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Latest From POM Wonderful LLC

Amarin's Asking ITC To Do FDA's Job, Federal Attorneys Tell Supreme Court

In petition to Supreme Court, Amarin does not assert it makes any fair trade claim "that could be proved without establishing" an FDCA violation, nor does it dispute that its "claims are ultimately premised on allegations that the FDCA was violated," say DoJ solicitor general and ITC counsel.

Legal Issues Dietary Supplements

Clinical Trials For Supplement Claims Not An FTC Rule, But A Standard

FTC Bureau of Consumer Protection official Richard Cleland takes on the hot-button issue by explaining that a supplement health or structure/function claim doesn't need support from research with the size and scope of studies looking at the safety and efficacy of a drug ingredient proposed for a certain indication. Supplement ad claims, though, still need competent and reliable scientific evidence as support.

United States Advertising, Marketing & Sales

Amarin Not Giving Up On Omega-3 Trade Battle

Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.

Drug Approval Standards FDA

Amarin Not Giving Up On Omega-3 Trade Battle

Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.

Drug Approval Standards FDA
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