subject: Dietary Supplement Regulation – A Brief Overview [print this page] Dietary supplement regulation could be described as something of a bit of a grey area. In the US, dietary supplement regulation falls separately under a piece of legislation known as the Dietary Supplement Health and Education Act of 1994 (DSHEA) which is regulated by the food and Drugs Agency (FDA). Similarly in the UK, dietary supplement regulation is recognised as being a unique area of manufacture and marketing, if not always clear-cut and distinct. In the UK therefore dietary supplement regulation covers products that are described as borderline' products.
Borderline products and the items covered by the US supplement regulation seek to clarify a grey area between medicines and foods in which many products don't immediately belong anywhere else. As an example, toothpaste that doesn't make medicinal claims about its product, but wants to market it by telling people that it can cure' sensitive teeth. If it were to advertise the latter, then the toothpaste would fall into the medical category requiring it to be subject to medical regulation, rather than that of cosmetics. This in turn has a cost to the company manufacturing the product. The MHRA Borderline Team is there to guide individual businesses falling into this grey area.
It's essential therefore that businesses and manufacturers of dietary supplements make sure that they take advice about supplement regulation and the category in which their product fits or whether it is requires further and more detailed regulation. Claims made about Vitamin C tablets being the cure for the common cold' for example would render the product a medicine and it would then be subject to stringent tests before being released as a common cold' cure. Of course, it is not a cure for the common cold, and whilst it is well documented that a lack of certain vitamins like but not exclusively Vitamin C can contribute to a person acquiring certain common cold' type symptoms which is very different from saying that it's the cure for that set of symptoms.
Supplement regulation therefore is a tricky balancing act between allowing manufacturers to produce and sell products that may carry some health benefit to consumers, but which cannot overtly be sold with this as its objective.
Dietary Supplement Regulation A Brief Overview
By: Paul baguley
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