Holistic Candlers and Consumer, et al. v. FDA, et al.

Appellants, manufacturers, distributors, and users of ear candles, along with organizations that advocate the use of holistic health remedies like ear candles, challenged warning letters the FDA issued to several manufacturers, advising that the agency considered their candles to be adulterated and misbranded medical devices. The district court dismissed appellants' complaint on the ground, among others, that the warning letters did not constitute final agency action. The court affirmed the district court's order to dismiss for failure to state a claim because the warning letters, even as supplemented by the FDA's website and appellants' conversations with FDA officials, did not constitute final agency action and therefore, appellants' complaint was not cognizable under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq. View "Holistic Candlers and Consumer, et al. v. FDA, et al." on Justia Law