FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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Dietary Supplements

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.)

Correspondence Related to Policy

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

General Compliance and Inspection Information for Industry

CFSAN Adverse Event Reporting System

Codex Activities

FDA-DSFL Electronic Newsletter


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

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