Key Points:

• Regulated claims must be truthful, evidence-based, and follow FDA, USDA, or FTC standards.
• Common regulated claims include health, nutrient content, organic, and gluten-free claims.
• Using claims incorrectly can create legal risk. Always verify claims with manufacturers or certifying bodies.

This article describes regulated claims and how sellers can use them correctly to help stay compliant with US regulations.

Regulated Claims

Regulated claims describe a product’s benefits and are governed by US regulatory agencies. This includes:

• Food and Drug Administration (FDA)
• US Department of Agriculture (USDA)
• Federal Trade Commission (FTC)

Regulated claims help ensure consumers receive accurate, science-based information. They help sellers promote products responsibly.

Common Types of Regulated Claims

Health Claims

• Describes the relationship between a food, ingredient, or supplement to a reduced risk of disease or health-related condition.
• Must be authorized by the FDA and supported by scientific evidence.

Examples:

• “Adequate calcium, as part of a well-balanced diet, may reduce the risk of osteoporosis.”
• "A diet low in total fat may reduce the risk of some cancers. Cancer development depends on many factors."
• “Diets low in sodium may reduce the risk of high blood pressure. This disease is associated with many factors.”
• "Three grams of soluble fiber from whole grain oats daily, as part of a low saturated fat and cholesterol diet, may help reduce heart disease risk."

Nutrient Content Claims

• Describe the amount of a nutrient in a product.
• Must meet FDA-defined thresholds.
• Example:
  • "Low calorie"
  • "Free total fat"
  • "Reduced saturated fat"
  • "Low cholesterol"
  • "Light in sodium"
  • "No added sugars"

Structure/Function Claims

• Describe how a nutrient or ingredient supports normal body structure or function.
• Do not require FDA pre-approval. They must include a disclaimer stating they are not FDA-evaluated.
• Example:
  • “Calcium builds strong bones.”
  • "Supports immune and digestive health."
  • "Fiber helps maintain bowel regularity."
  • "Antioxidants maintain cell integrity."

USDA Organic Claims

• Products labeled “Organic” must meet USDA National Organic Program (NOP) standards.
• Certification confirms compliance with approved farming and production practices.
• Example:
  • "Certified Organic by USDA"
  • "100% Organic"
  • "Organic

Gluten-Free Claims

• Regulated by the FDA.
• Products must contain less than 20 ppm of gluten.
  • Important for consumers with celiac disease or gluten intolerance.
• Example:
  • "Gluten-Free"
  • “No Gluten”
  • “Free of Gluten”
  • “Without Gluten”

Non-GMO Claims

• Must be truthful and not misleading under FDA standards.
  • Assures consumers that the product doesn't contain genetically modified organisms.
• Example:
  • “Not bioengineered.”
  • “Not genetically engineered.”
  • “Not genetically modified through the use of modern biotechnology.”
  • “We do not use ingredients that were produced using modern biotechnology.”
  • “This oil is made from soybeans that were not genetically engineered.”
  • “Our corn growers do not plant bioengineered seeds.”

FTC Green Guides & Environmental Claims

• Green marketing claims, such as “eco-friendly” or “biodegradable,” must follow FTC guidelines.
  • These claims must be substantiated to prevent misleading consumers.
• Example:
  • "Compostable"
  • "Biodegradable"
  • "Free-of Paraben"
  • "Ozone-Safe"
  • "Recyclable"
  • "Renewable Energy"

Made in USA Claims

• Regulated by the FTC.
• “All or virtually all” of the product must be made in the United States.
• Example:
  • "Made in USA"
  • "Our products are American-made."
  • "USA"

Best Practices for Compliance

• Check regulatory definitions before using a claim.
• Work with manufacturers and certification bodies to verify claims. This could be USDA Organic, Non-GMO Project, etc.
• Only use claims that appear on the original product label.
• If a claim is not on the label, do not include it in the listing.
• Stay informed about regulatory updates.

Importance for Sellers

Using regulated claims correctly helps you:

• Build customer trust
• Avoid legal and reputational risk
• Stay aligned with platform policies
• Create clear and compliant product listings

For more details, see official FDA, USDA, and FTC guidance.