The U.S. Supreme Court has been asked to hear an issue that could have great impact on how federal agencies interact with those who they deem not to be in compliance with their regulations and applicable statutes. The Holistic Candlers and Consumer Association filed a petition in the U.S. Supreme Court in April of this year, which was recently made public. In it, the petitioners request that the Court decide “[w]hether an agency’s warning letters, subsequent statements, and previous enforcement actions constitute ‘final agency action’ subject to judicial review under the Administrative Procedure Act.”

The petitioners in this case are manufacturers and distributors of ear candles. The Food and Drug Administration (FDA) sent the petitioners “Warning Letters” directing them to cease selling, marketing, promoting, and distributing their ear candles, claiming they are “devices” as defined by the Federal Food, Drug, and Cosmetic Act (the Act). See 21 U.S.C. § 321(h). The manufacturers contested the FDA’s letters, arguing that ear candles are not medical devices subject to regulation by the FDA. After several unsuccessful attempts to resolve the dispute outside the courtroom, the manufacturers filed suit against the FDA, requesting that the lower court determine whether ear candles are in fact medical devices as defined by the Act. The court dismissed the case, holding that the FDA’s warning letters did not constitute a final agency action and, consequently, were not subject to judicial review. Thereafter, the manufacturers petitioned the Supreme Court, asking it to hold that a warning letter is a final agency decision that is subject to judicial review.

The outcome of this dispute could shed light on two important issues. First, assuming the Court grants the writ of certiorari, the Court would decide whether or not an agency’s warning letters are reviewable by the courts. If they are, this could change the dynamic of the relationships between agencies and those subject to their jurisdiction. An agency may give a little more consideration before issuing a warning letter that could be immediately appealable to the courts. Second, the outcome of this litigation could determine whether ear candles are considered “medical devices” subject to regulation by the FDA. If they are classified as medical devices, then other similar holistic products may also be classified as medical devices subject to the FDA’s regulation. Such a result would greatly increase the number products regulated by the FDA pursuant to the Act.

The U.S. Supreme Court case is Holistic Candlers and Consumers Ass’n v. FDA et al., Case No. 11-1454. The case appealed from is Holistic Candlers & Consumers Ass'n v. FDA, 664 F.3d 940 (D.C. Cir. 2012).