$12 Mill for false claims

Bryan Haycock

Administrator
Staff member
Rexall Sundown to Pay up to $12 Million to Settle Charges Regarding Cellulite Treatment Product


Company Allegedly Made False and Unsubstantiated Claims for "Cellasene"

Rexall Sundown, Inc. (Rexall) will pay up to $12 million to resolve Federal Trade Commission charges regarding its marketing of the dietary supplement, "Cellasene," a purported cellulite treatment product. The settlement is contingent on approval by the federal district court in Miami and approval of related settlements in class action lawsuits currently pending against Rexall in California and Florida. If approved, the FTC and class action settlements together will provide up to $12 million in redress for consumers throughout the United States who purchased Cellasene.

"Hundreds of thousands of consumers were misled by the claims for this product," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "This case should alert advertisers to the fact that their chances of getting away with making unsubstantiated claims are slim to none."

Rexall is a Florida-based subsidiary of Royal Numico, N.V. that manufactures and markets a variety of nutritional supplements and consumer health products. In 1999, Rexall launched a national public relations campaign that heralded the introduction of Cellasene as a major news event, and hired an agency to distribute widely a "video news release" that described the Cellasene clinical studies as "impressive." News stories on Cellasene appeared throughout the country. Shortly thereafter, Rexall advertised Cellasene in major newspapers including The Washington Post and USA Today. The company also advertised Cellasene in magazines, on the Internet, on television and radio, and through free-standing inserts in newspapers. Sales of Cellasene exceeded $40 million in the United States. The eight-week Cellasene regimen cost consumers almost $200.

In July 2000, the FTC sued Rexall in the U.S. District Court for the Southern District of Florida, alleging that the company violated the FTC Act by making unsubstantiated claims about the ability of Cellasene to eliminate or substantially reduce cellulite and false claims that it had clinical evidence establishing Cellasene's efficacy. In its promotional materials, Rexall had stated that "clinically researched" Cellasene was "The One That Works," and that, "Unlike massages and creams, Cellasene works from within, nutritionally, to help eliminate cellulite at its source."

In addition to its consumer redress provisions, the stipulated final order prohibits Rexall from making any unsubstantiated cellulite reduction or elimination claim for Cellasene. It also prohibits the defendant from making unsubstantiated claims regarding cellulite, body fat or weight loss for drugs or dietary supplements and from misrepresenting test or study results in connection with the sale of any dietary supplement or drug.

The settlement will become final when the class action settlements are approved in final form by the California and Florida State courts, a process that may take several months. After these approvals are obtained, the FTC will administer a redress fund of up to $12 million for consumers who were dissatisfied with Cellasene. Consumers who purchased Cellasene and want to participate in the redress program should call the Commission's settlement hotline at: 202-326-3793.

The Commission vote authorizing staff to file the stipulated final order was 5-0. It was filed in the U.S. District Court, Southern District of Florida, in Miami, on March 11, 2003.

--------------------------------------------------------------------------------

NOTE: This stipulated final order for permanent injunction is for settlement purposes only and does not constitute an admission by the defendant of a law violation. Stipulated final orders have the force of law when signed by the judge.


For More Information Contact:
Brenda Mack, Office of Public Affairs
Federal Trade Commission (FTC)
Telephone: 202-326-2182

Posted: 3/13/2003
 
Bryan

Sorry but I couldn't start a new post: Just picked this up:

March 06, 2003 01
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California Suit Involving Ephedra Diet Pill Alleges Fraud
By Penni Crabtree, The San Diego Union-Tribune
Mar. 6--The company whose ephedra diet pill gained national notoriety when it was linked to the death of a Baltimore Orioles pitcher faces allegations in a San Diego courtroom of fraudulently promoting the herbal stimulant.

A California class-action lawsuit, filed in San Diego Superior Court, alleges that New Jersey-based Cytodyne Technologies manipulated data from clinical research studies on its flagship product, Xenadrine, to present a deceptive picture of the product's benefits and safety.

