Warnings alone are not enough to protect consumers from the health risks associated with diet supplements that contain the natural stimulant ephedra, some consumer advocates argue.
In a letter last week to the Food and Drug Administration, Consumers Union, publishers of Consumer Reports magazine, called upon the federal agency to pull ephedra off retail shelves.
The FDA in February proposed new warning labels for diet and sports enhancement supplements containing ephedra. The period for public comment on the proposal ended Monday.
“We believe the FDA’s proposed warning label is an inadequate response to this serious public health hazard and fails to protect consumers from those risks,” Janell Mayo Duncan, legislative and regulatory counsel for Consumers Union, wrote to the agency.
A spokesman declined Tuesday to discuss the comments the agency has received. The spokesman said “we have received a tremendous number of responses” from industry, consumer and public groups.
The debate over the effectiveness and safety of ephedra has intensified in the last year.
Concern soared after significant amounts of ephedra were found in the body of Baltimore Orioles pitcher Steve Bechler, 23, who died of heatstroke Feb. 17 at spring training.
Last week, the call to ban ephedra got a boost when Missouri Attorney General Jay Nixon sued the makers of Hydroxycut, a diet supplement that until recently contained ephedra.
Though the Canadian-based MuscleTech Research and Development Inc. now advertises “ephedra-free” Hydroxycut, a version containing ephedra still can be purchased at health stores and on the Internet.
Nixon’s lawsuit, filed in St. Louis, alleges the company used deceptive advertising to mislead consumers into thinking they can burn fat safely using Hydroxycut.
The lawsuit contends that MuscleTech’s claims overstate Hydroxycut’s ability to burn fat and understate the risks. Company officials did not respond to a phone request for an interview.
Nixon also alleges that Hydroxycut’s maker failed to adequately describe studies it conducted in which participants had adverse reactions, including serious heart problems.
The lawsuit alleges that “before” and “after” photos used professional fitness instructors and models.
“Billions of dollars are spent on these products, and yet the FDA doesn’t regulate them,” Nixon said. “So we have a heightened responsibility to make sure these advertisements that sell to impressionable kids are accurate.”
Food and Drug Administration officials say they want to better inform consumers with supplement labels that state, “Use of ephedra has been associated with heart attacks, strokes, seizures and death.”
“Consumers should use the same kind of care when using dietary supplements as they would when using any pharmacologically active product,” FDA Deputy Commissioner Lester M. Crawford said in February in announcing the proposal for warning labels.
The agency has limited power to regulate dietary supplements under the Dietary Supplement Health And Education Act of 1994.
The law does not allow the agency to review dietary supplements for safety and effectiveness, as it can with prescriptive drugs. The law does, however, allow the agency to stop the sale of a supplement if it presents an unreasonable risk of injury.
Industry officials deny that ephedra, a naturally occurring stimulant, is dangerous. They say it is safe and effective when taken as recommended and when it is not used by people with medical conditions that might make them susceptible to its side effects, which include rapid heartbeat.
Studies show ephedra has limited ability to speed the metabolism, which can help some people lose weight. Studies also suggest users risk having a heart attack, seizure or stroke.
The Consumers Union letter argued that evidence shows dietary supplements containing ephedra “do indeed pose an unreasonable risk of illness or injury.” It asked the Food and Drug Administration and the Department of Health and Human Services “to ban ephedra immediately.”
The FDA spokesman said the agency has begun analyzing the comments from consumer and industry groups. The agency will publish its conclusions later this year, he said.