However, this is not enough to deter Americans quest for a bottle cure, and while spending some money on a product that simply does not work is acceptable to many, what most don’t realize are the real dangers of these types of products. Many assume that manufactures cannot make the exaggerated claims on television unless they are true, or because the Food and Drug Administration regulates prescription drugs so heavily, that they regulate these as well. These assumptions are simply incorrect. The truth of the matter is that the exaggerated claims are made because there is so little regulation and because there is so much money to be made---$22 Billion-a-year. Yes, that is correct, Billion, not Million.
A 1994 law leaves this industry 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 does not step in until after problems are reported.
The industry argues that the current regulation works well and that one bad apple is not representative of an industry whose manufactures, for the most part, go to great lengths to ensure they sell a safe, quality product. The problem is that the Hydroxycut has become just another addition to a long list of dietary and nutritional supplements that were heavily hyped and then discovered after perhaps millions were sold, to pose significant and harmful risks. Last year, Total Body Formula, was recalled after it was determined that it contained toxic amounts of Selenium---the same substance that killed polo horses in Florida. If selenium will kill horses, imagine what it would do to humans. 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.
Incredibly, Hydroxycut was marketed as a better alternative after the ephedrine ban. It’s name comes from hydroxycitric acid, which comes from a tropical fruit. Reportedly, Hydroxycut sold 9 million units last year. After 23 reported cases of serious health problems in people taking the product, including liver abnormalities, heart problems and possible kidney failure -- Hydroxycut's manufacturer agreed to recall at least 14 products late last week.
The time has long come for Congress to more strongly regulate dietary and nutritional supplements. Of course, once this occurs, we will only have to worry about altered data being sent to the F.D.A. and a revolving door of regulators moving on to work for the industry.
Chris Hellums is the managing partner of Pittman Dutton Kirby & Hellums and is currently co-lead counsel of the Executive Committee to the Personal Injury Plaintiff's Steering Committee for the Total Body Multi-District Litigation. He can be reached at ChrisH@PDKHLaw.com