Ear candlers, such as popstar Jessica Simpson, may want to find another way to treat their earwax issues.
The D.C. Circuit Court of Appeals threw out a lawsuit brought by ear candle advocates against the FDA, finding that the candle advocates lacked a cause of action.
The court held that the Holistic Candles and Consumers Association failed to state a legitimate claim under the Administrative Procedures Act, which prevented them from suing the FDA for urging ear candle makers to stop promoting them as medical treatments.
Ear candles are long tubes of fabric covered in wax. Users place one end into their ear and light the other on fire to pull wax and debris out. Ear candles have been touted as remedies for everything from sinus infections to hearing loss.
The FDA disagreed with that assessment and issued an alert about the dangers of ear candles, such as inner ear burns, bleeding and eardrum puncture, in 2010. The FDA then issued warning letters to 15 ear candle manufacturers, urging them to stop marketing their products as medical treatments since they were not FDA-approved.
Claiming their candles were not medical devices, ear candle advocates sued the FDA, arguing that their First Amendment rights were being violated.
The D.C. Circuit agreed with the FDA attorneys and the lower court that the letters did not constitute "final agency action," which is required to subject the letters to judicial review under the Administrative Procedure Act. Instead, the letters were merely "informal and advisory" and did not "commit FDA to taking enforcement action."
It looks like the ear candlers' attorneys couldn't hold a candle to the FDA's attorneys in this case.
- Holistic Candlers and Consumers Association v. Food Drug Administration (FindLaw's CaseLaw)
- Reservation of Agency Discretion Not "Arbitrary and Capricious" (FindLaw's D.C. Circuit blog)
- DC Circuit Strikes SEC Proxy Access Rule (FindLaw's D.C. Circuit blog)