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This article applies to selling in: Saudi Arabia

Food Supplements

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, fiber, plants or herbal extracts.

Food supplements are a restricted product type on Amazon. You must obtain approval to sell food supplements, and not all sellers are permitted to do so. At this time, we are not accepting applications to sell food supplements. If you are interested to learn more about selling food supplements on Amazon, you may contact us.

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 and KSA laws, the main one being EU Directive 2002/46/EC and GSO CAC/GL 55:2015 Guidelines for Vitamins and Food Supplements and GSO 2539:2017 Vitamins and Minerals permitted for use in foodstuff.

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, for sellers who are approved to do so.

Requirements to list Food Supplements

  • The products you sell must be lawfully permitted for sale, fit for consumption, sealed (if applicable), and not expired.
  • All products must be intended for sale within the KSA and compliant with all laws and regulations of the Kingdom of Saudi Arabia.
  • Each product requires a valid barcode (product identifier) registered with the relevant authorities and associated with the product.
  • You must list products under the correct “Product Type” within the Health and Personal Care Inventory File Template so that your listings are correctly categorized and display the correct, relevant information to customers.

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.

  • Nutritional supplements
  • Nutrition bars and drinks
  • Vitamin supplements
  • Sports nutrition and supplements
  • Slimming and weight loss aids (subject to relevant regulatory requirements)

You can also refer to our Help page on Personal Care Appliances Product Types and our list of permitted and prohibited listings for Drugs, Drug Paraphernalia and Dietary Supplements.

Labeling requirements

The following information should be included on the labelling of a Food Supplement, in addition to the information required under Regulation GSO 9:2013/ and 1:2016 on Labelling of Pre-packaged Foods and GSO 2471:2015 Labelling of Body Building Food:

  • The indication “food supplement”
  • The name(s) of nutrients or substances that characterize the product and have a nutritional and/or physiological effect
  • The portion recommended for daily consumption
  • A warning not to exceed the stated recommended daily dose
  • A statement that food supplements should not be used as a substitute for a varied diet
  • A statement that the product should be stored out of reach of young children
  • Statement “not given except with the consent of a doctor or dieticians”
  • The information on vitamins and minerals must also be expressed as a percentage of the reference intake values listed in GSO 2233:2012 on Requirements of nutritional labelling.

Claims

Only nutrition and health claims that have been approved under GSO 2333:2013 (Requirements for nutrition and health claim in the food) can be used on the label.

The aim of the Regulation is to protect consumers from misleading and false claims made on products.

Nutrition claims

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 fiber”, or “reduced salt”.

Only nutrition claims listed in Table 1 in the Regulation (GSO 2333:2013) 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.

Health claims

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 supported by a sound and sufficient body of scientific evidence to substantiate the claim, provide truthful and non-misleading information to aid consumers in choosing healthful diets and be supported by specific consumer education. An example of a specific health claim would be “calcium helps maintain normal bones”. Foods should not be described as “healthy” or be represented in a manner that implies that a food in itself will impart health. Foods may be described as part of a “healthy diet” provided that the label carries a statement relating the food to the pattern of eating described in the dietary guidelines.

Health claims cannot:

  • imply that health could be affected by not consuming the food,
  • make reference to the rate or amount of weight loss, or
  • make reference to recommendations of individual doctors or health professionals.

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.

Medicinal claims

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.

Banned ingredients

The Guidelines for vitamins and minerals food supplements (GSO CAC/GL 55:2015) list the compositional requirement of vitamins and minerals Vitamins/provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognised by FAO and WHO and their chemical forms permitted for use in the manufacture of food supplements can be used in food supplements. The sources of vitamins and minerals may be either natural or synthetic and their selection should be based on considerations such as safety and bioavailability. In addition, purity criteria should take into account FAO/WHO standards, or if FAO/WHO standards are not available, international Pharmacopoeias or recognized international standards. In the absence of criteria from these sources, national legislation may be used.

There are certain ingredients are not permitted in food supplements. For example, the following substances are not permitted as ingredients in the manufacture of food supplements:

  • Certain banned and restricted herbal ingredients, particularly those for medicinal use, such as ephedra herb and kava kava,
  • Medicinal ingredients, including ingredients authorized as traditional herbal medicines, and
  • Medicinal levels of otherwise permitted ingredients.
  • Alcohol and ingredients from non-halal sources.
  • List of substances which are banned to be used in body building foods (Appendix 2 in GSO 2209/2012).
  • Any other internationally banned materials.

Products for sale on Amazon cannot contain any unauthorized ingredients (for example, unauthorized vitamins or minerals, additives, or flavorings), novel foods, or banned ingredients.

Safe upper limits

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. European Food Safety Authority has published scientific opinions about upper safe levels for various vitamins, minerals, and other substances. Also, the UK provides Guidance on Upper Levels for Vitamins and Minerals from the Expert Group on Minerals and Vitamins.

Comments:

  • We recommend leaving the link to the EU Directive 2002/46/EC beside the link to the GSO CAC GL 55:2015 as it contains useful information and principles that are used in the KSA standards (which is adopted from CODEX). Also, in this standard there is a reference to international Pharmacopoeias or recognized international standards to be taken into consideration.
  • The links to Amazon Help page on Personal Care Appliances Product Types and Amazon list of permitted and prohibited listings for Drugs, Drug Paraphernalia and Dietary Supplements are also left in the text.
  • In labelling requirements section, we added: Statement “not given except with the consent of a doctor or dieticians”. (this is according to the GSO 2397:2014 on Foods For Special Dietary Uses – General Requirements for Athlete Food. Please feel free to feedback on this or if you need to discuss the option of removing or keeping this statement.
  • Novel foods part is removed as there are no specific requirements regarding novel food in the GCC and KSA.
  • Banned ingredients list is left as it is, as it contains recognised unsafe substances. We have added alcohol and ingredients from non-halal sources, beside a reference to Annex 2 in GSO 2209:2012 on general requirements for supplements which use for body building.
  • The link to the UK Guidance on Upper Levels for Vitamins and Minerals is also left in the text as it contains useful information.
  • Note that you need to have an account with the Gulf Standards Organization GSO) to be able to access their website and buy standards.
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