Are supplements regulated?

Are supplements regulated by the FDA?

Yes. The Dietary Supplement Health and Education Act of 1994 amended the Federal Food, Drug, and Cosmetic Act to create a separate framework for supplements, treated as a subset of foods. Its effect is that FDA has no authority to approve a supplement before it is marketed, and in general a company does not have to give FDA its safety evidence before or after selling a product. FDA's role mainly begins after a product enters the market.^1,2,6

• Exception for new ingredients: a supplement with a new dietary ingredient, one not marketed in the US before October 15, 1994, needs a safety notification to FDA at least 75 days before sale.¹
• Manufacturing rules: FDA's regulations require current good manufacturing practices meant to ensure the identity, purity, quality, strength and composition of supplements, and facilities must register with FDA.^1,7
• After sale: FDA inspects manufacturing sites, monitors the marketplace, examines imports, reviews notifications and investigates adverse event reports and complaints.¹
• Testing: FDA does not routinely analyze the content of supplements. It focuses first on emergencies and products that may have caused injury, then on suspected violations, and it does not test supplements before they are sold.¹

Who is responsible for a supplement's safety and label?

How are supplements different from medicines?

NIH puts it plainly: medicines must be approved by FDA before they can be sold, and supplements do not require this approval. NCCIH adds that the rules for manufacturing and distributing supplements are less strict than those for prescription or over-the-counter medicines, and that companies must show FDA evidence that their medicines are safe and effective before marketing them. Supplement companies are responsible for having evidence that their products are safe and that claims are truthful, but they do not have to hand that evidence to FDA first.^9,10

What does not evaluated by the FDA mean on a supplement label?

The disclaimer reads that FDA has not evaluated the statement and that the product is not intended to diagnose, treat, cure or prevent any disease. The law requires it whenever a label makes a structure/function claim, because those claims are not approved by FDA. The company must have evidence that the claim is truthful and not misleading and must notify FDA of the claim's wording within 30 days of first marketing it.^1,11

A product sold as a supplement and presented as a way to treat, prevent or cure a specific disease meets the definition of a drug and is regulated as one. NCCIH also warns that some products promoted for weight loss, sexual enhancement and bodybuilding have been found to contain prescription drugs or other ingredients not on the label. Ask a doctor or pharmacist about any supplement you take with medicines, since FDA says some supplements can interact with them.^1,2,10

Are supplements regulated in Europe and the EU?

Yes, as food. In the EU, food supplements are regulated as foods, and the business placing a product on the market is responsible for its safety. Directive 2002/46/EC sets harmonized lists of the vitamins and minerals that may be used and the substances allowed as their sources, plus labeling rules, and EU countries may ask for notice that a product has been placed on their market.^3,12

Other ingredients, such as botanicals, may fall under national rules or other EU law, for example the novel foods rules for substances without a history of safe use in the EU before 1997. Health claims for foods are assessed by EFSA under a separate regulation, and at present there are no binding EU-wide maximum or minimum levels for vitamins and minerals in supplements.³

Are supplements regulated in the UK?

Yes, as food. Guidance from the Food Standards Agency says food supplements in England, Wales and Northern Ireland are regulated as food under general food law, sellers must register as food business operators, and sellers are responsible for making sure products are safe. Labels must say food supplement rather than dietary supplement, give the recommended daily dose with a warning not to exceed it, and state that supplements should not replace a varied diet.⁴

Are supplements regulated in Canada?

Yes, under a separate system. Health Canada regulates most supplements as natural health products. Manufacturers must get a product license before sale, and a licensed product carries an NPN or DIN-HM number showing Health Canada assessed it for quality, safety and efficacy. A review of the three systems describes Canada's model as a premarket assessment, with site licenses and good manufacturing practice guidelines.^5,6

How do the US, EU, UK and Canada compare?

How are supplements regulated in other countries?

There is no global agreement. A review of regulatory challenges says that no consensus exists on either what falls in the category or what to call it: a dietary supplement in the US is not the same as a natural health product in Canada, a traditional herbal medicine in the EU or a complementary medicine in Australia. Melatonin is a supplement in the US, a natural health product in Canada and a prescription medicine in Australia.⁶

In Australia most supplements are regulated as therapeutic goods called complementary medicines, either listed or registered, with new listable substances assessed before sale. Most countries do not regulate supplements as a stand-alone category: they fit them into existing food or drug law.⁶

What regulation does not tell you about a product

Regulation sets duties, not outcomes. FDA says it cannot analyze most products before sale, and its manufacturing-rule backgrounder notes that earlier analyses by private laboratories found a substantial number of supplements did not contain the amounts of dietary ingredients on their labels. NCCIH says what is on the label may not be in the product. Our guides on reading a label and on third-party testing cover how to read the claims, and the evaluating-a-study guide covers the research behind them.^1,7,10

Questions people ask

Sources

1. U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Content current as of August 27, 2026. Opened 2026-10-11.
2. U.S. Food and Drug Administration. FDA 101: Dietary Supplements. FDA Consumer Update. Content current as of June 2, 2022. Opened 2026-10-11.
3. European Food Safety Authority. Food supplements. Last reviewed January 6, 2026. Opened 2026-10-11.
4. Food Standards Agency. Food supplements: guidance for businesses. Published July 2, 2018. Opened 2026-10-11.
5. Health Canada. Questions from Consumers: Regulation of Natural Health Products. Page dated July 24, 2018. Opened 2026-10-11.
6. Dwyer JT, Coates PM, Smith MJ. Dietary Supplements: Regulatory Challenges and Research Resources. Nutrients. 2018;10(1):41. Review. Opened 2026-10-11.
7. U.S. Food and Drug Administration. Backgrounder on the Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements. June 22, 2007. Opened 2026-10-11.
8. U.S. Food and Drug Administration. How to Report a Problem with Dietary Supplements. Content current as of March 13, 2025. Opened 2026-10-11.
9. National Institutes of Health, Office of Dietary Supplements. Dietary Supplements: What You Need To Know. Fact Sheet for Consumers. Updated January 4, 2023. Opened 2026-10-07.
10. National Center for Complementary and Integrative Health. Using Dietary Supplements Wisely. Last updated January 2019. Opened 2026-10-11.
11. U.S. Food and Drug Administration. Structure/Function Claims. Content current as of March 28, 2024. Opened 2026-10-11.
12. European Commission. Food supplements. Food Safety. Opened 2026-10-11.