Dietary Supplement Labeling

Requirements and guidance for labeling and making claims for supplements (e.g. qualified and structure/function claims).

• Nutrition Labeling, Statement of Identity and Ingredient Labeling. Final Rule:  Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation (Federal Register, September 23, 1997) (also available in PDF, 300KB)
  • Sample Labels (available in PDF)
• Nutrient Content and Health Claims, Comparative Percentage Claims, and Mandatory Structure/Function Claim Disclaimer. Final Rule: Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements (Federal Register, September 23, 1997)
• Requirements to Use the Nutrient Content Claims "High Potency" and "Antioxidants". Final Rule:  Food Labeling; Nutrient Content Claims: Definition for "High Potency" and Definition of "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Federal Register, September 23, 1997)

• Botanical Ingredients - Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals, (Federal Register, August 28, 2003)
  • Direct Final Rule
  • Proposed Rule
  • Direct Final Rule Withdrawn December 28, 2005
• Defining Structure/Function Claims That Can Be Used for Dietary Supplements. Final Rule: Statements Made for Dietary Supplements Concerning the Effect of a Product on the Structure or Function of the Body (Federal Register, January 6, 2000)
• Mandatory Warning Statement for Iron-containing Supplements and Special Packaging Requirements for High-Potency Iron Supplements. Final Rule: Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements (Federal Register, January 15, 1997)
• Notice: Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act; Availability
• Final Rule: Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day'' Basis
• Notification Procedures for Structure/Function Claims (30 Day Notifications). Final Rule:  Food Labeling; Notification Procedures for Statements on Dietary Supplements (Federal Register, September 23, 1997)
• Information related to qualified health claims (includes explanation, regulations, FDA letters, public meetings and other information).
• Other Labeling Information can be found on the Food Labeling Website.