A pharmaceutical firm’s fair trade complaint targeting purified eicosapentaenoic acid (EPA) dietary supplements or omega-3 formulations containing primarily EPA in ethyl ester or re-esterified raises a broader issue of concern to supplement marketers: FDA's criteria for allowing the use of certain ingredients in supplement products.
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.