The article from the World Journal of Gastroenterology is clearer than most in sounding the alarm about the recently recalled Hydroxycut weight loss aid and other over-the-counter dietary supplements. But the warning is still couched in typical medical journalese.
"Ingredients do not need to be considered 'generally recognized as safe' as pharmaceuticals or food additives do, and the [U.S. Food and Drug Administration] must prove that a supplement is harmful before taking regulatory action. This means consumers in effect become unwitting subjects in a large scale post-marketing trial of a product's safety.''
Translation? You're the guinea pig. Thanks to a 1994 law that leaves this $22 billion-a-year industry far too lightly regulated, supplement manufacturers don't have to provide scientific proof of a product's purity, safety or effectiveness before they put it on the market. Instead, the FDA generally steps in after problems are reported. If you're swallowing a supplement, congratulations: You're a test subject and part of a vast experiment to see if this stuff is safe.
Naturally, the industry argues that the current regulation works well and that unethical manufacturers are far outnumbered by those who take pains to ensure they sell a safe, quality product. Still, Hydroxycut is yet another addition to a long list of dietary supplements that were heavily hyped and then discovered after thousands, even millions have used them to pose big risks. Most recently, StarCaps, a product used by overweight Minnesota Vikings Kevin and Pat Williams, was found late last year to contain an unlisted prescription diuretic that could increase users' risk of heat stroke and dehydration. In 2004, the FDA banned ephedrine diet aids after a major study linked the products' use to more than 16,000 adverse events, including cardiovascular problems.
Ads pitched Hydroxycut as a better alternative after the ephedrine ban. Its name apparently was inspired by a key ingredient: hydroxycitric acid, which is found in a tropical fruit known as Garcinia cambogia. According to a drug store industry journal, Hydroxycut is the top-selling product in its class, with about 9 million units sold last year. After the FDA reported 23 cases of serious health problems in people taking the product -- liver abnormalities, heart problems and a condition that may lead to kidney failure -- Hydroxycut's manufacturer agreed to recall at least 14 products late last week. Although the FDA said it has not determined which ingredient may be harmful, the gastroenterology journal article called hydroxycitric acid "potentially hepatoxic,'' meaning it could damage the liver. Many other products contain garcinia extract, and future FDA action bears scrutiny even by those not using Hydroxycut.
Ongoing problems with products like Hydroxycut clearly illustrate the need to tighten up regulations. But Congress has a lot on its plate right now: the recession, swine flu, health care reform. Supplement regulation may not be a priority. In the meantime, consumers can protect themselves. No pill can shave off pounds, so why buy these products? Instead, see a doctor, join a gym or check out a reputable commercial diet program. Consumers shouldn't be guinea pigs, and in this case they can choose not to be.