Candlers v. Food

• Decision Date: 16 March 2011
• Docket Number: Civil Case No. 10–582 (RJL).
• Citation: 770 F.Supp.2d 156
• Parties: HOLISTIC CANDLERS AND CONSUMER ASSOCIATION, et al., Plaintiffs,v.U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
• Court: U.S. District Court — District of Columbia

770 F.Supp.2d 156

HOLISTIC CANDLERS AND CONSUMER ASSOCIATION, et al., Plaintiffs,

v.U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants.

Civil Case No. 10–582 (RJL).

United States District Court, District of Columbia.

March 16, 2011.

James S. Turner, Swankin & Turner, Washington, DC, for Plaintiffs.Andrew E. Clark, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendants.

MEMORANDUM OPINION

RICHARD J. LEON, District Judge.

Plaintiffs, the Holistic Candlers and Consumer Association and other individual manufacturers, consumers, and private associations (“plaintiffs”), bring this action against the U.S. Food and Drug Administration (“FDA” or the “agency”) and other agencies and officials in the United States government (collectively, “defendants”) alleging violations of plaintiffs' First, Ninth, Tenth, and Fourteenth Amendment rights; seeking injunctive relief staying the FDA's determination that plaintiffs' holistic candles are unapproved medical devices under 21 U.S.C. § 321; and seeking declaratory relief voiding the FDA's determination. Before this Court is defendants' Motion to Dismiss [Dkt. # 7]. Upon consideration of the parties' pleadings, relevant law, and the entire record, the defendants' motion is GRANTED.

BACKGROUND

Plaintiffs are a collection of individuals, organizations, and associations who manufacture, distribute, consume, and advocate for the use of “holistic candles,” commonly referred to as “ear candles.” Pls.' Compl. (“Compl.”), Apr. 12, 2010, ¶¶ 2–3, 15 [Dkt. # 1]. Made of fabric soaked in beeswax or paraffin, ear candles are hollow cones placed into the ear and set on fire with an open flame. Defs.' Mot. to Dismiss, June 10, 2010, at 1 [Dkt. # 7]. Certain of the plaintiff-manufacturers historically ¹ marketed ear candles for uses such as “[h]elping people with ... sinus congestion, colds, the flu, sore throats, earaches, ear infections, sinus infections, lymphatic congestion, swollen glands,” (Defs.' Mot. to Dismiss, Ex. B at 3 [Dkt. # 7–2] ); obtaining relief from Meniere's Disease, tinnitus, sleep disorders, and vision disorders ( id. at 5); and extracting wax and infectious fluid from a child's ear ( id. at 7).

On February 17, 2010, the FDA issued Warning Letters to fifteen manufacturers and distributors of ear candles (Compl. ¶ 17; Defs.' Mot. to Dismiss at 1)—including five named plaintiffs ² in this case (Defs.' Mot. to Dismiss at 15)—objecting to certain marketing claims the manufacturers made about ear candles.³ In the letters, the FDA explained that ear candles are considered “devices” under the Federal Food, Drug, and Cosmetic Act (“the FDCA” or “the Act”), and thus regulated by the FDA, because they are

“an instrument, apparatus, [or] implement ... which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, ... or intended to affect the structure or any function of the body of man.”21 U.S.C. § 321(h)(2), (3).

Further, the FDA advised the plaintiff-manufacturers that they had violated the FDCA by labeling and marketing devices (ear candles) without the agency's clearance or approval. Defs.' Mot. to Dismiss at 1.⁴ The agency referred the manufacturers to the FDA website for information about how to obtain approval and clearance for devices and noted that the “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Id. at 1.⁵ The FDA requested that the manufacturers “cease marketing and distribution of ear candles ... the same as or similar to those described [in the letter]” and stated that the failure to correct FDCA violations “may result in regulatory action.” Defs.' Mot. to Dismiss, Ex. B at 6. Finally, the FDA asked recipients of the Warning Letters to submit, within fifteen business days, a written response outlining each recipient's intent to comply with the FDA's request. Defs.' Mot. to Dismiss at 19 n. 20; Ex. B at 3. Some of the fifteen letter recipients—including Harmony Cone, a named plaintiff in this case—complied with the FDA's request for a written response; others agreed to voluntarily cease marketing ear cones or to remove health claims from promotional materials. Defs.' Mot. to Dismiss at 11. But no company presented the FDA with proposed labeling disclaimers or disclosures for the agency's evaluation. Id.

Notwithstanding their prior marketing and representations, plaintiffs now claim that ear cones “are not medical devices,” Compl. ¶¶ 18–19, 29. Instead, they contend, ear candles are generic products used for “holistic ... relaxation [and] comfort” and are thus exempt from FDA regulation. Id. ¶¶ 3, 19–23. Alleging that the FDA's issuance of Warning Letters constituted final agency action (Pls.' Opp'n at 5) and that the agency has “effectively outlaw[ed]” ear candles (Compl.¶ 3), plaintiffs filed this suit against the FDA on April 9, 2010: less than two months after the FDA issued the February 17 Warning Letters. See Defs.' Mot. to Dismiss at 12.

