Consumers are often confused by the term nutraceuticals. Throughout the years, an increasing number of dietary supplements have become readily available through big retail stores such as supermarkets and health and wellness retailers as well as pharmacies. But how do they differ from regular food supplements and pharmaceuticals? Where do they fit?

The definition of a nutraceutical is still a grey area for many, being placed somewhere between the two. Nutraceuticals are defined as “a foodstuff, such as a fortified food or dietary supplement, that provides health benefits in addition to its basic nutritional value”. The adoption of nutraceuticals in daily diets may help prevent the onset of pathological conditions by possibly delaying or avoiding the need to use pharmaceuticals in subjects who qualify for an alternative, nonpharmacological approach to a health condition.

The term “Nutraceutical” was created in 1989 by Stephen De Felice, founder and chairman of the Foundation for Innovation in medicine, an American Organisation which encourages medical health research.

How are food supplements and medicinal products defined and relative to nutraceuticals?

Food supplements are defined as “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, marketed in dose form, namely, forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules or liquids, drop dispensing bottles and other similar forms of liquids and powders designed to be taken in measured small unit quantities”.

Medicinal products are defined as “any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or any substance or combination of substances that 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”.

Although all three categories have different definitions, a lot of characteristics from nutraceuticals overlap into food supplements and pharmaceuticals. Nutraceuticals can be marketed with the same pharmaceutical form of food supplements, but always have specific added health value for the prevention or treatment of pathological conditions.

nutraceuticals

The global functional food and nutraceuticals market is expected to grow by 7.39 percent between 2016 and 2020 and by £30million in the UK alone. However, currently, the nutraceutical market is a confusing one, with various research claims and counterclaims affecting health communications. Combined with influencers and the media adding their input, it is often hard for consumers to know what to believe.

There is huge potential for nutraceutical products with substantial health benefits to be used as a powerful tool in preventing medical conditions. However, it is vital that proper definitions and regulations are available for use beforehand as consumer confusion extends to regulation and policymakers. From within, the nutraceutical industry may see itself as reasonably well defined, however from the outside to consumers, it is very vague. Health messages and claims around nutraceuticals, from maintaining mental sharpness, reducing cancer risk, improving the skin, tend to add to the confusion regarding the identity and purpose of nutraceuticals.

20 years ago, nutraceuticals were on the verge of a health and food revolution, but the properties never managed to materialize. However, in the last few years, they have started to resurface as more consumers become wary of side effects of pharmaceutical medicines and treatments. The message for how your product truly benefits health naturally has to be as strong as the product. The target customer must be identified efficiently, with no money spent developing the product until you have a solid foundation of who you are trying to reach. Numerous claims are repellent for consumers, but being 100% transparent entices them in while sticking to the correct regulations.

nutraceuticals worldwide

Current nutraceutical regulations around the world

In Europe, nutraceuticals are classified under the European Food and Safety Authority (EFSA). The mission of the EFSA is to provide the basis for the assurance of a high level of protection of human health and consumer interest in relation to food, considering the diversity in the supply of food, including traditional products, while ensuring the effective functioning of the internal market.

In the USA, The UK Food & Drug Association, FDA, focuses on safety aspects and food supplements, acknowledges the term nutraceutical and applies a different set of regulations to them than those of conventional food and drugs. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

In Canada, nutraceuticals are regulated more like a drug than as a food category. Under the Food and Drugs Act, natural health products must be classified as either a food or a drug since they do not have a category to section them. As functional foods are taken for therapeutic reasons, they are more similar to drugs than food.

Indian legislation does not ascribe any specific legal status to nutraceuticals. The government of India established the Food Safety and Standards Act (FSSA) in 2006 to introduce a legislation system. FSSA does not separate functional foods, nutraceuticals and dietary supplements; instead, each is indicated as food for a special dietary application.

Australia and China regulate nutraceuticals simply as a category of food and the national regulations valid for food supply. A simple registration-based approach has been adopted by some countries, such as Columbia, Brazil and Argentina. A notification-based approach addressed to the local competent authority is valid in Mexico and Chile. Brazil, China and Taiwan have stricter requirements and prior to registration, a complete animal or human clinical study is required.

Japan was among the first countries to face the issue of regulating food supplements and foodstuff by issuing the Foods for Specified Health Use or FOSHU. FOSHU refers to foods containing ingredients with functions for health and officially approved to claim its physiological effects on the human body.