ban on the sale of ephedra was scheduled to take effect Monday, April 12,
according to documents from the federal Food and Drug Administration.
rule banning ephedra was published Feb. 6. Typically, such actions take
effect 60 days after the publication of a final rule.
FDA rule reflects what the scientific evidence shows - that ephedra poses
an unreasonable risk to those who use it," Health and Human Services
Secretary Tommy G. Thompson said in a statement. "The regulations
prohibit the sale of dietary supplements containing ephedra, and we intend
to take swift action against anyone who puts consumers at risk by continuing
to sell such products after the prohibition takes effect."
is a naturally occurring substance derived from plants, the FDA said. It
is often referred to by its Chinese name, Ma huang. The dietary supplement
contains ephedrine, which is regulated as a drug when it is produced artificially.
is often marketed as a weight loss aid, and many athletes use it in an
attempt to enhance sports performance.
announced in December that the FDA planned to ban the supplement. In addition,
the FDA issued a consumer alert at that time regarding the safety of dietary
supplements containing ephedra and 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.
December, we advised consumers to stop using ephedra products, and we asked
responsible companies to stop selling them," FDA Commissioner Mark
B. McClellan said.
in statements regarding the ban, pointed to a number of studies, including
one by Rand Corp., noting safety risks associated with products containing
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.
the agency and a number of states that have already banned the substance
pointed to the deaths of a number of prominent athletes who used the drug,
including Baltimore Orioles pitching prospect Steve Bechler.
months of government buildup to the ban, it was nearly held up after one
manufacturer of the herbal supplement made an 11th-hour attempt
to block the ban. Late Monday, a judge rejected the request.
Inc. of Newton, NJ, which makes the ephedra product Stacker 2, had asked
U.S. District Judge Joel Pisano to block the FDA’s action, The
Associated Press reported. Pisano refused to grant a temporary restraining
order after a hearing April 12, the date the ban was to take effect.
and other officials waited for Judge Pisano’s decision and for the
ban to take effect, they issued a warning to consumers.
the final rule prohibiting the sale of ephedra-containing dietary supplements
takes effect, FDA reiterates its warning to consumers: ‘Do not take these
products. They are simply too risky,’” McClellan said.
H. Reddig, associate editor
can be reached at email@example.com.