16 September 1999

Fat Free?

by Kate Melville

In 1998 US consumers spent in excess of $12 billion on dietary supplements - ingredients extracted from foods, herbs and plants that are ingested for their possible 'health benefits'.

Unlike drugs, the compounds are mostly unregulated. This huge market shows few signs of slowing and the impact of the products can't be all that great as US citizens are amongst the most seriously obese in the world! With such great interest in these supplements, some scientists are now urging the US government to protect the public by creating a new special supplement category known as "nutraceuticals", and requiring that they be proven safe before they're sold.

In the September edition of Science Dr. Steven Zeisel, professor and chairman of nutrition at the University of North Carolina at Chapel Hill says the idea that dietary supplements are natural and therefore must be safe is false. "Increased review and regulation of dietary supplements will decrease public access to some beneficial products. For supplements administered at doses that can be found in foods, adoption of Good Manufacturing Practices (rules proposed by the U.S. Food and Drug Administration for manufacturers) should not significantly alter availability." For nutraceuticals that expose humans to ingredients at doses they would normally not be exposed to, demonstration of safety could mean it would take years rather than weeks to introduce new products, and some products might never be introduced. "This seems a reasonable cost to protect the public health. The hazards of not testing supplements for safety are real" Zeisel said. "To date, the FDA has asked for the voluntary recall of a product containing the herbal ingredient plantain contaminated with Digitalis lanata after an individual consuming the product suffered a complete heart block.

The FDA proposed a regulation to limit the amount of ephedrine alkaloids in dietary supplements after serious side effects, including death, were observed." Recently, the FDA asked for voluntary recall of supplements containing a form of butyrolactone because it appeared responsible for serious side effects, including coma and death. The Dietary Supplement Health and Education Act was passed by the US Congress in 1994 and ensures people can buy products quickly, but also makes it likely that some of those sold will harm people.

Professor Zeisel proposes, "to define nutraceuticals as those diet supplements that deliver a concentrated form of a presumed bioactive agent in a nonfood matrix and used to enhance health in doses that exceed those that could be obtained from normal foods. A good example is genistein purified from soybeans and delivered in a pill in doses greater than could be consumed in soy."

Even though manufacturers are sure to oppose Zeisel's proposals for new regulations and testing, this proposal may actually benefit manufacturers in the long run. Any dietary supplement that harm people could would almost inevitably result in hugely expensive class action litigation as well as potentially damaging the reputation of the entire supplement industry. Some of the major players in this area include multibillion dollar companies like Monsanto, Bristol-Myers Squibb, Lipton, Johnson & Johnson, DuPont, Procter & Gamble and Novartis.

Editors Note: If you ever visit the US the solution to many of the problems of obesity are immediately obvious in every restaurant and fast food outlet - the gargantuan proportions! Simply reducing the size of portions would probably have just as much impact on the national level of obesity as all the various diet programs and supplements combined!