Safety and regulatory status

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The safety of HCA has been investigated in several studies, reviewed by Soni et al. (2004). No adverse effects have been observed either in animal toxicity tests or in human studies. Teratogenicity studies and long-term feeding studies still need to be completed.

As noted above, G. cambogia extract/HCA has been a component of dietary supplements in the USA for some years. In 2003 InterHealth announced that a panel of scientific experts had affirmed Super CitriMax® as GRAS (generally recognized as safe) for use in functional beverages in the USA (Interhealth website, GRAS affirmation). This is the first step towards more general food application of HCA. It seems likely that if HCA becomes a mainstream ingredient raw material supply might become an issue. This has obviously been predicted by the Ireland-based Company, Shannon Minerals Ltd, who recently submitted a premarket notification of intention to market synthetic HCA as a new dietary ingredient for dietary supplement applications. The FDA rejected this application, unconvinced of equivalence to the currently marketed HCA extracted from G. cambogia.

In Europe it is likely that HCA would fall under the remit of the Novel FoodsRegulation (EC) No. 258/97 although to date there is no evidence that this has been explored in any detail.

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