Made in USA claims: the FTC's “all or virtually all” standard, the Labeling Rule and supplements

A product can carry an unqualified Made in USA claim only if it is "all or virtually all" made in the US: final assembly or processing here, all significant processing here, and all or virtually all ingredients or components made and sourced here. Since August 13, 2021, the FTC's Made in USA Labeling Rule has backed that standard with civil penalties, now up to $53,088 per violation.

What does a Made in USA claim require?

The FTC's standard has three conditions, written into the Made in USA Labeling Rule at 16 CFR 323.2. A product may be labeled Made in the United States only if:

1. its final assembly or processing happens in the US;
2. all significant processing that goes into it happens in the US; and
3. all or virtually all of its ingredients or components are made and sourced in the US.

The FTC's business guide, Complying with the Made in USA Standard, puts it in one line: the product "should contain no — or negligible — foreign content."

What counts as a claim is broad. The rule covers any unqualified representation, express or implied, that a product is of US origin, including saying it is made, manufactured, built, produced, created or crafted in the United States or America (323.1). The FTC's guide adds that US flags, outlines of US maps and references to a US headquarters or factory can convey the claim without any of those words.

Three points are easy to miss:

• The claim is voluntary. US law requires a US-content disclosure only on certain products, such as automobiles and textile, wool and fur products. For everything else, the rules apply when you choose to make the claim.
• Nobody pre-approves it. The FTC doesn't pre-approve Made in USA claims. You need competent and reliable evidence that the product is all or virtually all made in the US, and you have to update your marketing when that changes, for example when you start sourcing parts abroad.
• It covers every channel. The FTC's policy applies to origin claims on products and labeling, in advertising and in other promotional materials, including digital marketing. For the other claims a VSL makes, see the VSL compliance guide.

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

The FTC's guide weighs three things: how much of the product's total manufacturing cost is US content, how far removed any foreign content is from the finished product, and how important that content is to the product's form or function. Cost alone doesn't settle it. Look back far enough in the supply chain to be reasonably sure no significant foreign content is hiding there.

The guide's two raw-material examples show how the factors play out:

• A gold ring. If the gold is imported, an unqualified Made in USA claim for the ring is deceptive.
• A clock radio. If the plastic case is made from imported petroleum, the claim is likely appropriate, because the petroleum is far enough removed from the finished product.

The FTC says you can rely on information from suppliers in good faith, but you shouldn't assume any input is 100% US-made. Ask each supplier in writing where its material is made and sourced, and keep the answers with their dates. Then run each product through these questions in order:

Can this product say Made in USA?

1. 1Final assembly or processing in the US?If not, no unqualified claim. Describe what you do here, or say nothing about origin.
2. 2All significant processing in the US?If not, no unqualified claim.
3. 3All or virtually all inputs made and sourced in the US?Weigh each input's cost share, its distance from the finished product and its importance.
4. 4Yes to all threeAn unqualified Made in USA claim can work, with the evidence on file.
5. 5OtherwiseA qualified claim only if US content or processing is significant; if not, no origin claim.

The Made in USA Labeling Rule: what it covers and the penalties

The FTC published the Made in USA Labeling Rule on July 14, 2021, and it took effect on August 13, 2021 (Federal Register). It applies to:

• labels on products that make an unqualified Made in USA claim; and
• mail order catalogs and mail order promotional materials, printed or electronic, that carry a Made in USA seal, mark, tag or stamp. The rule defines those as materials used to sell directly, by mail, phone, email or another method, where the buyer can't examine the product before buying (323.1 and 323.3).

On our reading of those definitions, a VSL page that sells your product online and shows a Made in USA badge is promotional material with a mark, and the rule's standard applies to the badge. Origin claims without a seal or mark, such as a narrator saying "made right here in America", are judged under the FTC's broader Made in USA policy, which applies the same standard by net impression.

Violations are treated as violations of a rule under section 18 of the FTC Act (323.4), which brings civil penalties. The maximum is $53,088 per violation (16 CFR 1.98); in September 2026 the FTC said it would keep that 2025 level after the 2026 inflation adjustment was canceled (Federal Register, 2026). The rule doesn't push aside state country-of-origin laws except where they conflict with it, and a state rule that gives consumers more protection doesn't count as a conflict (323.5).

Here is the rule's short history, with the two cases that show how it is enforced:

The Made in USA Labeling Rule

1. Jul 14, 2021Rule publishedMade in USA Labeling Rule, 86 FR 37022
2. Aug 13, 2021Rule takes effectCivil penalties apply to non-compliant labels and seal-bearing promotional materials
3. Apr 2022First case under the ruleLithionics Battery: a proposed civil penalty of $105,319.56
4. Jan 26, 2024Largest penalty under the ruleKubota: $2 million for Made in USA labels on parts made overseas
5. Sep 15, 2026Penalty level heldThe FTC keeps the 2025 maximum of $53,088 per violation

Lithionics Battery (2022). In the first case under the rule, the FTC alleged that the company's products carried a flag image with the words "Made in U.S.A.", sometimes with "Proudly Designed and Built in USA", on its website, in catalogs and on social media, while its battery products used lithium-ion cells made in China. The proposed order included a civil penalty of $105,319.56 (FTC).

