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FDA allows qualified health claim for omega-3
fatty acids
11/03/2000-FDA is allowing a qualified health
claim, for EPA and DHA omega-3 fatty acids
in dietary supplements and reduced risk of
coronary heart disease (CHD). This claim
is being allowed even though the agency had
determined that it did not meet the "significant
scientific agreement" (SSA) standard
that had been previously established for
such claims. The qualified health claim states:
"The scientific evidence about whether
omega-3 fatty acids may reduce the risk of
coronary heart disease (CHD) is suggestive,
but not conclusive. Studies in the general
population have looked at diets containing
fish and it is not known whether diets or
omega-3 fatty acids in fish may have a possible
effect on a reduced risk of
CHD. It is not known what effect omega-3
fatty acids may or may not have on
risk of
CHD in the general population."
Such
a claim may be used in labeling for
EPA and
DHA omega-3 fatty acid-containing dietary
supplements, provided that such supplements
do not recommend or suggest in the
labeling,
or under ordinary conditions of use,
daily
intakes exceeding 2 grams EPA and DHA
omega-3
fatty acids.
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