FDA restriction on fish oil in foods

From: Hua Kul (gmp_at_adres.nl)
Date: 10/12/04 

Date: 12 Oct 2004 01:34:12 -0700

The FDA has published a rule listing maximum levels of menhaden oil
that it will allow to be used in commercial foods. (Menhaden is a
bony fish harvested for it's oil content). The goal is to limit total
EPA/DHA intake to no more than 3g/person/day. They list three main
reasons for this restriction; "possible adverse effects of fish oil
consumption on bleeding time, glycemic control, and LDL cholesterol."
Does anyone know of any group of peer-reviewed studies that would
indicate these problems can be caused by taking more than 3g per day
of EPA/DHA?

======================================================================
 As part of FDA's evaluation of GRASP 6G0316, FDA examined the
scientific literature for evidence that consumption of fish oils may
contribute to excessive bleeding. In the June 1997 final rule, FDA
concluded based on this examination of the scientific literature,
including more than 50 reports on fish oils with data on bleeding
time,
that when consumption of fish oils is limited to 3.0 g/p/d or less of
EPA and DHA, there is no significant risk for increased bleeding time
beyond the normal range (62 FR 30751 at 30752 to 30753). FDA also
concluded that amounts of fish oils providing more than 3.0 g/p/d of
EPA and DHA have generally been found to produce increases in bleeding
time that are statistically significant, but that there are
insufficient data to evaluate the clinical significance of this
finding. Therefore, because of the lack of data on clinical
significance and because of the potential risk of excessive bleeding
in
some individuals with intakes at higher levels, FDA concluded that the
safety of menhaden oil was generally recognized only at levels that
limit intake of EPA and DHA to 3.0 g/p/d.
    FDA also concluded in the June 1997 final rule that 3.0 g/p/d of
EPA and DHA is a safe level with respect to glycemic control (62 FR
30751 at 30753). This conclusion was based on FDA's review of a series
of studies on non-insulin-dependent diabetics. Studies on type-II
diabetics that reported increased glucose used higher amounts (4.5 to
8
g/p/d) of omega-3 fatty acids. One study found no change in fasting
blood glucose levels among type-II (non-insulin-dependent) diabetics
treated with 3.0 g/p/d EPA plus DHA for 2 weeks. Two other studies
that
used 3.0 g/p/d EPA plus DHA for 6 weeks and 2.7 g/p/d EPA plus DHA for
8 weeks found only transient increases in blood glucose halfway
through
their respective supplementation periods. Another study that used 3.0
g/p/d EPA plus DHA for 3 weeks found comparable increases in fasting
blood glucose when either fish oil or safflower oil was fed, so the
increase cannot be attributed specifically to omega-3 fatty acids. A
study that compared the effects of fish oil and olive oil fed 3.0
g/p/d
of EPA plus DHA did not find a difference in fasting glucose or
glycosylated hemoglobin after fish oil supplementation compared to
baseline; they did find a significant difference compared to the olive
oil treatment, which produced changes in the opposite direction from
fish oil. Based on its evaluation of the available information, FDA
concluded in the June 1997 final rule that consumption of EPA and DHA
in fish oils at 3.0 g/p/d by diabetics has no clinically significant
effect on glycemic control, although higher amounts of EPA and DHA
(4.5
g/p/d and above) remain of concern.
    The June 1997 final rule also considered the reported effects of
fish oil on LDL cholesterol levels in healthy persons with normal
cholesterol levels, as well as in persons with diabetes mellitus,
hypertension, abnormal blood lipid levels, and cardiovascular disease
(62 FR 30751 at 30753 to 30754). As a result of its evaluation, FDA
found that although reported study reports are variable, there appears
to be a trend toward increased LDL cholesterol values with increased
fish oil consumption in all population subgroups, with the magnitude
of
the increase appearing greater and more consistent in populations with
abnormal blood lipid levels, hypertension, diabetes, and
cardiovascular
disease. Based on its evaluation, FDA concluded that 3.0 g/p/d of EPA
and DHA is a safe level with respect to LDL cholesterol.
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-811.htm
============================================================================

--Hua Kul
huakul@REMOVEhotmail.com

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