Replies to post #116395 on Amarin Corp Plc (AMRN)

[dmlcento]

Can you post a link to that guidance?

[dmlcento]

Can you please comment on the quote below?

In fact, as noted in the complaint, FDA has already determined that synthetic fatty acid esters derived from fish oil "do not fit within the statutory definition of 'dietary ingredient' because they are not constituents of a dietary substance for use by man under section 20l(ff)(l)(F).

[HDGabor]

r-

Could you please, specify how do you mean, what do you would like to suggest?

The Draft includes "esterification" 3 times:

1.) "In general, FDA considers a process that does not result in chemical alteration to mean a process that: (1) involves an ingredient composed of one single raw material, or derived from a single raw material using a manufacturing process that involves only physical steps (e.g., water extraction and condensation); and (2) does not involve attempts to selectively increase the concentration of particular active ingredients or cause a chemical reaction (other than esterification) that would modify the covalent bonds of any substance in the original material. This type of rocess is unlikely to affect the safety profile of the ingredient in question or of dietary supplements containing the ingredient."

2.) "Altering the chemical structure of a dietary ingredient (e.g., creation of new stereoisomers, addition of new chemical groups as in esterification) creates a new substance that is different from the original dietary ingredient. The new substance is not considered to be a dietary ingredient merely because it has been altered from a substance that is a dietary ingredient and, therefore, is in some way related to the dietary ingredient."

3.) "Vinpocetine can be formed synthetically from vincamine, including via a ‘‘one-pot’’ synthesis, through transesterification and/or dehydration of vincamine in ethanol using Lewis acids and catalyzed by ferric chloride ... is a synthetic derivative of vincamine or tabersonine ... We therefore tentatively conclude that vinpocetine is not a dietary ingredient"

None of these against Amarin's Complaint ... the Draft supports Amarin's approach.

Feel free to correct.

Best,
G