New Yorkers Get a Sneak Peek at alli®

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It's designed not to have an adverse effect on the cardiovascular system as did other weight-loss products such as ephedra, Cadle said. The FDA banned ephedra after medical evidence indicated it increased heart attack risk.

Alli is not without its critics, however, chief among them Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., who has spoken against orlistat's side effects before.

When another pharmaceutical company, Roche, marketed orlistat in prescription strength as Xenical, Wolfe spoke out. "Animal studies done by Roche show that rats developed aberrant crypti foci, ACF, precancerous lesions in the colon from Orlistat, which put them at higher risk of colon cancer," Wolfe said in a recent interview. "An independent study by researchers in 2006 found the same thing."

But another expert said Wolfe's concerns are unfounded.

"There are more than 100 clinical studies, including 30,000 clinical trial patients, and nine years of post-marketing surveillance with more than 29 million patient treatments, all showing no such risk with orlistat use," said Dr. Vidhu Bansal, director of medical affairs for GlaxoSmithKline Consumer Healthcare. "The FDA concluded the same in their recent review," she added.

Wolfe maintained that the FDA relied heavily on testimony by a panel comprised of pharmaceutical company representatives. But that is only part of the difficulty, he said. The side effects were embarrassing, dramatic and distasteful enough to cause orlistat to lose popularity.

"The RX (prescription) drug's popularity went down, because it caused all sorts of acute problems, mainly gastrointestinal," Wolfe said. "Twenty-five percent of people got oily spotting (from the rectum), because the fat is going in one end and coming out the other. You definitely wouldn't want to take it while on a first date."

Wolfe said some people also experienced gas, loose or more frequent stools, and inhibition of fat-soluble vitamins. "We wanted the FDA to ban the RX version," he said. "It should never have been approved for over-the-counter sales."