US Regulation: DSHEA and FDA Oversight of Dietary Supplements

This page describes the United States only, using FDA and NIH pages we read on 2026-10-23. Other countries use different systems; see the EU and the UK, Canada and Australia. A shorter first read is How supplements are regulated.

The law in one paragraph

The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the main U.S. food and drug law and set up a separate framework for supplements. FDA says that under DSHEA it is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. [1] FDA also says that in many cases firms can lawfully introduce supplements to the market without even notifying FDA. [1]

What counts as a dietary supplement

FDA's definition covers vitamins, minerals, herbs and other botanicals, amino acids, other dietary substances and concentrates, metabolites, constituents or extracts of these. [2] Herbs are therefore named in the legal definition. The same FDA page says topical or inhaled products are not supplements. [2] That matters for essential oils applied to skin or breathed in, which are covered in our essential oils safety guide.

Who is responsible for what

New dietary ingredients

A "new dietary ingredient" is one that was not marketed in the United States before October 15, 1994. [2] For such an ingredient, with an exception for ingredients already in the food supply in an unaltered form, FDA says the firm must notify FDA with safety information at least 75 days before marketing. [2] FDA's page does not list which herbs fall on which side of that date, and we do not guess.

Manufacturing and amounts

FDA says facilities that manufacture, process, pack or hold supplements for U.S. consumption must register with FDA. [2] On amounts, the same page says there are no laws or regulations that limit the serving size of a supplement, other than the firm's duty to meet safety and labeling rules. [2] In other words, a larger amount on a label is not evidence that regulators reviewed it. See Amounts and duplicate ingredients.

Label claims

A supplement sold for treatment, prevention or cure of a specific disease meets the definition of a drug, according to FDA. [2] FDA says structure/function claims (claims about effects on a structure or function of the body) are not approved by FDA and do not require FDA evaluation before they are used in labeling, and it explains the "not evaluated" disclaimer on labels on that basis. [2] Our guide to claims on labels explains the difference.

After a product is on the market

Firms must record, investigate and forward to FDA any reports they receive of serious adverse events. [2] FDA says that if you think a supplement harmed you, the first thing to do is contact or see your health care provider immediately; then you or the provider can report it. [2] Steps are in How to report a side effect in the US.

A documented example of FDA acting

In 2004 FDA issued a rule declaring supplements with ephedrine alkaloids adulterated, effective April 12, 2004. [4] It cited the pharmacology of the compounds, the peer-reviewed literature and reported adverse events. [4] More in Banned and restricted ingredients.

Limits of what we read

• How often FDA tests products on shelves is not described in the sources we read beyond its statement that it has limited resources for analysis. [2]
• "Legal to sell" does not mean "reviewed for safety." Quality can still vary; see Product quality and contamination.
• FDA advises talking with a doctor, pharmacist or other health care professional before using a supplement. [2] Ask especially if you take medicines, are pregnant or breastfeeding, or have surgery planned.