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FDA Warns Consumers About Tainted Weight Loss Pills

Ruzanna Harutyunyan's picture

GlaxoSmithKline Consumer Healthcare, makers of alli, the only FDA-approved over-the-counter weight loss product, supports the U.S. Food and Drug Administration (FDA) seeking a recall of weight loss products that pose serious health risks, particularly during this New Year's period, when many people are making resolutions to lose weight and purchasing products to help them.

GSK Consumer Healthcare also strongly supports that all dietary weight loss products be held to the same regulatory and scientific standards. According to a major research survey, many Americans erroneously believe that all dietary supplements have been approved by the FDA as safe and effective products.(1)

In April 2008, GSK Consumer Healthcare along with the American Dietetic Association, The Obesity Society and Shaping America's Health jointly filed with the FDA a Citizen Petition asking, among other things, to require that manufacturers of dietary weight loss products submit their scientific evidence behind weight loss claims to the FDA for review prior to making those claims.

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"Weight loss is one of the top New Year's resolutions for many people but it is often a difficult resolution to keep. GSK Consumer Healthcare is pleased to offer the only FDA approved over-the-counter aid to help consumers lose weight safely and improve their lives. When consumers use alli, they can rest assured that the product has been thoroughly tested and proven to be safe and effective. That's a commitment we've made to consumers and one we intend to keep," said Karen Scollick, Vice President, Behavioral Sciences Business Unit for GSK Consumer Healthcare.

alli, marketed by GSK Consumer Healthcare, is the only FDA-approved weight-loss product available to overweight adults, 18 years or older, without a prescription that has been proven to be both safe and effective. No other weight loss product sold directly to consumers has the same scientific rigor behind it as alli.

alli is proven to help people lose 50% more weight than dieting alone. alli works with any low-fat reduced calorie diet. alli is more than a pill, it is also a program that includes lifestyle changes such as physical exercise for optimal results. The program encourages gradual weight loss which experts recommend as the healthiest and most successful way to lose weight. Resources to support the user's weight loss program include the allicircles message board and website on which experts and other users share advice and experiences.

alli works only in the digestive system, not in the heart or brain. It will not cause jitters, sleeplessness, or a racing heart. It simply works with your body to keep some of the fat you eat from being absorbed.

The safety and efficacy of orlistat -- the active ingredient in alli -- is very well established. A higher dose of orlistat has been marketed as the prescription drug Xenical in the U.S. since 1999 and is supported by nine years of worldwide use in 145 other countries. Orlistat experience in more than 25 million patient treatments and more than 100 clinical studies with more than 30,000 patients is unprecedented.