| U.S. Dept. of Health & Human Services |
HHS News Release, Jun 14, 2002
HHS Announces Plans to Study Ephedra;
Steps Up Enforcement of Illegal Ephedrine Marketing
HHS Secretary Tommy G. Thompson today announced new
efforts to expand scientific research on the safety of ephedrine alkaloids and
to aggressively pursue the illegal marketing of non-herbal synthetic ephedrine
alkaloid products.
"It is crucial that we have a full understanding of these dietary
supplements," Secretary Thompson said. "By increasing our breadth of knowledge
about these supplements, we can give consumers the information they need to make
informed decisions about these products."
HHS recently funded the RAND Corporation to conduct a comprehensive review of
the existing science on ephedrine alkaloids, particularly those in dietary
supplements. The review is projected to be finished by early fall and, once
complete, will clarify the existing state of the science on ephedrine alkaloids.
The National Institutes of Health (NIH) will use this information to guide an
expanded research effort to better understand the safety of ephedrine alkaloids.
Herbal ephedrine alkaloids, which are commonly referred to as ephedra, are
marketed in the United States as weight loss, energy and sports supplements.
Ephedrine alkaloids are active chemicals found naturally in a number of plants,
including the Ephedra species, but can also be produced synthetically (i.e.
non-herbal).
Adverse event reports regarding the use of dietary supplements containing
ephedrine alkaloids have been received by the Food and Drug Administration (FDA)
and have raised questions regarding the safety of these products. However, the
FDA has advised that adverse event reports alone regarding dietary supplements
containing ephedrine alkaloids do not provide a scientific basis for assessing
the safety of these products and that there is need for further scientific
research.
The FDA has begun a major effort to strengthen its adverse event monitoring
system by incorporating existing reporting systems into a new, unified reporting
system to track and analyze adverse event reports. The new system will improve
FDA's ability to conduct market surveillance and better monitor the safety of
all dietary supplements, including ephedrine alkaloids.
Secretary Thompson encouraged industry to work with the FDA in this endeavor
and to develop labeling that best protects consumer health. "I urge
manufacturers to include FDA's 1-800-MEDWATCH telephone number on their product
labels. Consumers can use the Medwatch number to report adverse events," he
said.
Secretary Thompson also announced today new efforts to aggressively pursue
the illegal marketing of non-herbal synthetic ephedrine alkaloid products. As
part of these efforts, FDA today sent six warning letters to firms unlawfully
selling non-herbal ephedrine-containing products over the Internet. Six letters
went to manufacturers of products that contain the drug ephedrine or
norephedrine hydrochloride (a synthetic, non-herbal, version of the herbal
ingredient ephedra) labeled as dietary supplements of use in weight loss,
suppression of appetite, enhanced libido, and the like. These products violate
the law because they are not legal dietary supplements and are illegal drugs.
Also, FDA warned another company for illegally promoting its ephedrine product
as an alternative to street drugs.
"This action is yet another example of HHS' strong commitment to protecting
the public from the dangers of unlawfully marketed drug products," said
Secretary Thompson.
Last October, at FDA's request, U.S. Marshals seized $2.8 million worth of a
non-herbal synthetic ephedrine product marketed as a dietary supplement. The
manufacturer in April signed an agreement prohibiting it from manufacturing and
distributing such products. The firm also agreed to destroy the seized products
at its own expense.
Today's warning letters notify the firms that they must inform FDA within 15
days of their plans to correct the violations or else face further enforcement
actions by the FDA. Enforcement options include seizure of the illegal product
and injunction from manufacturing and distributing the product, as well as
prosecution of the companies and individuals.
"These products are not for everyone," said Dr. Lester M. Crawford, Deputy
Commissioner of FDA. "Consumers should read the labels carefully to ensure their
proper use."
Consistent with industry standards and warnings that already appear on many
products, consumers under the age of 18 or pregnant or nursing women should not
use these products. As the warnings further state, adult consumers should
consult a health care provider prior to using such products if they have current
or previous history of high blood pressure, heart or thyroid disease, a seizure
disorder, depression, diabetes, difficulty urinating, prostate enlargement,
glaucoma, or are using any prescription drug.
Consumers should consult with a physician prior to using dietary supplements
containing ephedrine alkaloids if they are using a monoamine oxidase (MAO)
inhibitor (MAO inhibitors are drugs used in the treatment of selected atypical
depressions) or any allergy, asthma, or cold medications containing ephedrine,
pseudoephedrine or phenylpropanolamine. Consumers should discontinue use if any
of the following symptoms are experienced: rapid or irregular heartbeat, chest
pain, severe headache, shortness of breath, dizziness, loss of consciousness,
sleeplessness or nausea.
This advisory was prepared by the U.S. Dept. of Health and Human Services.
Update to this advisory on ephedra