United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued March 27, 2007 Decided April 13, 2007
No. 06-1147
MOMS AGAINST MERCURY, ET AL.,
PETITIONERS
v.
FOOD & DRUG ADMINISTRATION,
RESPONDENT
On Petition for Review of Agency Action of the
Food and Drug Administration
Charles G. Brown argued the cause for petitioners. With
him on the briefs was Robert E. Reeves.
Catherine Y. Hancock, Attorney, U.S. Department of
Justice, argued the cause for respondent. With her on the brief
were Peter D. Keisler, Assistant Attorney General, Jeffrey A.
Taylor, U.S. Attorney, Mark B. Stern, Attorney, Daniel Meron,
General Counsel, U.S. Department of Health & Human
Services, and Eric M. Blumberg, Deputy Chief Counsel.
Before: SENTELLE, HENDERSON and TATEL, Circuit Judges.
Opinion for the Court filed by Circuit Judge SENTELLE.
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SENTELLE, Circuit Judge: A number of advocacy
organizations and individuals seek review of regulatory inaction
by the Food and Drug Administration (“FDA”). They assert that
the FDA should classify, under the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. §§ 301-399 (“FDCA” or the “Act”), a
material commonly used for dental fillings. The material, they
contend, must be regulated by the FDA in order to protect
consumers against its deleterious health effects. We hold that
we lack jurisdiction over the subject matter, and thus dismiss the
petition.
I.
The dental fillings at issue in this case are comprised of
approximately equal parts (1) dental mercury and (2) amalgam
alloy comprised of silver and other metals. Dentists typically
receive these fillings in encapsulated form. The two
components are separately sealed in one capsule, and are
combined to create the “silver” material used to fill dental
cavities. In encapsulated form, the device is called
“encapsulated amalgam alloy and dental mercury,” or
“EAADM.”
The FDCA, as amended by the Medical Device
Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976),
authorizes the FDA to regulate “medical devices,” a broad
category of instruments and implants that includes items such as
syringes, surgeon’s gloves, and dental fillings. The FDA
regulates a device by placing it into one of three classes,
depending on the extent of regulatory control necessary to
ensure its safety and effectiveness. Class I devices are safe
enough to be regulated only by “general controls,” the lowest
level of regulation. 21 U.S.C. § 360c(a)(1)(A). Class II devices
present a higher risk and thus require stricter “special controls.”
Id. § 360c(a)(1)(B). Devices placed in class III are subject to the
3
highest level of controls, including pre-market approval, because
their risks cannot be addressed by general or special controls.
Id. § 360c(a)(1)(C).
When it enacted the classification system, Congress
provided that all devices not yet on the market would be
automatically classified as class III devices. Id. These “post-
amendment devices” are thus subject to strict pre-market
approval requirements unless FDA determines that they are
“substantially equivalent” to class I or II devices that are already
on the market. Id. § 360c(i). Devices that predated the
amendments (“pre-amendment devices”) were not automatically
classified, but were left for FDA to classify under specified
procedures. Id. § 360c(b)(1). If, after classification by either
method, the FDA determines that a device has been placed into
the wrong class, the agency can reclassify it on its own initiative
or in response to a petition. Id. § 360c(e).
