Just in time for summer 2007, the FDA has approved the first diet pill for sale without a prescription. Until now, the diet pill market has been dominated by companies selling unregulated over-the-counter supplements. The effectiveness of diet supplements is unproven and their use can be dangerous. The FDA’s stamp of approval for GlaxoSmithKline Consumer Healthcare’s product, which will be sold under the name “Alli”, should cause the pill to have an immediate impact on the market.
Product labeling will emphasize that modest weight loss can be achieved by using Alli in conjunction with exercise and a low fat diet. Studies offered to the FDA by GlaxoSmithKline reveal that approximately 28% of those using the drug shed 5 to 10% of their body weight. The label will warn persons with diabetes and those taking blood thinning drugs to consult a physician before using Alli. The label will also encourage consumers to take a multivitamin concurrently to offset nutrient loss.
Side effects of Alli usage are gastrointestinal, including gas, oily spotting, loose stools, and bowel movements that are difficult to control. The FDA is hoping that the diet pill will only be used by those who are age 18 or older. It only approved Alli as safe for those in that age group. However, the FDA did not require consumers to show proof of age at point of sale or otherwise force pharmacies to restrict consumer access.
The weight loss industry is a 23 billion dollar enterprise. With the nation’s obesity issues continuing to grow, an FDA approved diet pill may score a big hit for GlaxoSmithKline.