Food supplements are foods that intend to supplement a normal diet. Supplements have ingredients that have a nutritional or physiological effect, which means that they create a physical effect in the human body. Examples of food supplements include vitamins, minerals, trace elements, amino acids, fibre, plants or herbal extracts.
To ensure these products are safe for use, there are many different requirements for their composition and presentation. These additional requirements are laid down in several European laws, the main one being EU Directive 2002/46/EC. This Directive is implemented by national legislation in each member state, so there can be slight differences in approach for each jurisdiction. One example of this relates to what constitutes a food supplement and which ingredients can be contained in a food supplement.
Food Supplements are sold in dosage form as tablets, capsules, coated tablets, or powders and liquids intended to be ingested in small, measured amounts. In contrast to regular foods, food supplements require a recommended dosage along with other mandatory information and warnings for consumers, for example, that they should be stored out of the reach of small children.
Below is an overview of what is required for the sale and labelling of food supplements. You should also refer to the Food Standards Agency (FSA) brochure on food supplements: https://www.food.gov.uk/sites/default/files/media/document/foodsupplementsenglish_0.pdf
Food supplements are a restricted product type on Amazon. You must obtain approval to sell food supplements. You can apply for approval here.
Additionally, in some marketplaces a national pre-market notification is required before a food supplement can be listed and sold on Amazon for that jurisdiction.
The list below clarifies the type of products that should be uploaded under Dietary Supplements, but it is not exhaustive. If you cannot find your product in this list, or if you are unsure which Product Type to list your product under, contact Seller Support.
The following information should be included on the labelling of a Food Supplement, in addition to the information required under Regulation 1169/2011 on food information for consumers:
Only nutrition and health claims that have been approved under EU Regulation (EC) No 1924/2006 on nutrition and health claims made on food (the ‘Regulation’) can be used on the label.
The aim of the Regulation is to protect consumers from misleading and false claims made on products and harmonize the rules across the EU to facilitate trade.
A nutrition claim is any claim that states, suggests, or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy, or of a particular nutrient or other substance. Nutrition claims provide factual information about the nutritional composition of the food, for example “source of calcium”, “low fat”, “high fibre”, or “reduced salt”.
Only nutrition claims listed in the Annex to the Regulation can be made on food and only if the product meets with the specific conditions of use for that claim. For example, “low fat” can only be made on products containing no more than 3g of fat per 100g for solids.
A health claim is any claim that states, suggests, or implies that a relationship exists between a food category, a food or one of its ingredients, and health. Only health claims that have been authorised by European Food Safety Authority (EFSA) and the Commission are permitted. The EU Register contains a list of specific health claims and the outcome of their assessment, whether authorised or not, as well as their conditions of use. An example of a specific health claim would be “calcium helps maintain normal bones”. More general, non-specific claims, such as “good for you” or “healthy”, may be allowed if they are accompanied by a relevant specific authorised health claim listed in the EU Register, provided they meet the specific conditions of use.
Health claims cannot:
In general, claims must not be false, ambiguous or misleading, encouraging or condoning excess consumption of a food, or imply that a balanced diet cannot provide the necessary nutrients. Claims cannot give rise to doubt about the safety and/or nutritional adequacy of other foods. They cannot refer to changes in bodily functions that could give rise to or exploit fear in the consumer.
Nutrition and health claims are only permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim. As above, if general wellbeing claims are used (such as “superfoods”, “antioxidants”, ‘good for you”), then these must be accompanied by a specific health claim, that is they need to explain why it is considered a “superfood”. For example, mackerel as part of a healthy balanced diet can be considered a superfood because it is a source of Omega-3 fatty acids (contains x mg of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal). Omega 3 contributes to normal heart function.
Food supplements cannot claim the property of preventing, treating, or curing human disease or refer to such properties. Such medicinal claims are never permitted for food supplements. Only products licensed as medicinal products can bear such claims.
The Annexes to the Directive 2002/46/EC list the vitamins and minerals and their chemical forms permitted for use in the manufacture of food supplements. For additional vitamins and minerals to be considered for inclusion on this list, they would need to be authorised by the commission following a safety assessment by EFSA.
“Novel Foods” are foods that have not been consumed to a significant degree by humans in the EU before 15 May 1997. A novel food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food that is or has been traditionally eaten outside of the EU. Examples of novel food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries (e.g. chia seeds, noni fruit juice), or food derived from new production processes (UV-treated foods such as milk, bread, mushrooms and yeast).
A safety assessment must be conducted and pre-market authorization must be given before a novel food can be marketed in the EU.
In addition to novel foods, certain other ingredients are also not permitted in food supplements. For example, the following substances are not permitted as ingredients in the manufacture of food supplements:
Products for sale on Amazon cannot contain any unauthorised ingredients (for example, unauthorised vitamins or minerals, additives, or flavourings), novel foods, or banned ingredients.
To ensure that food supplements are safe for consumption, the manufacturer must take into account the upper safe levels established by scientific risk assessment and data on vitamin and minerals intake from other foods, while also taking into account what is considered an adequate vitamin and mineral intake for an average person. EFSA has published scientific opinions about upper safe levels for various vitamins, minerals, and other substances. Some member states have legal maximum limits for vitamins and minerals, while others provide only guidance only. For example, the UK provides Guidance on Upper Levels for Vitamins and Minerals from the Expert Group on Minerals and Vitamins.