The FTC Made in USA Labeling Rule, codified at 16 CFR Part 323, became effective August 13, 2021. It is the first time the FTC's "all or virtually all" standard for domestic origin claims has been codified as a formal trade regulation rule — meaning the FTC can now seek civil penalties for violations rather than relying solely on its general authority under Section 5 of the FTC Act.
For food and supplement brands, origin claims on labels and in advertising must now satisfy either the unqualified or qualified claim standard, or be avoided entirely when supply chains involve foreign-sourced components or ingredients.
The "All or Virtually All" Standard for Unqualified Claims
An unqualified "Made in USA" claim — meaning a claim that does not include any qualification about the extent or nature of US content — must meet the "all or virtually all" standard under 16 CFR 323.3(a). This means:
The final assembly or processing must take place in the United States
All significant parts and processing that go into the product must be of US origin
The product must contain no — or negligible — foreign content
For food and supplement brands, this standard creates a high bar because most supply chains involve ingredients, extracts, or components sourced from outside the United States. Common foreign-sourced inputs include:
Botanical extracts from India, China, or South America
Vitamins and minerals synthesized overseas
Omega-3 fish oil from international fisheries
Protein isolates manufactured outside the US
Flavor compounds or carrier ingredients from global suppliers
If any significant ingredient or component is sourced from outside the US, an unqualified "Made in USA" claim generally cannot be made.
Qualified Claims
When a product does not meet the "all or virtually all" standard, a brand may make a qualified origin claim that accurately describes the extent of US content. Under 16 CFR 323.3(b), a qualified claim must be truthful and non-deceptive, and the qualification must appear clearly and conspicuously with the claim.
Examples of acceptable qualified claims:
"Made in USA from imported and domestic ingredients"
"Assembled in USA from foreign and domestic components"
"Manufactured in USA with [X]% US content"
Qualified claims allow brands to promote US manufacturing operations while being honest about the sourcing of ingredients or materials.
Civil Penalties for Violations
The Made in USA Labeling Rule enables the FTC to seek civil penalties of up to $51,744 per violation for companies that make unqualified "Made in USA" claims that do not satisfy the "all or virtually all" standard — without needing to prove prior notice or a consent order violation.
Prior to the rule's codification, the FTC could only pursue violations through its general Section 5 deception authority, which required consent orders before civil penalties could be imposed. The rule eliminates that procedural hurdle.
Interaction with Other Labeling Requirements
The FTC Made in USA Labeling Rule applies to labeling and advertising claims — it does not preempt USDA country-of-origin labeling (COOL) requirements that apply to certain agricultural commodities, or FDA's labeling authority over food and supplement products. For food and supplement brands, compliance with the Made in USA rule is a separate obligation alongside FDA labeling requirements under 21 CFR Part 101.
The FTC rule also does not affect the "Product of USA" claim for meat, poultry, and egg products, which is governed by USDA FSIS rules.
Common Violation Scenarios for Food and Supplement Brands
"Made in USA" on a supplement with imported botanicals or minerals — If any significant ingredient is sourced outside the US, an unqualified claim is not supportable
"American-made" claims in advertising without substantiation — The rule applies to advertising, not just labels; digital ads, social media posts, and website copy are covered
Flag imagery or other implied origin claims — The FTC treats implied origin claims the same as explicit claims; using American flag imagery on a product with foreign-sourced ingredients may imply an origin claim that cannot be substantiated
"Manufactured in our US facility" without qualification — If manufacturing occurs in the US but ingredients are sourced abroad, this statement may be interpreted as an implied "Made in USA" claim
How Truli Helps with Made in USA Compliance
Origin claim detection: Truli scans label copy and advertising for explicit and implied "Made in USA" or domestic origin claims
Ingredient origin flagging: Truli identifies common supplement and food ingredients typically sourced from outside the US that create compliance risk for unqualified origin claims
Cross-channel monitoring: Truli checks website copy, social media, and marketplace listings for origin claim language
Related Regulations
FTC Health Claims in Advertising — Substantiation requirements for health claims in advertising
FTC Endorsement Guides — Disclosure requirements for influencer and testimonial marketing
21 CFR Part 101 — FDA food labeling requirements
Frequently Asked Questions
Does the FTC Made in USA rule apply to digital advertising?
Yes. The rule applies to labeling and advertising across all channels — labels, packaging, websites, social media posts, digital ads, email marketing, and marketplace listings (such as Amazon product pages).
Can I say "Made in USA" if my product is manufactured in the US but uses imported ingredients?
Generally no, if the imported ingredients are significant. To make an unqualified claim, the product must be "all or virtually all" of US origin. If significant ingredients are imported, you must use a qualified claim such as "Made in USA from domestic and imported ingredients."
Does the rule apply to my website copy even if the label doesn't make a Made in USA claim?
Yes. The rule covers both labeling and advertising. If your website, social media, or paid advertising includes "Made in USA" claims that are not substantiated, you are exposed to FTC civil penalty risk regardless of what the label says.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Civil penalty amounts are adjusted periodically — Truli monitors FTC enforcement actions and penalty updates affecting food and supplement brands. Book a demo to see how.
