DSHEA 1994: The Magna Carta of Sovereign Health

DSHEA 1994 (The Dietary Supplement Health and Education Act) is the federal law that established the modern legal category of “dietary supplements” inside the Federal Food, Drug, and Cosmetic Act. It set the framework for the definition of supplements, ingredient status (including the New Dietary Ingredient process), labeling concepts, manufacturing quality expectations (cGMP), and enforcement. It became Public Law 103-417.

The official law text is available publicly via Congress.gov, GovInfo, and the Statutes at Large PDF for Public Law 103-417 (108 Stat. 4325).

A dietary supplement is a product (other than tobacco) intended to supplement the diet, intended for ingestion, not represented as a conventional food or as a sole item of a meal or diet, and labeled as a dietary supplement. It contains one or more dietary ingredients (vitamins, minerals, herbs/botanicals, amino acids, or other dietary substances) and related forms such as extracts. The definition is codified at 21 U.S.C. § 321(ff).

In the statute’s plain-language criteria, a supplement must meet all conditions: it is intended to supplement the diet, contains qualifying dietary ingredients, is intended for ingestion (not injection or topical use), is not represented as conventional food or a sole item of a meal/diet, and is explicitly labeled as a dietary supplement.

A dietary ingredient is a substance that can legally qualify as the content of a dietary supplement. The statutory categories are: vitamins, minerals, herbs or other botanicals, amino acids, and other dietary substances used to increase total dietary intake, plus concentrates, metabolites, constituents, extracts, and combinations. These categories appear in 21 U.S.C. § 321(ff).

DSHEA places dietary supplements inside the food framework of the Federal Food, Drug, and Cosmetic Act rather than the drug framework. In plain terms, supplements are regulated as a special category of food with their own distinct safety and labeling rules, not as drugs by default.

Statutes (U.S. Code) are the law passed by Congress. Regulations (CFR) are the binding rules issued by agencies (like FDA) to enforce the law. Agency guidance documents explain how agencies operationalize and enforce the framework, though they often point back to the statute and binding regulations as the authority.

DSHEA defined “dietary supplement” in federal law, placed supplements inside the food framework, created an ingredient-status boundary tied to October 15, 1994 (grandfathered vs. new ingredients), authorized GMP rules tailored to supplements (now 21 CFR Part 111), and embedded labeling concepts including the structure/function statement framework and the famous DSHEA disclaimer.

An NDI is a dietary ingredient that was not marketed in the United States before October 15, 1994. Any ingredient that falls into this “new” category is subject to the NDI notification requirement under 21 U.S.C. § 350b, requiring safety data submission to the FDA before marketing.

DSHEA established October 15, 1994, as the cutoff date for ingredient status. Ingredients marketed in the U.S. before this date are generally presumed to be safe based on history of use. Ingredients introduced after this date are considered “New Dietary Ingredients” (NDIs) and require a safety notification to the FDA.

Dietary supplement cGMPs (Current Good Manufacturing Practices) are the mandatory regulations governing the manufacturing, packaging, labeling, and holding of dietary supplements. They ensure products are consistent, pure, and safe. They are codified at 21 CFR Part 111.

Part 111 mandates a documented quality system. This includes establishing specifications for every ingredient and finished product (identity, purity, strength, composition), conducting testing, maintaining master and batch manufacturing records, controlling packaging/labeling, and maintaining systems for complaint handling and investigations.

Supplement Facts is the standardized information panel required on supplement labels. It declares the serving size, servings per container, and amount per serving of all dietary ingredients. The formatting rules are strict and defined in 21 CFR § 101.36.

A structure/function statement describes how a dietary ingredient affects or maintains the normal structure or function of the human body (e.g., “calcium builds strong bones”). These statements are permitted for supplements but must be truthful, not misleading, and must include the mandatory DSHEA disclaimer.

Structure/function statements describe support for normal health processes. Disease claims imply that a product can diagnose, treat, cure, mitigate, or prevent a disease. Supplements are legally permitted to make structure/function statements, but disease claims are strictly reserved for approved drugs. Making a disease claim causes a supplement to be considered an unapproved new drug.

When a supplement makes a structure/function statement, the label must bear the 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.” This is required by 21 U.S.C. § 343(r)(6).

FDA (Food and Drug Administration) regulates the product itself: safety, manufacturing (cGMP), labeling, and adverse event reporting. FTC (Federal Trade Commission) regulates the advertising: ensuring marketing claims are truthful and substantiated by evidence. They share jurisdiction under a long-standing liaison agreement.

FTC evaluates advertising based on the “net impression”—what a reasonable consumer would believe after viewing the ad (including images, text, and testimonials). Objective claims must be substantiated by competent and reliable scientific evidence. Disclaimers cannot cure a misleading net impression.

Yes. Manufacturers must report serious adverse events to the FDA. The FDA monitors these reports via the FAERS dashboard and has the authority to remove unsafe products from the market.

DSHEA established the Office of Dietary Supplements (ODS) at the National Institutes of Health. Its mandate is to support research and disseminate accurate scientific information about supplements to the public and policy makers. It acts as the federal scientific anchor for the industry.

Core sources include the DSHEA public law text (Public Law 103-417), the U.S. Code definition of dietary supplement (21 U.S.C. § 321(ff)), the NDI statute (21 U.S.C. § 350b), supplement cGMP regulations (21 CFR Part 111), Supplement Facts regulations (21 CFR § 101.36), structure/function statement statute (21 U.S.C. § 343(r)(6)), and official FDA/FTC/NIH ODS pages.