Metabolife International Inc, manufacturer of Metabolife 356, announced its support of FDA's actions initiating a regulatory, science-based process that could result in a strict federal warning label regarding uses of ephedrine-based products, including limits on dosages consistent with clinical studies. It also endorsed HHS's announced effort to "reduce [the] potential risks of dietary supplements containing ephedra."

Metabolife had previously endorsed regulatory bans on "irresponsible marketing practices," resulting in athletes possibly misusing and abusing the product. It also called for an absolute ban on sales of ephedra-based products to minors.

Metabolife urged the FDA to adopt a regulation that would:

-- mandate detailed warning language, designed to ensure that consumers do not abuse or misuse such products;
-- set strict dosage limitations;
-- require rigorous good manufacturing practice standards, including mandatory batch testing; and
-- mandate a call reporting system for adverse health events that are part of a comprehensive and consistently applied evaluation system.

Metabolife cited the Rand study's findings to reiterate its position that "adverse event reports" are unreliable and not scientific evidence. "For rare outcomes, we reviewed case reports, but a causal relationship between ephedra or ephedrine use and these events cannot be assumed or proven," the Rand report stated.

Contrary to assertions made by today's press conference at the HHS, there is substantial clinical data demonstrating the ephedrine-based products, when used strictly according to label instructions and warnings, are both safe and effective. For example, a recent peer-reviewed, published study conducted at Harvard and Columbia showed that those taking the ephedrine-caffeine combination similar to that found in Metabolife 356 resulted in greater weight loss than placebo.

"We look forward to studying the FDA's proposal and working with the agency to create effective and appropriate regulation of ephedrine-based products. We have long condemned marketing these products in ways that could lead to abuse by young people, or as surrogates for street drugs," said David Brown, President of Metabolife.

Reportedly some 40% of all Americans are overweight, potentially leading to serious health problems. Although ephedra-containing dietary supplement products are not for everyone, more than 50 studies and 15 years of research have demonstrated that ephedra-caffeine combinations similar to those contained in Metabolife 356 are safe and effective when stringent Good Manufacturing Practices (GMPs) are employed and when used as directed on the label.

The fact that over the last five years, approximately 5 billion tablets of Metabolife 356 alone have been sold demonstrates the strong desire by consumers to make choices and take control of their weight problems. We believe that strong regulation can ensure the ability of consumers to make informed choices and keep dangerous, non-conforming products off the market.