What "Made in the USA" Has to Be True Of

Answer first: three conditions, joined by 'and'

16 CFR 323.2 states the standard in a single sentence, and every clause in it is a separate requirement. In connection with promoting or offering for sale any good or service, it is an unfair or deceptive act or practice "to label any product as Made in the United States unless the final assembly or processing of the product 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 of the product are made and sourced in the United States."

Three things have to be true simultaneously: final assembly or processing here, all significant processing here, and all or virtually all ingredients or components both made and sourced here. A product assembled domestically from imported components satisfies the first and fails the third.

Note also the two verbs in the last clause. Ingredients must be "made and sourced" in the United States — origin and supply chain, not one or the other.

The rule identifies its own statutory footing in the same sentence, describing the conduct as "an unfair or deceptive act or practice within the meaning of section 5(a)(1) of the Federal Trade Commission Act, 15 U.S.C. 45(a)(1)," and defines commerce by reference to section 4 of that Act, 15 U.S.C. 44.

The definition catches the synonyms, not just the phrase

A rule that only reached the literal words "Made in the USA" would be trivial to route around. Section 323.1(a) is written to prevent that.

It defines "Made in the United States" to mean "any unqualified representation, express or implied, that a product or service, or a specified component thereof, is of U.S. origin, including, but not limited to, a representation that such product or service is 'made,' 'manufactured,' 'built,' 'produced,' 'created,' or 'crafted' in the United States or in America, or any other unqualified U.S.-origin claim."

Four features of that definition do the work. It reaches representations that are "express or implied." It reaches claims about "a specified component" as well as about the whole product. It lists six verbs and then declines to stop there with "any other unqualified U.S.-origin claim." And it applies to services as well as products.

The operative word throughout is "unqualified." The rule is aimed at the bare claim. A claim that carries its own qualification — stating what is domestic and what is not — is a different representation, and the statute behind the rule addresses that case directly, as the next section describes.

Mail-order and online material is covered explicitly rather than by inference. Section 323.3 provides that "To the extent that any mail order catalog or mail order promotional material includes a seal, mark, tag, or stamp labeling a product Made in the United States, such label must comply with § 323.2." Section 323.1(b) defines those terms to include materials "disseminated in print or by electronic means" that solicit a purchase "by mail, telephone, electronic mail, or some other method without examining the actual product purchased" — which is a description of most online health sellers.

What the statute behind the rule says

15 U.S.C. 45a is short and older than the rule. It provides that where any person "introduces, delivers for introduction, sells, advertises, or offers for sale in commerce a product with a 'Made in the U.S.A.' or 'Made in America' label, or the equivalent thereof, in order to represent that such product was in whole or substantial part of domestic origin, such label shall be consistent with decisions and orders of the Federal Trade Commission issued pursuant to section 45 of this title."

It then states its own boundaries. "This section only applies to such labels. Nothing in this section shall preclude the application of other provisions of law relating to labeling." A domestic-origin claim on a drug product may sit alongside labeling requirements from an entirely different agency, and this section does not displace them.

The statute also anticipates the qualified claim. "Nothing in this section shall preclude use of such labels for products that contain imported components under the label when the label also discloses such information in a clear and conspicuous manner." Disclosure is the route by which a product with imported content may still carry an origin statement — and the disclosure standard is the same clear and conspicuous test used throughout consumer-protection law.

Section 45a gives the Commission rulemaking authority and states the consequence of using it: "If a rule is issued, such violation shall be treated by the Commission as a violation of a rule under section 57a of this title regarding unfair or deceptive acts or practices." 16 CFR 323.4 says the same thing from the rule's side: "Any violation of this part shall be treated as a violation of a rule under section 18 of the Federal Trade Commission Act, 15 U.S.C. 57a, regarding unfair or deceptive acts or practices."

State law, and the exemption route

Section 323.5 sets out how the rule interacts with other law, and it is more permissive of state regulation than a preemption clause usually is.

Paragraph (a) provides that the part "shall not be construed as superseding, altering, or affecting the application of any other federal law or regulation relating to country-of-origin labeling requirements," naming the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act as examples. It goes on to say the part does not supersede any state statute, regulation, order or interpretation on country-of-origin labeling "except to the extent that such statute, regulation, order, or interpretation is inconsistent with the provisions of this part, and then only to the extent of the inconsistency."

Paragraph (b) then narrows what counts as inconsistent: a state rule "is not inconsistent with the provisions of this part if the protection such statute, regulation, order, or interpretation affords any consumer is greater than the protection provided under this part, as determined by the Commission on its own motion or upon the petition of any interested party." A stricter state rule survives.

Section 323.6 provides an exemption route, and it runs through the Commission rather than through a company's own judgment. Any person to whom the rule applies "may petition the Commission for a partial or full exemption," and the Commission may grant one "if the Commission finds application of the rule's requirements is not necessary to prevent the acts or practices to which the rule relates," resolving petitions using the procedures in 16 CFR 1.31 and conditioning exemptions on alternative standards where appropriate.

In other words, the rule contemplates that a company that believes the standard should not apply to it asks, on the record, rather than deciding for itself.

A 2026 executive order printed alongside the statute

The Law Revision Counsel's page for 15 U.S.C. 45a prints, under Executive Documents, the text of Executive Order 14392, "Ensuring Truthful Advertising of Products Claiming To Be Made in America," dated March 13, 2026 and published at 91 F.R. 13201. It is worth reading because it describes the marketplace problem in the government's own words.

Its policy section states that "Americans have a right to clear, accurate, substantiated, and accessible information regarding whether products advertised as 'Made in America' are actually made in the United States," and that "in the age of the modern digital marketplace, foreign manufacturers and sellers represent that their products are made in the United States to target patriotic consumers when, in fact, those products are largely produced and manufactured in other countries."

The order directs the Chairman of the Commission to "wherever appropriate, prioritize enforcement actions in cases in which a seller's or manufacturer's claim that a product is 'Made in America' or 'Made in the U.S.A.', or any similar American-origin claims, constitutes a violation of law," consulting other agencies with subject-matter expertise as needed.

It also directs the Commission to "consider issuing proposed regulations providing that the failure of an online marketplace to establish procedures for verifying country-of-origin claims may constitute an unfair or deceptive act or practice." That is a direction to consider a rule, not a rule; nothing in the order changes what 16 CFR part 323 currently requires.

The order closes with the standard limitation: it "is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party."

For a reader comparing sellers, the practical residue of all this is a single question to ask of an origin claim. Is it unqualified? If so, the rule's three conditions are what it is asserting — final assembly here, all significant processing here, and all or virtually all ingredients made and sourced here. If it is qualified, the statute expects the qualification itself to be clear and conspicuous.