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
"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
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
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
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 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
Former California Gov. Gray Davis
signed a law earlier this year that will ban ephedra sales beginning in
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
--by Mark H. Reddig,
Mark Reddig can be
reached at email@example.com.