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For centuries, human civilizations have taken food for medicine. Star anise, a common spice in Eastern Chinese slow cook dishes has traditionally been used as food and medicine. Shikimic acid, the spice’s active, is known for its antiviral potency. The father of western medicine, Hippocrates, said 2,500 years ago: “Let food be thy medicine and medicine be thy food”. The term “Nutraceuticals” was coined by Stephen DeFelice – founder and chairman of the Foundation for Innovation in Medicine (FIM). It was first introduced in 1989 to categorise products carrying both “nutrition” and “pharmaceutical” properties that offered health benefits to consumers.1 Developed in Japan in the 80s and booming by the 90s as people became more nutrition conscious, the global nutraceuticals industry is predicted by BCC Research2 to be worth $207bn in 2016.
With a worldwide growth rate of 6.5%, the EU and UK market values of nutraceuticals are estimated to be $49bn and $3.9bn respectively.3 Although larger than the coffee industry, there is a lack of consensus concerning international regulation of nutraceuticals.
Nutraceutical is an umbrella term covering food that offers health benefits besides nutritional values, such as:
• Dietary supplements: The FDA defines dietary supplements as tablets, capsules, softgels, gelcaps, liquids, or powders containing diet ingredients extracted from food that offer additional nutritional benefits through ingestion. Examples of these nutritional diet ingredients include vitamin, mineral, herb/botanical, amino acid.4
• Functional food: The European Food Information Council (EUFIC) says:
“Although functional foods have not as yet been defined by legislation in Europe, generally they are considered within the EU as those foods which are intended to be consumed as part of the normal diet and that contain biologically active components which offer the potential of enhanced health or reduced risk of disease”.5
As an alternative to taking supplements, functional food already has the additional nutritional diet ingredients added. Common examples include milk with added vitamin D and probiotic yoghurt.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for setting the regulatory framework for medicinal products in accordance with EU directives. The MHRA classifies medicinal products as substances that can change physiological functions by exerting a pharmacological, immunological or metabolic action.6
Nutraceuticals do not satisfy the MHRA’s medicinal framework, often because they are not required to provide the mechanisms of the active ingredients, a very strict process observed by the pharmaceutical industry. So it is not possible to conclude whether nutraceuticals can induce pharmacological actions on the body to restore, correct or modify a physiological effect.
According to the UK Food Standards Agency (FSA), food shall not include “medicinal products within the meaning of Council Directives 65/65/EEC and 92/73/EEC”.7 Nutraceuticals do not fit within the food regulatory framework either because they offer values beyond mere nutrition. Instead nutraceuticals have been covered by the EU novel foods regulation (Regulation EC No 258/97) since 1997,8 which means any food that doesn’t have a well-known history of consumption in the EU before 1997 must be assessed before appearing on the market. Although not as strict as regulations imposed on pharmaceuticals, novel food regulations help ensure that novel foods or novel food ingredients must be safe for consumers and labelled properly to avoid misleading consumers. While regulations for novel foods in Canada and Australia are similar to that of the EU, they are different in the US.
Variations in the classification of ingredients added into food are one reason why regulations for nutraceuticals vary between countries. Health Canada requires natural health products (vitamins, minerals, herbal supplements, Traditional Chinese Medicine TCM) sold in Canada to have natural product numbers, similar to drug ID numbers in the EU. Differences in cultures also influence the directives. In China where the practice of TCM is very popular and traditional ingredients make up 70% of health food, foods and drugs are treated as the same source.9 Another challenge is the quantitative studies to prove real long-term benefits of nutraceuticals, as studies must be conducted over such a long period of time. Dosing is also a significant factor to take into account. A high dose of added vitamins into supplements to treat illness could be subjected to medicine regulation. Controlling the amount of ingredients in food is harder than in prescriptions, because one doesn’t know how much a person can eat, hence introducing the risk of under-dosing.10
A lack of clearly defined regulations from the European Commission in the last decade resulted in over-regulating and rejections of many manufacturers’ products previously sold on the market, as documented by the BBC in 2010.11 The good news is after 20 years of discussion, the Commission recently agreed it would stop vague claims and allow hard claims of disease reduction for foods which have solid evidence.
The next step is for the EU Parliament to decide whether to accept this new proposal. If it does, then the EU will join the WHO, also working to set international standards for nutraceuticals. This will help build a standard regulatory framework with consensus from different continents to ensure that manufacturers are given clear instructions to claims that they can and cannot make. Subsequently this will help improve standards of the nutraceuticals industry to let consumers have better products and know how to make the right choices for food, medicine, supplements or functional food for particular needs.
What can be agreed for now, is that no matter how effective a nutraceutical is, it still cannot replace the demonstrated benefits of good nutrition, exercise and a healthy lifestyle.12
(1) Kalra, E. K. AAPS PharmSci 2003, 5, 27.
(2) BCCResearch, http://www.bccresearch.com/pressroom/fod/global.
(3) Cogent SSC-Skills for Science Base Industries 2013, UK Cosmeceutical and Nutraceutical Sectors: Market and Employment Profile.
(9) Shimizu, T. Nutrition Research Reviews 2003, 16, 241.
(10) Hughes, E. Chemistry World 2012, October.
(12) Bodeker, G. Leading authority globally on Wellness, Traditional Complimentary and Integrative Medicine and Chairman of GIFTS of HEALTH personal communication, http://giftsofhealth.org/.