FOR IMMEDIATE RELEASE:
July 14, 2003

FOR FURTHER INFORMATION CONTACT:
Peter Aseltine (609) 292-4791

NEWARK - New Jersey today filed suit against the manufacturer of Xenadrine RFA-1 and Xenadrine EFX, alleging it misrepresented the efficacy of those dietary supplements and deliberately withheld material information about potentially life-threatening side effects of the products, Attorney General Peter C. Harvey and Division of Consumer Affairs Director Reni Erdos announced. The State is seeking civil penalties and restitution for affected consumers, as well as an order halting any advertisements for the products that contain unsubstantiated or misleading claims or that fail to adequately warn of their health risks.

The State's seven-count suit was filed today in Monmouth County Superior Court against Cytodyne Technologies, the Manasquan-based manufacturer of Xenadrine, alleging it engaged in multiple violations of New Jersey's Consumer Fraud Act in connection with its sale of the products. The suit also names Robert Chinery, Cytodyne's owner and operator, who directed the production, sales, marketing and advertising of the Xenadrine dietary supplements, and Kelly Conklin, a Cytodyne representative who arranged for payment to five New Jersey-licensed physicians in exchange for their endorsement of Xenadrine. The physicians have also been named in the State's suit.

Cytodyne Technologies has been the subject of a number of lawsuits, including a wrongful death suit brought on behalf of the estate of Baltimore Orioles pitcher Steve Bechler, who died during a spring training workout following his ingestion of Xenadrine RFA-1. Xenadrine RFA-1 contained ephedra, a potentially dangerous stimulant derived from the Chinese herb ma huang that has become popular in recent years with people seeking to lose weight or enhance their performance in sports.

The State's complaint alleges that the defendants made misrepresentations in advertisements and labels for Xenadrine RFA-1 and Xenadrine EFX, touting them as "revolutionary," "clinically proven," and/or "clinically tested" weight loss, body building and energy enhancement products, while omitting material facts about the potentially dangerous side effects of the products. Xenadrine RFA-1, which has been marketed since at least 1997, and Xenadrine EFX, marketed since 2002, sold for more than $30 a bottle.

"Millions of Americans struggle to lose weight," Attorney General Harvey said. "They join gyms, follow special diets, consume diet shakes, diet bars, diet pills and herbal supplements in their attempts to lose weight. It's no wonder that when a company like Cytodyne offers what seems to be a magic pill, promising dramatic weight loss with little to no effort, desperate dieters jump at the chance to take it too."

"What's shameful here is not only that these defendants broke the law, but that they risked the health of innocent consumers just to turn a profit," Attorney General Harvey added.

"These defendants played on the hopes and desires of dieters and athletes who wanted to lose weight or maximize their performance in sporting events," Director Erdos said. "They irresponsibly touted the so-called benefits of the products, while ignoring the serious risks associated with them."

The complaint alleges the defendants repeatedly made references to purported studies demonstrating the efficacy and safety of Xenadrine RFA-1. However, the complaint alleges, they concealed and omitted results of clinical studies showing that significant adverse cardiovascular results occurred in clinical studies or trials regarding Xenadrine RFA-1. The complaint further alleges that the defendants failed to disclose in advertisements and labels the range of adverse health effects associated with Xenadrine RFA-1, including headaches, irritability, heart palpitations, hemorrhage, cardiac arrest, high blood pressure, stroke and death.

In addition, while touting its Xenadrine EFX as being ephedra-free, the defendants allegedly failed to disclose that the product's other ingredients, which include Tyramine, Octopamine, Synephrine and Hordenine (a banned horse stimulant), have the same severe adverse effects as ephedra.

The complaint alleges the defendants made numerous false and misleading claims, including:

• "Hundreds of thousands of ordinary people...have built extraordinary physiques thanks to help of Xenadrine's (RFA-1) scientifically proven thermogenic power."
  
  
• "Xenadrine RFA-1 is far and away the #1 selling fat burning formula in bodybuilding history because it's clinically proven to deliver dramatic results " fast."
  
  
• "Xenadrine-EFX is a revolutionary super-supplement that increases energy, enhances mental acuity and suppresses appetite..."
  
  
• "Xenadrine-EFX is precision-engineered to burn the fat and spare the muscle, while increasing mental focus, raising your energy level and maximizing workout intensity."

In fact, the complaint alleges, there was no scientific basis for some of their claims, while other claims were based on studies that did not involve the testing of Xenadrine, did not substantiate their claims or were flawed. In addition, the complaint alleges that Cytodyne entered into agreements with five New Jersey physicians to provide testimonials that were prepared by Cytodyne and written to create the false impression that each physician based his endorsement of Xenadrine RFA-1 on clinical studies that he had conducted or reviewed. One testimonial stated: "Xenadrine RFA-1 by Cytodyne Technologies is the single most impressive approach to weight loss that I have ever seen. This product has produced consistent and dramatic results in all of the subjects I have reviewed. In all my years of medicine I have never seen a natural product that can help people lose weight like this revolutionary compound."

Deputy Attorneys General Sunil R. Raval and Joshua T. Rabinowitz of the Division of Law are handling this matter for the State.

In May, Attorney General Harvey and Department of Health and Senior Services Commissioner Clifton Lacy, M.D., sent a letter to the federal Food and Drug Administration urging it to ban dietary supplements containing ephedra.