In a land gushing with promises of unwrinkled skin, smaller noses and a head full of hair, nothing caught attention quite like the pill that does away with cellulite.

The product, a softgel called Cellasene, incited a consumer stampede when it was introduced in March 1999. ``Fights cellulite from the inside,'' the ads claimed. ``This summer, show off your legs,'' said another.

The ads worked. People, mostly women, bought $54 million worth of Cellasene in six months. The company that sold it, Rexall Sundown of Boca Raton, called Cellasene the ``most successful product introduced in the vitamin and nutritional supplement industry in 1999.'' Within three months of its launch, the herbal concoction accounted for a whopping 21 percent of Rexall's sales.

Cellasene won the battle, but cellulite won the war. The government accused the company of false advertising, Cellasene sales fizzled by the end of 1999 and Rexall pulled the plug on production. The company is still trying to shed its unsold inventory.

The government, however, didn't relent. Today, two years after the Federal Trade Commission planted its red flag on Cellasene, the agency's false-advertising case against Rexall has escalated into an all-out legal showdown and perhaps a test case for the limits of herbal health claims. If a court-appointed mediator can't broker a truce by December, it will fall to a federal judge in Fort Lauderdale to decide finally if Rexall's pill can do a vanishing act on cellulite.

Rexall, a unit of Dutch nutritionals giant Royal Numico, wants to have its reputation upheld as the Mercedes-Benz of dietary supplements. The FTC, which is seeking millions in customer refunds, is drowning in its fight against a gullywasher of unregulated dietary supplements and could use a big victory.

``The FTC goes after the big cases -- and this is one that the FTC couldn't ignore,'' said David Schardt, an associate nutritionist with the Center for Science in the Public Interest in Washington, D.C.

A browse through the foot-thick lawsuit before U.S. District Judge Wilkie Ferguson reveals two parties very much on the offensive.

Rexall wants the FTC to produce investigative materials from all prior dietary supplement and weight loss cases -- a request the FTC says would involve the retrieval of records from hundreds of cases dating back to 1917. Rexall says the records could prove that the FTC is singling out the company with tougher enforcement standards.

For its part, the FTC wants Rexall to turn over financial records on Cellasene so it can argue the extent of alleged monetary harm to consumers. And it cites several experts who argue that the primary clinical studies behind Cellasene, done at the University of Pavia in Italy, were too flawed to support claims of eliminating cellulite.

To the FTC, Rexall's retreat from the manufacture and promotion of Cellasene is irrelevant to the case.

``Simply the fact that the company pulled back from aggressive marketing doesn't mean consumers haven't suffered serious financial injury and were very dissatisfied with the product,'' said FTC attorney Stacy Feuer. ``We're sticking with it.''

Cellulite, the dimpled fat on the thighs and buttocks of many women, has been described as ``fat gone wrong.''

Over the years, it has been attacked with exercise; massage; special diets; pills; creams; gels; minerals; herbs; bath liquids; brushes; rollers; loofah sponges; cactus fibers; horsehair mitts; body wraps; rubberized pants; inflatable, hip-high pressurized boots; hormone and enzyme injections; heating pads; vibrating machines; and electrical muscle stimulators. People have made a lot of money promoting these remedies, but a cellulite ``cure'' remains undiscovered.
HELPING MISS ITALY

Gianfranco Merizzi, an Italian chemist, proclaimed a cure in 1997. Eager to help Miss Italy contestants stave off cellulite outbreaks, he developed Cellasene from grape seed, evening primrose oil, fish oil, soya lecithin and extracts of sweet clover, gingko biloba and the herb bladderwrack. After a 25-woman test at the University of Pavia, Cellasene was launched in Australia.

Stores couldn't keep enough of it on the shelves. And what they got, they marked up. Women didn't care. One reportedly paid $1,000 for a 10-day supply.

To Rexall Sundown, one of the biggest makers of vitamins and nutritional aids in the nation, Cellasene became a must-have item.

Obtaining exclusive rights for the U.S. market, Rexall introduced Cellasene in March 1999 with a $20 million ad campaign and media blitz. It hired an ad agency to distribute a ``video news release'' touting the Cellasene study as ``impressive.'' A brochure entitled, ``Want to Eliminate Cellulite?'' was disseminated. Ads said Cellasene ``helps eliminate cellulite'' without exercise or dieting.

Women, toning up for swimsuit season, forked over $40 for a box of 30 pills, or more than $200 for the initial eight-week regimen of three pills a day. By the end of 1999, Cellasene was the primary cause of a 15 percent increase in Rexall's annual sales to retailers. It also brought Rexall a top new product award from Drug Store News.

The government was not impressed. Not the Food and Drug Administration, which only investigates dietary supplements alleged to be unsafe, but the Federal Trade Commission, which rolled its eyes at the Cellasene ads.

Egged on by members of the medical and scientific community, the FTC tried to persuade Rexall to tone down the ads. Talks went nowhere, and in July 2000, the FTC filed a civil lawsuit accusing Rexall of making false and unsubstantiated claims about Cellasene. Consumers also sued Rexall. Those lawsuits have been consolidated into two cases, one in Palm Beach County, one in Los Angeles.

