Holistic Candlers & Consumers Ass'n v. Food & Drug Admin.

• Citation: 664 F.3d 940,398 U.S.App.D.C. 378
• Decision Date: 03 January 2012
• Docket Number: No. 11–5118.,11–5118.
• Parties: HOLISTIC CANDLERS AND CONSUMERS ASSOCIATION, et al., Appellants v. FOOD & DRUG ADMINISTRATION, et al., Appellees.
• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)

398 U.S.App.D.C. 378

664 F.3d 940

HOLISTIC CANDLERS AND CONSUMERS ASSOCIATION, et al., Appellants

v.FOOD & DRUG ADMINISTRATION, et al., Appellees.

No. 11–5118.

United States Court of Appeals, District of Columbia Circuit.

Argued Nov. 17, 2011.Decided Jan. 3, 2012.

Appeal from the United States District Court for the District of Columbia (No. 1:10–cv–00582).James S. Turner argued the cause and filed the briefs for appellants.

Andrew E. Clark, Senior Litigation Counsel, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Tony West, Assistant Attorney General, U.S. Department of Justice, William B. Schultz, Acting General Counsel, U.S. Department of Health and Human Services, and Eric M. Blumberg, Deputy Chief Counsel. Robert E. Kopp, Attorney, U.S. Department of Justice, entered an appearance.

Before: TATEL and GARLAND, Circuit Judges, and GINSBURG, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge GARLAND.

GARLAND, Circuit Judge:

Ear candles are hollow tubes made of fabric soaked in beeswax or paraffin; a user places one end in his ear and sets the other on fire with an open flame. The appellants are manufacturers, distributors, and users of ear candles, along with organizations that advocate the use of holistic health remedies like ear candles. Their lawsuit challenges warning letters the Food and Drug Administration (FDA) issued to several of the appellant manufacturers, advising that the agency considered their candles to be adulterated and misbranded medical devices. The district court dismissed the appellants' complaint on the ground, among others, that the warning letters did not constitute “final agency action” subject to judicial review under the Administrative Procedure Act. We agree and affirm the dismissal of the complaint.

I

In February 2010, FDA issued “Warning Letters” to fifteen manufacturers and distributors of ear candles, including several of the appellants. A typical warning letter advised the recipient that FDA considered its candles to be adulterated and misbranded medical devices because “[b]ased on the labeling ..., it appears your ear candles are intended to mitigate or treat allergies, headaches, colds, flu, sinus congestion, sore throat, ear infections” and a variety of other medical disorders, yet “you have not obtained marketing approval or clearance before you began offering your product for sale.” Letter from FDA to Harmony Cone (Feb. 17, 2010) (J.A. 42–43) [hereinafter FDA Warning Letter]; see Letter from FDA to King Cone Int'l (Feb. 17, 2010) (J.A. 45) (stating that the manufacturer's website contains claims that the “device is intended to relieve,” inter alia, “vision disorders [,] ... depression, and attention deficit disorder”); see also J.A. 47, 49 (warning letters to other manufacturers).¹ FDA further noted that it “has received medical device reports consistent with the danger to health posed by your device[s,] ... including reports involving ruptured tympanic membranes and burns.” FDA Warning Letter (J.A. 43). The letters advised the appellants to “take prompt action to correct [the identified] deviations” from the Food, Drug, and Cosmetic Act (FDCA). Id. (citing, inter alia, 21 U.S.C. §§ 321(h), 351(f)(1)(B), 352(a), 352(f)(1), 352(j)). They also “request[ed]” that the appellants cease marketing, promoting, and distributing ear candles and “correct the problem,” and warned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Id.

On March 26, 2010, after receiving such a letter, representatives of one of the appellant companies met with FDA officials. According to the appellants, at the meeting an FDA agent reiterated the agency's position that ear candles are medical devices, and the then-Deputy Director for Regulatory Affairs asserted that FDA did not intend to approve ear candles for use in the market. See Certification in Support of Compl. ¶¶ 4–5. Even so, the Deputy Director concluded the meeting by telling the representatives that “we look forward to your response[,] ... and we will evaluate that response and make decisions on what we are going to do, going forward.” Id. ¶ 4. The company never responded and never submitted the information required to seek approval or clearance for its ear candles.

Instead, the appellants filed this lawsuit. Their complaint alleges, among other things, that FDA's warning letters, coupled with the statements made by FDA officials during the March 2010 meeting, are contrary to the FDCA and violate the First Amendment.² “Plaintiffs have a right to bring this action pursuant to the Administrative Procedure[ ] Act,” the complaint states, “because ... FDA [has] engaged in final agency actions that ‘are contrary to law.’ ” Compl. ¶ 10.

