Editors of the leading Journal of the American Medical Association have published an editorial urging new legislation to regulate dietary supplements.
The editorial was prompted by a review carried out by the Rand Corporation on ephedra, published in the same issue of the journal, which finds that the herb widely used in weight loss supplements has only small long-term benefits and may also pose significant health risks.
"The public, aware of recent reports of deaths in young athletes reportedly taking ephedra or ephedrine, is right to be alarmed that the regulation Congress has in place does so little to protect them from the hazards posed by these potentially dangerous compounds," write Dr Phil Fontanarosa, Dr Rennie Drummond and Dr Catherine DeAngelis in the journal.
The authors claim a key paradox in the marketing of dietary supplements. They write that if supplements have biological activity, they should be considered to be active drugs. "On the other hand, if dietary supplements are claimed to be safe because they lack or have minimal biological activity, then their ability to cause physiologic changes to support 'structure /function' claims should be challenged, and their sale and distribution as products to improve health should be curtailed," they say.
"Manufacturers of dietary supplements are trying to have it both ways. They claim their products are powerfully beneficial, on the one hand, but harmless on the other. To claim both makes no sense, and to claim either without trials demonstrating efficacy and safety is deceptive."
The authors further add that supplements should be brought entirely under FDA regulation. The editorial says that the very definition of dietary supplements, which they claim is too broad, needs to be addressed. "The number of products marketed as dietary supplements has increased considerably in the nearly 10 years since DSHEA was passed into law. Each class of products within dietary supplements should be re-examined, and the types of products within each class should be reviewed and classified according to possible biological action, purported benefit, and potential risks."
They also believe that health claims for dietary supplements should meet the same criteria as claims by drugs used to prevent or treat disease. Both scientific evidence backing the supplements and manufacturing practices should be regulated by the FDA, and mandatory adverse event reporting should be established "to replace the current system of haphazard, voluntary reporting of anecdotal reports".
The article concludes that the recent study on ephedra and other evidence is sufficient to restrict the sale of the herb.
"However, the most important lessons from the new information on ephedra are demonstration of the inadequate nature of the current system of regulation of dietary supplements and recognition that much more rigorous oversight of these biologically active agents is necessary to protect the health and safety of the public," they write.