FDA has classified a number of pre-amendment dental
devices, including dental mercury in class I and amalgam alloy
in class II. 21 C.F.R. §§ 872.3700, 872.3050 (1987). FDA
acknowledged that dental mercury presents some risks to
patients and dentists, but concluded that those risks were
adequately addressed by labeling requirements and other general
controls. Dental Devices; General Provisions and
Classifications of 110 Devices, 52 Fed. Reg. 30,082, 30,089
(Aug. 12, 1987). Although FDA has not yet classified the
encapsulated form of these two devices, the agency notes that it
is in the process of reaching a classification decision. A
proposed rule issued in 2002 would classify EAADM as a class
II device, and would amend or revise the classifications of
amalgam alloy and dental mercury. Dental Devices:
Classification of Encapsulated Amalgam Alloy and Dental
Mercury and Reclassification of Dental Mercury; Issuance of
Special Controls for Amalgam Alloy, 67 Fed. Reg. 7620
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(Feb. 20, 2002). In 2006, in light of emerging research and
requests for reconsideration of its proposed rule, FDA convened
a panel meeting of two advisory committees. Notice of Meeting,
71 Fed. Reg. 16,582 (Apr. 3, 2006). FDA’s efforts to classify
EAADM continue: currently the agency is conducting an
extensive review of scientific literature, the panel
recommendations, and the comments to its proposed rule. Until
it is classified, FDA states that EAADM is effectively regulated
as a class II device because that is the highest classification
attaching to one of its component parts.
Petitioners are four organizations, representing the
economic, health and environmental interests of their members
and the public generally; and five individuals, representing their
personal economic, medical and professional interests. They
believe that mercury in dental fillings causes physical harm to
dental office employees who must handle the material when
they implant and remove fillings, and to dental patients (and
their unborn children) who inhale mercury vapors emanating
from the fillings in their mouths. Petitioners contend that, if
FDA were to classify EAADM, the public would be better
informed of its dangers in choosing whether to accept it or
demand other, safer filling materials. They argue that FDA’s
decision not to classify EAADM, knowing the risks it poses to
individuals and the environment, constitutes a violation of the
FDCA. Petitioners ask this Court to order FDA to classify
EAADM, and to remove the device from commerce until it has
done so.
II.
FDA argues that this Court should dismiss the instant
petition because this Court lacks subject matter jurisdiction and
because petitioners lack standing. In every case, the
jurisdictional requirements of Article III must be present before
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a court may proceed to the merits. Steel Co. v. Citizens for a
Better Env’t, 523 U.S. 83, 94-95 (1998). Where both standing
and subject matter jurisdiction are at issue, however, a court may
inquire into either and, finding it lacking, dismiss the matter
without reaching the other. See Ruhrgas AG v. Marathon Oil
Co., 526 U.S. 574, 584 (1999) (holding that, because Steel Co.
“does not dictate a sequencing of jurisdictional issues,” a court
may “choose among threshold grounds for denying audience to
a case on the merits”). In this case, we hold that we lack
jurisdiction over the subject matter of petitioners’ claim. We
thus dismiss the petition without reaching the question of
standing.
As to subject matter jurisdiction, FDA’s failure to classify
a device does not directly give rise to judicial review in this
Court under the FDCA. Under section 360g, persons who are
adversely affected by specified FDA regulations or orders may
file, in the courts of appeals, a petition for judicial review within
thirty days of the relevant FDA action. 21 U.S.C. § 360g(a).
Specifically, petitioners invoke provisions authorizing this
Court’s review of three FDA decisions: (1) subjecting a device
to pre-market approval under subsection (a)(4); (2) determining
that a post-amendment device is substantially equivalent to a
pre-amendment device under subsection (a)(8); and (3)
reclassifying a device from one class to another under
subsection (a)(9). As petitioners concede, however, the FDA
has engaged in none of these actions with regard to EAADM.
These provisions thus cannot support jurisdiction in this Court.
Section 360g(a)(4) authorizes judicial review of “the
promulgation of a regulation under paragraph (3) of section
360e(b) of this title requiring a device to have an approval of a
premarket application, a regulation under paragraph (4) of that
section amending or revoking a regulation under paragraph (3),
or an order pursuant to section 360e(g)(1) or 360e(g)(2)(C) of
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this title.” All of the referenced subsections address procedures
for requiring a device to obtain pre-market approval. In this
case, the FDA has not promulgated any regulations relating to
pre-market approval of EAADM, nor has it issued any order
relating to such application. Subsection (a)(4), therefore, cannot
be the basis of our jurisdiction.
Section 360g(a)(8) brings under the judicial review
provision “an order pursuant to section 360c(i) of this title.”
