The FTC's Made in USA Labeling Rule (16 CFR Part 323), finalized in 2021 and codified from decades of FTC enforcement guidance, establishes the legal standard for unqualified "Made in USA" claims on products sold in the United States. For supplement and food brands, the rule creates significant compliance risk because ingredient supply chains in these industries are overwhelmingly international.
The "All or Virtually All" Standard
Under 16 CFR Part 323, an unqualified "Made in USA" claim — stated without any qualification about which components are domestic — must meet the "all or virtually all" standard. This means:
All significant parts and processing that go into the product must be of U.S. origin
The product must contain no (or negligible) foreign content
"All or virtually all" does not mean a majority. It does not mean the manufacturing occurred in the U.S. A product assembled in the U.S. from predominantly foreign-sourced ingredients does not qualify for an unqualified Made in USA claim.
Why This Is Hard for Supplements
The supplement industry's ingredient supply chain is global. The majority of vitamins, botanical extracts, amino acids, and mineral compounds used in U.S. supplements are sourced from China, India, and other international suppliers. A supplement that is:
Formulated in the U.S.
Manufactured (encapsulated, tableted, blended) in the U.S.
Using predominantly imported ingredients
...does not qualify for an unqualified Made in USA claim under the FTC standard.
This is true even if the final manufacturing step occurs domestically. The test is the origin of the finished product's components, not just where the last manufacturing step happened.
Qualified Claims: What You Can Say
The FTC's rule permits qualified Made in USA claims that accurately describe the domestic content. Permissible qualified claims include:
"Made in USA with imported ingredients" — discloses the foreign content
"Manufactured in the USA from domestic and foreign materials" — describes the hybrid sourcing
"Assembled in the USA" — if assembly is the primary domestic activity
"Product of USA" paired with a specific percentage claim — if the domestic content percentage is accurate
A qualified claim must be accurate and not misleading about the extent of domestic content. "Made in the USA from domestic and imported ingredients" when 95% of ingredients are imported is accurate. "Made with pride in the USA" with no qualification, when all ingredients are imported, is a potentially misleading unqualified claim.
The USDA "Product of USA" Standard
For food products, the USDA administers a separate "Product of USA" standard under its voluntary labeling program and, for meat and poultry, through mandatory COOL (Country of Origin Labeling) requirements. USDA's 2023 final rule tightened the "Product of USA" standard for meat and poultry, requiring that animals be born, raised, and slaughtered in the United States. The FTC and USDA standards both apply depending on the product category.
FTC Enforcement Patterns
FTC has pursued Made in USA enforcement across industries. In the supplement and consumer goods space, enforcement typically targets:
Unqualified Made in USA flags or seals on products with imported ingredients
"American-made" or "USA-made" claims in advertising without qualification
E-commerce listings (Amazon, DTC websites) making unqualified origin claims
Influencer and affiliate content making Made in USA claims the brand didn't script but is responsible for under 16 CFR Part 255
Under 16 CFR Part 323, civil penalties for Made in USA violations can reach $50,120 per violation. FTC issued this rule as a standalone regulation specifically to allow monetary penalties — the FTC Act Section 5 administrative process doesn't allow first-instance monetary penalties, but the Made in USA Rule does.
"Made in USA" is a precise legal claim with a high threshold — qualification is almost always the right approach for supplement brands
Truli reviews Made in USA and origin claims on supplement labels, product websites, and marketing materials against the FTC's "all or virtually all" standard — identifying unqualified claims where ingredient sourcing data doesn't support the domestic content representation, and recommending qualified claim language that is accurate and legally defensible.
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.
