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A regulatory overdose - debate regarding vitamin B6

Jane Feinmann

Vitamin B6 is in short supply these days, thanks to a bizarre ministerial decision

Three months into his term of office the food safety minister, Jeff Rooker, has managed to antagonise not just the food industry but consumers as well. His announcement last month that the government will legislate to restrict severely the sale of high doses of vitamin B6, a popular remedy for premenstrual syndrome, has set off a flurry of pretests.

The vitamin and health food industry has taken Rooker to task for his "illogical and unscientific" stance. And women are signing petitions and writing to their MPs, insisting that, thank you very much, they would prefer not to be protected from a natural product that has eased their symptoms without any evidence of harm for 16 years. By the autumn PMS could be on the political agenda, with the government accused of infringing rights and curtailing consumer choice.

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Although Rooker inherited the issue from the previous government, his decision to take action can, on the face of it, be seen as entirely right-minded. The Consumers' Association has campaigned for several years for government regulation of the burgeoning natural-remedy market, worth more than [pounds]280 million in 1995 and growing rapidly.

The market for products such as royal jelly, evening primrose oil, ginseng, spirulina and garlic pearls, as well as high-dose vitamins and minerals, is a consumer-driven success story, rooted in the practice of nutritionists and other complementary therapists. They appear to offer a kinder, more natural but no less effective alternative to pharmaceutical drugs for the "worded well" and to those with chronic illnesses that do not respond well to conventional medicines.

These natural remedies are classed as "food supplements" and aren't allowed to make unproven medical claims on their packaging. But they don't have to. Their target audience reads widely about their health and natural remedies are extensively written about in the health pages of the popular dailies, women's and health magazines and the expanding sector of health books. The coverage frequently relies on impressive but wholly anecdotal evidence.

What worries the Consumers' Association is that 40 per cent of consumers believe that food supplements are medicines - a belief often encouraged by the brand names and packaging that manufacturers use. Yet there are no checks on toxicity levels and no system for reporting adverse effects. Their popularity sometimes appears to be based less on scientific principles than clever PR.

Take one of the latest "miracle" health fads: the blue-green algae of Klamath Lake. Is it, as posters and newspaper cuttings in the windows of health food shops claim, the purest source of nutrition in the world, giving an instant energy buzz, clearer skin, stronger nails and shinier hair? Or is it, as one dissenting health writer wrote recently in Self magazine, mere "pond scum", cynically marketed to a credulous public at ridiculous prices? There again, if it makes people feel better and does no harm, does it matter whether it really has an active ingredient?

The Consumers' Association says the fact that "there is much potential to mislead consumers" does matter. It wants all dietary supplements to be subjected to independent scrutiny by an unbiased centre of expertise which will license products only with approved health claims, checked by an independent scientific government committee. It has welcomed the government's proposals for action on vitamin B6 as a first step to a wider regulatory system.

The natural-health lobby says the boom in food-supplement sales represents a "positive move towards greater self-care" with more and more people taking physical and financial responsibility for their health and well-being - not to be sniffed at when NHS funds are under strain. If the government wants to impose curbs on the sale of food supplements, why should it not also subject mainstream foods that make health claims, such as vitamin-enriched cereal, porridge oats, olive oil or even broccoli, to independent scrutiny by an unbiased centre of expertise before they're allowed on our shelves?

The government's case against vitamin B6, however, is not that the 50 or more products containing the supplement make fraudulent claims. It is, after all, already available in high doses as a prescription medicine to treat vitamin B6 deficiency, including the symptoms of PMS, and has therefore proved its case to the licensing authorities.

The concern is that the vitamin is toxic in high doses, specifically causing (reversible) nerve damage with symptoms of tingling and numbness. As such, the government says, it should be available only under the supervision of a pharmacist or a GP, not through health food shops or supermarket outlets. It is proposing to restrict over-the-counter sales to a maximum of 10mg doses (to alleviate PMS effectively, you need to take between 50mg and 200mg).

But the case for regulation of high doses is contested. The government's 10mg safety level is based on two pieces of research reviewed by the Department of Health's committee on toxicity (COT), which was asked two years ago to advise on B6.

The committee, which deals with matters of toxicity relating to food, consumer products and the environment, had access to a number of studies that have found vitamin B6 safe at 200mg a day. But it based its recommendation on a small 12-year-old study carried out by a Harley Street gynaecologist, Dr Katherina Dalton, who is best known for her work with progesterone in treating PMS. This study stands alone in finding vitamin B6 toxic at 50mg doses. The committee's review stated: "We consider it would be unwise to ignore this evidence in the light of other supporting animal data" - data that included evidence of toxicity in dogs at levels equivalent to a human intake of 3,000mg a day.

The argument of the food-supplement lobby is that COT, which normally deals with toxins or artificial additives used in the basic food-production process, where any level of toxicity is unacceptable, does not have the right expertise to make recommendations about vitamin supplements. Dr John Hathcock, a former regulatory scientist with the US Food and Drug Administration brought over to Britain by the supplement manufacturers in July, says: "All [the report] really shows is that if you take vitamin B6 in ridiculously large doses over a very long time, then you'll eventually develop reversible adverse effects."

The FDA has investigated the toxicity of vitamin B6 and, like most of Europe, allows it to be sold freely at levels up to 200mg.

The conclusion the government needs to take from all this, according to the Centre for Complementary Health Studies at Exeter University, is that the food-supplement market is an area which is short on hard data, and even on methods for collecting hard data - and is a field where almost everyone has an axe to grind. The pharmacy press, for instance, greeted Rooker's announcement with a roar of triumph, interpreting it as a welcome move against health food shops. Even the Consumers' Association has a reputation for taking a negative and, some would argue, outdated approach to vitamin supplements.

The director of the Complementary Studies Centre, Simon Mills, has quietly and uncontroversially supervised the introduction of a regulatory scheme for herbal medicines, including the annual publication of a directory of approved remedies and an adverse-reaction reporting scheme which is being extended across Europe. But nothing, he says, would persuade him to take on a similar job for food supplements.

"It's the wild west out there, full of fear and loathing," he says. "Of course the Consumers' Association is right that the natural-health world has been remarkably free of consumer principles for a surprisingly long time. But to do more than tinker around the edges - perhaps banning the use of medical-sounding brand names or taking action where there is clear evidence of a health risk - will be difficult, if not impossible."

Mills' words should ring warning bells for the food safety minister. His decision to get involved in this fraught area may be laudable in principle but he may find himself rapidly drawn into a quagmire of claim and counter-claim, in which the consumer ends up both confused and hostile towards a government seen as intrusive and meddlesome. If it all gets too much, he could always try taking a good vitamin B-complex to calm him down.

Jane Feinmann is health editor of "Family Circle"

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