UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
BELLION SPIRITS, LLC, et al.,
Plaintiffs, v. Civil Action No. 17-2538 (JEB) UNITED STATES OF AMERICA, et al.,
Defendants.
MEMORANDUM OPINION
A vodka maker’s hopes of advertising the health benefits of its product were thwarted
when a federal administrative agency found the claims to be unsubstantiated. This vodka maker,
which is actually two entities — Plaintiffs Bellion Spirits, LLC and Chigurupati Technologies
Private Ltd. (jointly, “Bellion”) — then filed suit in this Court against the administrative agency
— the Alcohol and Tobacco Tax and Trade Bureau (TTB) — and a host of other governmental
entities. Bellion asserts claims under the Administrative Procedure Act and the First and Fifth
Amendments to the U.S. Constitution. In this litigation’s first volley, Plaintiffs seek to
supplement the record with two peer-reviewed scientific articles and three declarations. Finding
that this case does not present one of the narrow circumstances in which a party can supplement
an administrative record on judicial review, the Court will deny the Motion.
I. Background
Given the early stage of this litigation, a cursory rehearsal of the facts will do. Bellion
Spirits is an independent distributor of Bellion Vodka, which is infused with NTX, a proprietary
blend of ingredients developed by Chigurapati Technologies. See ECF No. 16 (Am. Compl.), ¶¶
15–16. Plaintiffs sought approval to add eight claims espousing the health benefits of NTX to
1 the label of Bellion Vodka. These statements included, among other things, that NTX reduces
“alcohol-induced oxidative damage to the liver,” “helps maintain normal liver enzyme
production and function,” “helps protect DNA from alcohol-induced damage,” and “reduces
alcohol-induced DNA damage.” Id., ¶ 24. Under the applicable regulatory regime, Bellion first
had to pass through TTB’s administrative process before printing these claims, as the agency’s
governing regulations prohibit health-related claims that are false or misleading. See 27 C.F.R.
§ 5.42(b)(8)(ii)(A). A sub-category of such statements — those that make a “specific health
claim” — must also be “adequately substantiated by scientific or medical evidence,” among
other additional requirements. Id. § 5.42(b)(8)(ii)(B)(2); see also id. §§ 4.39(a)(1), 7.29(a)(1).
Bellion thus filed a petition with TTB, which sought the Food and Drug Administration’s
counsel in evaluating the health claims. See ECF No. 22 (Pl. Motion) at 4; ECF No. 23 (Def.
Opp.) at 4. After receiving and reviewing a memorandum from the FDA memorializing its
findings, TTB denied Bellion’s petition. It found that “none of the eight claims is adequately
substantiated” and their inclusion on a label would “create a misleading impression as to the
effects on health consumption of alcoholic beverages infused with NTX.” Pl. Motion, Exh. F
(Petition Response Letter) at 35.
Bellion, dissatisfied with TTB’s ruling, filed this suit against the agency and a number of
other governmental entities, which the Court will collectively refer to as “TTB.” Plaintiffs
challenge TTB’s denial of Bellion’s two claims concerning NTX’s effect on DNA, but raise no
opposition to TTB’s denial of the other six here. See Am. Compl., ¶¶ 1, 24. Plaintiffs bring both
statutory and constitutional causes of action. In their statutory count, Bellion contends that, by
relying on the FDA’s advice, TTB acted beyond its authority and thus ran afoul of the APA
2 (Count III). See 5 U.S.C. § 706(2)(C); Am. Compl., ¶¶ 89–101. Only TTB, and not the FDA,
Plaintiffs posit, may regulate the sale of alcohol. See Am. Compl., ¶¶ 93–94.