The district court dismissed the appellants' suit on several grounds, including that the appellants lack standing and that the warning letters do not constitute final agency action. Holistic Candlers & Consumer Ass'n v. FDA, 770 F.Supp.2d 156, 160–62 (D.D.C.2011). Because standing is a “threshold jurisdictional question,” we must address it first. Byrd v. EPA, 174 F.3d 239, 243 (D.C.Cir.1999). FDA argues that the appellants lack standing because the letters “do not impose any requirements on the recipients,” FDA Br. 14, and hence have not caused them the “injury in fact” required to establish standing, id. at 17. See Bennett v. Spear, 520 U.S. 154, 167, 117 S.Ct. 1154, 137 L.Ed.2d 281 (1997). “In analyzing whether [a plaintiff] has standing at the dismissal stage,” however, “we must assume that [the plaintiff] states a valid legal claim and ‘must accept the factual allegations in the complaint as true.’ ” Info. Handling Servs., Inc. v. Def. Automated Printing Servs., 338 F.3d 1024, 1029 (D.C.Cir.2003) (internal citation omitted). The appellants here claim that the warning letters announce “FDA's determination that ear candles are, per se, unapproved Medical Devices and cannot be sold in the United States,” Compl. ¶ 17, which “effectively outlaw[s] the manufacture” of ear candles, id. ¶ 3. If the appellants are right that FDA's actions outlaw the manufacture of ear candles, there is no doubt that the appellants that manufacture such devices have suffered the requisite “injury in fact.” See Bennett, 520 U.S. at 167–68, 117 S.Ct. 1154.³

Although the appellants have standing, we conclude that they cannot satisfy another requirement for maintaining this suit: a cause of action. The appellants' claims all rely upon the Administrative Procedure Act (APA), 5 U.S.C. §§ 701 et seq., to provide a cause of action. Compl. ¶ 10; see Trudeau v. FTC, 456 F.3d 178, 185 (D.C.Cir.2006). The APA, however, only provides a right to judicial review of “ final agency action for which there is no other adequate remedy in a court.” 5 U.S.C. § 704 (emphasis added); see Trudeau, 456 F.3d at 185 (“ ‘If there was no final agency action ..., there is no doubt that appellant would lack a cause of action under the APA.’ ” (quoting Reliable Automatic Sprinkler Co. v. Consumer Prod. Safety Comm'n, 324 F.3d 726, 731 (D.C.Cir.2003))). “As a general matter, two conditions must be satisfied for agency action to be ‘final’: First, the action must mark the consummation of the agency's decisionmaking process—it must not be of a merely tentative or interlocutory nature. And second, the action must be one by which rights or obligations have been determined, or from which legal consequences will flow.” Bennett, 520 U.S. at 177–78, 117 S.Ct. 1154 (internal citations and quotation marks omitted); see AT & T Co. v. EEOC, 270 F.3d 973, 975 (D.C.Cir.2001). FDA's warning letters fail to satisfy either condition: they neither mark the consummation of the agency's decisionmaking process nor determine the appellants' legal rights or obligations.⁴

The letters plainly do not mark the consummation of FDA's decisionmaking. The FDA Regulatory Procedures Manual describes FDA warning letters as giving “firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action.” FDA Manual, § 4–1–1 (emphasis added). The Manual states that the violations for which warning letters are issued “ may lead to enforcement action if not promptly and adequately corrected,” not that they inevitably will. Id. (emphasis added).

Consistent with this description, the warning letters at issue here advise the recipients that “it appears your ear candles are intended to mitigate or treat” the listed disorders, explain where to get the “information you need to submit in order to obtain approval or clearance for your device,” and state that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” FDA Warning Letter (J.A. 42–43) (emphasis added). They further state that “failure to promptly correct these deviations may result in regulatory action being initiated.” Id. (J.A. 43) (emphasis added). According to the letters, such regulatory actions “include, but are not limited to seizure, injunction, and/or civil monetary penalties.” Id. No such actions have been taken against the appellants to date.

Nor do the letters represent a decision determining rights or obligations, or one from which legal consequences flow. The FDA Manual explains that “[a] Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug and Cosmetic Act.” FDA Manual, § 4–1–1 (emphasis added). Although a warning letter “communicates the agency's position on a matter,” it is only “informal and advisory” and “does not commit FDA to taking enforcement action.” Id. Indeed, the Manual states that, “[d]espite the significance of the violations [for which a warning letter may be issued], there are some circumstances that may preclude the agency from taking any further enforcement action following the issuance of a Warning Letter.” Id. In short, an FDA warning letter compels action by...