Amarin Decision Could Spur Pressure Against FDA On Supplement Claim Policy
This article was originally published in The Tan Sheet
First Amendment advocate Jonathan Emord says the industry bows to FDA “intimidation” in not making truthful claims for their products. But the federal district court ruling for Amarin is the latest decision to strike against FDA’s policy on regulating supplement label claims, he says.
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The drug maker says it's not asking ITC to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC on Oct. 27 will vote on whether to investigate the complaint targeting a large part of the omega-3 market.
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.
The trade group Global Organization for EPA and DHA Omega-3 petitions FDA for an unqualified health claim related to reduced blood pressure as a surrogate marker for coronary heart disease risk.