Bellion also advances three constitutional claims, two of which arise under the First
Amendment. In one (Count I), Plaintiffs take issue with TTB’s conclusion that Bellion’s health
claims are not substantiated by credible scientific evidence. They allege various errors in TTB’s
conclusion and assert that, because Bellion’s claims are in fact supported by credible evidence,
barring them violates Plaintiffs’ First Amendment rights. Id., ¶¶ 71–79. Bellion’s second First
Amendment claim (Count II) takes a categorical shot at TTB’s procedures. Plaintiffs contend
that the applicable regulations amount to an unconstitutional prior restraint because they lack
definite standards for approving a label’s health-related claims and do not impose on the agency
any timeframe for responding to a petitioner’s request, thus granting the agency “unbridled
discretion.” Id., ¶ 86. In a similar vein, Bellion’s last constitutional cause of action asserts that
TTB regulations are unconstitutionally vague. They thus bring a “facial and as-applied
challenge” under the Fifth Amendment’s Due Process Clause (Count IV). Id., ¶ 103.
Before any briefing on the merits of the parties’ dispute has occurred, Bellion now moves
to supplement the administrative record with five documents and the testimony of two live
witnesses. The first two documents are peer-reviewed studies that, Plaintiffs say, support their
claims about NTX’s effect on alcohol-induced DNA damage. See Pl. Motion at 10–11. TTB,
however, did consider these studies before their publication in peer-reviewed literature, and those
earlier versions are indeed part of the administrative record. Plaintiffs thus seek only to add to
the record the fact of peer review. Id.
Bellion also wishes to submit three declarations and in-court testimony of two of those
declarants. The first declaration, from Dr. Jeffrey Blumberg, concludes that credible scientific
3 studies support Bellion’s health claim and criticizes FDA’s memorandum finding the contrary.
Id. at 12–13. Plaintiffs also ask that Dr. Blumberg be permitted to testify at a hearing. In the
second declaration, Plaintiffs attack what they see as a weakness in the logical chain that
permitted TTB to deny their request. They say that TTB’s decision hinges on a conclusion that
consumers would draw a particular inference from Bellion’s claims regarding the effect of NTX
on DNA — namely, that “consuming an alcohol[ic] beverage infused with NTX will provide a
reduction of risk from alcohol induced damage to the liver and brain.” Id. at 15 (quoting Petition
Response Letter at 41). Plaintiffs thus submit the declaration of Dr. David Stewart, a marketing
expert, to “explain[] what an implied claim is, and how TTB erred by finding the existence of an
implied claim without requisite data to support that conclusion.” Id. at 15. They also request
that Dr. Stewart have an opportunity to testify. Finally, Plaintiffs move to add an affidavit from
Harsha Chigurupati, Bellion’s President and owner, “confirming that the active compound
studied in the Bellion research was the commercially available Bellion Vodka.” Id. at 2.
Plaintiffs say that TTB doubted this link. Id.
II. Legal Standard
In reviewing agency action, “it is black-letter administrative law that . . . a reviewing
court ‘should have before it neither more nor less information than did the agency when it made
its decision.’” Hill Dermaceuticals, Inc. v. Food & Drug Admin., 709 F.3d 44, 47 (D.C. Cir.
2013) (quoting Walter O. Boswell Mem’l Hosp. v. Heckler, 749 F.2d 788, 792 (D.C. Cir. 1984)).
It is only in “certain limited, and highly exceptional, circumstances” that a court may permit a
party to supplement the administrative record. The Cape Hatteras Access Preservation Alliance
v. U.S. Dep’t of Interior, 667 F. Supp. 2d 111, 114–15 (D.D.C. 2009). There are, nonetheless,
several “accepted exceptions” to the general rule barring extra-record evidence. IMS, P.C. v.
4 Alvarez, 129 F.3d 618, 624 (D.C. Cir. 1997). Although courts have articulated these exceptions
in slightly divergent manners, see United Student Aid Funds, Inc. v. DeVos, 237 F. Supp. 3d 1, 3
(D.D.C. 2017) (noting these variations), the parties here repeat the same four exceptions. See Pl.
Motion at 8; Def. Opp. at 9.
