Also Supports Strict Federal Science-Based Regulations Preserving Consumer Choice for Weight-Loss Purposes
SAN DIEGO, Feb. 28 --Metabolife International, Inc., which manufactures Metabolife 356(R), the nation's leading dietary supplement used for weight loss, today repeated its support for federal prohibition of what it described as "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 and strict federal 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.
"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 over-weight, 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(R) are safe and effective when stringent Good Manufacturing Practices (GMPs) are employed and when used as directed on the label.
We believe dietary supplements should be evaluated based upon science, and therefore support Secretary Thompson's statement on June 14, 2002, where he indicated the FDA advised him that the types of observed outcomes reported in relationship to the ingestion of ephedrine alkaloids are not uncommon in the general population and therefore anecdotal adverse event call records alone do not provide a scientific basis for assessing the safety of ephedrine alkaloids or establish a link between the reported events and the ingestion of ephedrine alkaloids.
The fact that over the last five years, approximately 5 billion tablets of Metabolife 356(R) 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.
"Based upon this substantial body of scientific evidence suggesting that ephedra-caffeine combinations are safe and effective when used as directed for weight control," Mr. Brown said, "I believe it is imperative that consumers continue to have the choice to use these beneficial weight-loss products, safely and effectively, as millions have done, in their battle to control and maintain their weight."