Made in USA Compliance Guide

“Made in USA” is a regulated claim. Get it right and it’s a real selling point; get it wrong and it’s an FTC problem. Here’s the standard in plain language, the difference between qualified and unqualified claims, and checklists for buyers and suppliers.

The standard: “all or virtually all”

For an unqualified “Made in USA” claim, the FTC requires that the product be “all or virtually all” made in the United States — all significant parts, processing, and labor of U.S. origin, with any foreign content negligible. Final assembly in the U.S. by itself does not meet the bar. The FTC enforces this under the FTC Act, and the Made in USA Labeling Rule (16 CFR Part 323), effective 2021, covers labels — including online and mail-order listings — with civil penalties.

Claim types

Types of U.S.-origin claims and what they mean
Claim	What it means
Made in USA (unqualified)	“All or virtually all” of the product — significant parts, processing, and labor — is of U.S. origin, with only negligible foreign content.
Assembled in USA	The product’s principal assembly happens in the U.S. and its last “substantial transformation” occurred here, even if parts are imported.
Made in USA of U.S. and imported parts	A qualified claim that’s accurate when the product mixes domestic and foreign content — must not overstate the U.S. portion.
Designed / Engineered in USA	Speaks only to design or engineering, not manufacture — must be truthful and not imply U.S. manufacture.

Buyer checklist

Decide whether you need an unqualified "Made in USA" claim or a qualified one ("Assembled in USA", etc.).
Put the origin requirement in the RFQ and PO — don’t assume it.
Require suppliers to document the origin of significant parts and processes.
Collect supporting records (mill certs, country-of-origin declarations) and keep them.
For government work, check the separate Buy American / BABA rules — they are not the same as the FTC standard.

Supplier checklist

Trace the origin of raw material and significant components, not just final assembly.
Quantify foreign content; “negligible” is the bar for an unqualified claim.
Use a qualified claim if you can’t meet "all or virtually all."
Keep substantiation on file before making any origin claim on labels or listings.
Apply the same care to online and mail-order listings — the Labeling Rule reaches those.

This is general information, not legal advice. Confirm specifics against current FTC guidance (the “Complying with the Made in USA Standard” guide and 16 CFR Part 323) and consult counsel for your products.

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Frequently asked questions

What does "all or virtually all" mean?: It is the FTC standard for an unqualified "Made in USA" claim: all significant parts, processing, and labor are of U.S. origin, and any foreign content is negligible. Final assembly in the U.S. alone is not enough.
Is there a law, or just guidance?: Both. The FTC enforces the standard under the FTC Act, and the Made in USA Labeling Rule (16 CFR Part 323, effective 2021) covers labels — including online and mail-order listings — and carries civil penalties.
What if my product has some imported parts?: Use a truthful qualified claim, such as "Assembled in USA" or "Made in USA of U.S. and imported parts." The claim must not overstate the U.S. content.
Is Buy American the same thing?: No. The FTC standard governs marketing claims to consumers. Government procurement uses separate Buy American Act / Build America, Buy America (BABA) content rules with their own thresholds.

Made in USA Compliance Guide

The standard: “all or virtually all”

Claim types

Types of U.S.-origin claims and what they mean
Claim	What it means
Made in USA (unqualified)	“All or virtually all” of the product — significant parts, processing, and labor — is of U.S. origin, with only negligible foreign content.
Assembled in USA	The product’s principal assembly happens in the U.S. and its last “substantial transformation” occurred here, even if parts are imported.
Made in USA of U.S. and imported parts	A qualified claim that’s accurate when the product mixes domestic and foreign content — must not overstate the U.S. portion.
Designed / Engineered in USA	Speaks only to design or engineering, not manufacture — must be truthful and not imply U.S. manufacture.

Buyer checklist

Decide whether you need an unqualified "Made in USA" claim or a qualified one ("Assembled in USA", etc.).
Put the origin requirement in the RFQ and PO — don’t assume it.
Require suppliers to document the origin of significant parts and processes.
Collect supporting records (mill certs, country-of-origin declarations) and keep them.
For government work, check the separate Buy American / BABA rules — they are not the same as the FTC standard.

Supplier checklist

Trace the origin of raw material and significant components, not just final assembly.
Quantify foreign content; “negligible” is the bar for an unqualified claim.
Use a qualified claim if you can’t meet "all or virtually all."
Keep substantiation on file before making any origin claim on labels or listings.
Apply the same care to online and mail-order listings — the Labeling Rule reaches those.

Frequently asked questions

What does "all or virtually all" mean?

It is the FTC standard for an unqualified "Made in USA" claim: all significant parts, processing, and labor are of U.S. origin, and any foreign content is negligible. Final assembly in the U.S. alone is not enough.

Is there a law, or just guidance?

Both. The FTC enforces the standard under the FTC Act, and the Made in USA Labeling Rule (16 CFR Part 323, effective 2021) covers labels — including online and mail-order listings — and carries civil penalties.

What if my product has some imported parts?

Use a truthful qualified claim, such as "Assembled in USA" or "Made in USA of U.S. and imported parts." The claim must not overstate the U.S. content.

Is Buy American the same thing?

No. The FTC standard governs marketing claims to consumers. Government procurement uses separate Buy American Act / Build America, Buy America (BABA) content rules with their own thresholds.