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