The lawsuit also alleges that Cytodyne paid professional models and bodybuilders to temporarily gain weight and then slim down for "before and after" photographs designed to mislead consumers.

Opening arguments in the scheduled four-week trial begin today. case, which will be tried by San Diego Superior Court Judge Ronald Styn, could shine new light on the company and the beleaguered dietary supplement industry, which has been in the spotlight since the death last month of 23-year-old Orioles pitcher Steve Bechler.

Bechler's death, which a Florida medical examiner attributed in part to Xenadrine, helped spur the Food and Drug Administration on Feb. 28 to propose tough new warning labels on products that contain ephedra.

The amphetamine-like herb, which promotes slight, short-term weight loss, also raises blood pressure and increases heartbeat effects that have been linked to numerous deaths, heart attacks and strokes.

The FDA is contemplating further action, including a possible ban on ephedra. Meanwhile, the House Energy and Commerce Committee which held hearings on the Enron accounting debacle and the ImClone Systems/Martha Stewart insider trading scandal has launched its own investigation into safety issues involving ephedra.

The committee is taking a particular interest in Cytodyne. Last week, the committee wrote Cytodyne President Robert Chinery requesting the company turn over all records relating to consumer complaints, clinical studies performed on its products and lawsuits.

In San Diego, the battle playing out in Styn's courtroom concerns some crucial issues the congressional committee will explore, including the quality of the scientific research the ephedra industry conducts to support claims of safety and benefits.

Jason Park, a La Jolla commercial pilot who bought a bottle of Xenadrine in 2001, filed the class-action lawsuit in June 2001. The lawsuit alleges that Cytodyne falsely advertised Xenadrine as safe and effective and seeks reimbursement and disgorgement of profits from Cytodyne for California consumers who purchased the product.

In court documents filed last March, Cytodyne cites published, peer-reviewed studies as proof of advertising claims that its products are safe and effective in reducing weight.

One of the studies, conducted by University of Eastern Michigan researcher W. Jeffrey Armstrong and published in the Journal of Exercise Physiology, was featured by Cytodyne in various magazine ads.

Among other benefits, the study showed that volunteers who took Xenadrine gained 61 percent more lean body mass muscle than volunteers who took a placebo. Another advertisement boasted the study showed that test subjects who took Xenadrine lost 759 percent more weight and fat than those using the placebo.

"Allegations that no reliable research exists is just flat wrong," concluded J. Mark Childs, an attorney for Cytodyne, in the March 2002 court filing.

But according to Armstrong, the study demonstrated no significant difference between volunteers who took Xenadrine and those who took a placebo in most clinical measurements, including body fat and the amount of lean muscle acquired over a six-week period.

Those who took Xenadrine did lose modest weight an average of 4.5 pounds through the six-week study, or less than half a pound each week when compared with those who took a placebo.

Armstrong said Cytodyne's math is technically accurate but dishonest.

Percentages were used to inflate what were in many cases differences of no or little statistical importance, he said.

Armstrong said he was pressured by Cytodyne representatives to use similar language in his own scientific abstracts, which he declined to do. Cytodyne representatives also implied the company would sue him if he refused to withdraw a far less flattering presentation of the study results from an American College of Sports Medicine conference, Armstrong said.

"They didn't like the numbers," said Armstrong, who made the presentation despite Cytodyne's objections. "Any dietary supplement company is more concerned about being able to use (studies) for marketing than anything else very few are concerned with whether it actually works."

In a May editorial in the journal that published the Armstrong study, the editor in chief blasted Cytodyne for intentionally misinterpreting the clinical results in its advertisements.

For instance, Cytodyne in its advertisement said the Armstrong study showed that "resting energy expenditure was greatly increased for the Xenadrine group, meaning that the Xenadrine subjects were burning far more calories without even exercising."

In reality, the study found no significant difference between volunteers who took Xenadrine and those who didn't, according to the journal.