The cross-referenced section describes procedural requirements
for the FDA to determine that a post-amendment device is
substantially equivalent to a pre-amendment device. In this
case, EAADM has not been – and indeed, as a pre-amendment
device, could not be – the subject of any order deeming it
substantially equivalent to a pre-amendment device. The final
subsection petitioners cite as a source of subject matter
jurisdiction is similarly inapposite. Section 360g(a)(9) applies
to “a regulation under section 360e(i)(2) or 360j(l)(5)(B).” The
cited provisions, in turn, relate to orders revising the
classification of a device. Since the FDA has issued no order
classifying EAADM, provisions relating to the revision of its
classification are not applicable. These three subsections cited
by petitioners, then, apply only to certain agency actions, none
of which has occurred here.
Nor can this Court assert jurisdiction under a theory that
agency actions can be challenged in this Court as long as the
FDCA does not provide for exclusive jurisdiction elsewhere. If
judicial review of an FDA action or inaction is not provided for
in the Act, challenges to such actions may be brought only in the
district court. See Cutler v. Hayes, 818 F.2d 879, 887 n.61 (D.C.
Cir. 1987) (“Agency action taken under sections silent” as to
judicial review “are directly reviewable only in a district court
under some appropriate head of its jurisdiction, for courts of
appeals have only such jurisdiction as Congress has chosen to
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confer upon them.”). We have, however, previously recognized
a limited exception to this rule. When the agency’s final action
is exclusively reviewable in this Court, we have exercised
jurisdiction over a claim that the agency has unreasonably
delayed that action. In Telecommunications Research & Action
Center v. FCC, 750 F.2d 70, 75 (D.C. Cir. 1984) (“TRAC”), this
Court held that a claim of unreasonable delay was reviewable
directly and exclusively in this Court because any final FCC
order could be reviewed in this Court. On those facts, the Court
asserted jurisdiction over the intermediate issue in order to
“protect its future jurisdiction.” Id. at 76.
It is this Court’s interest in protecting its future jurisdiction
that gives rise to jurisdiction under a TRAC theory. The interest
does not arise if the final agency action is not reviewable in this
Court. See Cutler, 818 F.2d at 887 n.61 (noting that “[e]ssential
to our holding” in TRAC “were statutory provisions enabling us
to review any final FCC order”) (emphasis added). In the
instant case, the FDA final action with regard to EAADM may
or may not be reviewable in this Court. For example, if the
FDA were to deem it a class I device, that regulation would be
directly reviewable in this Court. 21 U.S.C. § 360g(a)(1).
Classifications of devices into classes II or III, on the other
hand, are directly reviewable only in district court because the
FDCA does not provide for their review in the courts of appeals.
Cf. Cutler, 818 F.2d at 887 n.61. Any number of other scenarios
can be imagined as well. After the FDA classifies EAADM, it
might subsequently take some action that is directly reviewable
in this Court, such as reclassifying it or requiring manufacturers
to obtain pre-market approval. But we do not assert jurisdiction
on the basis of hypothetical scenarios. TRAC is not properly
extended to cases where the basis of prospective jurisdiction is
a speculative chain of events. Cf. In re Tennant, 359 F.3d 523,
529 (D.C. Cir. 2004) (holding that unless “there has been a
proceeding of some kind instituted before an agency or court
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that might lead to an appeal,” speculative claims of future
appeals court jurisdiction are not sufficient to confer prospective
jurisdiction). We have no reason to suppose that agency action,
reviewable in this Court, is imminent.
III.
Petitioners have failed to carry their burden of
demonstrating that this Court has subject matter jurisdiction
over their claim. See Georgiades v. Martin-Trigona, 729 F.2d
831, 833 n.4 (D.C. Cir. 1984) (citing McNutt v. Gen. Motors
Acceptance Corp., 298 U.S. 178, 189 (1936)). We are thus
compelled to dismiss their petition without considering the
merits of petitioners’ claim.
So ordered.