Amarin Corp Plc (AMRN)

[MedResCollab]

Citizen Petition Submission no.2

A. Actions Requested:

Medical Research Collaborative respectfully requests of the Commissioner that ethyl ester, re- esterified triglyceride, free-fatty acid (aka “carboxylic-acid”), mono- and di-glyceride forms of omega-3 fatty acids be officially ruled by the FDA as being dietary ingredients.

B. Statement of Grounds

In a bid to have the right to purchase high-purity omega-3 supplements stripped from U.S. consumers, Amarin Corp. attempted to circumvent the jurisdiction granted by Congress to the USFDA by issuing a Complaint to the ITC to judge all such supplements as “drugs” and not “dietary supplements.” ...

https://www.regulations.gov/document?D=FDA-2019-P-3266-0001

You may comment on the content of our petition submission by selecting the “Comment Now” button per the above link.

Regards,
-MRC Team