The US has thus far stood firm in its determination not to ban the popular herbal weight loss remedy ephedra despite similar bans in Europe and Canada. However, the Washington authorities have not been deaf to calls for action, and have announced plans for further research into the effects of the herb, and a clampdown on the illegal marketing of non-herbal synthetic ephedrine products.
"It is crucial that we have a full understanding of these dietary supplements," said Tommy Thompson, US Health and Human Services secretary. "By increasing our breadth of knowledge about these supplements, we can give consumers the information they need to make informed decisions about these products."
The 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 early in the autumn, and Thompson said that it would clarify the existing state of the science on ephedra and ephedrine products. "The National Institutes of Health (NIH) will use this information to guide an expanded research effort to better understand the safety of ephedrine alkaloids," he said.
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.
The US Food & Drug Administration has received a number of reports of adverse reactions from consumers using ephedra products, but the FDA has stated repeatedly that these so-called adverse event reports alone do not provide a scientific basis for assessing the safety of ephedra 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 analyse adverse event reports. The new system will improve the FDA's ability to conduct market surveillance and better monitor the safety of all dietary supplements, including ephedrine alkaloids, Thompson said.
But ensuring the absolute safety of the consumer can only be achieved in partnership with the industry, Thompson added, urging the dietary supplement industry to work with the FDA to develop labelling 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.
Thompson also said that the HHS planned to clamp down on the illegal marketing of synthetic ephedra products. He said that the FDA had already 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) labelled as dietary supplements for use in weight loss, suppression of appetite, enhanced libido, etc. These products violate the law because they are not legal dietary supplements and are illegal drugs. Also, the FDA warned another company for illegally promoting its ephedrine product as an alternative to street drugs."
The US health authorities have already acted to remove illegal ephedra products from the market. Last October, US Marshals seized $2.8 million worth of a non-herbal synthetic ephedrine product marketed as a dietary supplement. The manufacturer, Biogenics, signed an agreement in April this year prohibiting it from manufacturing and distributing such products. The firm also agreed to destroy the seized products at its own expense.
The warning letters give the firms implicated in the illegal activities 15 days to inform the FDA of their plans to correct the violations or else face further enforcement actions by the FDA. These include the seizure of the illegal product and an injunction from manufacturing and distributing the product, as well as prosecution of the companies and individuals.
Metabolife International, one of the largest US manufacturers of ephedra products and itself facing numerous lawsuits from consumers claiming that it did not do enough to warn them of the potentially dangerous side effects, welcomed the HHS decision to carry out further investigations of ephedra rather than rush into an all-out ban, as called for by a number of consumer advocacy groups.
These groups "relied upon unsubstantiated anecdotal reports in support of its petition and conveniently omitted reference to numerouspublished clinical studies over the past 10 years, including the recently published long-term Harvard/Columbia clinical trial that demonstrated that ephedra products are safe and effective when used as directed," the company said.