by Paul Ranson and Melanie Eggers
Medicinal products in the EU face large regulatory hurdles, so it's critical for dietary supplement manufacturers to ensure their products are not classed as medicinal products, either through how they are presented or through their constituents.
In the EU, “medicinal product" is defined in Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use (2001/83) as a substance:
- “presented for treating or preventing disease;" or
- “which may be administered … with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions."1
The "presentation" test will therefore take into account any claims (implicit or explicit) that are made for the product, and the characteristics of its presentation as a whole, based on the impression of the averagely informed consumer.
Claims to relieve symptoms or prevent, cure, remedy or heal a specific disease or adverse condition of body or mind are regarded as medicinal claims and can only be made by medicinal products. On the other hand, claims that a product “maintains" or “helps to maintain" or “supports" health or a healthy lifestyle, or claims made in relation to healthy bodily functions or organs are not likely to be considered as medicinal in themselves.
The "function" test is applied on a case-by-case basis, taking into account all the characteristics of the product, particularly its composition, pharmacological properties, use, the extent of its distribution, consumer perceptions and any inherent risks in its use. A recent case involving the status of red rice established a product that cannot be scientifically established to restore, correct or modify physiological functions by means of pharmacological, immunological or metabolic action cannot be considered a medicinal product.2
Competent authorities decide whether a product is medicinal based on legislation and decisions of the European Court.
Specific Laws Relating to Supplements
Directive 2002/46/EC should be the next consideration, assuming the manufacturer has successfully negotiated the issue of avoiding medicinal product status.
“Food Supplement" is defined in 2002/46 to mean, “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients [vitamins or minerals] or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms 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."3
A key principle is the product must contain only the permitted vitamins and minerals and their sources as listed in the "positive list" comprising the Annexes to 2002/46. Currently, the legislation contains positive lists only for vitamins and minerals. At this stage, other substances do not have such requirements. The vitamins, minerals and their sources permitted for use in food supplements are consolidated under Commission Regulation (EC) No.1170/2009.4
Vitamins or minerals on the list that are subsequently proven to endanger human health can be suspended from the market by member states and removed from the list by the European Commission..5 2002/46 also makes provision for the setting of maximum and minimum levels for vitamins and minerals in food supplements.6
In addition, food supplements must conform to the prescribed purity criteria.7 Dosage must also fall within safe levels established by scientific risk assessment based on generally accepted scientific data.8 A procedure is defined for the submission of requests for substances to be considered for inclusion in the permitted list.9
