Holistic Candlers & Consumers Ass'n v. Food & Drug Administration
398 U.S. App. D.C. 378
| D.C. Cir. | 2012Background
- Ear candles are hollow fabric tubes allegedly used for medical purposes; FDA issued February 2010 warning letters to fifteen manufacturers/distributors.
- Letters asserted ear candles are adulterated and misbranded medical devices because claims target various illnesses, and that no marketing approval/clearance exists.
- Letters urged prompt corrective action and cessation of marketing; warned that failure may trigger enforcement actions.
- Appellants filed suit challenging the letters as contrary to the FDCA and First Amendment, alleging final agency action under the APA.
- District court dismissed, including on grounds of lack of standing and lack of final agency action, prompting appellate review.
- Court analyzes standing first, then whether warning letters constitute final agency action under the APA, and ultimately affirms dismissal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Do appellants have standing to sue? | Appellants seek to challenge letters that purportedly outlaw manufacture. | Letters do not impose mandatory duties or injuries-in-fact. | Appellants have standing but failure on final agency action. |
| Are FDA warning letters final agency action subject to APA review? | Letters and accompanying statements render ear candles unlawfully marketed, constituting final action. | Letters are advisory, do not bind or determine rights, and may lead to future enforcement only. | No; warning letters are not final agency action under the APA. |
Key Cases Cited
- Ciba-Geigy Corp. v. EPA, 801 F.2d 430 (D.C. Cir. 1986) (finality depends on unequivocal agency position; warning letters here lack that finality)
- Reckitt Benckiser Inc. v. EPA, 613 F.3d 1131 (D.C. Cir. 2010) (supports distinction between advisory letters and final action)
- Bennett v. Spear, 520 U.S. 154 (1997) (final agency action requires consummation of decisionmaking and legal consequences)
- AT&T Co. v. EEOC, 270 F.3d 973 (D.C. Cir. 2001) (agency action not final when merely expresses view of law)
- Reliable Automatic Sprinkler Co. v. Consumer Prod. Safety Comm'n, 324 F.3d 726 (D.C. Cir. 2003) (letters indicating potential actions with no binding effect are not final)
- Indep. Equip. Dealers Ass'n v. EPA, 372 F.3d 420 (D.C. Cir. 2004) (advisory letters lacking binding effect are not final agency action)