Industry Information and Regulations

Proposed and Final Regulations and Related Information

(The section below is a compilation of the principal regulations that govern the labeling and claims for dietary supplements. Other related information can be found elsewhere on this site.) 

• Dietary Supplement Labeling
  • 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    • Direct Final Rule Withdrawn December 28, 2005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)
  • Labeling on a "Per Day" Basis. Proposed Rule: Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day" Basis (Federal Register, January 12, 1999)
  • 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.
  • Interim Final Rule Prohibiting Use of Certain Cattle Materials that May Carry Risk of Bovine Spongiform Encephalopathy in Human Foods and Cosmetics July 14, 2004
  • Proposed Rule on Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle July 14, 2004
  • Advance Notice of Proposed Rulemaking July 14, 2004

•  Current Good Manufacturing Practices (CGMPs)
  • Final Rule: Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements
    • Federal Register Final Rule June 25, 2007
    • Federal Register Interim Final Rule (IFR): Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements June 25, 2007
    • Fact Sheet: Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts June 22, 2007
    • Consumer Update: Final Rule Promotes Safe Use of Dietary Supplements June 22, 2007
    • FDA Press Release: FDA Issues Dietary Supplements Final Rule June 22, 2007
  • Proposed Rule: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements
    • Federal Register Proposed Rule March 13, 2003
      • Extension of Comment Period Federal Register, May 19, 2003
    • Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking October 21, 2002
  • Advance Notice of Proposed Rule: Current Good Manufacturing Practice in Manufacturing, Packaging and Holding of Dietary Supplements (Federal Register, February 6, 1997)
  • New Dietary Ingredients
    • Final Rule:  Premarket Notification for a New Dietary Ingredient (Federal Register, September 23, 1997)
    • New Dietary Ingredients in Dietary Supplements (Explanation including: definition, notification process, and table of notifications received) (February 2001)
  • Special Issues
    • BSE ("Mad Cow Disease")
      • FDA: Bovine spongiform encephalopathy (BSE) (background, industry and consumer information, recent actions, etc.)
    • Ephedrine Alkaloids
      • see Special Issues web page.
  • Warnings and Safety Information
    • Dietary Supplement Alerts and Safety Information (consumer advisories on specific supplements including kava, PC SPES, St. John's Wort, etc.; how to report problems; and other safety information )

Correspondence Related to Policy

• FDA Letter Regarding Enforcement Discretion With Respect to Expanded Use of an Interim Health Claim Rule About Plant Sterol/Stanol Esters and Reduced Risk of Coronary Heart Disease (February 14, 2003)
• FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market (July 6, 2001)
• Concerns About Novel Ingredients in Conventional Foods (Policy Letter, Talk Paper, and follow up Warning Letters)
• Correspondence Related to Drug/Dietary Supplement Combination Products
  • Regulatory Status of Products that Combine an Over-the-Counter Drug with a Dietary Supplement (May 30, 2000)

Compliance Actions: Warning Letters 

• FDA Warning Letters
  Includes CFSAN warning letters. This is a search page for warning letters issued by FDA. You can browse warning letters by the most recent, company, subject, issuing office or date.
   

• Additional Dietary Supplement Industry Information

  • Laws & Guidance Documents
    • Laws Enforced by FDA
      • Federal Food Drug and Cosmetic Act
    • Guidance Documents
      • Structure/Function Claims, Small Entity Compliance Guide  (January 2002)
      • Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide (January 1999)
      • Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)
      • Notification of a Health or Nutrient Content Claim Based on an Authoritative Statement (June 1998)
      • Guidance for Industry: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003)

General Compliance and Inspection Information for Industry

• Inspections, Compliance, Enforcement and Recalls
  • FDA Inspection References (Manuals and other documents that provide procedures and guidance to FDA personnel for conducting their inspection and investigation activities)
  • FDA Compliance References (Compliance Policy Guides and Regulatory Procedure Manual)
  • FDA Recalls and Safety Alerts (Policies, Enforcement Reports, Safety Alerts)
• FDA Federal Register Documents, Code of Federal Regulations & Food, Drug, and Cosmetic Act includes:
  • How to Obtain Federal Register Documents and the Code of Federal Regulations
  • Dockets Management Home Page
  • Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking
• HACCP
• Interacting with the Center for Food Safety and Applied Nutrition
  
  

Codex Activities

• Codex Committee on Nutrition and Foods for Special Dietary Uses updated February 2001
  • Responses to Questions about Codex and Dietary Supplements August 2005