FDA: Center for Drug Evaluation and Research (CDER) And Over-the-counter Weight Loss Medications

Obesity is one of the most serious epidemics facing the American public. "Over two-thirds of adults in the United States are overweight or obese, and over one-third are obese" (Overweight and obesity statistics, 2012, WIN). To address concerns about obesity, many adults turn to over-the-counter medications like dietary supplements that promise the user easy weight loss. The medications usually claim to increase metabolism and suppress appetite, while some also claim to inhibit the absorption of carbohydrates and calories. According to a recent study: "an estimated 15.2% of adults (women 20.6%, men 9.7%) had ever used a weight-loss supplement and 8.7% had past year use (women 11.3%, men 6.0%); highest use was among women aged 18 to 34 years (16.7%)" (Blanck et al. 2007). The FDA has tried to prevent the use of weight loss supplements with tainted ingredients and those which make misleading claims. However, from a legal standpoint, it is more difficult to regulate the natural supplement industry, versus prescribed medications that must pass through rigorous safety and purity screening.

"FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering 'conventional' foods and drug products... Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed" (Dietary supplements, 2012, FDA). The FDA monitors truthfulness as well as safety regarding claims made by supplement manufacturers. However, a natural supplement does not have to pass through different phases of clinical trials to win approval, like a prescription drug....

They also do not need the board's review and approval of the supplement's ingredients before selling these products" (FDA regulation of nutritional supplements, 2012, FDA). Because of the fact that natural supplements' claims are not tested by the FDA before they are on the market, they are required to be labeled with a warning noting "this product is not intended to diagnose, treat, cure, or prevent any disease" (FDA regulation of nutritional supplements, 2012, FDA).
Given this relatively lax oversight, it is not entirely surprising that misrepresentation of product safety and ingredients on weight loss supplements' labels is common. The FDA recently issued a warning, based upon its monitoring of over-the-counter weight loss supplements, that many contain tainted ingredients or active ingredients not listed on the label. "FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients" (Tainted weight loss products, 2012, FDA).

For example, the FDA recently issued a warning regarding a dietary supplement called

Japan Rapid Weight Loss Diet…