"The advertisement is nothing more than consumer fraud," said Tommy Boone, the journal's editor in chief. "Any respectable researcher will understand the fraud and quackery demonstrated by those responsible for the marketing piece from Cytodyne Technologies."

A second research study cited by Cytodyne in court documents as proof its product works safely was conducted by Dr. Carlon Colker of Peak Wellness.

Colker has been named in lawsuits in West Virginia and Missouri for allegedly conspiring with another ephedra company, Canada's ########## Research & Development, to produce fraudulent or deceptive ephedra research data.

Neither Cytodyne officials nor its attorneys returned telephone calls.

Lawyers representing California consumers in the Cytodyne case declined to comment.

The California lawsuit also alleges that Cytodyne uses questionable practices in its before and after photo ad campaigns that feature testimonials from consumers who've taken Xenadrine.

For instance, Mike Piacentino of Los Angeles managed in 10 weeks to drop "an extraordinary 46 pounds of fat while packing on a phenomenal 12 pounds of lean muscle mass" because of the "incredible fat burning power" of Xenadrine, according to one Cytodyne advertisement.

But in reality the metamorphosis was more smoke and mirrors, according to a signed declaration by Piacentino.

Piacentino, who competes in bodybuilding competitions, said he was approached by Cytodyne officials in 1999 when he was working as a trainer at a gym in New Jersey.

Piacentino, then 26, said a Cytodyne employee who was in charge of the company's before and after campaign agreed to pay him to stop working out and to gain as much weight as possible in a three-week period. At the end of the three weeks, Cytodyne would take the before picture.

On the date of the before photo, Piacentino said he was instructed to wear black long baggy pants to cover the muscularity of his thighs. He also was told to use drawstring pants to tie up below his stomach to make it appear as though he had a "hanging gut," Piacentino said in his declaration.

During the photo shoot, Piacentino was told to stand with bad posture, a distended stomach and to frown.

After the photo was taken, Cytodyne supplied Piacentino with Xenadrine, as well as several other dietary supplements, which the bodybuilder took for 14 to 16 weeks. One week before the after photo session, Piacentino was instructed to take a diuretic to eliminate as much water weight as possible.

Piacentino said the resulting before and after advertisement that displayed his pictures was false on several counts. For instance, he took numerous Cytodyne weight-loss products for as much as 16 weeks, not one product for the 10 weeks stated in the ad, and he didn't pack on 12 pounds of lean muscle he already had the underlying stomach muscle mass that he'd built up over years of workouts.

New Jersey model Maria Korsgaard told a similar tale: an ad that featured her claimed she lost 25 pounds in just three weeks using Xenadrine. In reality, charts that Korsgaard kept indicate she lost only 11 pounds in a four-month period, according to court documents.

Shortly after making a sworn statement to plaintiff attorneys in August, Korsgaard recanted after she indicated that Cytodyne had threatened to sue her.

Cytodyne filed a lawsuit against Piacentino alleging defamation and breach of contract after the bodybuilder made his sworn declaration.

John Tiedt, an attorney for Piacentino, said he has submitted affidavits to the Department of Justice and asked for an investigation into what he alleges is witness tampering and intimidation by Cytodyne.

"The company has filed a lawsuit against Mr. Piacentino for the sole purpose of dissuading him from testifying in the (San Diego) case," Tiedt said.

-----

To see more of The San Diego Union-Tribune, or to subscribe to the newspaper, go to http://www.uniontrib.com

© 2003, The San Diego Union-Tribune. Distributed by Knight Ridder/Tribune Business News.
 
[b said:
Quote[/b] (Bryan Haycock @ Mar. 14 2003,12:07)]Rexall Sundown to Pay up to $12 Million to Settle Charges Regarding Cellulite Treatment Product
Sales of Cellasene exceeded $40 million in the United States. The eight-week Cellasene regimen cost consumers almost $200.
that sucks. they dont have to admit to anything and get to pocket 28 million. wow.
 
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