A plaintiff can supplement an administrative record by adding evidence not before the
agency: “(1) when the agency failed to examine all relevant factors; (2) when the agency failed
to explain adequately its grounds for decision; (3) when the agency acted in bad faith; or (4)
when the agency engaged in improper behavior.” Styrene Info. & Research Ctr., Inc. v.
Sebelius, 851 F. Supp. 2d 57, 63 (D.D.C. 2012) (citing IMS, 129 F.3d at 624). These four
exceptions serve the same underlying purpose: they grant plaintiffs a means of securing
“effective judicial review” when the agency’s failure to explain its action or improper behavior
precluded the creation an adequate record. IMS, 129 F.3d at 624 (quoting Camp v. Pitts, 411
U.S. 138, 142–43 (1973)); see also Styrene Info. & Research Ctr., 851 F. Supp. 2d at 63
(“Underlying all of these exceptions is the assessment that resort to extra-record information [is
necessary] to enable judicial review to become effective.”) (quoting Calloway v. Harvey, 590 F.
Supp. 2d 29, 38 (D.D.C. 2008)).
III. Analysis
Because Plaintiffs’ claims arising under the APA and the Constitution implicate distinct
considerations, the Court will address each separately.
A. APA Claim
Little need be said here. In their Reply brief, Plaintiffs concede that “[n]one of Bellion’s
proposed extra-record evidence is relevant to Bellion’s lone APA claim” and urge the Court to
5 “resolve the APA claim by reviewing the extant record without regard to the scientific affidavits
and testimony.” ECF No. 25 (Pl. Reply) at 5. This settles the matter.
Even had Plaintiffs not made this concession, the Court would reach the same conclusion.
For the reasons articulated in its discussion of Bellion’s constitutional claims, none of the
accepted exceptions to the general rule barring extra-record evidence applies. Nor is there any
other reason that such material should be considered here. The core of Plaintiffs’ APA claim
asserts that TTB exceeded its statutory authority by relying on the FDA’s analysis in evaluating
Bellion’s petition. Bellion’s proposed extra-record evidence, which goes to whether their
asserted health benefits are substantiated by credible science, has no bearing on the merits of
their APA claim.
B. Constitutional Claims
The propriety of extra-record evidence for Bellion’s three constitutional claims,
conversely, warrants further scrutiny. Plaintiffs mount their attack from two fronts. First, they
contend that this case falls into one of the accepted circumstances in which a party is permitted
to supplement an administrative record on judicial review. Second, Bellion says that the Court
need not actually rely on these exceptions at all. Rather, they assert, the fact that they bring
constitutional claims frees them of the limitations of APA review. Neither argument persuades.
1. Accepted Exceptions
Taking the accepted exceptions first, Plaintiffs have not shown that their case falls into
one of the four “highly exceptional[] circumstances” in which a party may supplement an
administrative record. See Cape Hatteras Access Preservation Alliance, 667 F. Supp. 2d at 114–
15. The Court can knock out two of the four exceptions right off the bat: Bellion makes no
assertion that the agency “acted in bad faith” or otherwise “engaged in improper behavior.”
6 Styrene Info. & Research Ctr., 851 F. Supp. 2d at 63. Two remain: situations in which an agency
“failed to examine all relevant factors” or “failed to explain adequately its ground for decision.”
Id.
Bellion’s arguments on these grounds land wide of the mark. Although they repeatedly
maintain that TTB “failed to examine all relevant factors,” the grievances that back up this
assertion have little to do with an agency’s neglect of a factor that it was obligated to address.
They say, for instance, that “TTB based its decision on factors that could not have been foreseen
by Bellion,” Pl. Motion at 8 — i.e., by consulting with the FDA — and that the “abdication of
TTB’s statutory obligations” — again, by consulting with the FDA — “involved TTB’s failure to
consider all relevant factors.” Pl. Reply at 3. Tacking, Bellion also asserts that “[b]y refusing to
provide Bellion with an opportunity to present [its] evidence below before it issued a
Decision[,] . . . TTB failed to examine all relevant factors.” Id. at 12-13.
