Federal government says it will ban ephedra

| 12/31/2003

The Food and Drug Administration plans to ban the sale of dietary supplements containing the herbal product ephedra, Health and Human Services Secretary Tommy Thompson announced Dec. 30.

In addition, the FDA issued a consumer alert regarding the safety of dietary supplements containing ephedra and has notified manufacturers of its intent to publish a final rule that will say dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury, according to the statement from Thompson’s office.

"Today's action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now," Thompson said.

“Consumers should stop buying and using ephedra products right away,” Dr. Mark B. McClellan, commissioner of the FDA, added. “FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective."

The FDA said it is banning the products in part because of their effect on the body. The agency pointed to a number of studies, including one by Rand Corp., noting safety risks associated with products containing the chemical.

“Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes,” the FDA said in a statement.

Under the law, a dietary supplement is considered adulterated if the product or one of its ingredients presents a significant or unreasonable risk of illness or injury when used as suggested on the product’s label, according to FDA information.

The agency said it sent letters to 62 companies that market supplements containing ephedra and ephedrine alkaloids, alerting those firms of the coming ban. Any ban would become effective 60 days after it was formally published, which FDA said would happen “as soon as possible.”

Danger has been well-known
While the drug has been legal in most states up till now, it still represented a risk for truckers who had taken it.

Donna Ryun of OOIDA’s member services said truckers who are about to take a drug test “should advise the attending physician of any non-prescription drugs (even herbal) that you are taking.” Ephedra can initially cause a false positive on drug tests, making it look as if the trucker has taken a forbidden substance.

But legal concerns like that are only part of the picture. A number of studies announced in the past year have pointed to possible dangers the supplement poses to people’s health.

In making its decision, the FDA “worked hard to obtain and review all the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra's safety and effectiveness, adverse event reports, and reviews by independent experts," McClellan said.

One example: In April, a scientist at South Dakota State University told Land Line research indicated people who use caffeine and ephedra before exercise put a heavier demand on their hearts. Project director Matthew Vukovich said a study by the university looked at factors such as heart rate and blood pressure before, during and after exercise in people who had ingested 150 mg of caffeine and 20 mg of ephedrine.

The combination increased both the heart rate and systolic blood pressure, placing a heavier strain on the heart. The subjects of the study showed higher heart rate and blood pressure even after 60 minutes of rest.

Ephedra is an herbal supplement frequently sold at convenience stores, and is often marketed as an “energy booster” and weight-loss aid. Some brands specifically market to truckers, and several types of pills containing the substance are frequently found near checkout counters at truck stops and other fueling stations or other places frequented by truck drivers. They include Metabolife, Ripped Fuel, Up Your Gas, Truckers Luv It and Yellow Jackets.

States acted first
The federal action to ban the herbal supplement follows a host of state actions, many of which occurred after the sudden deaths of athletes who were using pills containing ephedra.

In November, New York Gov. George Pataki signed into law a measure that outlawed the substance. During the signing ceremony, Pataki cited one athlete who died after using the drug.

“Across the nation, dietary supplements containing ephedra have been implicated in serious health problems, yet few consumers are aware of the danger,” Pataki said. “By banning the sale of most ephedra products in New York State, this important new public safety measure will help to prevent the tragic deaths of young athletes like Steve Bechler.”

Bechler was a pitching prospect for the Baltimore Orioles who collapsed during spring training and died the next day. A Florida coroner’s report determined that ephedra was a contributing factor in the athlete’s death, which was primarily caused by heat stroke. Bechler was 23.

In May, Gov. Rod Blagojevich of Illinois signed a bill into law that banned all over-the-counter sales of ephedra, except in products that receive approval from the Secretary of Health and Human Services, and then only when deemed “safe and effective for its intended use” or under a label approved by the federal Food and Drug Administration.

That law was also inspired by the death of an athlete. Illinois student Sean Riggins, 16, died after taking the drug to enhance his performance on the football field, The Associated Press reported.

Former California Gov. Gray Davis signed a law earlier this year that will ban ephedra sales beginning in January.

But despite early actions by states, the federal government was hardly sitting still in regard to the dietary supplement.

The Federal Trade Commission announced in early July that it was taking enforcement actions against three companies that marketed diet or weight-loss pills that contained ephedra.

Two of the companies settled with the FTC. One complaint has been filed with the U.S. District Court. All, the agency said in a release, point to what the FTC calls deceptive claims regarding the effectiveness, safety and lack of side effects.

And the action Tuesday was not the first time the FDA had spoke out regarding ephedra. Possible action by the agency against the herbal supplement was first revealed by Commissioner McClellan as he spoke before two House panels earlier this year.

--by Mark H. Reddig, associate editor

Mark Reddig can be reached at mark_reddig@landlinemag.com.