Par Complaint Seeks to Ban Potassium Chloride Supplements

Foley & Larder says a recent complaint filed under Section 337 of the Tariff Act at the International Trade Commission (ITC) on behalf of Par Pharmaceutical and related parties will be heard by an administrative law judge. The complaint alleges that potassium chloride powder products are being unlawfully imported into the U.S. as dietary supplements, when Par has an approved ANDA for the drug’s use for preventing hypokalemia with or without metabolic alkalosis. Hypokalemia is a deficiency of potassium in the blood stream and it is potentially life-threatening when not treated.

Foley & Lardner says such cases typically invoke FDA jurisdiction, but a Supreme Court decision (Pom Wonderful), ruled that the Food, Drug and Cosmetic Act does not preclude a Lanham Act claim alleging unfair competition arising from false or misleading product descriptions. The complaint alleges that the importation and subsequent false product labeling misleads consumers and harms Par.