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.
2
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
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.
4
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.
5
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
6
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).
7
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
8
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).
9
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,” Ciba-
Geigy, 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.
10
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.