Safety and regulatory status

The fact that the Hoodia plant has been consumed by the San Bushmen as whole fresh plant or dried whole plant for thousands of years is an element in favour of its safety. However, it is not sufficient to definitely conclude that the plant, P57 and P57AS3 from H. gordonii are safe for human consumption.

Since P57AS3 has been found to have similarities to the steroidal core of cardiac glycosides, long-term research is needed to determine appropriate dosage and potential contraindications, risks and side effects such as potential disturbances to heart rhythm that may be triggered by its consumption. The lack of definitive safety data has been confirmed in several communications from the US FDA. These were rejections in response to new dietary ingredient notifications as required before marketing of supplements containing H. gordonii (see Section 10.3.2 above). Examples are given below.

1 June 19th 2003 - A letter from the FDA to Goen Technologies Corp. that their 3/27/03 New Dietary Ingredient (NDI) notification was inadequate; attached was their 61 page notification which included a 57 page patent (US patent 6,376,657) that contained several study reports (http://

www.fda.gov/ohrms/dockets/D0CKETS/95s0316/95s-0316-rpt0186-vol133-web.pdf).

2 March 3rd 2004 - A letter from the FDA to Hoodia Products LLC that their 10/29/03 NDI notification was inadequate; attached was the 1 page NDI notification (http://www.fda.gov/ohrms/dockets/dockets/95s0316/ 95s-0316-rpt0218-vol156.pdf).

3 October 6th 2004 - A letter from the FDA to Awareness Corp. that their 3/23/04 NDI notification for use of dried powdered H. gordonii cactus pulp as a weight loss dietary supplement was inadequate; attached was their 17 page notification (http://www.fda.gov/ohrms/dockets/dockets/ 95s0316/95s-0316-rpt0238-01-vol173.pdf).

Similarly in Europe, the Netherlands notified the European Commission, DG Health and Consumer Protection Rapid Alert System for Food and Feed (RASFF) that attempts had been made to import slimming pills containing H. gordonii, unauthorized as a novel food (http:europa.eu. int/comm./food/food/rapidalert/index_en.htm).

In the USA the next step will be to submit a further premarket notification of a new dietary ingredient once adequate safety data have been published. In Europe it is becoming increasingly clear that H. gordonii would be considered as a novel food. This is despite earlier speculation that it might fall under the remit of medicines legislation (Feord, 2005).

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