FOR IMMEDIATE RELEASE
CONTACT: Robert S. McCaleb
(303) 449-2265
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 a wide range of dietary supplements.
During 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). In a comment 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.
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