FDA Reports

In 2008, according to documents obtained by Sports Illustrated through a Freedom of Information Act request, the FDA received a variety of adverse health event reports from consumers using supplements. The bad reactions range from a man whose heart rate was stuck at 147 beats per minute (p. 39, PDF 1) for two hours after he took a product called Fireball Liquifusion, to a woman who experienced shortness of breath and shaky hands after using an energy and weight loss product that was sold to her out of the back room of a supplement store and that illegally contained ephedrine (p. 41, PDF 1). As noted in the FDA report, "this product appears to be readily available on the Internet."

Then, of course, there's the consumer whose tongue swelled to three times its normal size after the individual apparently took too much of a particular supplement. And there's a 41-year-old man who gulped a "performance drink" called Nuclear Garbage and showed up at the hospital with liver damage that the FDA reported was "possibly due to [the] dietary supplement." (p. 48, PDF 1) Creatine is safe when used appropriately, but one 38-year-old man apparently took so much that a doctor told him he had overloaded his kidneys and that excess creatine had crystallized and formed "razor blade crystals" in his joints, landing him in bed for over a month (p. 63, PDF 2). Many of the reports concern extremely popular products, like Bayer's One-A-Day Weight Smart Advanced, which lists increased heart rate -- one of the common complaints -- in its product information, according to the reports. The most popular brands and products tend to have the most reports: Herbalife, VPX, BSN, GNC, 5-Hour Energy -- and there are 14 reports about Hydroxycut, which was recalled by MuscleTech earlier this month after the FDA warned consumers that it could cause liver damage and had contributed to the death of a teenager in 2007.

In most cases, as the FDA reports state, it is difficult or impossible to tell whether the supplement was the cause of a particular consumer's ills. Many of the complaining consumers, whose names are redacted, take other medications, have prior health problems, or have their cases closed when they fail to follow up by providing the FDA with medical documentation or contact information for a doctor that examined them. Consumers can report bad health effects that they believe are related to supplements to local FDA representatives. We invite SI readers to take a look through adverse health event reports documented by the FDA in 2008 (Part 1, part 2, part 3, part 4).

SI also obtained a spreadsheet of 122 products that the FDA evaluated in 2008. Forty of the products did not meet all the necessary requirements of a dietary supplement. Most often, the ingredients label was missing key components. In some cases, though, products contained significantly less of particular vitamins or minerals than they claimed. Several products that presented themselves as dairy free contained dairy products, and a few products were contaminated with the potentially dangerous erectile dysfunction drugs sildenafil or hydroxyhomosildenafil. Several products that claimed to contain Ma Huang, the Chinese name for the outlawed herb ephedra, passed the tests because they did not contain it.

ALSO CHECK OUT:

• DEA Looking to Ban More