As ephedra ban takes effect, enforcement becomes the issue
The government’s ban on the herbal supplement ephedra begins today, which means it can no longer be sold at the supermarket or on drugstore shelves. But that doesn’t guarantee that the product won’t be available on the Internet, where other supplements targeted by the Food and Drug Administration are still readily available.
For years, consumer advocates and researchers have worried about the online sales of substances the FDA has warned may be unsafe. Although ephedra is the first supplement the agency has banned since the 1994 Dietary Supplement Health and Education Act deregulated the industry, it has recently issued consumer advisories, import bans and other actions on a number of other supplements, effectively yanking them from the market.
Examples include the weight-loss products comfrey and aristolochic acid and, most recently, the sports-enhancement supplement androstenedione, a steroid precursor that converts to steroids in the body. A few minutes on any Web search engine shows just how accessible they remain.
Ephedra, derived from the Asian herb ma huang, has been used by dieters to promote weight loss and by athletes to enhance performance. The amphetamine-like product can significantly increase blood pressure and heart rate and, according to the FDA, can lead to heart attacks and strokes in some users.
Because of the size of the ephedra market ($1.3 billion at its height) and the number of people in the U.S. who have tried it (an estimated 13 million), ephedra is likely to be a major test of whether the FDA can adequately scrutinize Internet sales of dangerous supplements, something the agency says it is spending an increasing amount of time and money trying to do.
Curtailing online sales of illegal substances -- whether supplements or narcotics -- is a daunting task. Online sites need little more than a basic Web page and a warehouse to start selling; many can close up shop and disappear in a matter of hours. The fact that a significant number of problematic sites are based overseas makes the cat-and-mouse chase even harder; the FDA does not have jurisdiction outside of the U.S.
Critics worry that the FDA simply doesn’t have the personnel to keep track of illegitimate Internet sales from sites in this country. They also question whether regulators can monitor the thousands of small mom-and-pop shops around the country that make up most of the industry’s sales.
“Anyone will still be able to get ephedra if they want,” says Bruce Silverglade, legal director for the Washington, D.C.-based Center for Science in the Public Interest.
Dr. Laura Tarantino, acting director of the FDA’s Office of Nutritional Products, Labeling and Dietary Supplements, acknowledges that the agency must make “resource choices” when enforcing sanctions. Still, she says the FDA is adequately scrutinizing both bricks-and-mortar and online sales of all supplements. “We diligently use the tools we have available to monitor the industry,” she says.
The FDA’s dietary supplement division has a staff of about 60 people and a budget of $10 million.
Last year, UC Berkeley researchers found that two years after the FDA warned that the weight-loss product aristolochic acid may be dangerous and imposed an import ban on the supplement -- which effectively took it off the market -- they were still able to find 112 products of the suspected carcinogen online.
Further regulation of the supplement industry may be brewing. This month, a report by the influential Institute of Medicine suggested the FDA may need broader regulatory ability to force manufacturers to report adverse events, something they don’t need to do now under the law.
Regulators seem to be “taking small steps in the right direction, but we have a long, long way to go,” Silverglade says.