How dietary supplements are regulated

In the USA, Dietary supplements are regulated by DSHEA (the Dietary Supplement Health and Education Act of 1994 and their manufacture is controlled by the FDA (Food & Drug Administration). DSHEA defines dietary supplements as food and not drugs. If supplements were categorized as drugs and required to go through the new-drug approval process, we would see most supplements disappear, mainly because of the significant costs associated with the Drug approval process (millions, or tens of millions of dollars).

DSHEA spells out Regulations regarding the manufacture and sale of dietary supplements and defines a Dietary Supplement as "a product (other than tobacco) intended for ingestion and to supplement the diet that bears or contains one of more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or a combination of any of these ingredients."

DSHEA defines permissible labeling claims and places the burden of proof on the FDA to show that a product is unsafe. It also outlines safety requirements for New Dietary Ingredients.

DSHEA grants the FDA the authority to regulate dietary supplements in two important respects:

  1. Product Labeling: Whenever a marketer wants to make a claim about a supplement, it must submit the proposed claim to the FDA within 30 days after its first use. Claims are limited to "general structure function" and as a rule may not assert that a product treats, cures, prevents or mitigates any disease. The FDA may stop the manufacturer from advertising the claim if it is deemed impermissible.

  2. Good Manufacturing Practices (GMP): DSHEA holds supplement manufacturers to industry standards for maintaining product quality. In addition, the Federal Trade Commission (FTC) maintains authority over supplement advertising: Manufacturers must report truthfully what their products contain and must have proof backing up any claims they make.

What are the allowable claims?

How are the regulated in Canada, or in Europe?

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