Food
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Industry Information
For a list of Federal Register Notices related to Dietary Supplements, see Regulations & Laws.
On this page:
Resources on Labeling
- Dietary Supplement Labeling Guide April 2005
- Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods December 2009
- Guidance for Industry: 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
- Guidance for Industry: 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
- Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act November 2004
- Guidance for Industry: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide October 17, 2003
- Information Related to Qualified Health Claims
- Food Labeling Website
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
Warning Letters & Alerts
- FDA Sample Ephedra Warning Letter
- 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. - Dietary Supplement Alerts and Safety Information
(consumer advisories on specific supplements including kava, PC SPES, St. John's Wort; how to report problems; and other safety information )
Additional Dietary Supplement Industry Information
- Laws & Guidance Documents
- Laws Enforced by FDA
- Guidance Documents
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues July 2011
- 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
- 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
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