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.

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.

Lower court decisions that Athena Cosmetics’ RevitaLash products is an unapproved drug competing unfairly against Allergan's Latisse drug could have broader implications if the Supreme Court denies the firm's request for review. Already beleaguered by class actions following FDA warnings, firms could face more opportunistic lawsuits if federal courts are left to determine a product's intended use and regulatory status.