s “All or Virtually All” Test, Qualified Claims and a Checklist

Short answer: Only if the product is “all or virtually all” made in the United States: final assembly or processing happens here, all significant processing happens here, and all or virtually all ingredients or components are made and sourced here. Filling in a U.S. facility is not enough on its own. With significant imported ingredients, use a qualified claim instead.

Made in USA claim: an unqualified statement, express or implied, that a product is of U.S. origin. Under Federal Trade Commission (FTC) rules it means the product is “all or virtually all” made in the United States, with no, or negligible, foreign content. ^[1]

Key stats: Made in USA claims at a glance

• August 13, 2021: the FTC’s Made in USA Labeling Rule (16 CFR Part 323) took effect, letting the FTC seek civil penalties, assessed per violation, for unqualified origin claims on labels. ^[1]
• 3 conditions must all be met for an unqualified “Made in USA” label. ^[2]
• $3.175 million: the civil penalty Williams-Sonoma agreed to pay in April 2024 for violating a 2020 FTC Made in USA order, which the FTC called the largest ever in a Made in USA case. ^[4]
• 4 warning letters went out in July 2025, one of them to a personal care products manufacturer; Amazon and Walmart also received letters about third-party sellers’ origin claims. ^[5][9]
• $625,000: consumer redress in one of three cases the FTC announced on April 14, 2026, which the FTC called the largest under the Labeling Rule to date. ^[6]
• 5% / 10%: California allows foreign parts worth up to 5% of the final wholesale value, or up to 10% if they cannot be made or obtained in the U.S. ^[7]

What does “Made in USA” legally mean for a supplement or skincare product?

The FTC’s Labeling Rule and its business guidance set out three conditions for an unqualified “Made in USA” label: ^[2]

1. 1.The final assembly or processing of the product occurs in the United States.
2. 2.All significant processing that goes into the product occurs in the United States.
3. 3.All or virtually all ingredients or components of the product are made and sourced in the United States.

The rule covers labels on products and online or mail-order marketing that includes a seal, mark, tag or stamp saying the product is made in the USA. ^[1] Origin claims in other advertising and promotional materials are still judged under the FTC Act and the FTC’s Enforcement Policy Statement on U.S. Origin Claims, which uses the same “all or virtually all” standard. ^[2] The definition covers claims that are “express or implied,” so wording and imagery that suggest U.S. origin can count as a claim. ^[1] The FTC does not pre-approve claims; you don’t need its permission, but you do need evidence. ^[2]

Does making your product in a U.S. facility qualify it?

Not by itself. U.S. final processing is the starting point, not the finish line. The FTC tells marketers to look back far enough in the manufacturing process to be reasonably sure any significant foreign content has been accounted for, and not to simply assume a supplier’s ingredient or component is 100% U.S.-made; ask the supplier. ^[2]

For raw materials, the FTC says “it depends on how much of the product’s cost the raw materials make up” and how far removed they are from the finished product. ^[2] Its Enforcement Policy Statement gives examples such as the coffee beans in ground coffee and the vanilla beans in vanilla ice cream: when an imported material is the whole or essence of the product, an unqualified claim would likely mislead consumers. ^[3]

Example (illustrative): a vitamin gummy mixed, deposited and bottled in a Florida facility, where the vitamin blend that defines the product is imported. The processing is American; a key ingredient is not. A qualified claim fits that product better than “Made in USA.”

What can you say if some ingredients are imported?

A qualified claim describes the extent, amount or type of a product’s domestic content or processing. The FTC’s own examples include “60% U.S. content” and “Made in USA of U.S. and imported parts.” ^[2] For formulated products, the same pattern can describe ingredients, for example “Made in USA of U.S. and imported ingredients.” The FTC also advises avoiding qualified claims unless the product has a significant amount of U.S. content or U.S. processing. ^[2]

Does California have its own Made in USA rule?

