FDA Pursues Better Health Information For Consumers
DC, 18 December 2002
of Food and Drugs Mark B. McClellan, M.D., today announced a major
new initiative to make available more and better information about
foods and dietary supplements, to improve the public health and
to help American consumers prevent a host of diseases and improve
their health by making sound dietary decisions.
Consumer Health Information for Better Nutrition initiative is designed
to foster two complementary goals concerning the labeling of food
and dietary supplements:
makers of conventional foods and dietary supplements to make
accurate, science-based claims about the health benefits of
eliminate bogus labeling claims by taking on those dietary supplement
marketers who make false or misleading claims.
putting credible, science-based information in the hands of consumers,
we hope to foster competition based on the real nutritional value
of foods rather than on portion size or spurious and unreliable
claims," Health and Human Services Secretary Tommy G. Thompson said.
"Such labeling can help empower consumers to make smart, healthy
choices about the foods that they buy and consume."
consumer health information initiative comprises three related actions:
guidance on qualified health claims for conventional foods and
dietary supplements. Any such claims must be pre-approved by
FDA and meet the "weight of the scientific evidence" standard,
including support by a credible body of scientific evidence.
enforcement of dietary supplement rules. Today, FDA is emphasizing
its commitment to carrying out the intent of Congress in the
Dietary Supplement Health and Education Act of 1994 by outlining
its enforcement strategy against false or misleading claims
about dietary supplements. As an example of its commitment to
strong enforcement, FDA is also announcing a seizure of a dietary
supplement making unapproved drug claims.
an FDA Task Force on Consumer Health Information for Better
Nutrition. This task force will develop a framework to help
consumers obtain accurate, up-to-date, and science-based information
about conventional food and dietary supplements. This includes
the development of additional scientific guidance on how the
"weight of the evidence" standard will be applied, as well as
the development of regulations that will give these principles
the force and the effect of law.
mission at FDA is to improve health outcomes for the nation, and
some of the best opportunities for improving health involve informed
choices by consumers," said Dr. McClellan. "Through this Better
Health Through Better Information initiative, we are committed to
improving opportunities for consumers to get scientifically accurate
information about the health consequences of the foods they consume,
and to enhancing our enforcement efforts against those who would
make false or misleading claims for their products."
guidance on health claims that FDA issued today sets forth the conditions
under which the agency intends to exercise enforcement discretion
for qualified health claims about conventional foods and dietary
supplements. FDA currently permits such claims for dietary supplements
under certain circumstances but not for conventional foodseven
though in general much more scientific data is available to support
the health benefits of foods.
meet the criteria for making a new, qualified claim on a conventional
food, the manufacturer would need to provide a credible body of
scientific data supporting the claim. The company would need to
demonstrate, based on a fair review by scientific experts of the
totality of information available, that the "weight of scientific
evidence" supports the proposed claim.
qualified health claims will require review by FDA before they may
be used on the food label.
the enforcement action being announced today, FDA revealed that
United States Marshals on Monday, December 16, 2002, seized approximately
3000 bottles, valued at more than $100,000, of EverCLR, a dietary
supplement. EverCLR is marketed by Halo Supply Company of San Diego
CA as a "natural" treatment for viruses, including the herpes virus,
and for "cold and flu protection."
of these claims has been substantiated. In court documents, FDA
charges that EverCLR is an unapproved and therefore illegal new
drug because it is promoted to treat or prevent specific diseases
and conditions. FDA also charges that EverCLR is misbranded because
its labeling lacks adequate directions for use.
addition, FDA today released a report on its strengthened enforcement
actions over the past year against dietary supplements that make
false or misleading claims. FDA's report also outlines an aggressive
enforcement strategy against such claims and outlines enforcement
priorities so that manufacturers will be on notice.
Notice of Availability about FDA's guidance on qualified health
claims went on display today at the office of the Federal Register.
Both the notice and the guidance itself are available online at
Dietary Supplement Enforcement Report is available on FDA's website
as is the document "FDA's Consumer Health Information for Better
Nutrition Initiative," a brief, descriptive summary of FDA's entire
consumer health information initiative.
advises consumers to consult a health professional before taking
dietary supplements. Information about dietary supplements is available
on FDA's website at www.cfsan.fda.gov/~dms/supplmnt.html.
Consumer advice from FDA about purchasing medicines on line may
be found at www.fda.gov/oc/buyonline/default.htm.
Food and Drug Administration.