Herb Research Foundation

FDA Backs Down on Proposed Disease Definition

January 7, 2000: In a major victory for the dietary supplement industry and the American public, the Food and Drug Administration issued a final ruling in the January 6, 2000 Federal Register, clarifying the types of health claims that can be made under the Dietary Supplement Health and Education Act of 1994. The agency announced that it will preserve the existing definition of "disease" as it relates to structure/function claims on dietary supplement labels. The ruling represents a substantial departure from the FDA’s proposed rule of April 29, 1998, that would have redefined the term "disease" to mean "any deviation from normal." Under the broad wording of the FDA’s proposal, virtually any normal or natural state could have been defined as a disease, including pregnancy and menopause, seriously restricting public access to information on a wide range of dietary supplements.

In 1998, the Herb Research Foundation joined more than 235,000 American citizens, health professionals, industry members, trade groups, and consumer advocacy groups in protesting the FDA’s attempt to curtail the public’s right to make important decisions about health and wellness. On March 25, 1998, HRF President Rob McCaleb testified before Congress as part of the Committee on Government Reform chaired by Rep. Dan Burton (R-IN). Commenting on the FDA’s final ruling, McCaleb stated, "This is good news for the public. The FDA has abandoned its position of defining disease as anything other than perfect health. FDA has also announced it will allow claims based on evidence provided by other government authorities such as the Centers for Disease Control."

Not surprisingly, the FDA’s ruling has been criticized by "consumer advocates" and members of the press who claim that it "weakens patient protections." However, the FDA has defended their position. Peggy Dotzel, FDA associate policy chief, stated "This is not a free-for-all. What the agency is doing is faithfully carrying out the intent of Congress in passing the law." After reviewing thousands of public comments, Dotzel maintained that "the agency was convinced that these [menopause, adolescence, and other natural states], in fact, are not diseases. They are normal, common conditions associated with the different stages of life."

According to the final ruling, manufacturers cannot make express disease claims ("prevents osteoporosis") or implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. On the other hand, the FDA stated that express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"); through a statement about the formulation of the product ("contains aspirin"); or through the use of pictures, vignettes or symbols (electrocardiogram tracings). The final rule allows health claims that do not relate to disease, including health maintenance claims ("maintains a healthy circulatory system’); other non-disease claims ("for muscle enhancement," "helps you relax"); and claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes"). The rule takes effect on February 7, 2000. Small businesses that had products on the market before January 6 will be granted an additional 11 months to bring their claims into compliance. Those who marketed a product on the January 6 publication date will be given 17 months to achieve compliance.