Replies to post #46464 on Amarin Corp Plc (AMRN)

[jessellivermore]

WoW...Thnx for posting this..

FDA comments Re: omega 3 Dietary Supplements

on FDA's consideration of the scientific evidence and other information submitted with your petition, and other pertinent scientific evidence and information, FDA concludes that there is sufficient evidence for a qualified health claim, provided that the qualified claim is appropriately worded so as to not mislead consumers. Thus, FDA will consider exercising enforcement discretion for the following qualified health claim:

Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat, and cholesterol content.]

So it seems the FDA is giving DS omega 3s the "label" to treat heart disease...and denying it to Vascepa..Please someone explain to me why this is not the case. Does Amarin know this? Apparently this DS label expansion resulted from the efforts of the DS industry to provide literature supporting this notion to the FDA..Time for the company, or perhaps zum to start flooding the the M&E division with the thousands of articles on the benefits of EPA that the FDA must be unaware of.

":>) JL

[sts66]

FDA is allowing some sort of CV protection for OTC fish oil but refuses to allow AMRN to put anything similar on it's label? WTF? How does that make any sense?!?


FDA still concludes that the weight of the scientific evidence for a health claim for EPA and DHA omega-3 fatty acids outweighs the scientific evidence against such a claim. The most significant change in the available body of evidence since 2000 is the additional observational studies, the majority of which consistently reported an associated benefit in CHD risk from EPA and DHA consumption from fish.

The observational studies estimating EPA and DHA omega-3 fatty acid intake from conventional foods support the expansion of the existing qualified health claim for EPA and DHA omega-3 fatty acids from dietary supplements and CHD to conventional foods.