Food
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Dietary Supplements Guidance Documents & Regulatory Information
Guidance documents contain nonbinding recommendations
Table of Contents
- Current Good Manufacturing Practice (CGMP)
- Warning Letters & Safety Alerts
- Labeling and Regulation
- Correspondence, Statements, and Agreements Related to Policy
- Health Claims
- Qualified Health Claims
- Adverse Events Reporting
- General Compliance and Inspection Information for Industry
- Codex Activities
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
- 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
- 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
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues July 2011
- 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.
- BSE ("Mad Cow Disease")
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 )
- 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 Regulation
- New Dietary Ingredients (NDI): New Dietary Ingredient Notifications and Related Issues July 2011
- Liquid Dietary Supplements: FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements June 2010
- Liquid Dietary Supplements: FDA Letter to Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages
- Liquid Dietary Supplements: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods December 2009
- Labeling: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act December 2007; Revised December 2008 and September 2009
- A Dietary Supplement Labeling Guide April 2005
- Ephedrine Alkaloids: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk July 17, 2008
- Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide October 17, 2003
- Labeling: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide January 1999
- Nutrient Content Claims: Food Labeling; Nutrient Content Claims; Definition for "High Potency" and Definition for "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods Small Entity Compliance Guide July 2008
- Structure/Function Claims: Small Entity Compliance Guide January 9, 2002
- Substantiation for Claims: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act November 2004
- Regulations & Laws about Dietary Supplements
Correspondence, Statements, and Agreements Related to Policy
- Concerns About Novel Ingredients in Conventional Foods
- Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods January 30, 2011
- FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements June 15, 2010
- FDA Letter to Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages November 30, 2009
- 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
- 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
- "Dear Colleague" Letter about August 8, 2000 Public Meeting Concerning the Safety of Dietary Supplements Containing Ephedrine Alkaloids June 8, 2000
- Regulatory Status of Products that Combine an Over-the-Counter Drug with a Dietary Supplement May 30, 2000
- Statement by Jane E. Henney, M.D., Commissioner Food and Drug Administration, Department of Health and Human Services, Before the Committee on Government Reform, U.S. House of Representatives March 25, 1999
- Laws Enforced by FDA
- Federal Food Drug and Cosmetic Act
Health Claims
- Evidence-Based Review System for the Scientific Evaluation of Health Claims January 2009
- Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements December 1999
- Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body June 1998
Qualified Health Claims
- Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 10, 2003
- More Information on Qualified Health Claims
Adverse Events Reporting
- Adverse Event Reporting and Recordkeeping: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act June 2009
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
- HACCP
Codex Activities
- Codex Committee on Nutrition and Foods for Special Dietary Uses updated February 2001
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