By then, the pro- and anti-Cellasene camps were deeply entrenched.

Merizzi said Cellasene's efficacy was affirmed in a second Pavia study involving 40 women, while Park Avenue plastic surgeon George Beraka endorsed it after 12-week trials on 10 women. A dermatological researcher in Paris, whose test was reviewed by Reading, Pa., biomedical consultant Peter Pugliese, reached the same conclusion.

``Thigh reduction is quite impressive and thus supports the initial conclusion of the Rexall staff that indeed Cellasene does work,'' Pugliese wrote in May 2000.

But the studies were roundly criticized for having inadequate sample sizes, poor controls and not being published in professional journals. Rexall commissioned a study of 200 women under University of Miami dermatology professor Brian Berman. It was called off in June 2000 when some participants didn't return to be measured.

In a deposition taken by the FTC, Rexall scientist Anita Boddie said management wanted a U.S. clinical study to fortify the Cellasene claims. The primary interest in the study, she reckoned, was for marketing purposes.

``They wanted to see if they could make more aggressive claims in the future,'' Boddie testified in March.
BATTLE OF EXPERTS

With five months until the scheduled Dec. 3 trial, the contestants in the Cellasene case now have to identify the experts they will be relying on at trial. The FTC has until July 30, Rexall two weeks hence.

Essentially, the FTC will be introducing experts to debunk the University of Pavia research as garbage.

The agency is lining up Arthur Ship, a New York plastic surgeon and cellulite expert who is expected to testify that the Pavia studies were scientifically unreliable. It will also present a 1999 study by London's South Bank University School of Applied Sciences that ``failed to find Cellasene effective at reducing or eliminating cellulite.''

Two others outspoken in their criticism of Cellasene won't be enlisted as experts, but the FTC has included their viewpoints in the case file. The views were expressed in a California Cellasene case that was dismissed on jurisdictional grounds.

One of those experts is Kim Barrett, professor of medicine and vice chairwoman for research at the University of California-San Diego Department of Medicine. She reviewed the Pavia studies, the Beraka study and the London study. and said sample sizes were too small in each case. She said the Pavia studies, which relied on tape measurements of hips and thighs, failed to measure cellulite ``per se.''

The other critic is Stephen Barrett, a retired Allentown, Pa., psychiatrist not related to Kim Barrett. Stephen Barrett is a member of the peer review panel of the Journal of the American Medical Association and the New England Journal of Medicine, widely considered the two most highly respected forums for medical research. He also heads the Web site Quackwatch.com and wrote 48 books, including Consumer Reports' Health Schemes, Scams and Frauds.

Barrett called the Pavia studies ``junk science'' and offered to testify at the Cellasene trial. He said products like Cellasene prey on the public's gullibility.

``With false advertising, you can develop a tremendous market for a product geared toward people who want to lose weight or improve their appearance,'' Barrett said. ``You can bring in six figures in one day from a single newspaper ad. The public's appetite for this stuff is enormous.''

Rexall stands by its research. Its in-house lawyer, Kenneth Strick, wrote in May that the FTC has ``essentially nothing'' discrediting the Pavia studies.
By the end of swimsuit season in 1999, the validity of the Cellasene research became a moot point for all but the lawyers haggling over it. After a strong six-month run and $54 million in sales, Rexall ceased production and marketing of Cellasene. The $20 million in remaining inventory would be sold without the help of advertising. As of last month, the company said it has succeeded in selling more than half of it.

``This category is a lot different from other categories of traditional consumer products like toothpaste,'' said Rexall President Tim Richerson. ``The life cycles are much more bullish and bearish.

``There was significant positive PR that drove a lot of consumers to the shelf to try the product,'' he said, ``but once we got the challenge from the FTC, we did not dedicate any additional marketing dollars for the brand and spent all of our resources on resolving the FTC challenge.''

Richerson went on to say that the sales falloff also stemmed in part from disappointment by consumers who mistakenly expected Cellasene to cure their cellulite almost immediately.

Today, Cellasene doesn't even rate a mention on Rexall Sundown's Web site, although it is still sold in stores like Wal-Mart and Walgreen. Critics say the absence of promotion and the trickle of sales are the market's way of saying that Cellasene doesn't work.

``You would think that is the case since so many women would love to have a noninvasive, self-applied way of dealing with cellulite,'' said Schardt of the Center for Science in the Public Interest.

``If it works,'' added Stephen Barrett, ``word would get around, and people would be buying it up.''

But if products like Cellasene really need a constant boost of advertising, the American people might not have seen the end of the cellulite-zapper on TV and in newspapers. Richerson holds out the possibility that Cellasene could return to its starting lineup of products.

``The FTC case has to be resolved,'' he said. ``When that's resolved, it opens up the opportunity to do a lot of things. We are looking forward to opportunities to go forward with this brand.''