Dietary Supplements: A Regulatory Guide

Authored by Olsson Frank Weeda Terman Bode Matz PC


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Dietary supplements are regulated by the Food and Drug Administration (FDA) very differently in important respects from "conventional foods." Manufacturers of dietary supplements and the dietary ingredients that they contain must comply with far more specific current good manufacturing practice (CGMP) requirements, distinct labeling requirements, separate adverse event reporting requirements, and several requirements not applicable to conventional foods (e.g., new dietary ingredient (NDI) notification). Dietary supplements and dietary ingredients also are regulated under a safety standard that is different from the food additive/GRAS framework, and therefore may contain ingredients not permitted in conventional foods.

Any company in the business of manufacturing, distributing, or otherwise selling dietary supplements or dietary ingredients must be familiar with FDA's regulatory regime. In some cases, a particular product might be marketed as a dietary supplement or as a conventional food, and businesses need to know the advantages and disadvantages of each approach.

This Guide covers all aspects of FDA regulation of dietary supplements under the Dietary Supplement Health and Education Act (DSHEA), an amendment to the Federal Food, Drug, and Cosmetic Act , as well as Federal Trade Commission (FTC) regulation of dietary supplement advertising.

Topics covered include:

  • The laws and agencies that regulate dietary supplements
  • What is, and is not, a "dietary supplement"
  • The DSHEA safety standard
  • NDI notifications
  • FDA prohibitions and warnings for particular dietary ingredients - including banned ingredients, required label warnings, Import Alerts, and unofficial FDA warnings
  • Labeling of a dietary supplement, including a detailed discussion of the Supplement Facts panel, ingredient labeling, nutrient content claims, health claims, and so-called "structure/function claims"
  • The "third party literature exemption" from "labeling" that facilitates marketing a dietary supplement for its health benefits
  • CGMP regulations and FDA enforcement priorities
  • FDA inspections, including authority to access company records
  • Bioterrorism Act requirements (e.g., facility registration, prior notice of imports, recordkeeping)
  • Adverse event reporting requirements
  • FTC advertising requirements and restrictions (e.g., endorsements and testimonials, "doctor recommended" claims, traditional use claims).

 

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