'Hoodia' diet pills

There are not many properly controlled tests on it, but it does seem to be a small help in controlling hunger.

However, if you've ever said "I'm stuffed, what's for dessert?" chances are that hunger is not your real problem. Most of us eat because it's dinner time, or because we're with friends who are eating, or because the food is tasty, or because we are bored or stressed or watching Lost.

Hoodia - a bit of the history of the Hoodia/P57 product

Hoodia is a plant extract used by the San bushmen of Namibia as an appetite suppressant while on hunting expeditions. BBC correspondent, Tom Mangold covered this story in May 2003. The rights to Hoodia were bought by a UK company called Phytopharm. Phytopharm refer to the active parts of Hoodia as P57. Phytopharm worked with the Pfizer Corporation to develop marketing rights for the giant Pfizer Corporation.

Unfortunately.........'in July 2003 the Natureceuticals group within Pfizer was closed due to internal re-organisations leading to the discontinuation of the development of the P57 programme. The upside of the announcement is that the value of this product has increased enormously and created an opportunity to extend the P57 programme into the dietary control of obesity with multiple licensing opportunities.'

At the time of the return of the license, Dr Richard Dixey, Chief Executive of Phytopharm, commented: “We have enjoyed our relationship with Pfizer over the past five years, during which a considerable body of clinical and pre-clinical data has been generated within the P57 program. We will now take further steps to build on this substantial foundation and seek other partners for this exciting opportunity.”

Since then Phytopharm have contracted with Unilever to develop hoodia extracts as dietary treatments. Phytopharm tried to take Hoodia/P57 to market under a set of regulations called GRAS - Generally Regarded As Safe.
The submission of P57/Hoodia to the FDA for GRAS status (Generally Regarded as Safe) may be more of a stumbling block to the successful commercialisation of the product than first realised. Phytopharm will take the less onerous route to commercialisation first, but if GRAS status is not granted, the FDA will require that P57/Hoodia undergo full regulatory approval. A process that is expensive and time consuming.

To understand the GRAS regulations, read the extract below from the FDA Consumer magazine March-April 2004 Issue. Then consider those substances that have GRAS status - salt, sugar, spices etc. Could the FDA grant GRAS status to an extract from a hoodia cactus that is used by 27,000 San bushmen in the deserts of Namibia, and nowhere else. The San bushmen use the hoodia cactus to supress appetite while on long hunting trips. But how often do they need to hunt ?

From the extract

A GRAS substance, therefore, is one that has a long, safe history of common use in foods, or that is determined to be safe based on proven science. Demonstration of either of the criteria in this sentence may prove difficult when relying on anecdotal evidence from the San bushmen. These people have no form of writing.

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The information below is from Phytopharms website

Weight management

Obesity is a major health problem and growing rapidly in numbers and severity. In the US, 65% of adults (127 million) are overweight or obese, and healthcare costs are thought to amount to $100 billion (Source: American Obesity Association). The problem is growing in Europe, and in the UK about 43% of men and 34% of women are overweight, and a further 22% of men and 23% of women are obese (Source: British Heart Foundation). There is a rising level of premature obesity in children and obesity is increasing in the developing world. In 2002, the market for the dietary control of obesity was $2.3 billion in the US alone, and this has continued to grow (Source: Market Research Report, Weight control – US).

Mode of action
Our weight management functional food product is based on an extract of the succulent plant, Hoodia. This extract contains a novel satiety stimulator that reduces caloric intake in overweight subjects, as demonstrated in our double-blind, placebo-controlled clinical study announced in December 2001.

Progress to date
In December 2004, we announced that we had granted an exclusive global licence for the Hoodia extract to Unilever plc. Under the terms of the agreement, Phytopharm and Unilever are collaborating on a five-stage research and development programme of safety and efficacy studies with a view to bringing new weight management products to market. In April 2006, we announced that we had successfully completed the first stage of our Joint Development Agreement. We also announced that we are now progressing through the second stage which includes clinical studies.As part of the agreement, Unilever committed to initial payments of approximately £6.5 million for the first stage and in April 2006 committed up to £3.5 million for the second stage. In addition, Phytopharm will receive an undisclosed royalty on sales of all products containing the extract. Unilever is also managing a separate agronomy programme and supporting the international patent programme for the products. Extracts of Hoodia and the active molecules therein are the subject of a global patenting programme, with major patents granted in the US, Europe and Japan. Phytopharm and Unilever have also become aware of many companies that are selling products over the Internet and in some stores claiming to contain Hoodia and causing weight loss. Analysis of these products has demonstrated that the great majority of them contain little or no Hoodia. Phytopharm and Unilever have made contact with the relevant authorities concerning this development and are satisfied with the progress being made in these key discussions.

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I believe that Phytopharm will eventually commercialise Hoodia as a dietary treatment. I am not fully up to date with their application for GRAS status, but doubt that it would be granted in any event. So I suspect that Phytopharm are having to conduct full efficacy trials before being allowed to bring it to market.

You can see from Phytopharm's statements that they believe the internet hoodia products are mostly placebos. This was uncovered by Tom Mangold in the original 2003 documentary.

I hope this helps.