Supplement Regulation by Country: US, UK, EU and Canada Compared

Read this first

Supplements are regulated differently around the world, and the same product can be a "dietary supplement" in one country, a "food supplement" in another and a licensed "natural health product" in a third. This page compares only the jurisdictions where we could read an official government or regulator page. Australia is not described: the Therapeutic Goods Administration (TGA) pages timed out or could not be reached from our tools, so we have not verified its rules. Laws change, and these pages describe the official text we read on the date shown, not legal advice.

At a glance

United States

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. [1] Companies are responsible for having evidence that supplements are safe and for truthful labels; FDA can act against adulterated or misbranded products only after they reach the market. [5] More detail is on the page How supplements are regulated.

United Kingdom

Guidance from the Food Standards Agency (it says it applies to England, Northern Ireland and Wales; Scotland has its own regulations) defines a food supplement as a concentrated source of a vitamin, mineral or other substance with a nutritional or physiological effect, sold in dose form. Food supplements are required to be regulated as food, are "not medicinal products," and their use is not intended to treat or prevent diseases. [2] Business owners must register as a food business operator and are responsible for the safety of what they sell. [2] Labels must say "food supplement" (not "dietary supplement"), give the recommended daily dose with a warning not to exceed it, state the amount of each nutrient, keep out of reach of young children, and say supplements should not be used as a substitute for a varied diet. [2] The page was published in 2018, so check the current version.

European Union

The European Commission says food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form such as pills or capsules. Directive 2002/46/EC aims to protect consumers from health risks and misleading information, with a list of vitamins and minerals that may be used and a list of permitted sources. [3] The Commission page also says maximum and minimum amounts of vitamins and minerals were envisaged but no proposal had been presented because of the complexity and divergent views. [3] The European Food Safety Authority (EFSA) is separate: it publishes the scientific Tolerable Upper Intake Levels, such as 100 micrograms a day of vitamin D for adults. [7]

Canada

Health Canada introduced the Natural Health Products Regulations under the Food and Drugs Act on January 1, 2004, with the stated goal of ensuring safety, efficacy and quality while enabling access. [6] Vitamins and minerals are listed as examples of NHPs. Companies that manufacture, package, label or import NHPs must hold valid product and site licences and follow good manufacturing practices. [4] Health Canada's overview page also describes proposed changes (such as reducing some pre-market requirements and a simple registration process for certain products); these are proposals, not current rules. [6]

What this means for you

• A "label that looks official" does not tell you which rules apply. Look at where the product is sold and who the importer is. In the UK, importers are legally responsible for composition, safety and labelling. [2]
• Buying across borders can mean a different level of oversight. The UK guidance warns about counterfeit products bought online, especially when prices are unusually low. [2]
• Reference intakes and upper limits also differ by jurisdiction; see RDA, AI, DV and UL.
• Quality seals are separate from regulation; see Quality testing and certifications.

What we could not verify

• Australia (TGA): pages unreachable from our tools. Not described.
• UK medicines regulator (MHRA) and herbal medicines: not read. This page covers food supplements only.
• Current enforcement practice, import rules and recent amendments in any country.