FOR IMMEDIATE RELEASE
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P04-38
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March 31, 2004
FDA MOVES FORWARD ON QUALIFIED
HEALTH CLAIMS
The Food and Drug Administration today announced that a qualified health claim
will soon appear on product labels for walnuts and the reduced risk of coronary
heart disease. This qualified health claim is part of the FDA's initiative
to provide Americans with better information to help them make healthier dietary
choices.
"By using science based information
to evaluate qualified health claims, the FDA is making sure that
consumers get information about the nutritional value of foods," said
FDA Acting Commissioner, Lester M. Crawford, D.V.M., Ph.D. Part
of the criteria for making a qualified claim on a conventional
food is to provide credible scientific evidence supporting the
claim. Based on a systematic evaluation of the available scientific
data, as outlined in FDA's "Interim Procedures for Qualified Health
Claims in the Labeling of Conventional Human Food and Human Dietary
Supplements", FDA moved forward to allow a qualified health claim
for whole and chopped walnuts. FDA's review concluded that supportive
research shows that walnuts may reduce the risk of coronary heart
disease when consumed as part of a low saturated fat and low cholesterol
diet and not resulting in increased caloric intake. While this
research is not conclusive, FDA believes that consumers will benefit
from having information that may help them improve their dietary
health. As a result, consumers will soon see claims on walnuts
stating: "Supportive but not conclusive research shows that eating
1.5 oz of walnuts per day, as part of a low saturated fat and low
cholesterol diet, and not resulting in increased caloric intake
may reduce the risk of coronary heart disease. See nutrition information
for fat [and calorie] content."
The use of the bracketed
phrase "and calorie" is optional because FDA believes that this
additional information would benefit consumers by heightening their
awareness of the caloric contribution from walnuts. The presence
or absence of the bracketed phrase will not be a factor in FDA's
enforcement of this qualified health claim.
The guidance on health claims,
issued July 2003, sets forth the conditions under which the agency
intends to exercise enforcement discretion for qualified health
claims about conventional foods and dietary supplements.
The qualified health claim
may be viewed on line at http://www.cfsan.fda.gov/~dms/qhcnuts3.html.
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