DSHEA and FDA supplement rules in plain English

By the DieticiansWorldwide.com editorial team · 18 October 2026 · Supplements & industry

What DSHEA is

The Dietary Supplement Health and Education Act became US law on 25 October 1994 as Public Law 103-417, amending the Federal Food, Drug, and Cosmetic Act (DSHEA, Public Law 103-417, govinfo). Its table of contents is a good summary of what it did: it defined "dietary supplement", set rules on safety with the "burden of proof on FDA", created a category of statements of nutritional support (now usually called structure/function claims), set labelling rules, introduced the concept of new dietary ingredients, gave the FDA power to write good manufacturing practice rules, and established the Office of Dietary Supplements at the National Institutes of Health.

The core decision was to treat supplements as a category of food rather than as medicines. That one choice explains most of what follows: there is no pre-market approval, the manufacturer is responsible for safety and labelling, and the FDA's main tools are inspections and action after products are on sale.

This guide explains how that framework works in 2026, for dietitians who advise patients, and for brands, manufacturers and importers who need to stay compliant. The United States country guide covers the wider market and the profession, and our nutrition industry outlook covers the size and growth of the supplement sector.

Does the FDA approve dietary supplements?

No. The FDA's own answer is direct: "Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed" (FDA, Questions and Answers on Dietary Supplements). Instead, the agency says a firm "is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated" or misbranded.

What the FDA does do, according to the same page, is enforce the law after products reach the market: inspecting facilities, reviewing new dietary ingredient notifications, investigating complaints, monitoring the marketplace and reviewing adverse event reports.

This has practical consequences you can pass on to patients:

• "FDA approved" on a supplement is a red flag. The agency warns: "Be cautious when a product is marketed as being manufactured in an FDA-approved facility; FDA does not approve facilities" (FDA, Avoiding Products Contaminated with Hidden Ingredients).
• Being on sale is not evidence of benefit. A product can be legally sold without any clinical trial showing that it works.
• Safety is mostly checked after problems appear. That is why adverse event reporting and independent quality testing matter; our guide to third-party tested supplements explains what the testing marks do and do not prove.

What does need to involve the FDA

DSHEA and later laws created a handful of obligations that bring a company into contact with the FDA. None of them is an approval.

New dietary ingredients

A new dietary ingredient is one that "was not marketed in the United States before October 15, 1994". If a supplement contains one, the manufacturer or distributor must notify the FDA "at least 75 days before introducing" it into interstate commerce, unless the ingredient has been present in the food supply as an article used for food in a form that has not been chemically altered. The regulation requires the notification to include the history of use or other evidence on which the company has concluded that the supplement "will reasonably be expected to be safe" (21 CFR 190.6, eCFR).

The FDA does not approve these notifications. The Congressional Research Service describes four kinds of response the agency generally sends: acknowledgement without objection, a letter listing deficiencies, an objection raising safety concerns or gaps in the evidence, or a letter raising other regulatory issues. It reports that in fiscal year 2020 the FDA responded to 43 notifications, acknowledging 16 without objection, finding 9 incomplete and raising safety or identity concerns with 18 (Congressional Research Service, R43062, September 2021). The FDA's current procedural guidance on notifications was issued in 2024, with a draft guidance on NDI master files the same year.

Good manufacturing practice

The FDA published the dietary supplement cGMP rule, 21 CFR part 111, on 25 June 2007. Compliance was phased in by company size: June 2008 for firms with 500 or more full-time employees, June 2009 for those with 20 to 499, and June 2010 for those with fewer than 20 (FDA, Small Entity Compliance Guide). The rule applies to anyone who manufactures, packages, labels or holds a supplement, including imported products. Among its requirements, every component that is a dietary ingredient must have at least one appropriate test or examination to confirm its identity before use, and finished batches must meet specifications for identity, purity, strength and composition. Our guide to supplement GMP covers the rule in detail.

Structure/function claims, health claims and disease claims

The most practical part of DSHEA for anyone writing a label or a social media post is the difference between three kinds of claim.

Structure/function claims

A structure/function claim describes how a nutrient or ingredient affects the normal structure or function of the body. The FDA's examples are "calcium builds strong bones", "fiber maintains bowel regularity" and "antioxidants maintain cell integrity". These claims are not pre-approved, but the manufacturer "must have substantiation that the claim is truthful and not misleading" and must notify the FDA "no later than 30 days after marketing the dietary supplement with the claim" (FDA, Structure/Function Claims).

Every such claim must carry this disclaimer, set out word for word in the regulation: "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." The disclaimer must sit next to the claim or be linked to it with a symbol such as an asterisk (21 CFR 101.93). In December 2025 the FDA wrote to industry about the requirement for the disclaimer to appear on each label panel where a claim is made, saying it was considering a regulatory amendment and intended to exercise enforcement discretion in the meantime (FDA, letter on the DSHEA disclaimer).

Disease claims

A claim that a product diagnoses, treats, cures, mitigates or prevents a disease makes it a drug. As the FDA puts it, "only a drug can legally make such a claim". This is the line most often crossed in marketing: "supports healthy blood sugar" may be a structure/function claim; "lowers blood sugar in diabetes" is a disease claim. The FDA allows one narrow exception, for claims about classical nutrient deficiency diseases, provided the label also says how common the disease is in the United States.

Health claims

Health claims describe a link between a food substance and a reduced risk of a disease, and they need FDA authorisation in regulations. One example is the soluble fibre claim for psyllium husk, which our guide to gut health supplements discusses.

