The Food and Drug Administration is calling for bottles of the popular herb ephedra to bear warning labels that the pills can cause heart attacks, strokes or even death.
The warning would appear in a black box on ephedra products, and would say that ephedrine alkaloids have been linked to heart attacks, stroke, and even death. It would also carry a warning for athletes.
The FDA proposed the warning labels while saying a ban on at least some products containing ephedra remains under discussion.
The powerful dietary supplement industry has blocked the idea of warning labels for ephedra for years.
The action comes less than two weeks after a medical examiner announced the heatstroke death of a Baltimore Orioles pitcher was probably linked to his use of ephedra.
Despite public complaints about the safety of the herb, the dietary supplement can only be taken off the market if the FDA can prove that it presents an unreasonable public health risk.
“The law has created a tough burden for the Food and Drug Administration,” Health and Human Services Secretary Tommy Thompson said at a press conference Friday.
A new government-sponsored study by the RAND Corp. found that no studies have approved the use of ephedra for athletic performance. The study also found that four small studies have found the herb helps people achieve modest short-term weight loss, but there is no evidence for sustainability of weight loss, Thompson said.
The FDA tried to restrict ephedra use in 1998, but regulatory committees decided the agency didn’t have enough evidence about the herb’s risks.
FDA Commissioner Mark McClellan announced Friday that the agency will reopen its case against ephedra, and federal officials are calling for public testimonies to update their case.
Thompson said officials are seeking public comment on health risks associated with ephedra and a new warning label. Medical professionals are also called upon to offer scientific evidence about ephedra’s risks.
Comments will be allowed for only 30 days so officials can move forward quickly.
Government officials are also sending out warning letters to companies making unsubstantiated claims about athletic enhancers that contain ephedra. Companies have 15 days to explain why they have scientific basis for claims, or how they will modify their marketing.
“I want to caution all Americans, particularly athletes, and those who engage in exercise of strenuous actiivety, aobut using dietary supplements with ephedra, especially when combined with other stimulants, such as caffeine,” Thompson said.
“I said it before, and I’ll say it again, I would not take this, and I wouldn’t give it to my family. I don’t know why anyone would take these products, take the risk,” he said.
Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years the products have been promoted and used with the goals of aiding weight loss, enhancing sports performance, and increasing energy.