Help may be on the way for the millions of overweight and obese Americans.

In an 11-3 vote, a Food and Drug Administration health advisory committee recommended the approval of an over-the-counter weight loss pill.

The FDA generally follows the outside panel committee recommendations.

The pill, orlistat, would be the only FDA-approved weight loss medication available without a prescription.

Orlistat is already sold as a higher-dosage prescription marketed as Xenical.

"Other over-the-counter pills are dietary supplements and not FDA-approved for weight loss," GlaxoSmithKline Consumer Healthcare spokesperson Malesia Dunn said.

Roughly 127 million adult Americans are either overweight or obese, according to the American Obesity Association.

"This (pill) is not for people who want to lose a few pounds," Dunn said. "This is for the consumer that will be committed to weight loss through a gradual and meaningful weight loss program."

Dunn added the consumer would have to adopt lifestyle changes such as eating better and exercising.

The company still needs the FDA's final approval before it hits the stores, Dunn said.

If approved, the pill would be marketed as Alli, she said.

Orlistat is unique among other weight loss medications because it does not affect the central nervous system, brain or heart, she said.

The pill is taken with meals to help block fat absorption in the body.

It will be used to help aid a reduced-calorie diet that contains no more than 30 percent of calories from fat, Dunn said.

The pill has been marketed as a prescription drug since 1999, Dunn said. Xenical is a 120 mg capsule and Alli would be 60 mg, she said.

"We are excited by the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said GlaxoSmithKline Consumer Healthcare North America president George Quesnelle in a written statement.

Olin nutritionist Ronda Bokram said there is no guarantee that when you stop the pill, you will keep the weight off. Bokram also questions the pill's effects if a person's diet is low in fat.

"It is important to get to the root of the problem of a person's relationship with food or emotional eating," she said.

Bokram added there is no regulation over how much a person can take at each meal.

GlaxoSmithKline will recommend the consumer only takes one 60 mg pill per meal.

"Their recommendation of one pill is just a liability issue," she said. "They don't acknowledge the misuse of [the pill]."

Other prescription and over-the-counter pills have traditionally had a bad reputation in the public's eye.

In 1997, fen-phen was taken off the shelves when it was linked to heart valve damage, Bokram said.

GlaxoSmithKline's own product, Xenical, has side effects like diarrhea, oily stools and malabsorption, she said.

About two years ago the government pulled Ephedra, a common stimulant in dietary supplements aiding weight loss, because it caused an adolescent's death in Illinois, Bokram said.

"It is sending the wrong message that you can just take a pill to take care of the problem," Bokram said.