By Susan J. Matthees –
Earlier this week, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the U.S. District Court for the District of Columbia’s decision granting FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear candle advocates. As we previously reported, ear candle advocates filed suit after FDA issued about 15 Warning Letters to companies marketing ear candles, an alternative medicine practice that advocates claim improves general health and well-being. FDA stated in the Warning Letters that ear candles are unapproved devices, a determination the ear candlers alleged violated their First, Ninth, Tenth, and Fourteenth Amendment Rights.
The District Court granted FDA’s Motion to Dismiss on the ground, among others, that the Warning Letters were not final agency action subject to judicial review under the Administrative Procedure Act (“APA”). The Court of Appeals affirmed this decision, explaining that the Warning Letters are not final agency action because “they neither mark the consummation of the agency’s decisionmaking process nor determine the appellants’ legal rights or obligations.” Citing FDA’s Regulatory Procedures Manual, the Court noted that FDA Warning Letters provide an opportunity for a company to correct their actions before the Agency initiates enforcement actions and are merely “informal and advisory.” The Court also noted that FDA does not commit to taking action in a Warning Letter and that FDA acknowledges that it can only ban a device through a formal process that was not taken in this case. Because there was no final agency action, the ear candlers’ claims could not hold a candle to the requirements of the APA.
The D.C. Circuit’s decision is consistent with previous judicial rulings. Indeed, it appears that almost every court to consider the question has held that an FDA Warning Letter does not constitute “final agency action.” See, e.g., Biotics Research Corp. v. Heckler, 710 F.2d 1375 (9th Cir. 1983); Clinical Reference Lab., Inc. v. Sullivan, 791 F. Supp. 1499 (D. Kan. 1992), rev’d sub nom. on other grounds, United States v. Undetermined No. of Unlabeled Cases, 21 F.3d 1026 (10th Cir. 1994); Estee Lauder, Inc. v. FDA, 727 F. Supp. 1 (D.D.C. 1989); IMS Ltd. v. Califano, 453 F. Supp. 157 (C.D. Cal. 1977). More recently, the U.S. District Court for the District of Wyoming considered the issue in Cody Laboratories, Inc. v. Sebelius in the context of a Warning Letter for a marketed unapproved drug and found there was not final agency action. On appeal, the U.S. Court of Appeals for the Tenth Circuit did not grapple with the issue. However, in 1992, Den-Mat Corporation sued FDA for sending a Warning Letter that concluded that its product was a drug, not a cosmetic. The Warning Letter stated that FDA would recommend that actions be taken against the products, and Den-Mat reported that its business was suffering as a result of the letter and would continue to suffer until there was a determination whether FDA was correct in its position. FDA sought to have the case dismissed, but the U.S. District Court of the District of Maryland permitted a company to continue a case against FDA because FDA’s warning letter stated an “unqualified intent” to take affirmative action against the company. Den-Mat Corporation v. United State of America, No. MJG-92-44, 1992 U.S. Dist. LEXIS 12233 (D. Md. Aug 17, 1992). The court stated that FDA may have “gone beyond a statement of its position and taken an affirmative action to enforce its decision.” There was no similar affirmative action by FDA in the case against the ear candlers.