The Food and Drug Administration (FDA) has urged the U.S. Supreme Court to reject the petition for review filed by the Holistic Candlers and Consumers Association and companies making ear candle products from a D.C. Circuit Court of Appeals ruling dismissing their challenge to FDA’s warning letters about their products. Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454 (U.S., opposition to cert. petition filed September 10, 2012). Additional information about the certiorari petition appears in the June 14, 2012, issue of this Report.
FDA argues that “[t]he decision of the court of appeals that the warning letters are not final agency action subject to judicial review is correct and does not conflict with any decision of this Court or any other court of appeals.” FDA contends that warning letters do not mark the consummation of a decision-making process; rather, they give a company the opportunity to correct a violation before the agency takes action to enforce the law.