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When Can You Legally Say 'Made in USA'?

The FTC's labeling rule requires that all or virtually all of the product be U.S.-made — and unqualified claims now carry civil penalties per violation.

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Isabel Duarte, · July 14, 2026 · 4 min read
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Production line worker applying origin labels

"Made in USA" is a legal claim, not a marketing mood. The Federal Trade Commission's Made in USA Labeling Rule, in force since 2021, codified the standard the Commission had enforced for decades: an unqualified claim requires that the product be last substantially transformed in the United States, that all significant parts and processing be U.S., and that all or virtually all of the product be domestic. Violations are now subject to civil penalties under the FTC Act, each mislabeled product a separate violation. Orer News publishes information, not legal advice.

The standard's teeth are in "all or virtually all": a threshold with little room for meaningful foreign content.

What does "all or virtually all" mean in practice?

Practically, the foreign content must be negligible — the benchmark the FTC applies is that a reasonable marketer could substantiate the U.S. origin of effectively everything that matters. A screwdriver assembled in Ohio from U.S. steel with a small imported component might qualify if that component is negligible; the same tool with a foreign motor or substantial imported subassembly does not. The cost test is the honest screen: if a meaningful share of the total manufacturing cost is foreign, the unqualified claim is not defensible. Last-substantial-transformation — where the product became what it is — happens in a U.S. factory, and the analysis follows that U.S. factory's inputs.

What about qualified claims?

Qualified claims are the legal middle path when origin is mixed: "Made in USA with imported parts," "Assembled in the USA of domestic and imported components." The qualification must be clear, prominent, and honest about what is domestic — a fine-print qualifier under a big unqualified claim is treated as an unqualified claim. "Assembled in USA" specifically requires that the assembly be substantial — last substantial transformation — not merely screwdriver work tightening imported components into a box. Other origin claims follow other regimes: country-of-origin marking at customs follows CBP rules for imports, and textile and wool products carry their own labeling statutes; the FTC rule governs the marketing claim itself.

Why did the rule get codified?

Before 2021 the standard existed in FTC enforcement guides and case law; the Labeling Rule gave it rule-based force, including civil penalties, and was followed by a broader 2024 rule-making that extended penalty authority to unqualified USA claims on the internet, catalogs, and labels beyond mail-order marketing. The enforcement wave since has targeted importers relabeling foreign goods and marketers making unqualified claims on websites — a reminder that the claim follows the product everywhere it is described.

What should a business do before claiming?

Assemble the substantiation before the copy: a bill-of-materials level accounting of where cost and transformation occur, supplier origin certifications, and the manufacturing record of the final U.S. step. If the accounting shows meaningful foreign content, use a qualified claim sized to the truth — or market origin differently, through state or regional origin claims that still must be accurate. Review claims when supply chains change: a switched component supplier can silently convert a compliant claim into a violation, and the label does not update itself. And keep the analysis dated and filed — the FTC's standard is reasonable basis at the time of the claim, which means documentation you can produce.

Origin claims sell because buyers care. The FTC rule is what keeps that caring from becoming liability — and the businesses that document their supply chain before printing the label get the marketing benefit without the enforcement education.

Frequently Asked Questions

When can a product be labeled Made in USA?
When it was last substantially transformed in the U.S. and all or virtually all of its content and processing are domestic — foreign content must be negligible. The FTC's Labeling Rule carries civil penalties per violation, online claims included.
What is a qualified Made in USA claim?
A claim like "Made in USA with imported parts" used when origin is genuinely mixed. The qualification must be clear and prominent and honestly describe what is domestic — fine print under a big unqualified claim is treated as unqualified.
Does Assembled in USA mean the same thing?
No — assembly claims require that the U.S. assembly be the last substantial transformation, not minor screwdriver work on imported components. Otherwise the claim must reflect the imported content.