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Article from www.kilosports.com
Health and Human Services Secretary Tommy Thompson announced plans Friday to study the controversial dietary supplement ephedrine alkaloids (ephedra), and to crack down on the illegal marketing of non-herbal synthetic ephedrine alkaloid products.
HHS announced that the agency had recently funded a comprehensive review of the existing science on ephedra -- particularly those in diet supplements -- to be conducted by the RAND Corp. The review is expected to be finished by early fall and is intended to clarify what HHS knows about ephedra dosages, use, and possible harmful effects. The National Institutes of Health will then use this information to guide an expanded research effort to better understand the safety of ephedrine alkaloids.
"It is crucial that we have a full understanding of these dietary supplements," 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"
Ephedra is commonly sold in the United States as a product to enhance weight loss, increase energy, and enhance sports performance. Ephedrine alkaloids are active chemicals found naturally in a number of plants, but can also be produced synthetically. Non-herbal synthetic ephedra compounds are illegal in the United States because they are not legal dietary supplements, but illegal drugs.
HHS also announced it sent six warning letters to companies unlawfully selling non-herbal ephedra products over the Internet as part of its new effort to cracking down on these drugs. Last October, the FDA had U.S. marshals seize $2.8 million worth of a non-herbal synthetic ephedra, marketed as a dietary supplement.
"This action is yet another example of HHS's strong commitment to protecting the public from the dangers of unlawfully marketed drug products" Thompson said.
Last fall, Dr. Sidney Wolfe and his group, Public Citizen, filed a complaint with the FDA, charging that the product should be pulled from the market because of reports of adverse events related to the dietary supplements containing ephedra.
"This just happens to be the most dangerous herbal supplement, and even though the FDA is somewhat handicapped in regulation of dietary supplements and herbals, this one is so dangerous that it really should come off the market."
But the FDA has said that the adverse event reports alone do not provide a basis for halting sales of the products, and they called for further scientific research. Dr. Lester M. Crawford, deputy commissioner of the FDA, said consumers should read the labels carefully to ensure their proper use. "Although warning labels appear on many of these products, adult consumers need to consult their health care provider if they have a history of high blood pressure, 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," he said. Crawford warned pregnant or nursing women should not use these products.
Health and Human Services Secretary Tommy Thompson announced plans Friday to study the controversial dietary supplement ephedrine alkaloids (ephedra), and to crack down on the illegal marketing of non-herbal synthetic ephedrine alkaloid products.
HHS announced that the agency had recently funded a comprehensive review of the existing science on ephedra -- particularly those in diet supplements -- to be conducted by the RAND Corp. The review is expected to be finished by early fall and is intended to clarify what HHS knows about ephedra dosages, use, and possible harmful effects. The National Institutes of Health will then use this information to guide an expanded research effort to better understand the safety of ephedrine alkaloids.
"It is crucial that we have a full understanding of these dietary supplements," 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"
Ephedra is commonly sold in the United States as a product to enhance weight loss, increase energy, and enhance sports performance. Ephedrine alkaloids are active chemicals found naturally in a number of plants, but can also be produced synthetically. Non-herbal synthetic ephedra compounds are illegal in the United States because they are not legal dietary supplements, but illegal drugs.
HHS also announced it sent six warning letters to companies unlawfully selling non-herbal ephedra products over the Internet as part of its new effort to cracking down on these drugs. Last October, the FDA had U.S. marshals seize $2.8 million worth of a non-herbal synthetic ephedra, marketed as a dietary supplement.
"This action is yet another example of HHS's strong commitment to protecting the public from the dangers of unlawfully marketed drug products" Thompson said.
Last fall, Dr. Sidney Wolfe and his group, Public Citizen, filed a complaint with the FDA, charging that the product should be pulled from the market because of reports of adverse events related to the dietary supplements containing ephedra.
"This just happens to be the most dangerous herbal supplement, and even though the FDA is somewhat handicapped in regulation of dietary supplements and herbals, this one is so dangerous that it really should come off the market."
But the FDA has said that the adverse event reports alone do not provide a basis for halting sales of the products, and they called for further scientific research. Dr. Lester M. Crawford, deputy commissioner of the FDA, said consumers should read the labels carefully to ensure their proper use. "Although warning labels appear on many of these products, adult consumers need to consult their health care provider if they have a history of high blood pressure, 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," he said. Crawford warned pregnant or nursing women should not use these products.