The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted

September 18, 2012

By Kurt R. Karst & JP Ellison –     

The U.S. Solicitor General filed a brief last week urging the U.S. Supreme Court not to grant a Petition for Writ of Certiorari filed earlier this year by a group of ear candle advocates after the U.S. Court of Appeals for the District of Columbia Circuit affirmed in a January 2012 decision the U.S. District Court for the District of Columbia’s March 2011 decision granting FDA’s Motion to Dismiss an April 2010 lawsuit brought by the ear candlers (see our previous posts here, here, and here).  The case, Holistic Candlers and Consumers Association v. FDA, is assigned Supreme Court Docket No. 11-1454.  According to Petitioners, a decision by the Supreme Court to grant the Petition for Writ of Certiorari “will clarify how far an agency can pressure citizens before its position becomes unequivocal or final.”

The case stems from FDA’s decision to issue about 15 Warning Letters to companies marketing ear candles, an alternative medicine practice that advocates claim improves general health and well-being (see more here).  FDA stated in the February 2010 Warning Letters – see, e.g., here and here – that ear candles are unapproved medical devices and requested that the companies cease marketing and distributing their products.  (At about the same time, FDA also warned consumers and otolaryngological healthcare professionals not to use ear candles “because they can cause serious injuries.”)  Several ear candle advocates objected to FDA’s statement that holistic candles are medical devices and sued the Agency alleging violations of their First, Ninth, Tenth, and Fourteenth Amendment rights, and seeking injunctive relief staying FDA’s determination that their ear candles are unapproved medical devices, as well as declaratory relief voiding FDA’s determination.  FDA moved to dismiss the case on several grounds, including lack of standing, lack of ripeness, and failure to exhaust administrative remedies. 

The D.C. District Court granted FDA’s Motion to Dismiss on various grounds, including that the Warning Letters are not final agency action subject to judicial review under the Administrative Procedure Act (“APA”), and that the holistic candlers’ efforts to obtain injunctive and declaratory relief “is nothing more than a pre-enforcement challenge foreclosed by” the U.S. Supreme Court’s decision in Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950), and is therefore not ripe.  The D.C. Circuit affirmed the district court 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 [Petitioners’] legal rights or obligations.”  Citing FDA’s Regulatory Procedures Manual, the Court noted that FDA Warning Letters are merely “informal and advisory” and that FDA did not commit to take action in the Warning Letters, but rather, “would await [Petitioners’] responses before taking any final regulatory action.”

Both the holistic candler advocates and FDA present similar, but noticeably different, versions of the question posed to the Supreme Court.  Compare Petitioners’ “[w]hether the U.S. Court of Appeals erred in ruling that the [Petitioners’] claim is unripe for review” and “[w]hether an agency’s warning letters, subsequent statements, and previous enforcement actions constitute ‘final agency action’ subject to judicial review under the [APA]” to the Government’s “[w]hether warning letters sent by the [FDA]—which identify possible violations of federal law and ask for corrective action from the recipients, but have no legal consequences—constitute ‘final agency action’ subject to judicial review under the [APA].”  According to Petitioners, the D.C. Circuit’s decision rules against the Supreme Court’s decisions in Sackett v. EPA, 132 S.Ct. 1367 (2012), Bennett v. Spear, 520 U.S. 154 (1997), and Abbott Labs v. Gardner, 387 U.S. 136 (1967), and, “if allowed to stand, allows federal agencies to inform citizens that they are acting in violation of the law and subject to enforcement should the agency initiate the action while ignoring citizens’ requests to challenge the factual findings of that agency and be protected from postponed judicial review.”   FDA, in its opposition brief, says that the D.C. Circuit correctly decided that the Agency’s Warning Letters do not satisy either of the Bennett finality criteria, that Abbott Labs is only relevant where there is final agency action, and that this case it not at all similar to Sackett, in which the Supreme Court, in a unanimous decision, ruled that an EPA compliance order was final agency action reviewable in federal court under the APA. 

Petitioners’ reliance on Sackett caught our attention.  As we noted in a post just days after the Supreme Court ruled in Sackett, “[w]e don’t think it will take long for an FDA regulated entity to cite Sackett as the basis of challenging an FDA Warning Letter, or other agency enforcement action that the agency claims is not final.”  And it did not take long at all for our prediction to become reality.  According to FDA, however:

FDA warning letters do not manifest the same “hallmarks of APA finality” as the EPA compliance order in Sackett.  Unlike that order, FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response.  Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review.  Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA.  If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA. [(Internal citations omitted)]

Although FDA’s Warning Letters to the ear candlers do not include language about real-world consequences, many Warning Letters do.  For example, there have been Warning Letters stating: “Federal agencies may be advised of the issuance of warning letters pertaining to devices so they may take this information into account when considering the award of contracts,” “PMA applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected, and “Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.”  Whether such Warning Letters can be sufficiently final to allow judicial review under Sackett remains to be seen.  In a case in which a Warning Letter contains language akin to that in the previous sentence (especially where FDA uses “will” instead of “may”), the government could have a more difficult time arguing that the Warning Letter is not “final” for some purposes and that it has no effect.

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