A thorough understanding of food law has always been central for the successful formulation, manufacture and marketing of functional foods. Each of these is also affected by other regulations, especially the laws governing the advertising of medicines. This complex regulatory framework can be even more difficult to navigate when products fall into different regulatory categories for different EU member states. The combination of more complex regulations and increasing enforcement, have moved food compliance issues into the spotlight. Successful interpretation of the regulations covering ingredient compliance, labeling, health claims and medicines law can deliver huge commercial success. In contrast, a failure to comply in just one area can result in enforced product withdrawal causing irreparable damage, both to the brand and consumer confidence. Increasingly breaches in food law result in substantial fines for both product manufacturers and retailers and can even result in imprisonment.

Regulatory authorities are placing increasing demands on the food industry to provide supporting evidence that functional food products are legally on sale and safe. For example many ingredients will be assumed to unsafe unless there is evidence to the contrary. Health claims require evidence they are valid both for a specific product formulations and the associated directions for use. Functional food manufacturers must also take great care to ensure that their products are not classified as medicines. This can easily happen by using medicinal parts of plants, high concentrations of specific ingredients, or by making strong marketing claims, even if they can be substantiated scientifically. In reference to ‘borderline’ food products the MHRA state “…. In accordance with article 2(2) of the directive, where doubt remains as to its classification as a medicine or other type of product it will be classified as a medicinal product”. For products lacking medicinal registration this frequently results in removal from the market with immediate effect, without the opportunity to sell through existing stock. In 2012 this situation occurred with food supplements containing geranium oil and the reputed bioactive 1,3-dimethylamylamine (DMAA). A failure to comply with MHRA classification rulings is a criminal offence that can result in proceeding via the courts. MHRA guidance notes on the classification of functional foods can be downloaded here. Such issues highlight the extremely complex borderline between foods and medicines and a failure to meet these regulatory challenges can have a catastrophic commercial impact. A selection of case studies showing how Alimentarius successfully defended clients products against legal and regulatory challenges is given here.