MONDAY, March 10, 2003 (HealthDayNews) -- The editors of one of the nation's leading medical journals have joined the growing chorus of voices calling for changes in the way dietary supplements are regulated.
The call to action appears as an editorial in the March 26 issue of the Journal of the American Medical Association (JAMA), and essentially seizes upon the release of a long-awaited report on ephedra and ephedrine by the Rand Corp. to denounce current regulatory practices.
The authors of the Rand study summarize their findings in an article in the same issue of the journal, although the U.S. Department of Health and Human Services had released the report last month. It found scant evidence that ephedra or ephedrine enhance athletic performance or promote long-term weight loss, two of the most common claims made on behalf of the substances. On the other hand, the report's authors did find links to heart palpitations and psychiatric, gastrointestinal, and nervous system problems.
Products containing the herb ephedra have been implicated in more than 100 deaths, including that of Baltimore Orioles pitcher Steve Bechler last month. Ephedrine, the active ingredient in ephedra, increases metabolic rate, heat production, and the risk of heatstroke. Last month, a group of San Francisco researchers claimed that ephedra is the most dangerous herbal product on the market and should be banned. They based their statement on data collected from poison control centers.
While the Rand report found the existing universe of literature on ephedra and ephedrine inconclusive and called for more studies, that was enough to prompt the U.S. Food and Drug Administration to call for tougher labeling on ephedra-containing products.
On Friday, the FDA proposed new rules that would establish tougher labeling on dietary supplements. The agency wants the labels to accurately state the content of the supplements, including the active ingredient and other additives. "Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels," said Health and Human Services Secretary Tommy Thompson.
The JAMA editorial went even further by calling for an overhaul of the nation's regulatory system.
"Our feeling is that ephedra is probably just the tip of the iceberg here with respect to the need for solid data on safety and efficacy on a lot of dietary supplements, said Dr. Phil B. Fontanarosa, JAMA's executive deputy editor and one of the authors of the editorial.
"While ephedra has garnered a lot of attention and for good reason, it really points to differences in regulation for these types of products compared with other products that are available," Fontanarosa said. "Our feeling is that the example of this one product points out the weaknesses in our current system. Yes, indeed, additional studies are needed, not only studies looking at ephedra but studies on a whole host of products that make health claims that really need to be supported."
The editorial stated that the public 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."
It went on to state that "the current system for regulation of dietary supplements is inadequate for ensuring the protection of the health and safety of the public" and that "major changes in the system used to regulate these products are required."
The FDA regulates nutritional supplements (including ephedra) differently than either "conventional" foods or drugs, both prescription and over-the-counter. Under the terms of the Dietary Supplement and Health Education Act of 1994, the manufacturer is responsible for making sure a dietary supplement is safe before putting it on the market. The FDA can take action only if something goes wrong after that point. In other words, the burden of proof is on the government.
A definitional issue seems to be at the heart of the matter. Specifically, what is a dietary supplement?
"My feeling is that if a product can make a health claim then that product has to be biologically active, and biologically active agents don't just focus on one little area of the body. They get into many cells and can do a lot of things," Fontanarosa said. "If they are biologically active, then they need to be regulated with more scrutiny. If they're not biologically active, we should be questioning the ability to deliver on their health claims."
The JAMA editors called for a four-point plan of action, starting with a review of the scope of products currently listed as dietary supplements. The current scope is too broad, they say, and each class needs to be examined and possibly reclassified. "The many, many products under this broad umbrella of dietary supplements need to be examined," Fontanarosa said. "Just because something fits into the broad umbrella doesn't mean that it can't cause harm."
Second, dietary supplements need to be more rigorously regulated by the FDA. If a health claim is made, then they should have to live up to the same standards as drugs and submit data from scientific studies.
The government also needs to have systems in place for post-marketing surveillance and adverse event reporting, not the current "haphazard" system of voluntary reporting.
Finally, the FDA with the Federal Trade Commission need to make sure that advertising is accurate and not misleading.
After analyzing dozens of studies, the authors of the Rand report concluded that ephedra and ephedrine are associated with two to three times the risk of psychiatric symptoms, gastrointestinal symptoms, and heart palpitations. Out of 16,000 adverse events, the authors uncovered five deaths, five heart attacks, 11 cerebrovascular accidents, four seizures, and eight psychiatric cases associated with taking ephedra or ephedrine. The authors also note that many ephedra products also contain caffeine, which may have contributed to the effect.
More information
To view the full Rand report, visit the Food and Drug Administration. The Ephedra Education Council has additional information on ephedrine.
