gms | German Medical Science

Food supplements are foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect alone or in combination. Food supplements are marketed in dose form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities [1].

Products in dose forms were formerly only known as medicinal products. Therefore, it is very easy and at a superficial glance very common to mistake food supplements for medicinal products. However, as food supplements and medicinal products belong to two different fields of law. The fundamental legal differences between food supplements and medicinal products are presented in this talk, concerning e.g. composition and production of the product, quality and quantity of the substances used, effect on the human body as well as labeling and advertising.

Food or foodstuff are defined to article 2 of Regulation (EC) No 178/2002 as “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. […] Food shall not include […] (d) medicinal products within the meaning of Council Directives 65/65/EEC and 92/73/EEC” [2]. As medicinal products are defined in article 1 of directive 2001/83/EC as “any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” [3].

Crucial to distinguish a food supplement from a medicinal product is the effect on humans. As soon as a product is pharmacological effective, according to article 2 of Regulation (EC) No 178/2002 it is per definitionem a medicinal product and it is legally not possible to place it a food supplement product on the market.

Food law is largely harmonized within the European Union. The statutory rules of food law are based on the same principles of general food law and on specific provisions e.g. for labelling, terms of use including upper limits for most substances. For the use of substances like e.g. food additives and flavours the same specific rules apply in all Member states. Still, legal harmonization and implementation of specific provisions are still pending for vitamins, minerals and other substances crucial for food supplements. For vitamins and minerals upper limits are not set, yet. For “other substances with a nutritional or physiological effect alone or in combination”, only general principles of food law apply as exact provisions are still not set. Therefore, classification of “borderline” products still differs between member states. As the classification of a product as medicinal or as food supplement, exclude each other, food business operators have to ensure, that their products have only a nutritional or physiological but not a pharmacological effect.

To classify a product correctly as food supplement, it should not have a significant pharmacological effect. A list with minimum and maximum levels for all vitamins, minerals and other substances in food supplements would be helpful for the competent authorities and the food business operators to classify products correctly. The legal framework for such lists is already in place. Based on article 8 annex 3 of regulation (EC) No 1925/2006 provides lists for substances prohibited, restricted or under community scrutiny [4]. A substance can be listed in annex 3 based on a scientific assessment. To set upper limits for a substance it is necessary to find the concentration based on a scientific risk assessment. In many cases, it is not possible to assess the correct concentrations for maximum levels due to a lack of suitable scientific data on the substances in question. Consequently, annex 3 is still nearly empty and no specific community law applies for other substances with a nutritional or physiological effect.

Therefore, Member States of the European Union still continue to use their national law for the regulation of maximum levels of vitamins, minerals and other substances in food supplements. Some Member states classify other substances based on traditional lists of substances or have to make a case by case assessments based on general principles of the European food law. A case-by-case assessment procedure is very time consuming and ineffective. In addition, when the product is already on the market, the burden of proof for a unbearable risk for the consumer lies within the competent authorities of the Member states.

For a more systematic approach, the Competent Federal Government and Federal State Authorities in Germany published a list of Substances starting with the category “Plants and plant parts for plants and plant parts”. Its scope is to facilitate the classification and assessment of substances regarding their use as food or food ingredient. It serves as a reference guide for competent authorities and food distributors. The final assessment of products containing these substances or preparations thereof must still be made on a case-by-case basis, giving due regard to all criteria relevant to that assessment [5].

Additionally, The Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM) have initiated an expert commission for the classification of substances. The main reason for creating the new commission is that substances, which until recently were mainly or only used in drugs, are increasingly put into circulation as foodstuffs or foodstuff ingredients. According to the authorities there are still frequent concerns regarding the safety and the marketability of these products as foodstuffs.

Other than medicinal products, food supplements with the exception of novel foods may be placed on the market without prior approval, as long as they meet all requirements of food law. The person or company who markets the products has to make sure that the products comply with the governing food law [2]. In Germany, the federal states (Bundesländer) enforce food law regulations. The Bundesländer, their supreme food control authorities and subordinate food control offices, make random tests to check whether food products are in conformity with the food law.

Production of food supplements has to follow the principles of food law. According to article 14 of regulation (EC) No. 178/2002 foodstuffs are not allowed to be not safe, so no special (pharmaceutical) skills are required to produce capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders like e.g. a production and control manager. The person or company who markets the products has to make sure that the products comply with the governing food law. In food law, tolerances between the labelled and actual content of substances are usually quite generous (see Table 1 [Tab. 1]).

Food supplements have to be notified in Germany. In the course of the notification process, the food supplement in question is not examined by the competent authorities for food control on its conformity with the relevant food legislation. Thus, the successful notification of a food supplement does not discharge the manufacturer/ importer from his own responsibility to assure that his products do not present any risk for the consumers and comply with the requirements of German Food Law. Some of the main differences between food supplements and medicinal products are shown in Table 1 [Tab. 1].

The principles for labelling a food product are laid down in regulation (EU) No 1169/2011 [6]. All provisions for compulsory and optional labelling are set therein. According to article 7 (3.) “food information shall not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties”.

A food supplement may be labelled with approved health claims [7]. Regulation (EC) No 1924/2006 shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer. Only approved health claims may be used [8]. Any food business operator can use authorized health claims if the conditions of use and any applicable restrictions are respected. Non-authorized health claims should not be used. National authorities control the use of claims. Health claims should only be made for the nutrient, substance, food or food category for which they have been authorized, and not for the food product that contains them. Some flexibility of wording of the claim is possible provided its aim is to help consumer understanding taking into account factors such as linguistic and cultural variations and the target population. Adapted wording must have the same meaning for the consumer as the authorized claim in the EU Register.

For the authorization procedure for a new health claim, applicants must submit an application to an EU-country's competent authority that checks admissibility before transmitting it to EFSA. The Commission's implementing rules, established by Commission Regulation (EC) No 353/2008, inform applicants what their application should include. Within the context of this authorization procedure, EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA) is responsible for verifying the scientific substantiation of the health claims. More guidance on the definition and classification of the scientific data for the assessment of a health claim is available on the EFSA website [9]. Usually, scientific data include tests and clinical trials.