BETWEEN foods and drugs is a twilight zone that is guaranteed to cause trouble, especially for governments. Under the catch-all heading 鈥渇ood supplements鈥�, lies a vast array of substances: from vitamins and minerals through to tonics such as ginseng, preventatives such as echinacea and cod liver oil, to potent herbs such as St John鈥檚 wort.
It is, it seems, a God-given right for anyone to consume any of these substances without hindrance from doctors or government regulators. Indeed, over the past decade, as the cost of 鈥� and disillusionment with 鈥� conventional medicines has grown, consumers have turned more and more to supplements. In the US alone, the market is worth $18 billion. Supplement makers and some complementary therapists are adamant in their efforts to defend the market.
Yet while most food supplements are innocuous, a few are not. People have been harmed and even killed by them, while others have been tricked into buying sham products or poisoned by contaminants. And when supplements interfere with prescription drugs, serious complications can ensue. Clearly, something has to be done.
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Attempting to deal with this in the US has put the Food and Drug Administration in a bind. While the FDA is charged with guarding public health, a law dating from 1994 makes it virtually impossible for it to do so. The law implicitly assumes that as supplements are natural and have a long history of use, no safety assessments are needed. So supplement manufacturers do not have to seek approval from the FDA before putting a product on sale. Contrast this with the rules for conventional medicines. To be allowed to sell their products, drug companies must provide the FDA with exhaustive data on efficacy, quality and safety. If anything goes wrong, the FDA has plenty of information to find out why.
But when it comes to dietary supplements there is nothing: a black hole. The FDA may not learn of a problem until large numbers of people are already dead. No wonder it took seven years to collect enough evidence to ban the energy and weight-loss supplement ephedra earlier this year.
But things are moving. Last month, the FDA published draft guidelines to ensure that supplements are made in clean factories and that they are genuine and free of contaminants. Last week, the US Institute of Medicine called for revisions of the 1994 act to provide better safety data for the FDA (see 鈥淎 health fad that鈥檚 hard to swallow鈥�). Supplement makers have defended the act in the past, and are likely to do so again: one company has already planned a legal challenge to the FDA鈥檚 ban of ephedra.
The European Union has also found itself in deep water over efforts to regulate dietary supplements. It has split them into several categories and is seeking to regulate them through different directives. For vitamins and minerals, the first job is to create a list of approved substances and to set safe doses 鈥� to replace the differing rules in force in member states. But even this first step has been referred to the European Court of Justice after health store owners and health food manufacturers in the UK claimed it would threaten 鈥渉ealth, freedom of choice and legitimate commercial interests鈥�.
Europe is having more success with herbal medicines, which will have to be registered with the European Agency for the Evaluation of Medicines. Manufacturers will have to submit safety data 鈥� though for 鈥渢raditional鈥� remedies that may mean providing historical evidence rather than mounting fresh trials. The directive sets quality standards for herbal remedies.
Supplement makers, wherever they are, will be understandably unhappy about the expense and hassle of complying with new laws. But ultimately it makes no sense for them to argue against the idea that their products should be genuine, untainted and safe. There is also a potential pay-off: their products will have an added stamp of quality and safety.
Consumers will then have only one missing piece of information: evidence that what they are taking really works. A review of herbal medicines published in The American Journal of Medicine (vol 116, p 478) found that only four of the top 10 botanicals taken in the US are likely to be effective, and that there is little evidence on which to judge the value of 20,000 others. Why anyone would want to take supplements of uncertain value is an interesting question. But that, as they say, is another story.