Judge Snuffs Out Holistic Candlers Lawsuit; Constitutional Challenge Falls on Deaf Ears

By Kurt R. Karst –

Last week, Judge Richard Leon of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear candle advocates after the Agency issued about 15 Warning Letters (see e.g., here) to companies marketing the products saying that their ear candles are unapproved medical devices and requesting that the companies cease marketing and distributing their products.

Ear candling, also known as “ear coning” or “thermal-auricular therapy,” is an alternative medicine practice that advocates claim improves general health and well-being.  Ear candles are, according to FDA, “hollow cones that are about 10 inches long and made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two” that are being marketed as treatments for a variety of conditions, including “ear wax buildup, sinus infections, hearing loss, headaches, colds, flu, and sore throats.” 

And what does one do with an ear candle to promote holistic relaxation and comfort?  That’s right, you light it up, and lay on your side, potentially allowing hot wax to drip into your ear, apparently to create negative pressure that supposedly draws wax and debris out of the ear canal. 

In this case, which we previously posted on, the holistic candlers alleged violations of their First, Ninth, Tenth, and Fourteenth Amendment rights, and sought 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. 

In addition to ruling that the holistic candlers lacked subject matter jurisdiction (standing, ripeness), Judge Leon ruled 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 61-year old decision in Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950).  Ewing and its progeny established that courts lack jurisdiction to enjoin FDA from initiating enforcement proceedings under the FDC Act.  Specifically, the Supreme Court held in Ewing that a district court lacked jurisdiction to review the FDA’s preseizure determination of probable cause because "Judicial review of this preliminary phase of the administrative procedure does not fit the statutory scheme nor serve the policy of the [FDC Act].”  (The Supreme Court’s decision in Ewing also formed the basis for a 2010 decision out of the U.S. District Court for the District of Wyoming in a case against FDA involving marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL products – see our previous post here.)

Finally, Judge Leon wrote in his opinion that even if the holistic candlers had standing to sue the FDA, if their claims were ripe, and their administrative remedies were exhausted, their remaining statutory and constitutional claims would still fail.  “Some of these claims fail because they assert conclusory allegations without pleading the elements necessary to prevail as a matter of law.  Others claims are insufficient as a matter of law.  Still others fail because no private right of action exists for the alleged violations,” wrote Judge Leon in his 14-page opinion.  Thus, “[i]n sum, plaintiffs’ remaining claims are foreclosed by plaintiffs’ failure to exhaust administrative remedies, or they fail simply as a matter of law.”