Regulatory overview

Regulatory overview

Although consumers are learning the benefits of taking supplements to promote their wellbeing, the global regulation of these products is unappreciated. It is a common error to believe that the supplements category is not regulated, when in fact it is regulated by multiple government Agencies, with manufacturers and retailers also managing responsibility throughout the process.
While the definition of a food supplement is quite clear to understand the definition of a nutraceutical is still in the grey area between food, food supplements and pharmaceuticals.

Food supplements are substances in a capsule, tablet, liquid, or powder form intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic action. Therefore their use is not intended to treat or prevent diseases in humans or to modify physiological functions.

Nutraceuticals are substances that have both therapeutic and nutrient effects. A growing demand exists for nutraceuticals, nonetheless, given specific legislation from different countries, nutraceuticals are experiencing challenges with safety and health claim substantiation. The term ‘nutraceuticals’ is the combination of the two words nutrition and pharmaceuticals, nutraceuticals can be defined as ‘a food or part of a food that provides medical or health benefits including the prevention and/or treatment of a disease’. On the other hand the word nutraceutical is generally used in the marketing world but has no regulatory definition.

Each country has its own definitions and classification criteria; hence, it is important to ensure the product is classified correctly before proceeding ahead with the registration/notification process, because classification will provide a clear pathway.
In Europe, food supplements are regulated as foods. The European Commission has left it up to EU Member States whether a food supplement has to be notified in the respective country before it will be placed on the market. As a result, the requirements can vary widely: whereas a food supplement can be marketed immediately in one EU Member State, in others the product may have to be notified, which includes the submission of various documents, in order to be marketable.

In the US, the term "nutraceutical" is not defined by US law. Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food.

Dietary supplements are meant to supplement the diet and they are regulated as such (Dietary Supplement Health and Education Act, DSHEA 1994). As is the case with foods, FDA regulates the types of ingredients allowed in dietary supplements and the types of claims that can be made about an ingredient and/or a product. FDA also has detailed requirements for the labeling of dietary supplements.

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