• Corpus ID: 44442798

Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease ( Docket No

  title={Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease ( Docket No},
  • Published 2005
This letter is in reference to the court decision directing the Food and Drug Administration (FDA) to reconsider the health claim “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease” in dietary supplement labeling (Pearson v. Shalufu, 164 F.3d 650 (D.C. Cir. 1999)). FDA has sent you replies on two of the other health claims that the court directed FDA to reconsider, namely, folic acid and neural tube defects and fiber and colorectal cancer. FDA will address, in a… 
1 Citations
Dispelling the Myths About Omega-3 Fatty Acids
There are now evidence-based clinical guidelines for the use of omega-3 fatty acids in clinical practice, and studies using Food and Drug Administration-approved dosages of P-OM3 have not substantiated various myths surrounding the negative effects of omega, 3 fatty acids.


Dietary fish oil (4 g daily) and cardiovascular risk markers in healthy men.
It is indicated that lowering of postprandial triglycerides is the only n-3 VLCPUFA effect that could contribute to primary prevention of IHD in healthy middle-aged men as assessed by currently measurable lipid and hemostatic risk markers.
Fish consumption and cardiovascular disease in the physicians' health study: a prospective study.
Data do not support the hypothesis that moderate fish consumption lowers the risk of cardiovascular disease, and the relative risks were similar for omega 3 fatty acid intake and for specific types of fish, and did not change after adjustment.
The effect of dietary omega-3 fatty acids on coronary atherosclerosis. A randomized, double-blind, placebo-controlled trial.
Dietary intake of omega-3 fatty acids modestly mitigates the course of coronary atherosclerosis in humans.
Health aspects of fish and n-3 polyunsaturated fatty acids from plant and marine origin
An expert workshop reviewed the health effects of n-3 polyunsaturated fatty acids (PUFA), and came to the following conclusions. Consumption of fish may reduce the risk of coronary heart disease
Does vegetable oil attenuate the beneficial effects of fish oil in reducing risk factors for cardiovascular disease?
The efficacy of fish oil in favorably modifying certain risk factors for CVD was not attenuated by vegetable oil and changes in membrane fatty acid composition, blood lipids, and thrombotic profile were included.
Omega-3 fatty acid content of the US food supply.
The EPA level was slightly lower in 1985 than in 1935-1939, reflecting a marked decline in use of certain fatty fish, and the level of LNA increased because of greater use of soybean oil.
Dietary intake and cell membrane levels of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest.
Dietary intake of n-3 polyunsaturated fatty acids from seafood is associated with a reduced risk of primary cardiac arrest.
Influence of supplementation with N-3 fatty acids on different coronary risk factors in men--a placebo controlled study.
  • J. Deslypere
  • Medicine
    Verhandelingen - Koninklijke Academie voor Geneeskunde van Belgie
  • 1992
It seems improbable that the anti-atherosclerotic action of n-3 FA is due to an effect on the lipid, apoprotein, coagulation or fibrinolysis parameters as measured in this study, so further research must be focused on other parameters (prostaglandins) which can be influenced by n- 3 FA and which probably play an equally important role in the atherosclerosis process.
Modulation of lipid profile by fish oil and garlic combination.
  • N. Morcos
  • Medicine
    Journal of the National Medical Association
  • 1997
The results suggest that in addition to the known anticoagulant and antioxidant properties of both fish oil and garlic, the combination causes favorable shifts in the lipid subfractions within 1 month, suggesting that these combinations may have antiatherosclerotic properties and may protect against the development of coronary artery disease.
Long-term metabolic effects of n-3 polyunsaturated fatty acids in patients with coronary artery disease.
No adverse metabolic effects of long-term fish-oil supplementation assumed to be of clinical importance were seen and no group difference in the serum concentrations of thiobarbituric acid-reactive substances was observed.