These are simply not the circumstances contemplated by the exception. Nowhere does
Bellion point the Court to a specific factor that TTB was required, but failed, to examine and that
the Court must also consider on judicial review. This is what the exception demands. See, e.g.,
United Student Aid Funds, 237 F. Supp. 3d at 5 (permitting extra-record evidence when
administrative agency failed to articulate whether its policy differed from industry practice or
otherwise constituted a change in position); Cape Hatteras Access Preservation Alliance, 667 F.
Supp. 2d at 116 (denying a motion because plaintiffs had “not identified any particular factors
[the agency] failed to consider” nor “what factors [the agency] needed to consider”). If an
agency never considered a factor that the reviewing court must evaluate, “reviewing agency
action would be unnecessarily difficult.” Cape Hatteras Access Preservation Alliance, 667 F.
Supp. 2d at 114.
7 That is not the case here. Bellion’s primary arguments all trace back to their unhappiness
with TTB’s decision to involve the FDA. This decision does not establish, however, that TTB
failed to consider a relevant factor. Perhaps, as Plaintiffs contend, they were not afforded a
sufficient opportunity to counter the agencies’ findings before TTB, or perhaps, as the
Government argues, these processes were adequate. That dispute is for another day. What
matters here is that, regardless of its merit, TTB’s decision does not deprive the Court of a
sufficient administrative record to evaluate the agency’s finding on a relevant factor. In fact, on
the key question to which Bellion’s proposed extra-record evidence is relevant — whether their
health claims are true (or, at least, not false) — the administrative record already contains a heap
of studies and articles submitted by Bellion to TTB (112, to be precise) along with additional
expert reports. See Pl. Motion at 3.
Lurking behind this deficiency in Plaintiffs’ argument is a larger one. It is only in
Bellion’s APA count (Count III) that they specifically target TTB’s interaction with the FDA. As
already detailed, however, Plaintiffs concede that the Court need not admit extra-record evidence
to evaluate this part of their suit. To succeed in admitting extra-record evidence on their
constitutional claims, the “relevant factor” must be one relevant to the constitutional analysis.
Plaintiff has articulated no connection — and the Court discerns no link — between TTB’s
purported “statutory abdication” and this analysis.
Bellion does say, however, that “[b]y refusing to provide Bellion with an opportunity to
present [its] evidence below before it issued a Decision[,] . . . TTB failed to examine all relevant
factors.” Pl. Reply at 12–13. To the degree this statement is intended to refer to Bellion’s
contention in its Motion that TTB’s process is constitutionally inadequate because it did not give
Bellion an opportunity to respond, it does not help them. Bellion’s desire to critique the
8 agencies’ analysis implies not that the agency failed to consider a factor, but that Bellion
disagrees with its conclusion as to those factors.
The nature of the evidence Bellion seeks to add confirms that its actual beef is with the
substance of the agency’s decision. Such a position does not permit Bellion to supplement the
record. As the Court of Appeals has stated, “[T]he familiar rule that judicial review of agency
action is normally to be confined to the administrative record . . . exerts its maximum force when
the substantive soundness of the agency’s decision is under scrutiny.” Esch v. Yeutter, 876 F.2d
976, 991 (D.C. Cir. 1989). TTB already considered the two studies Bellion seeks to add; only
the fact of peer review — which occurred after TTB’s decision — is new. Because the agency
already considered and addressed these studies, see Def. Opp. at 4, there can be no real argument
that peer review supplements a record “silent” on an “unresolved factual issue.” United Student
Aid Funds, 237 F. Supp. 3d at 5. Bellion also seeks to submit a declaration verifying that Bellion
Vodka contains the compounds studied in its submitted articles. It contends that the record is
silent on this point, thus permitting supplementation. See Pl. Reply at 12. But the record is
“silent” not because TTB “failed to consider a relevant factor” — in fact, it expressly addressed
this logical link — but because Bellion never submitted evidence to the agency. Plaintiffs do not
get a do-over in this Court. See Bradley v. Weinberger, 483 F.2d 410, 415 (1st Cir. 1973)
(characterizing judicial review of agency action as a “re-view, a second look at the same
material, not a re-doing”).
