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.)

• Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 (Federal Register Notice of Availability November 9, 2004)
  • Fact Sheet on FDA's Strategy for Dietary Supplements November 4, 2004
  • Questions and Answers: Strategy for Dietary Supplements November 4, 2004
• Dietary Supplement Labeling
  • http://www.cfsan.fda.gov/~dms/ds-labl.html
    Requirements and guidance for labeling and making claims for supplements (e.g. qualified and structure/function claims).
  • Dietary Supplement Rules Published (Talk Paper, September 23, 1997)
    • 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    • Direct Final Rule Withdrawn December 28, 2005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 at: http://www.cfsan.fda.gov/label.html
  • Fact Sheet about FDA's New Interim Rule and Proposed Rule on Prohibited Cattle Materials in Food and Cosmetics July 9, 2004  
    • 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
    • Backgrounder: Final Rule for Current Good Manufacturing Practices for Dietary Supplements 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
    • Satellite Broadcast May 9, 2003 April 15, 2003
      • Federal Register Notice April 21, 2003
    • Public Meetings April 29 and May 6, 2003 Federal Register March 28, 2003
      • Meeting Correction Federal Register April 14, 2003
      • Current Good Manufacturing Practices (CGMP's) (Slide presentation) April 29 and May 6, 2003
        • FDA Proposal for Dietary Supplements
        • Analysis of Economic Impact
        • How to Comment to Improve the Regulation
    • Federal Register Proposed Rule March 13, 2003
      • Extension of Comment Period Federal Register, May 19, 2003
      • FDA Backgrounder: FDA Proposes Labeling and Manufacturing Standards for all Dietary Supplements March 7, 2003
      • FDA Fact Sheet: FDA Proposes Labeling and Manufacturing Standards Dietary Supplements March 7, 2003
      • FDA Press Release: FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements March 7, 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
  • Premarket Notification for New Dietary Ingredient Notifications; Public Meeting, November 15, 2004 (Federal Register, October 20, 2004)
    • Transcript of November 15, 2004 Public Meeting (Also available in Word and PDF*)
    • Meeting Information and Pre-Registration Form
  • 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 Ephedrine Alkaloids web page. (alerts, public meetings, and regulations)
  • Warnings and Safety Information
    • http://www.cfsan.fda.gov/~dms/ds-warn.html (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 Warns Manufacturers to Stop Distributing Products Containing Androstenedione March 11, 2004
• 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 Letter on Labeling Food Products Presented or Available on the Internet (this includes Dietary Supplements) (also available in PDF) (November 1, 2001)
• 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)
• Letter to Reiterate Certain Public Health and Safety Concerns to Firms Manufacturing or Importing Dietary Supplements that Contain Specific Bovine Tissues (November 14, 2000)
• Dietary Supplement Claim for Saw Palmetto Extract and Benign Prostatic Hyperplasia: Denied (May 26, 2000)
• Correspondence Related to Drug/Dietary Supplement Combination Products
  • Concern About Marketing the Melagesic PM Product and All Other Products that Combine a Dietary Supplement and a Drug (May 30, 2000)
  • Regulatory Status of Products that Combine an Over-the-Counter Drug with a Dietary Supplement (May 30, 2000)
  • Regulatory Status of the Good News Andy Pill (May 30, 2000)
  • Warning Letters Related to Combination Products
    • Letter on Melagesic (available in PDF) (October 16, 2001)
    • Letter on Inholtra Joint Pain Caplets (available in PDF) (October 16, 2001)

Compliance Actions: Cyber and Warning Letters and Related Information

• "Cyber" Letters
  FDA's Center for Food Safety and Applied Nutrition (CFSAN) issues cyber letters to firms that market dietary supplement products on the Internet, advising them that the therapeutic claims, e.g., to diagnose, mitigate, treat, cure, or prevent a specific disease or diseases, on their Web site, establish that the products are drugs. Examples of products addressed in these cyber letters include: "colloidal silver," "red thyme," flaxseed oil," and "colostrum."
• 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.
• FDA Grants Citizen's Petition Seeking Unapproved Drug Classification for "Nicotine Water" (July 2, 2002)

Additional Dietary Supplement Industry Information

• Laws & Guidance Documents
  • Laws Enforced by FDA
    • Dietary Supplement Health and Education Act of 1994 (amended the Federal Food, Drug and Cosmetic Act)
    • Federal Food Drug and Cosmetic Act
    • Fair Packaging and Labeling Act
  • Guidance Documents
    • Structure/Function Claims, Small Entity Compliance Guide (also available in PDF) (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)
    • Iron-Containing Dietary Supplements (November 1997)
    • Gelatin - Guidance for Industry: Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-regulated Products for Human Use (September 1997)
• Contracts and Agreements
  • Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition to Assist FDA in Implementing DSHEA Regarding Products that Bear Structure/Function and/or Disease Claims (June 1, 2005)
  • Letter to Stakeholders Regarding Contract on Dietary Supplement Safety Issues (December 15, 2000)
• Other
  • Economic Characterization of Dietary Supplement Industry (also available in PDF) (March 1999)
  • Dietary Supplement Sales Information (also available in PDF) (October 1999)

General Compliance and Inspection Information for Industry

• Imports and Exports (Procedures, Compliance Programs, Import Alerts, Detentions)
  • Certificates of Free Sale
  • FDA Certificates to Foreign Governments: FDA Points of Contact
  • Guidance for Industry: FDA Export Certificates (also available in PDF) (August 2002)
• 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
• Information Materials for the Food and Cosmetics Industries (How to reach FDA small business representatives, FDA field offices, and FDA import and domestic compliance offices; and information materials for industry, e.g., publications and other materials)

CFSAN Adverse Event Reporting System

• Letter to Stakeholders: Announcing CAERS - the CFSAN Adverse Event Reporting System (August 29, 2002)
• Special Nutritional Adverse Event Monitoring System Website Removed (August 29, 2002)

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
  • Risk Assessment Model for Establishing Upper Intake Levels for Nutrients
    • Full Paper (June 1998) (117 KB compressed, self-extracting, MS Word document)
• Issues Surrounding Elaboration of a Codex Guideline for Vitamin and Mineral Supplements (March 15, 2000)

FDA-DSFL Electronic Newsletter

• How to Subscribe to the Dietary Supplement and Food Labeling Electronic Newsletter or Obtain Past Issues

*PDF Readers are available for free from the Adobe Acrobat web site.