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Herbal Sleep Aid With Rx 'Reformulation' Gives FDA A Nightmare

This article was originally published in The Rose Sheet

Executive Summary

FDA inspects Belmora's website and product labeling in March and issues a warning letter that firm’s Elavil OTC Sleep Aid is an unapproved new drug with inadequate directions for its intended use.

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Amarin's recent fair trade complaint targetting purified EPA dietary supplements and formulations also raises broader questions about using synthetic dietary ingredients in consumer supplements and the extent to which a substance’s identification in an IND precludes subsequent use as a dietary ingredient.

Amarin's Omega-3 Fair Trade Complaint Questions US Dietary Ingredient Standards

Amarin's recent fair trade complaint targetting purified EPA dietary supplements and formulations also raises broader questions about using synthetic dietary ingredients in consumer supplements and the extent to which a substance’s identification in an IND precludes subsequent use as a dietary ingredient.

Omega-3 Drug Firm’s Trade Complaint Questions US Dietary Ingredient Standards

Amarin targets purified EPA dietary supplements or formulations containing primarily EPA in ethyl ester or re-esterified form and raises general questions about using synthetic dietary ingredients in supplements and about the extent to which a substance’s previous identification as an IND candidate precludes its subsequent use as a dietary ingredient.

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