Kubota (2024). The FTC said Kubota North America labeled thousands of replacement parts for its tractors and other equipment as Made in USA even though they were made entirely overseas, including parts whose manufacturing it moved abroad without updating the labels. The $2 million civil penalty was the largest ever in a Made in USA case (FTC).

Kubota is the case for supplement brands to study: manufacturing moved, and the labels stayed the same. Every supplier or formula change should trigger a check of every origin claim you make.

How to write a qualified Made in USA claim

A qualified claim "describes the extent, amount or type of a product's domestic content or processing." The FTC's examples include "60% U.S. content", "Made in USA of U.S. and imported parts" and "Couch assembled in USA from Italian Leather and Mexican Frame". The same guide adds two cautions:

• Qualified claims can still overstate. Even a qualified claim may imply more US content than the product has, so the FTC advises avoiding them "unless the product has a significant amount of U.S. content or U.S. processing." In its treadmill example, the machine is assembled in the US but the motor, frame and display are imported, and US parts are about 3% of the parts cost. "Made in USA of U.S. and Imported Parts" is deceptive there, while "Made in U.S. from Imported Parts" or "Assembled in U.S.A." would not be.
• A claim about one step must say so clearly. "Designed in USA — Made in Finland" is fine, because no reasonable buyer would think the whole product was made in the US. "Created in USA" on a product made abroad is deceptive, because buyers read "created" as made.

Applied to a fictional supplement whose active ingredient is imported but which is blended, encapsulated and bottled in the US, the wording sorts like this:

Origin wording for a supplement

Fictional product: imported active ingredient, blended, encapsulated and bottled in the US

Deceptive for this productUnqualified claims

• Made in USA
• American-made formula
• A US flag next to the product name
• Proudly made in America

Can be truthful, with evidenceSpecific or qualified claims

• Blended, encapsulated and bottled in the USA from imported ingredients
• Encapsulated in [state] from ingredients made in [countries]
• Made in USA from domestic and imported ingredients, only if the US share is significant

When can you say "Assembled in USA"?

A product "may be called 'Assembled in USA' without qualification when its principal assembly takes place in the U.S." and the assembly is substantial. Its last substantial transformation must also happen in the US, and a simple "screwdriver" assembly of imported parts usually doesn't qualify.

For supplements, "assembled" is an odd word, and the FTC's guide has no guidance specific to food or supplements. Describe the step you really perform in plain words (blended, encapsulated, tableted, bottled, packed) and say where the ingredients come from. Whether mixing imported powders counts as a substantial transformation is a question for your lawyer, not your copywriter.

Made in USA claims for supplements

A supplement has more inputs than its label suggests: the dietary ingredients, the other ingredients such as fillers and binders, the capsule, and the packaging. The standard covers "all or virtually all ingredients or components," so each one goes into the analysis, weighed by the three factors.

The active ingredient carries the most weight. It is the reason the product exists, which goes to the factor about importance to the product's form or function, and it can be a large share of the cost. If it's imported, an unqualified Made in USA claim is hard to support, even when every step after that happens in the US.

Packaging doesn't rescue the claim. The FTC says that putting Made in USA on the package of an imported product "would deceive consumers about the origin of the product inside," and it suggests keeping the two apart, as in "Computer Made in Korea. Packaging Made in USA."

Three familiar supplement phrases deserve a second look:

• "Made in the USA in a GMP-certified facility." The origin half is an unqualified claim and needs the all-or-virtually-all standard behind it; the certification half needs its own proof.
• "Manufactured in a US facility." The FTC's guide doesn't address this exact phrase, but it notes that references to US factory locations can convey an origin claim. If the ingredients are imported, say so in the same sentence.
• "Made in USA with globally sourced ingredients." "Globally sourced" says something is foreign, but not what or how much. Name the imported ingredients, and don't lead with Made in USA when most of the value is foreign.

Check the video as well as the page. If your VSL shows an origin badge, it's a mark on promotional material like any other. RevvyScales' video watermark (Growth plan and up) places an image overlay, such as a compliance mark, on the video (watermark); if you use one for an origin statement, use the accurate, qualified wording and change it when your suppliers change.

When you choose a supplement manufacturer or a private label formula, ask for the country of origin of every ingredient in writing, and keep the claims on your label and your page consistent (supplement label requirements). Origin is one decision among many in our guide to starting a brand:

A Made in USA claims checklist

Before you print a label or publish a page with an origin claim, check:

Made in USA claims: pre-launch check

• List every place an origin claim appears: label, box, VSL, page badges, ads, emails, marketplace listings
• Include implied claims: flags, maps, lines about your US factory or headquarters
• Get the country of origin of every ingredient, capsule and packaging part in writing
• Check the three conditions: final processing, all significant processing, all or virtually all inputs
• If any input is imported and not negligible, rewrite as a qualified or specific-step claim
• Make a qualified claim say what is imported, in the same line as the claim
• Keep the evidence file, with a date on each supplier statement
• Re-check every origin claim when a supplier, ingredient or manufacturing site changes

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If the answers are uncertain, leave the claim off. US law doesn't require most products to carry one, and an origin claim you can't prove is a risk you don't need to take.