FDA: Center for Drug Evaluation and Research

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. The user of a supplement cannot assume that he or she is as safe as when taking a drug prescribed by a doctor (although even prescription weightloss medications have been found to have problematic side effects after being approved by the FDA).

According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), "manufacturers of nutritional supplements do not need to provide information to the Food and Drug Administration Board, before they can get a product out on the market. 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 Pills Yellow. The product is available over the Internet, and is advertised on many websites, including the popular Internet auction portal eBay. After testing the diet pills, the FDA determined they contained the controlled substances sibutramine and phenolphthalein. Sibutramine has been illegal in the U.S. since October 2010 because it can raise the heart rate and blood pressure to dangerously high levels in some patients and "may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke" (Public notification: Japan Rapid Weight Loss Diet Pills Yellow contains hidden drug ingredient, 2012, FDA). Phenolphthalein is a suspected carcinogen. These weight loss supplements are also flagged as potentially being able to interact with current medications that the patient may be taking, rendering them either more dangerous or inactive. Ironically the patients most likely to be negatively affected by the most common unlisted ingredients in weight loss supplements (which also include fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat) are those with conditions that are often co-morbid with obesity, such as heart disease and high blood pressure (Q&A, 2011, FSA).

Most of the recent drugs flagged as potentially dangerous originate in China, although some also originate in Brazil, Malaysia, and Peru (Q&A, 2011, FSA). The FDA's warnings regarding these products are part of an ongoing fight by the FDA to ensure that consumers are kept safe. The FDA's last major initiative to regulate the weight loss supplement industry was the 2004 banning of Ephedra, which was found to cause "high blood pressure, irregular heartbeat, insomnia, nervousness, tremors, seizures, heart attacks, strokes, and even death" in some patients (Over-the-counter and herbal remedies for weight loss, 2011, WebMD).