Labelling basics

Labels are not approved either. The FDA's Dietary Supplement Labeling Guide states that "label approval is not required to import or distribute a dietary supplement", and then works through each required element in question-and-answer form: the statement of identity, net quantity of contents, the Supplement Facts panel, the ingredient list, and the name and address of the responsible firm, along with rules on proprietary blends, percentage claims and iron warnings (FDA, Dietary Supplement Labeling Guide). Separately, manufacturers and distributors must "record, investigate, and forward to FDA" any reports of serious adverse events they receive, so the contact details on the label are part of the safety system.

How the FDA enforces the rules

Because there is no gate before the market, enforcement is the system. The FDA's inspection manual for supplements, Compliance Program 7321.008, took effect on 30 September 2024. It covers full-scope cGMP inspections of manufacturers, inspections of firms that put their own brand of finished product on the market, warehouses, packers and labellers, and health fraud. During an inspection, investigators are told to identify who controls the formulas, the label and the website, and who the firm's contract manufacturers are, including any quality agreements. They also review the firm's online labelling for structure/function and disease claims, the disclaimer and adverse event reporting (FDA, Compliance Program 7321.008, PDF).

That matters for brands that outsource production: owning the label does not move the legal responsibility onto the factory. Our guide to choosing a supplement contract manufacturer explains how to share that responsibility in a written quality agreement.

At the serious end, the FDA warns about products sold as supplements that contain hidden drug ingredients, and tells consumers to be "especially wary of products sold for sexual enhancement and energy, weight loss, pain, bodybuilding or sleep". The agency also says that labels including the words "herbal" or "all natural" do not make those words true. When inspections find problems, the compliance programme lists escalating options, from untitled and warning letters to administrative detention, registration suspension, mandatory recall, seizure and injunction. For dietitians, the most useful step is often simply to help patients report a suspected reaction.

Calls to modernise DSHEA

The most persistent reform debate is about visibility. Supplement facilities must register with the FDA, but the agency cannot require each product to be listed, so it does not know everything on the market.

In its fiscal year 2025 legislative proposals, the FDA said that since DSHEA was enacted "the dietary supplement market in the U.S. has grown from approximately 4,000 products to well over 100,000 products". It asked Congress to require all supplements to be listed with the agency, including the label and other basic information, and to clarify its authority over products marketed as supplements (FDA, FY 2025 Legislative Proposals, PDF). The Congressional Research Service records that some industry trade groups supported mandatory listing while others opposed it as "redundant" and "unnecessary", and that some stakeholders want safety data required for all new dietary ingredients.

Bills have been introduced in the current Congress. The Dietary Supplement Listing Act of 2026 was introduced in the Senate as S.3677 on 15 January 2026 and referred to the Committee on Health, Education, Labor, and Pensions; a House version, H.R.8370, was introduced on 20 April 2026 and referred to the Committee on Energy and Commerce. When we checked on 18 October 2026, neither had moved beyond committee referral.

The FDA's case is that listing would let it see new products as they launch and act quickly against dangerous or illegal ones; the trade groups opposed to it describe the requirement as redundant. Whatever happens, dietitians who know where the gaps in the current system lie can give more honest advice than either the marketing or the alarm.

Legal in one market, banned in the next

DSHEA is a US law, and US-style claims often do not travel. A structure/function claim that is acceptable in the United States with a disclaimer may be unlawful elsewhere.

• European Union. Food supplements are foods under Directive 2002/46/EC of 10 June 2002, which says that only vitamins and minerals listed in its annexes, in the listed forms, may be used, and requires labels to state the recommended daily dose, warn against exceeding it, say that supplements should not replace a varied diet, and tell people to keep them out of reach of young children (Directive 2002/46/EC, EUR-Lex). Health claims must be authorised at EU level; our guide to EU health claims explains the register.
• United Kingdom. The Food Standards Agency's guidance for England cites the Food Supplements (England) Regulations 2003 and requires sellers to register as a food business with their local authority. It also says the product must be labelled "food supplement" and "not 'dietary supplement'", and that supplements "cannot exert a pharmacological, immunological or metabolic action" (Food Standards Agency, Food supplements guidance).
• Canada. Supplements are natural health products. Health Canada says manufacturers must get a product licence to sell them, and that a Natural Product Number (NPN) or DIN-HM on the label means the product "has been assessed for quality, safety and efficacy by Health Canada" (Health Canada, questions from consumers). See our Canada country guide and our explainer on the NPN system.
• Australia. Most supplements are listed medicines. The Therapeutic Goods Administration says listed medicines may use only low-risk ingredients and low-level indications chosen from approved lists, and "are not individually evaluated by the TGA before they are released onto the market"; they carry an AUST L number (TGA, listed and registered complementary medicines).

So a product sold in all four markets may need four different labels: different claims, different warnings and, in Canada, a pre-market licence. Our dietary supplements guide compares the main regulatory models country by country, and our guide to halal supplements covers one of the certification layers that sits on top of them.

What this means in practice

For dietitians and nutritionists:

1. Explain to patients that "sold in shops" does not mean "tested for effect", and that the disclaimer on the label is a legal requirement, not a formality.
2. Ask about every supplement a patient takes, including products bought abroad or online, and report suspected adverse reactions.
3. Check claims against the evidence, not the wording on the pack.

For brands and manufacturers:

1. Keep substantiation on file for every structure/function claim before it goes on a label or a website, and send the 30-day notification.
2. Check NDI status for every novel ingredient before you formulate around it.
3. Put responsibilities in writing with your contract manufacturer, and audit them.
4. Review claims market by market before you export.

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