Selling food supplements: the rules by market
The rules food supplements must meet before going on sale in the EU, the UK, Switzerland, the US, Canada, Mexico, Brazil, Australia, New Zealand, Japan, South Korea, Singapore, India, the UAE and Saudi Arabia: who writes them, who enforces them, and what has to be registered, tested and labelled, with the official source for each. Compliant Always shows which of them apply to your product.
Europe
- European UnionIn the EU, food supplements are food. Directive 2002/46/EC lists the vitamins and minerals they may contain and the sources those may come from, and the general food labelling, claims and novel food rules apply on top. There is no EU-wide approval of each product, but a member state may ask to be notified.Selling food supplements in the EU
- United KingdomIn Great Britain, food supplements follow the general food labelling rules and The Food Supplements (England) Regulations 2003. The label says 'food supplement', gives the daily dose with a warning not to exceed it, and says it is not a substitute for a varied diet. The business registers locally and keeps purchase and sale records.Selling food supplements in the UK
- SwitzerlandIn Switzerland, food supplements are foodstuffs, governed by the FDHA Ordinance on Food Supplements (VNem) alongside general food law. They need no authorisation unless they contain a novel food or GMOs or carry an unlisted health claim. The business placing them on the market answers for their safety; cantonal authorities run spot checks.Selling food supplements in Switzerland
The Americas
- United StatesIn the US, dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act of 1994. There is no approval before sale: firms are responsible for the safety and labelling of their products before marketing, and the FDA acts after a product reaches the market. Manufacturing follows 21 CFR Part 111.Selling dietary supplements in the US
- CanadaIn Canada, vitamins, minerals, probiotics and similar supplements are generally natural health products under the Natural Health Products Regulations, overseen by Health Canada's Natural and Non-prescription Health Products Directorate. Each product needs a product licence and an eight-digit NPN on the label, and sites that manufacture, package, label or import need a site licence.Selling vitamins and supplements in Canada
- MexicoIn Mexico, food supplements (suplementos alimenticios) are defined in the General Health Law and regulated by COFEPRIS under the Reglamento de Control Sanitario de Productos y Servicios. They may not contain pharmacological substances or claim therapeutic effects, must stay within daily vitamin and mineral limits, and carry two mandatory legends in Spanish.Selling food supplements in Mexico
- BrazilIn Brazil, food supplements (suplementos alimentares) follow ANVISA's RDC 243/2018. Ingredients, limits and claims come from the lists in IN 28/2018, the product is notified to ANVISA before sale, and the label carries the name "Suplemento Alimentar", set warnings in Portuguese and a nutrition table.Selling food supplements in Brazil
Asia and the Pacific
- AustraliaAustralia has no single supplement category. A product represented for therapeutic use is a therapeutic good regulated by the TGA, and is usually entered in the Australian Register of Therapeutic Goods before supply. A product that stays a food, such as a formulated supplementary sports food, follows the Food Standards Code. Ingredients, claims and dosage form decide which.Selling supplements in Australia
- New ZealandIn New Zealand, dietary supplements fall under the Dietary Supplements Regulations 1985, made under the Food Act 2014. Medsafe administers the regulations and MPI the Food Act. There is no pre-approval: the sponsor answers for quality, safety and compliance. A supplement may not contain scheduled medicines or controlled drugs, or claim a therapeutic purpose.Selling dietary supplements in New Zealand
- JapanIn Japan, supplements are food under the Food Sanitation Act and the Food Labelling Act. A function may be stated only as a Food for Specified Health Uses, a Food with Nutrient Function Claims, or a Food with Function Claims notified to the Consumer Affairs Agency 60 days before sale. Medicinal claims fall under pharmaceutical law.Selling supplements in Japan
- South KoreaIn South Korea, supplements made with functional ingredients are sold as health functional foods under the Health Functional Foods Act, regulated by the Ministry of Food and Drug Safety (MFDS). They use ingredients MFDS has notified or recognised, carry the labelling the Act on Labeling and Advertising of Foods sets, and imports follow the imported food rules.Selling supplements in South Korea
- SingaporeIn Singapore, health supplements in dose forms such as capsules and tablets come under the Health Sciences Authority (HSA). They need no HSA approval or licence, but dealers answer for safety, quality and labelling. Supplements in the form of food, such as drinks and biscuits, are food under the Singapore Food Agency.Selling health supplements in Singapore
- IndiaIn India, health supplements and nutraceuticals are food under section 22 of the Food Safety and Standards Act, 2006, not medicines. FSSAI's regulations set the permitted ingredients, cap nutrients at the ICMR recommended daily allowance, and require the words "HEALTH SUPPLEMENT" and "NOT FOR MEDICINAL USE" on the label.Selling health supplements in India
The Middle East
- United Arab EmiratesIn Dubai, health supplements are a regulated consumer product: each must be registered by Dubai Municipality in its Montaji system before it is placed on the market, with a free sale certificate, composition report and GMP evidence. A product presented as preventing or treating disease is not a supplement; medical products fall to the Emirates Drug Establishment.Selling food supplements in the UAE
- Saudi ArabiaIn Saudi Arabia, a supplement may be regulated by the Saudi Food and Drug Authority (SFDA) as a food, as a health product under its drug sector, or as a drug, depending on its composition, form and claims. Food supplements go through SFDA's pre-registration evaluation; health products are registered through the Saudi Drug Registration system.Selling food supplements in Saudi Arabia
Other products
- Food
- Beverages
- Alcohol
- Infant formula and baby food
- Pet food
- Cosmetics and beauty
- Cleaning products and detergents
- Toys
- Electrical and electronics
- Clothing, footwear and textiles
- Kitchenware and food contact articles
- Consumer goods
Selling food supplements somewhere not listed here? Tell us the product and the market, and we will come back to you with the rules that apply.
Tell us where you sellCompliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.