The dictionary definition of a nutraceutical is, “any food or food ingredient which is considered to have a beneficial effect on health”. The term has since been adopted by the food marketing industry to describe any food product or supplement that may have a functional or physiological effect that may be beneficial, such that the description nutraceutical is broadly used and can refer to anything from a vitamin supplement pill, to an energy enhancing drink, and more recently to foods which are claimed to have physiological effects e.g. Benecol™ a margarine that allegedly reduces cholesterol.

Nutraceuticals or medicines?

Although by definition nutraceuticals are classed as food products, use of the term nutraceutical and the claims attributed to the properties of the product have lead to some confusion as to whether nutraceuticals should be classed as medicinal products. Currently the consensus is that nutraceuticals are not caught by the provision of s130(2) Medicines Act 1968 which states that a medicinal product is a substance or ingredient used in the preparation of a substance which is administered for a medicinal purpose where a medicinal purpose is defined as the following:

• treating, preventing or diagnosing disease;

• contraception; or

• inducing anaesthesia.

Fortified Cereals: many breakfast cereals contain added vitamins and minerals (iron, zinc, vitamin B12 and folic acid)

Vitamin and mineral supplements: either sold as separate supplements or as a mixture with varying amounts of the different compounds.

Additional supplements: supplements other than vitamins and minerals which are believed to have beneficial effect on health (cod liver oil, primrose oil, glucosamine, garlic, echinacea, Coenzyme Q10 and ginkgo biloba).

Energy drinks and tablets: drinks that contain stimulants such as caffeine and sugars or isotonic drinks containing sugars and salts to mimic the solute potential of the cytosol and thus create a solution which is osmotically balanced with the body.

Foods to reduce cholesterol levels: the most common example of which is Benecol™ a margarine, and possibly in the future a whole range of foods which will contain Abcor™ a compound developed by Nutri-pharma and claimed to reduce cholesterol by 15-20% in four months.

Pro-biotics: foods containing bacteria that are believed to improve health e.g. Yakult™ (“with 6.5 million friendly bacteria in every drink”) which contains lactobacillus casei shirota, a bacteria which is thought to improve gut health and reduce the incidence of heart disease and certain cancers.

Although the name implies that nutraceuticals have medicinal properties they are in fact food types. Due to this, claims regarding the beneficial effects of nutraceuticals can only be “health claims” and not “medicinal claims”. For instance the claims must not state that by eating/taking the nutraceutical a disease will be prevented or cured but only that it may help to improve health, possibly assisting in the avoidance of the onset of illness.

If indeed a claim was made that implied medicinal benefit regarding a nutraceutical product, the product would be required to comply with the regulatory requirements for medicinal products, in respect of safety, efficacy and quality testing and marketing authorisation procedures.

As it stands nutraceuticals are required to comply with food law. The Food Safety Act 1990 (FSA), subsequent primary and secondary legislation and codes of practice ensure that food placed on the market is safe and that any information provided about the product is not misleading.

The two key areas of food regulation to be considered in relation to nutraceuticals are those of labelling and advertising.

The Food Labelling Regulations 1996, as amended, prohibit certain claims such as those that state or imply that a product has tonic or medicinal qualities, and establishes conditions for the use of phrases that imply that a product has beneficial qualities.

In addition to the Labelling Regulations, the Codex Alimentarius Commission (CAC) has produced international guidelines which assist in interpretation on the use of general claims, nutritional claims, and potentially misleading claims.

Finally, the Joint Health Claims Initiative (JHCI), a collaboration of the Food and Drink Federation, the National Food Alliance (now Sustain) and the Local Authority Co-ordinating Body on Food and Trading Standards (LACOTS), has produced a Code of Practice. This Code of Practice enables manufacturers to establish a uniform approach for labelling of food products, which complies with labelling legislation and advertising codes, and takes into account the requirement for a scientific approach regarding nutritional and functional claims.

If a nutraceutical is not a medicinal product, it does not fall within the scope of the Association of British Pharmaceutical Industry (ABPI) Code of Practice.

Instead, advertising and promotional activities for nutraceuticals are required to comply with general standards and codes. TV advertising should comply with the provisions of the Independent Television Commission (ITC) Code of Advertising Standards and Practice, and other promotional activity (newspaper ads, billboard posters, etc) must comply with the British Codes of Advertising and Sales Promotion (BCASP), regulated by the Advertising Standards Agency.

The codes require that all adverts are legal, decent, honest and truthful, but also establish specific requirements for certain product types. Specific requirements exist in both codes to ensure that adverts for vitamins, minerals and food supplements do not make any unsubstantiated claims, or indeed encourage the consumption of supplements in a manner which may be detrimental to an individual’s health.

A key piece of legislation regarding nutraceuticals that is likely to be adopted in the near future is a “Directive on the approximation of laws of the Member States relating to food supplements”. The proposal, drafted as announced in the White Paper on Food Safety, was originally presented by the Commission in May 2000, and has since been amended. The European Parliament voted in favour of the amended proposal in March 2002, clearing the way for its final adoption, estimated to be around May 2002.

The proposed Directive concentrates solely on supplements (defined as concentrated sources of nutrients or substances with a nutritional or physiological function), but states that specific rules on other substances with a nutritional or physiological function shall be laid down at a later stage. The proposed Directives sets out requirements for:

• purity criteria to be observed;

• the establishment by the manufacturer of upper safety levels and maximum daily dosages, taking into account other dietary sources of vitamins and minerals;

• the inclusion of the word “supplement” in the names of products;

• additional particulars to be included in the labelling of the products.

In addition to the proposed Directive the Commission also recently produced a Discussion Paper, which looked into issues of nutritional and functional claims attributed to foodstuffs.

The paper addressed the following issues:

• the definitions of claims used, e.g. what constitutes a nutritional claim and how does this differ/relate to a functional claim;

• conditions under which claims may be made, are the conditions appropriate/too stringent?;

• the types of evaluation and authorisation systems used for claims, and whether they are adequate.

The Commission received over 80 responses to the paper, from interested parties such as food manufacturers, national regulatory bodies and consumer associations. It is intended that the Commission will use the responses to evaluate existing provisions and if necessary produce proposals on new measures designed to address any outstanding issues.

This article first appeared in Ipeye, the intellectual property newsletter published by Eversheds Solicitors. For more information about, or to receive copies of Ipeye, please contact Janet Knowles on 0161 831 8207 or 0113 243 0391 or at janetknowles@eversheds.com.

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