AT LEAST HALF OF AMERICANS (MAYBE as many as two-thirds) take dietary supplements. They assume the government will guarantee safety, efficacy, and truthful advertising. They couldn't be more wrong. The very term dietary supplement is based on a fiction.
While dietary supplements are regulated by the FDA, the regulations are very different from those governing approval of prescription and over-the-counter medicines. Under the ill-conceived Dietary Supplement Health and Education Act of 1994 (DSHEA), (1) dietary supplements are considered to be food, not medicine. They are not intended to diagnose, mitigate, prevent, or cure diseases. But the reality is that they are being used as medicines.
How Did This Happen?
In the late 1980s and early 1990s, Congress was considering legislation that would have increased the powers of the FDA. A proposed amendment to the Federal Food, Drug, and Cosmetic Act would have authorized any U.S. district court to "order the recall of a food, drug, device, or cosmetic which is in violation of the FDCA if the violation involves fraud or presents a significant risk to human or animal health." (2) The Nutrition Advertising Coordination Act was introduced in the House in 1991 to tighten the regulations governing labeling of supplements. (3) Marketers of supplements erupted in protest, claiming that the FDA was trying to ban dietary supplements, which it clearly wasn't. What the proposed legislation actually said was that it:Amends the Federal Trade Commission Act to deem a food advertisement misleading if it expressly or by implication characterizes the level of any nutrient, the relationship of any nutrient to a disease or a health-related condition, or the amount of any nutrient in a serving or portion of the food, unless the characterization is in accordance with specified provisions of the Federal Food, Drug, and Cosmetic Act. Deems a food advertisement misleading if it contains a claim that fails to: (1) disclose the level of fat or saturated fat when a claim characterizes the level of cholesterol; (2) disclose the level of cholesterol when a claim characterizes the level...