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        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Dietary Supplements Guidance Documents & Regulatory Information Home
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          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Dietary Supplements Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Dietary Supplements Guidance Documents & Regulatory Information
  	
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    PrintFDA develops regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act or other laws under which FDA operates.

Dietary Supplements Proposed and Final RulesTo 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 InterestWe 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)
	Hazard Analysis Critical Control Point (HACCP)New Dietary Ingredients

Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification (May 2022)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 (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)Labeling and Claims

**General Labeling Guidance:**

	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)
		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)
		Small Entity Compliance Guide: Structure/Function Claims (January 2002)
		Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements (January 1999)
	**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)
		Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 1998)
	**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 AgreementTo 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)
	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)

                                                                                  Content current as of:
      03/06/2023
                  
                   
Regulated Product(s)
		 Dietary SupplementsDietary Supplements Guidance Documents & Regulatory Information
 
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