Even more probative, two of the declarations’ stated purpose is to attack the substance of
TTB’s decision and FDA’s memorandum and demonstrate why the “DNA Claims are
substantiated by credible evidence.” Pl. Motion at 13. This charge, quite clearly, attempts to
strike at the substantive heart of FDA’s decision. Where Plaintiffs’ complaint is with the
9 substance of the decision rather than the agency’s failure to consider any relevant factor, they are
confined to the administrative record.
For similar reasons, Bellion’s contention that the agency failed to adequately explain its
reasoning is unavailing. Plaintiffs contend that the agency’s decision is “void of any
foundational explanation in science for its conclusion that the two DNA claims were invalid.”
Pl. Motion at 9. TTB, however, articulated its reason for denying Bellion’s claim in a 47-page
letter. See Petition Response Letter. Bellion may very well disagree with its conclusion. But
“[t]his is not a case where the agency failed ‘to explain administrative action [so] as to frustrate
effective judicial review.’” IMS, 129 F.3d at 624 (quoting Camp, 411 U.S. at 142–43). This
Court has previously pointed out that “[d]isagreement with an agency’s analysis is not enough to
warrant the consideration of extra-record evidence.” Standing Rock Sioux Tribe v. U.S. Army
Corps of Engineers, 255 F. Supp. 3d 101, 125 (D.D.C. 2017).
Finally, Bellion sprinkles throughout its briefs additional arguments untethered to any of
the specified exceptions. Most prominently, they point out that supplementing the record may be
appropriate where “the procedural validity of the agency’s action remains in serious question.”
CTS Corp. v. EPA, 759 F.3d 52, 64 (D.C. Cir. 2014) (quoting Hill Dermaceuticals, 709 F.3d at
47). Here, Plaintiffs say, they have brought a challenge to the agency’s procedures, thus entitling
them to a broader record. See Pl. Reply at 10. Bellion misunderstands the law. A plaintiff is not
entitled to supplement the record merely because she challenges an agency’s procedures. See
Esch, 876 F.2d at 991 (noting that it is only “sometimes” appropriate to admit extra-record
evidence when procedural validity of an agency action is challenged). Such a categorical
exception would threaten to swallow the rule. Rather, it is only where there are “gross
procedural deficiencies” that render the “administrative record . . . so deficient as to preclude
10 judicial review” that a plaintiff may add more than the agency had before it. See CTS Corp., 759
F.3d at 64 (quoting Hill Dermaceuticals, 709 F.3d at 47); see also Esch, 876 F.2d at 992
(permitting supplementation where agency “failed woefully in complying with the hearing
requirement” such that “[n]one of the proceedings that did occur was conducted in a manner
conducive to obtaining the relevant facts”); United Student Aid Funds, 237 F. Supp. 3d at 6
(finding that lack of any evidence on key issue was a qualifying “gross procedural deficiency”).
Here, on the other hand, for the reasons already mentioned, the administrative record is
sufficiently developed on the challenged points. The Court, therefore, concludes that none of the
accepted exceptions applies.
2. Constitutional Argument
Perhaps anticipating this conclusion, Plaintiffs alternatively offer a different approach.
They eschew any reliance on the exceptions addressed above and instead argue that because their
claim originates under the Constitution, the strictures of the APA do not apply. As a quick
reminder, Plaintiffs assert three constitutional causes of action. Bellion’s first constitutional
claim (Count I) arises under the First Amendment and challenges the agency’s finding that their
health claims are misleading and insufficiently substantiated. Counts II (also under the First
Amendment) and IV (under the Fifth Amendment), conversely, take issue with the procedures
employed by TTB. Because the proposed extra-record evidence either criticizes the agencies’
analysis or adds purported substantiation for Bellion’s health claims, it is most clearly relevant to
Count I. It is with that count, therefore, that the Court begins.
