FDA: Eases Rules on Dietary Supplement Claims
Newly established FDA regulations expand the number of claims dietary supplement manufacturers can make regarding their products' health benefits. The new rules, effective in 30 days, stem from the FDA's belief of the need to clarify the Dietary Supplement Health and Education Act of 1994 that allowed supplement makers to claim their products affected the body's "structure or function," but prohibited language that made "disease claims." But the industry and consumers remained confused about the difference between the two (Adams, Wall Street Journal, 1/6). After receiving a negative response from both sides to their 1998 proposals that prevented industry claims of treatment, prevention or diagnosis, the FDA relented. Now, supplement makers can claim their products -- valued at $6 billion -- can help "common conditions" associated with the "passages of life," including pregnancy, aging and menopause, but not with clear diseases or serious symptoms. For example, supplements can claim to relieve ordinary morning sickness but not serious pregnancy complications such as toxemia (AP/Philadelphia Inquirer, 1/6).
Peggy Dotzel, associate acting commissioner for policy with the FDA, said the FDA is "faithfully carrying out the intent of Congress in passing" these new regulations . But not everyone shares these sentiments. Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, commented, "This is a snake-oil exemption. It's a complete cave-in to the industry" (Stolberg, New York Times/Arizona Daily Star, 1/6). The Center for Science in the Public Interest's Bruce Silverglade said the new rules allow the supplement industry to "make claims regarding serious health conditions without any pre-market review by the FDA" (AP/Philadelphia Inquirer, 1/6). Dr. Richard Friedman of Cornell University's Weill Medical College added, "If they are going to make a distinction between diseases and normal states, they are on a slippery slope" (New York Times/Arizona Daily Star, 1/6). Finally, an editorial in USA Today concluded, "Until the industry either reforms itself or is forced to account by a Congress that wakes up to the public interest, self-medication with supplements is truly a matter of buyer beware" (1/6).