Death by Dietary Supplement? - consumer education on risks of supplements

Nutrition Health Review, Wntr, 2001 by Henry I. Miller, David Longtin

The Dietary Supplement Health Education Act provides consumers with the ability to purchase health supplements over the counter. But with freedom comes responsibility. Dr. Henry Miller, a former official with the FDA, wrote the following article and he discusses potential problems associated with herbal supplements.

Dietary supplements are advertised everywhere, for all manner of ailments, and about one third of Americans regularly buy herbal products like echinacea, ginseng, and St. John's wort. They spend about $5 billion annually at retail outlets, and sales are rising about 18 per cent a year. Thousands of products cram the shelves of health-food stores, grocery markets, and pharmacies nationwide; they are also widely available through catalogs and the Internet. Even major pharmaceutical companies are adding dietary supplements to their lines. But what assurances do consumers have about exactly what they are getting, and about the safety of the products?

A Regulatory Vacuum

Regulation of dietary supplements varies considerably among developed countries, even among member states of the European Union, which has yet to adopt any transnational standards for these products. Under the most extensive legal framework, Germany has tested more than 300 herbal remedies since 1980, finding about two thirds of these products to be safe and at least minimally effective. It controls these substances as drugs. But consumers in other Western societies receive little protection.

The U.S. Congress has virtually exempted herbal remedies from government oversight. When the Food and Drug Administration (FDA) considered regulating these products in the early 1990s, manufacturers and health-food stores orchestrated a massive lobbying campaign against stricter controls. The industry produced television commercials that depicted movie star Mel Gibson handcuffed by FDA agents for possessing vitamins. The result was the Dietary Supplement and Health Act of 1994.

The FDA can restrict the sale of an herbal product only if the agency receives well-documented reports of health problems associated with it. The FDA formed its Special Nutritionals Adverse Event Monitoring System in 1993 as an important component of its MEDWatch program, which is designed to track problems arising from the range of drugs and medical devices the FDA is charged with regulating. The Special Nutritionals monitoring system was established to record adverse reactions associated with the more than 3,000 dietary supplement products that were then on the market.

But sometime around October 1998, after logging 2,621 "adverse reactions," including 184 fatalities, associated with these products, the FDA quietly stopped monitoring most cases in which herbal remedies had been linked to illness or death. Top agency officials said that they cut the monitoring program because of budgetary constraints. Although the FDA insists that it still collects data on medical emergencies linked to dietary supplements, only three staff members are now assigned to evaluate adverse reactions caused by the industry's products, which are made by hundreds of private companies.

The agency and its herbal monitoring system have been criticized by the congressional General Accounting Office (GAO). In July 1999, the GAO said that the FDA's adverse-reaction reports were incomplete, poorly documented, and inadequate to use as a basis to establish safe dosages for herbal supplements. The FDA requested an additional $2.5 million specifically to improve its dietary supplements tracking program in its fiscal 2000 budget, but this was among several FDA requests eliminated by a Senate subcommittee.

Underreported Medical Problems

With FDA authority limited by the 1994 law, the Federal Trade Commission (FTC), which monitors advertising, has taken a more vigorous role in regulating the makers of supplements. In 1999, the FTC took legal action against seven manufacturers that had violated regulations requiring advertising to be truthful and verifiable. The companies were selling cure-ails for conditions such as impotence, cancer, and obesity. The commission also sent e-mail warnings to 1,200 Internet sites that it said had made "incredible claims" for drugs, devices, and supplements, including herbal remedies that would supposedly ward off AIDS. Late in 1999, the commission also issued its first set of advertising guidelines aimed specifically at the supplement industry.

Even with these FTC measures, however, consumers have no real guarantee that dietary supplements are safe or effective, that the information about dosage on the label is correct, or even that the substance in the container is genuine. Only a few herbal supplements--saw palmetto for treating enlarged prostate glands and ginkgo for improving memory slightly in patients with Alzheimer's disease--have been shown to be at all efficacious.

Moreover, because the demand for some herbal remedies exceeds the supply from natural sources, unscrupulous manufacturers occasionally have switched to cheaper look-alike substances that are pharmacologically different. In February 2000, researchers in Britain discovered that eight brands of herbal skin ointments sold as "natural" treatments for eczema illegally contained dexa-methasone, a potent prescription steroid. The creams had such huge quantities of steroid that they could have permanently damaged delicate skin.