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.
Note: All HHS press releases, fact sheets and other press materials are available at www.hhs.gov/news.