Which Governmental Agency Regulates Dietary Supplements In Australia

What are nutraceuticals?

In 1989, the term “nutraceuticals” was introduced by Dr. Stephen DeFelice meaning “food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease.1,2,3 Although this definition may be accurate, it is currently not recognized by any regulatory authority in any country. In order to understand the complex meaning of nutraceuticals, people used to associate it with the Hippocratic principle “let food be they medicine, and medicine be they food”, which led to a broad misunderstanding that food and medicine are the same.3 Today the regulatory definition of this term has not yet been finalized and is not well-established worldwide.1,4

All over the world, the nutraceutical market is rapidly growing, and regulations of nutraceuticals are continuously evolving without a clear regulatory definition.5 Due to this ambiguity, nutraceuticals are not regulated as pharmaceutical products in certain countries but as food supplements.4 In many countries, food supplements are consumed in order to complement the normal diet and ensure the proper intake of specific components (e.g., vitamins, minerals).3 Many health conditions result in unique nutritional requirements and the need to consume nutrients in nontraditional formats, so many physicians and consumers seek out nutraceutical products.6 In many countries, nutraceuticals are commercialized to minimize the risk factors of various diseases.3,4 One study in the United States showed that there is a role for the selected use of single and combined nutraceutical supplements, vitamins, and minerals in the treatment of hypertension as a complement to optimal nutrition and other lifestyle modifications.7

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These products are often perceived as “safe” and less likely to have side effects. The scientific research on nutraceuticals and nutrition supplements is often misinterpreted or overstretched for commercial interests because of high consumer demands.8 Within the last decade, consumers have increased their use of nutraceuticals to the point of intentionally avoiding pharmaceuticals and regarding prescription drugs as being unnecessary, too expensive, and sometimes unsafe.9

The use of nutraceuticals varies widely from country-to-country; nutraceutical use may be limited to general health and well-being while others permit use for medicinal purposes.5 The global prevalence of nutraceuticals is noticeably high but has minimal regulation compared to traditional drugs.4 The global market is flooded with nutraceuticals claiming to be of natural origin and sold with therapeutic claims by major online retailers. Nutraceuticals are at the interface between nutrition and pharma and have the capability of opening doors to seek new therapeutic alternatives for the prevention of nutrition-related diseases. Although, the possibilities are endless for the discovery of nutraceuticals products, their safety is at question due to the lack of regulation. Governmental agents are only providing surveillance activity rather than intervening to protect public health.1

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