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Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued November 17, 2011 Decided January 3, 2012

No. 11-5118

HOLISTIC CANDLERS AND CONSUMERS ASSOCIATION, ET AL.,

APPELLANTS

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

APPELLEES

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.

USCA Case #11-5118 Document #1350489 Filed: 01/03/2012 Page 1 of 10
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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

USCA Case #11-5118 Document #1350489 Filed: 01/03/2012 Page 2 of 10
3

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. 

1

The appellants dispute that ear candles are medical devices,

averring that “[p]roperly made Holistic Candles are a natural holistic

modality . . . used for and intended to be used for relaxation, comfort,

reduction of stress and for the natural furtherance of the well-being of

the user.” Compl. ¶ 19.

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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 (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

2

These are the only allegations that the appellants have raised on

appeal and are the only ones that we address in this opinion.

USCA Case #11-5118 Document #1350489 Filed: 01/03/2012 Page 4 of 10
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manufacture such devices have suffered the requisite “injury in

fact.” See Bennett, 520 U.S. at 167-68.3

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 (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

 

3

In light of this conclusion, we need not consider the standing of

the remaining appellants. See, e.g., Mountain States Legal Found. v.

Glickman, 92 F.3d 1228, 1232 (D.C. Cir. 1996).

4

Because we affirm on this ground, we do not address the

additional grounds for dismissal offered by the district court. In

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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

particular, although the parties focus considerable attention on whether

the case is ripe for judicial review, our conclusion that the warning

letters do not constitute final agency action makes it unnecessary for

us to consider the remainder of the ripeness inquiry. To determine

whether a dispute is ripe, a reviewing court must “evaluate both 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 (1967). Although both the fitness and hardship prongs

encompass a number of considerations, a dispute is not ripe if it is not

fit, see Natural Res. Def. Council, Inc. v. U.S. Nuclear Regulatory

Comm’n, 680 F.2d 810, 817 n.19 (D.C. Cir. 1982), and (at least in an

APA case) it is not fit if it does not involve final agency action, see

Natural Res. Def. Council v. EPA, 643 F.3d 311, 319 (D.C. Cir. 2011)

(citing Abbott Labs., 387 U.S. at 149). 

USCA Case #11-5118 Document #1350489 Filed: 01/03/2012 Page 6 of 10
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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 neither the recipient nor

the agency. 

Once again, the letters at issue here are consistent with the

Manual’s description. The letters tell the manufacturers that

they “should take prompt action to correct” the identified

deviations, “request[]” that they cease marketing, promoting,

and distributing ear candles, and state that “[f]ailure to promptly

correct these deviations may result in regulatory action being

initiated.” FDA Warning Letter (J.A. 43) (emphasis added). It

is plain, therefore, that “[n]o legal consequences flow from the

agency’s conduct to date, for there has been no order compelling

[the appellants] to do anything.” Reliable Automatic Sprinkler,

324 F.3d at 732.5

5

The appellants fear that if they cannot challenge the letters now,

they may ultimately have to expend resources defending themselves

in an enforcement action later. But the law is clear that “practical

consequences, such as the threat of having to defend [oneself] in an

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Accordingly, like other agency advice letters that we have

reviewed over the years, FDA warning letters do not represent

final agency action subject to judicial review.6 Ciba-Geigy

Corp. v. EPA, 801 F.2d 430 (D.C. Cir. 1986), cited by the

appellants, is not to the contrary. In that case, the court

determined that letters EPA sent to manufacturers were final

administrative hearing should the agency actually decide to pursue

enforcement, are insufficient to bring an agency’s conduct under our

purview.” Indep. Equip. Dealers Ass’n v. EPA, 372 F.3d 420, 428

(D.C. Cir. 2004) (internal quotation marks omitted); see FTC v.

Standard Oil of Cal., 449 U.S. 232, 244 (1980); Reliable Automatic

Sprinkler, 324 F.3d at 732.

