Written and maintained by CASRAI Editorial Board
Last updated
General regulatory information, not legal advice. Sources were last checked on 2026-10-31; check the current text before relying on any wording.
Short answer
Under the Federal Trade Commission’s Made in USA standard, an unqualified “Made in USA” claim requires that the product be “all or virtually all” made in the United States. The FTC’s Labeling Rule, 16 CFR Part 323, applies that standard to labels. It is a separate test from the customs country-of-origin mark that importers must apply to foreign goods.
Definition and scope
The FTC’s business guidance says an unqualified claim is one made without conditions or caveats, and that the marketer needs a reasonable basis for it, meaning competent and reliable evidence, and must keep the claim current. For this purpose “United States” includes the 50 states, the District of Columbia, and U.S. territories and possessions.
The rule text in 16 CFR 323.2 makes it unfair or deceptive to label a product as Made in the United States unless three conditions are met: final assembly or processing occurs in the United States; all significant processing that goes into the product occurs in the United States; and all or virtually all ingredients or components are made and sourced in the United States. The FTC says a product should contain no, or negligible, foreign content.
Made in USA labeling
The FTC’s August 2021 Labeling Rule codified the standard for labels. The FTC states that civil penalties can apply to an unqualified Made in USA label on a product that does not meet the standard, including in catalogs and online listings.
How the FTC standard is applied in practice
The FTC guidance treats final assembly or processing in the United States as a threshold requirement, then points to further factors: the share of total manufacturing costs attributable to U.S. parts and processing, how far removed any foreign content is from the finished product, and how important that content is to the product’s form or function. The marketer’s evidence has to support the claim product by product.
Country of origin marking
Country-of-origin marking is a different obligation. Under 19 CFR 134.11, section 304 of the Tariff Act of 1930 (19 U.S.C. 1304) requires every article of foreign origin, or its container, imported into the United States to be marked in a conspicuous place with the English name of the country of origin at the time of importation, unless excepted by law. U.S. Customs and Border Protection decides marking questions case by case using substantial transformation. The guide on substantial transformation explains that test, and the guide on country of origin marking for imported medical devices covers the CBP and FDA labeling side.
Unqualified and qualified claims
A qualified claim carries limitations or explanations; the FTC’s example is “60% U.S. content.” Qualified claims must still be truthful and substantiated.
Country of origin requirements compared: FTC and CBP
| Question | FTC Made in USA (16 CFR 323) | CBP marking (19 CFR 134) |
|---|---|---|
| Who it addresses | Marketers who make a Made in USA claim | Importers of foreign-origin articles |
| What triggers it | A label or claim saying the product is Made in the United States | Importation of an article of foreign origin, unless excepted by law |
| What it asks for | Final assembly or processing in the U.S., all significant processing in the U.S., and all or virtually all components made and sourced in the U.S. | The English name of the country of origin, marked conspicuously at the time of importation |
| How origin is judged | The FTC’s own “all or virtually all” standard | Substantial transformation, case by case |
Sources: FTC, Complying with the Made in USA Standard; 16 CFR 323.2; 19 CFR 134.11 (all checked 2026-10-31).
Where it matters for labs, clinics and supply decisions
The FTC states that CBP not requiring a foreign-origin mark does not necessarily mean a product may be promoted as Made in USA. For supply staff reviewing a product listing or label, the sourced questions are therefore narrow: does the product carry an unqualified Made in USA claim, is there a stated basis for it, and is the claim worded as qualified where the content is mixed. Each product is judged on its own claim. The FTC standard is also a different question from federal-funding domestic-preference rules; see our guide on Buy American compliance for federally funded medical equipment. For devices that cross the border, importing medical devices into the US covers the entry side.
Common misunderstandings
- “No foreign mark means it is American-made.” Not necessarily. The FTC says the absence of a CBP foreign-origin mark does not by itself make a Made in USA claim permissible.
- “Final assembly in the U.S. is enough.” It is one of three conditions in 16 CFR 323.2, not the whole test.
- “The rule only covers packaging.” The FTC says penalties can apply to labels in catalogs and online as well.
FAQ
Is country of origin marking the same as Made in USA?
No. Origin marking is a customs requirement for imported foreign-origin articles (19 CFR 134.11). A Made in USA label is a voluntary claim judged under the FTC standard in 16 CFR 323.
Does Made in USA require 100% U.S. content?
The FTC standard is “all or virtually all,” with no or negligible foreign content, so it does not demand a literal 100% but comes close.
What are the country of origin requirements for imports?
Under 19 CFR 134.11, the article or its container is marked in a conspicuous place with the English name of the country of origin at the time of importation, unless excepted by law.
Can a product say “60% U.S. content”?
The FTC gives that wording as an example of a qualified claim, which must still be truthful and substantiated.
Sources
- Federal Trade Commission, Complying with the Made in USA Standard, checked 2026-10-31.
- Federal Trade Commission, Made in USA rule, checked 2026-10-31.
- Legal Information Institute, 16 CFR 323.2, checked 2026-10-31.
- Legal Information Institute, 19 CFR 134.11, checked 2026-10-31.
