Hoodia's uncertain future in Europe

Extracts of the cactus-like plant hoodia gordonii have become one of the hottest products in the natural weight loss category in the last six months, particularly in the US where Americans are searching for a replacement for the banned herbal ephedra.

The plant, native to Africa's Kalahari desert, has been in the media spotlight in the US for several months following a deal between Unilever and UK-based drug developer Phytopharm. Phytopharm invested more than $18 million in researching active fractions of the hoodia plant that are said to suppress appetite, including a human clinical trial.

In December last year it said it had licensed an isolated molecule from the plant, called P57, to Unilever for use in a new range of weight loss products.

Other European companies have also been offering extracts of the plant in supplement form for around three years, despite restricted supply of the raw material that is gathered from the wild and protected by the South African government.

But the recall of a batch of hoodia slimming supplements by Dutch food authorities on 31 March alerted European authorities' attention to hoodia's lack of novel foods approval.

According to EU food law, any food that has not been available on the European market prior to 1997 must submit a dossier of scientific evidence to support the product's safety. This typically takes European officials at least two years to assess and approve and can take several more.

The Netherlands Food and Consumer Product Safety Authority (VWA) issued an alert notification of the hoodia product recall on the European Commission's rapid alert system, which is designed to inform all other member states of product recalls.

Peter van Doorn, chairman of the Dutch health foods trade association NPN​, suggested that recent media attention had prompted the VWA action.

"This action is a follow-up of certain events. Soon after Unilever announced its deal with Phytopharm, there was a TV programme in which a TNO expert declared that the safety of hoodia had not yet been properly evaluated. That prompted the VWA to act."​

The food authority told NutraIngredients.com that it continues to screen imports for hoodia supplements although in another market with growing hoodia sales, the UK, enforcement has now passed to the medicines authority, the MHRA.

According to the MHRA, hoodia can be sold in the UK under section 12 of the medicines act that exempts herbal remedies from registration provided they meet certain criteria. These products must not have a brand name, cannot contain any non-herbal ingredients and cannot make recommendations about their use.

If a product does comply with these criteria however, it is entitled to transitional protection under the new European directive on Traditional Herbal Medicinal Products (2004/24/EC). However this directive covers finished, manufactured herbal medicines which have a basis in tradition, a requirement that will be difficult for hoodia suppliers to meet, given the relatively short time it has been present on the European market.

A MHRA spokesman confirmed that "there are no licensed medicinal products containing hoodia and …we are not aware of any discussions about licensing hoodia".​

As at 16 May, no products have been withdrawn from the UKmarket.

In the Netherlands however a number of companies (less than 10, estimates van Doorn) had "a substantial turnover" from hoodia and will be impacted by the recent product recall.

While the NPN chairman agreed that the food authorities were merely following EU food laws, he added that there seems little basis for fears over hoodia's safety.

"To my knowledge no serious safety concerns have been brought to the attention of NPN. As hoodia has been on the market to a certain extent for some years, there is good reason to believe that the product didn't cause any safety problems,"​ he explained.

UK-based Pure Herbal Extracts says it has been selling hoodia extracts for the last three years, largely to the US market (98 per cent of its sales). But it is also selling around 4,000 bottles (90 capsules per bottle) to the German market, and a further 6,000 to the UK.

It is currently trying to change the label used by its UK customers to comply with MHRA regulations for section 12 products.

Nevertheless, Paul Pearson, CEO of the wholesaler, is also working to comply with new regulations on importing protected plant species, and feels legislation may raise too many barriers for hoodia.

"I believe it is going to die out in the UK because of all the rules and regulations."​

Jean Feord, business manager of legislation at the food consultancy Leatherhead Food, added that the Netherlands case "demonstrates that new ingredients are routinely monitored by enforcement authorities and that there is a significant risk associated with placing such ingredients on the European market without observing the appropriate legislation"​ .

She also noted that if a company does apply for a novel foods authorisation in a member state outside the UK, it could provide "a very interesting test case of the borderline between foods and medicines"​, given that hoodia is currently regulated as a medicine in the UK.

Earlier this month the MHRA launched an online guide​ to more than 600 plants that straddle different categories of regulation (medicine, food or cosmetics) depending on the type of product and part of the plant being used.