6

See Indep. Equip. Dealers, 372 F.3d at 427 (holding that an EPA

advice letter that “had no binding effect whatsoever -- not on the

agency and not on the regulated community” -- was not final agency

action); Reliable Automatic Sprinkler, 324 F.3d at 731-32 (ruling that

a Consumer Product Safety Commission letter, stating that agency

officials intended to make a preliminary determination that a

company’s products presented a substantial product hazard and

requesting “voluntary corrective action” from the company, did not

constitute final agency action); AT&T, 270 F.3d at 974-76 (holding

that EEOC Letters of Determination, “stating that in [the

Commission’s] view [the plaintiff] had unlawfully discriminated,” did

not constitute final agency action); Fla. Power & Light Co. v. EPA,

145 F.3d 1414, 1419-20 (D.C. Cir. 1998) (ruling that EPA letters that,

“without more, have no binding effect” on the plaintiff, are not “final

regulations” under the Resource Conservation and Recovery Act of

1976); id. at 1419 (noting with approval a Ninth Circuit decision

holding that an “agency letter alleging statutory violations and

warning of possible injunctive and civil penalty remedies did not

constitute final agency action” (citing Air Cal. v. DOT, 654 F.2d 616,

620-21 (9th Cir. 1981))); see also Standard Oil, 449 U.S. at 241-43

(holding that an FTC complaint, averring that the agency had “reason

to believe” the plaintiffs had committed statutory violations, was not

final agency action subject to immediate judicial review).

USCA Case #11-5118 Document #1350489 Filed: 01/03/2012 Page 8 of 10
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because they expressed EPA’s “unequivocal position” that it

could require labeling changes on a registered pesticide without

first following the cancellation procedures prescribed by the

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),

7 U.S.C. § 136d(b). Ciba-Geigy, 801 F.2d at 435-36; see Reckitt

Benckiser Inc. v. EPA, 613 F.3d 1131, 1136-37 (D.C. Cir. 2010). 

By contrast, FDA expresses no such position, unequivocal or

otherwise, regarding its authority to regulate ear candles without

taking further administrative action. To the contrary, it

acknowledges that, for example, it may “only ban devices after

going through a formal process that it has not undertaken here.” 

FDA Br. 19-20 (citing 21 U.S.C. § 360f). Moreover, unlike

EPA, which “gave no indication that [its position was] subject

to further agency consideration or possible modification,” CibaGeigy, 801 F.2d at 437, FDA advised the appellant

manufacturers to submit further information, which it said it

would “evaluate” and use to “decide whether [their] product[s]

may be legally marketed,” FDA Warning Letter (J.A. 43). 

In support of their claim of finality, the appellants also point

to language on FDA’s website and to the March 2010 meeting

in which agency officials allegedly stated that FDA would never

approve ear candles. FDA’s web page concerning ear candles

lists a variety of actions taken by the agency in the past,

including the issuance of warning letters, under a general

heading entitled “[e]nforcement.” See FDA Consumer Update,

Don’t Get Burned: Stay Away From Ear Candles (Feb. 18,

2010), http://www.fda.gov/ForConsumers/ConsumerUpdates/

ucm200277.htm. Such a generic heading, however, is

insufficient to transform advisory letters into final agency

action.7

 Similarly, a “statement or advice given by an FDA

7

It also “does not follow from the fact that [FDA] has brought

administrative proceedings against other manufacturers that the

agency will use its resources to proceed against” the appellants. 

Reliable Automatic Sprinkler, 324 F.3d at 733.

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employee orally . . . is an informal communication that . . . does

not necessarily represent the formal position of FDA, and does

not bind or otherwise obligate or commit the agency to the

views expressed.” 21 C.F.R. § 10.85(k); see id. § 10.65(a); cf.

AT&T, 270 F.3d at 975 (noting that agency action is not final

when the “agency merely expresses its view of what the law

requires of a party, even if that view is adverse to the party”). 

Moreover, FDA made clear in the March 2010 meeting, as it had

in the warning letters, that it would await the appellants’

responses before taking any final regulatory action. See

Certification in Support of Compl. ¶ 4 (“[W]e look forward to

your response[,] . . . and we will evaluate that response and

make decisions.”). In short, neither FDA’s website nor the

March 2010 meeting supplies the finality that the warning letters

lack.

II

Because the February 2010 warning letters, even as

supplemented by FDA’s website and the appellants’

conversations with FDA officials, do not constitute final agency

action, the appellants’ complaint is not cognizable under the

APA and must be dismissed for failure to state a claim. The

district court’s order granting FDA’s motion to dismiss is

therefore

affirmed.

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