DSHEA
DSHEA is the Dietary Supplement Health and Education Act of 1994, the US law that amended the Federal Food, Drug, and Cosmetic Act to create a regulatory framework for dietary supplements.
What it means in practice
Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed [1]. The firms that make and distribute supplements are responsible for evaluating the safety and labeling of their products before marketing, and FDA can take action against an adulterated or misbranded product after it reaches the market [2].
Under this framework, the term "dietary ingredient" includes vitamins and minerals, herbs and other botanicals, and amino acids [1]. A dietary ingredient that was not marketed in the United States before October 15, 1994, is a "new dietary ingredient" [1]. Unless the ingredient is already in the food supply in a form that has not been chemically altered, the manufacturer or distributor must notify FDA at least 75 days before introducing a supplement that contains it into interstate commerce [1].
Two more parts of the framework cover quality and labels. FDA's regulations require anyone who makes, packages or holds supplements to follow current good manufacturing practices that help ensure identity, purity, quality, strength and composition [1]. DSHEA also set special requirements and procedures for structure/function claims, the label statements about how a nutrient or dietary ingredient is intended to affect the normal structure or function of the human body [3].
Why it matters when reading nootropics research
A supplement being on sale in the US does not mean FDA approved it first, because the agency has no authority to approve supplements before they are marketed [1]. Structure/function claims on supplement labels must carry a disclaimer saying FDA has not evaluated them [4].
Whether an ingredient has shown an effect against placebo in controlled trials is a separate question that the law does not answer. NootropicsWork compound pages grade that evidence outcome by outcome, and their regulatory rows state the US framework when no FDA statement specific to the compound was found.
DSHEA covers the US only. Canada and Australia are covered in the NPN and ARTG entries, and the EU and UK rule in the novel food entry.
References
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Updated August 27, 2026.
- U.S. Food and Drug Administration. Dietary Supplements. Updated October 1, 2024.
- U.S. Food and Drug Administration. Structure/Function Claims. Updated March 28, 2024.
- Electronic Code of Federal Regulations (eCFR). 21 CFR 101.93 Certain types of statements for dietary supplements. eCFR title 21 up to date as of 2026-11-09.