To date, the FDA has not initiated enforcement action against any named plaintiff. Id. at 11.

ANALYSIS

I. Standard of Review

Defendants move to dismiss this action pursuant to Fed.R.Civ.P. 12(b)(1). A Rule 12(b)(1) motion shall be granted if a plaintiff fails to establish subject-matter jurisdiction. A plaintiff bears the burden of proving subject-matter jurisdiction, and the standing required to invoke it. See U.S. Ecology, Inc. v. U.S. Dep't of Interior, 231 F.3d 20, 24 (D.C.Cir.2000). In addition, a plaintiff's claim must also be ripe. Importantly, a “claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all.” Texas v. United States, 523 U.S. 296, 300, 118 S.Ct. 1257, 140 L.Ed.2d 406 (1998) (citations omitted).

Defendants also move to dismiss plaintiffs' complaint under Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief may be granted. To survive a Rule 12(b)(6) motion to dismiss, a plaintiff must support its complaint with “any set of facts consistent with the allegations” such that the complaint “possess[es] enough heft to show that the pleader is entitled to relief.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557, 563, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citations omitted).

Unfortunately for plaintiffs, even taking as true all allegations in the complaint, see Holy Land Found. for Relief & Dev. v. Ashcroft, 333 F.3d 156, 165 (D.C.Cir.2003), each of plaintiffs' claims must, for the following reasons, be dismissed.

II. Rule 12(b)(1) Motion

A. Plaintiffs Lack Standing Because They Cannot Demonstrate Actual Injury.

First, plaintiffs' claims must be dismissed for lack of subject-matter jurisdiction because plaintiffs cannot, and do not, demonstrate the actual injury required to establish standing. A litigant bears the burden of showing that is has “suffered, or be[en] threatened with, an actual injury traceable to the defendant and likely to be redressed by a favorable judicial decision.” Lewis v. Cont'l Bank Corp., 494 U.S. 472, 477, 110 S.Ct. 1249, 108 L.Ed.2d 400 (1990); see also Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). But plaintiffs do not “allege that [they] ha[ve] been or will in fact be perceptibly harmed by the challenged agency action, not that [they] can imagine circumstances in which [they] could be affected by the agency's action.” United States v. Students Challenging Reg. Agency Procs. (SCRAP), 412 U.S. 669, 688–89, 93 S.Ct. 2405, 37 L.Ed.2d 254 (1973) (emphasis added). In fact, despite plaintiffs' allegations of “imminent peril of risk of health or life, loss of liberty, property, [and] livelihood or licensure,” Compl. ¶ 14, plaintiffs' case is one of imagined injury. Indeed, the FDA's only official action in this case occurred in February 2010, when it issued Warning Letters to some named plaintiffs. ⁶ Defs.' Mot. to Dismiss at 11, 15. That the FDA has taken no additional official action—enforcement or otherwise—undercuts plaintiffs' assertion that they have suffered real (much less imminent) harm. The mere allegation that the FDA “effectively outlaw[ed]” ear candles, Compl. ¶ 3, or that plaintiffs are “at imminent risk of loss of income,” id. ¶ 8, does not suffice to prove actual injury where the FDA has initiated no enforcement action, seized no personal property, imposed no civil fine, and banned no device.⁷ See Estee Lauder, Inc. v. FDA, 727 F.Supp. 1, 4 (D.D.C.1989); see also Regen. Scis., Inc. v. FDA, No. 09–cv–00411, 2010 WL 1258010, at *8 (D.Colo. March 26, 2010) (“The fact remains that [plaintiff] has not shown any specific concrete action taken by the FDA that has harmed it or any specific losses it has suffered as a result of FDA action.”). Accordingly, plaintiffs do not have standing to bring their declaratory and injunctive claims against the FDA.⁸

B. Plaintiffs Lack Subject–Matter Jurisdiction Because There Has Been No Final Agency Action and Plaintiffs' Claims Are Not Ripe.

Plaintiffs also lack subject-matter jurisdiction on a separate but related ground: ripeness. A claim is not ripe for review if “judicial intervention would inappropriately interfere with further administrative action,” Ohio Forestry Ass'n v. Sierra Club, 523 U.S. 726, 733, 118 S.Ct. 1665, 140 L.Ed.2d 921 (1998), or if “it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all.” Texas, 523 U.S. at 300, 118 S.Ct. 1257 (internal quotations omitted). To determine whether a litigant's claims are ripe, courts look to two factors: “the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.” Abbott Labs. v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967) (abrogated on other grounds). When evaluating the first factor, fitness, our Circuit makes three additional...