Dietary Supplements Guidance Documents & Regulatory Information

FDA develops regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act or other laws under which FDA operates.

To further support the public health goals of the Dietary Supplements Health and Education Act (DSHEA), FDA also issues guidance documents containing nonbinding recommendations to help industry understand and comply with all regulations and the law. You can access guidance and other regulatory documents by clicking on the links below.

• Current Good Manufacturing Practice (CGMP)
• New Dietary Ingredients
• Warning Letters & Safety Information
• Labeling and Claims
• Adverse Events Reporting and Recordkeeping
• General Compliance and Inspection Information for Industry
• Special Issues/Miscellaneous Items
• Archived Items of Interest

We solicit information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to the implementation of DSHEA.

• Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking (October 2002)

For additional information, see the Dietary Supplements webpage.

---

Current Good Manufacturing Practice (CGMP)

• Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (December 2010)
• Final Rule: Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements (June 2007)
  • Fact Sheet: Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts (June 2007)
  • Fact Sheet: Backgrounder on the Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements (June 2007)
• Hazard Analysis Critical Control Point (HACCP)

New Dietary Ingredients

• Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (April 2024)
• Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes (March 2024)
• Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification (May 2022)
• Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues (October 2016)
• Final Rule: Premarket Notification for a New Dietary Ingredient (September 1997)
• New Dietary Ingredients in Dietary Supplements (Background for Industry; includes definition, notification process, and requirements for submission)

Warnings Letters and Safety Information

• Dietary Supplement Alerts and Safety Information
• FDA 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)

Labeling and Claims

• General Labeling Guidance and Regulations:
  • Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Last Revised September 2009)
  • Final Rule: Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day'' Basis (December 2006)
  • Guidance for Industry: Dietary Supplement Labeling Guide (April 2005)
  • Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (November 2004)
  • Final Rule: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (July 2003)
  • Small Entity Compliance Guide: Structure/Function Claims (January 2002)
  • Final Rule: Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body (January 2000)
  • Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements (January 1999)
  • Final Rule: Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements… (June 1998)
  • Final Rule: Food Labeling Regulation, Amendments… (September 1997)
  • Final Rule: Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements… (September 1997)
  • Final Rule: Food Labeling; Notification Procedures for Statements on Dietary Supplements (September 1997)
  • Final Rule: Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements (September 1997)
• Labeling for Specific Products:
  • Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials (September 2018)
  • Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018)
  • Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (January 2014)
  • Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Supplements and Beverages (January 2014)
  • Guidance for Industry: FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements (June 2010)
  • Small Entity Compliance Guide: Food Labeling; Nutrient Content Claims for "High Potency" and Definition of "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (July 2008)
  • Small Entity Compliance Guide: Label Warning Statements for Iron-Containing Supplements and Drugs (October 2003)
  • Final Rule: Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements; Removal of Regulations for Unit-Dose Packaging Requirements for Dietary Supplements and Drugs (October 2003)
  • Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 1998)
  • 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 (September 1997)
  • Final Rule: Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements (January 1997)
• Health Claims:
  • Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (January 2009)
  • Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 2003)
  • More Information on Qualified Health Claims
  • Health Claims with Significant Scientific Agreement

To view structure/function claim notifications submitted to FDA before 2012, please visit regulations.gov and type “FDA-1997-S-0039” in the search box.

Structure/function claim notifications submitted to FDA after 2012 are separated by year. To view those submissions, please include the 4-digit year in the following search term:  FDA-YEAR-S-0024. Therefore, if you are looking for submissions made in 2018, you would type “FDA-2018-S-0024” in the search box.

FDA’s courtesy letters responding to such notifications can be found by typing “FDA-1997-S-0006” in the search box on regulations.gov.

Adverse Event Reporting and Recordkeeping

• Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (September 2013)

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)

Special Issues/Miscellaneous Items

• N-acetyl-L-cysteine
  • Guidance for Industry: Policy Regarding N-acetyl-L-cysteine (August 2022) 
• Vinpocetine
  • Statement on Warning for Women of Childbearing Age About Possible Safety Risks of Dietary Supplements Containing Vinpocetine (June 2019)
  • Federal Register Notice: Request for Comment on the Status of Vinpocetine (September 2016)
  • Vinpocetine in Dietary Supplements
• Bovine Spongiform Encephalopathy (BSE):
  • Final Rule: Use of Materials Derived from Cattle in Human Food and Cosmetics (March 2016)
  • Bovine spongiform encephalopathy (BSE)
• Codex and Dietary Supplements:
  • Codex Guidelines for Vitamin and Mineral Food Supplements (August 2005)
• Ephedrine Alkaloids:
  • Small Entity Compliance Guide: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (July 2008)
  • Final Rule: Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (February 2004)

Archived Items of Interest

• 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 2005)
• Dietary Supplements Subcommittee of the Food Advisory Committee Meeting Summary – Discussion of the Term “Metabolite” (March 2003)
• FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products from the Market (July 2001)
• Concerns About Novel Ingredients in Conventional Foods (January 2001)
• Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods (January 2001)
• Regulatory Status of Products that Combine an Over-the-Counter Drug with a Dietary Supplement (May 2000)