DSHEA was enacted in 1994 after a period of significant regulatory uncertainty about how supplements should be classified and regulated. It established the legal category of "dietary supplement," defined who bears the burden of demonstrating safety, and created the structure/function claim framework that still governs supplement marketing today.
What DSHEA Defines as a Dietary Supplement
Under 21 U.S.C. 321(ff), a dietary supplement is a product intended to supplement the diet that contains one or more of the following:
A vitamin
A mineral
An herb or other botanical
An amino acid
A dietary substance used to supplement the diet by increasing the total dietary intake
A concentrate, metabolite, constituent, extract, or combination of any of the above
The product must be intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form. It must not be represented as a conventional food or as a sole item of a meal or diet. It must be labeled as a dietary supplement.
These definitions matter because they determine whether a product gets to operate under the supplement regulatory framework or must comply with drug or food rules.
The Pre-Market Safety Burden
One of DSHEA's most significant provisions — and a frequent source of public policy debate — is that FDA bears the burden of proving a dietary supplement is unsafe, rather than manufacturers bearing the burden of proving it's safe before market entry.
This is different from drugs, which must undergo pre-market approval demonstrating safety and efficacy. Under DSHEA, supplement manufacturers may bring products to market without FDA pre-clearance. FDA must demonstrate harm to take regulatory action.
The exception is New Dietary Ingredients (NDIs) — ingredients not marketed in the U.S. before October 15, 1994. NDIs require pre-market notification to FDA under 21 U.S.C. 350b and 21 CFR 190.6.
What DSHEA Allows: Structure/Function Claims
DSHEA created the structure/function claim framework under 21 U.S.C. 343(r)(6). Supplement manufacturers may make claims about:
How a nutrient or dietary ingredient affects normal structure or function in humans
The mechanism by which that nutrient or ingredient acts to maintain normal structure or function
Structure/function claims under 21 CFR 101.93(f) do not require FDA pre-approval. They require:
Truthfulness and not misleading
Substantiation ("competent and reliable scientific evidence")
A disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
Notification to FDA within 30 days of first marketing the claim (21 CFR 101.93(a))
DSHEA does not permit disease claims. A structure/function claim that implies the product treats, cures, or prevents a disease becomes a drug claim requiring pre-market drug approval under the Federal Food, Drug, and Cosmetic Act.
DSHEA's GMP Provisions
DSHEA authorized FDA to establish Good Manufacturing Practice (GMP) regulations for dietary supplements. FDA finalized these rules in 21 CFR Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements). GMPs cover identity, purity, quality, strength, and composition of supplement ingredients and finished products.
What DSHEA Does Not Cover
DSHEA does not preempt FTC authority over advertising. Supplement advertising — including digital ads, social media posts, influencer content, and any paid media — is regulated by the FTC under Section 5 of the FTC Act (15 U.S.C. 45). A brand that carefully complies with DSHEA on its label can still face FTC enforcement for advertising that makes the same claims without adequate substantiation.
DSHEA also does not govern state-level regulations. California's Prop 65, New York's supplement requirements, and various state consumer protection laws impose requirements beyond DSHEA's federal floor.
DSHEA is the foundation — but it's not the entire building
Understanding DSHEA explains why the supplement industry looks the way it does: relatively open pre-market entry, significant post-market enforcement, and a marketing framework that requires careful navigation of the structure/function vs. disease claim line. Truli's compliance scanning is built on the DSHEA-based regulatory framework — scanning label and marketing claims against 21 CFR 101.93's structure/function requirements and flagging claims that cross into prohibited disease territory under 21 U.S.C. 343(r)(6).
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