Yes. California Business and Professions Code Section 17533.7 bars “Made in U.S.A.” labels on merchandise substantially made outside the U.S. Since SB 633 took effect on January 1, 2016, it allows foreign parts worth up to 5% of the product’s final wholesale value, or up to 10% if the manufacturer shows the part can’t be made or obtained in the U.S. (a showing that can’t be based on the part’s cost). ^[7][8] The FTC rule says it does not supersede state laws except where they are inconsistent with it, so treat the federal and California tests as two separate checks. ^[1]

What if the finished product is made overseas?

Imported goods must be marked with their foreign country of origin under the Tariff Act, and U.S. Customs and Border Protection decides origin case by case using a “substantial transformation” test. Passing Customs’ test does not by itself permit a Made in USA claim; the FTC applies its own standard. ^[2] Repacking or relabeling an imported product in the U.S. doesn’t change that its contents were made abroad, so it doesn’t meet the “all or virtually all” standard.

How do you check a product before you print the claim? The TRACE check

1. 1.T — Track every ingredient and component back to where it was made, not only who sold it to you.
2. 2.R — Rank imported inputs by their share of product cost and by how central they are (the active, the base, the defining botanical).
3. 3.A — Assess where final processing and all significant processing happen.
4. 4.C — Choose the claim: unqualified, qualified, “Assembled in USA” or none. If you sell in California, run its 5%/10% test too.
5. 5.E — Evidence: keep a file with supplier origin statements and cost calculations, and re-check it whenever a supplier or formula changes.

Printable checklist: before you put “Made in USA” on a label or listing

Download the fillable checklist (PDF)

1. 1.Final processing (mixing, filling, encapsulating) happens in a U.S. facility.
2. 2.All significant processing steps happen in the U.S.
3. 3.Written country-of-origin statement for every ingredient and component.
4. 4.Imported inputs ranked by share of product cost.
5. 5.Defining ingredients (actives, base, signature botanical) are U.S.-made, or the claim is qualified.
6. 6.Qualifier, if any, is clear, prominent and easy to understand.
7. 7.California 5%/10% wholesale-value test run if you sell there.
8. 8.Packaging, Amazon/Walmart listings, website and ads all say the same thing.
9. 9.Flags, maps and “American-made” wording reviewed as possible implied claims.
10. 10.Evidence file dated and re-checked after any supplier or formula change.

Where does PMG fit?

PMG’s products are made in FDA-registered, GMP-compliant partner facilities in five U.S. states: Florida, North Carolina, Texas, Minnesota and Arizona (see our manufacturing locations). That covers where products are processed. Whether a specific product can carry an unqualified claim still depends on where its ingredients and components come from, so origin claims need to be checked product by product against ingredient and component sourcing, alongside the other required label elements covered in our supplement label guide. If you are preparing for retail, make sure the claim matches on packaging and every listing, and see what retailers require. Moving production to the U.S.? Start a project.

Frequently asked questions

Glossary

• Unqualified claim: a plain “Made in USA” (or similar) statement with no limits; it must meet the “all or virtually all” standard.
• Qualified claim: a statement that describes the extent or type of U.S. content, such as “Made in USA of U.S. and imported ingredients.”
• All or virtually all: the FTC standard; the product should contain no, or negligible, foreign content.
• Final assembly or processing: the last manufacturing step that makes the finished product; it must occur in the U.S. for an unqualified claim.
• Significant processing: processing steps that matter to the finished product; all must occur in the U.S. for an unqualified claim.
• Substantial transformation: processing that turns materials into a new and different product with a new name, character and use; the test Customs uses to decide origin.
• Country-of-origin marking: the Tariff Act requirement that imported goods be marked with their foreign country of origin.

Planning a supplement or skincare launch with a Made in USA claim? Read whether your product needs a Prop 65 warning, or start a project with PMG.

About Product Management Group

PMG is a full-service private label manufacturing partner for skincare, nutraceuticals, supplements, personal care, and wellness brands. We handle everything from R&D and formulation through manufacturing, packaging, regulatory compliance, and fulfillment, working with FDA-registered, GMP-compliant partner facilities in Florida, North Carolina, Texas, Minnesota, and Arizona. We work with everyone from first-time founders to established retail brands, with minimums starting at 1,000 units.