The caselaw on a plaintiff’s ability to supplement an administrative record to support a
constitutional cause of action is sparse and in some tension. See, e.g., Chiayu Chang v. U.S.
Citizenship & Immigration Servs., 254 F. Supp. 3d 160, 161 (D.D.C. 2017) (noting “some
11 disagreement among district courts” on this issue). Lacking explicit support in caselaw,
Plaintiffs’ primary argument leans on the Court’s independent role in reviewing constitutional
claims. See Pl. Motion at 9–10; Pl. Reply at 4–9. The Court agrees that this is the place to start.
Plaintiffs set forth the principle that constitutional claims are typically reviewed de novo.
See Pl. Motion at 9. As a general matter, they are correct. See Nat’l Oilseed Processors Ass’n v.
Occupational Safety & Health Admin., 769 F.3d 1173, 1179 (D.C. Cir. 2014). But de novo
review does not mean the same thing in all contexts. The D.C. Circuit recently held that, “even
in the First Amendment context,” a court must review certain agency “factual finding[s] . . .
under the ordinary (and deferential) substantial-evidence standard.” POM Wonderful, LLC v.
FTC, 777 F.3d 478, 499 (D.C. Cir. 2015). District courts in this circuit, addressing claims
substantially similar to those at issue here, reached the same conclusion prior to the D.C.
Circuit’s affirmation in POM Wonderful. See, e.g., Alliance for Nat. Health U.S. v. Sebelius,
786 F. Supp. 2d 1, 12 n.11 (D.D.C. 2011) (“The Court reviews an agency’s decisions on
constitutional issues de novo, but defers to an agency’s interpretation of scientific information
unless it is irrational or arbitrary and capricious.”). When the time comes, this Court will thus
review de novo any question of constitutional law but must apply the substantial-evidence test
and accord some deference to the agency’s scientific and fact-bound determinations.
Under this test (or any test, for that matter), evaluating an agency’s decision rooted in
complex scientific data is no easy lift. Reacting to this complexity, circuit precedent dictates that
a reviewing court’s task is to critically analyze the agency’s logic and explanation rather than
engage in a comparative evaluation of conflicting scientific evidence. See Whitaker v.
Thompson, 248 F. Supp. 2d 1, 11 (D.D.C. 2002). Its object is to ensure that the agency
“explicated the bases of its decision, and adduced substantial evidence in the record to support its
12 determinations.” Nat’l Oilseed Processors Ass’n, 769 F.3d at 1178. More specifically, this
process includes requiring the agency “to explain the logic and the policies underlying any . . .
choice,” “state candidly any assumptions on which it relies,” and “present its reasons for
rejecting significant contrary evidence and argument.” Id. (quoting United Steelworkers of Am.,
AFL–CIO–CLC v. Marshall, 647 F.2d 1189, 1207 (D.C. Cir. 1980)).
This task would be markedly harder with a supplemented record. There would be little
meaningful way to review the logic of an agency’s attempt to sort through scientific evidence
and the bases of its decision if the record before the court differed from that before the agency.
This is especially so for a scientific claim in a commercial-speech context. In this case, a court
may be called on to review an agency’s determination about the credibility of scientific evidence
in support of a health claim and whether that evidence is “qualitatively weaker than the evidence
against the claim.” Whitaker, 248 F. Supp. 2d at 10 (quoting Pearson v. Shalala, 164 F.3d 650,
659 n.10 (D.C. Cir. 1999)). Plaintiffs’ approach would have the Court make these credibility
determinations in the first instance. This is not the Court’s role nor is it consistent with the
substantial-evidence standard. See id. at 11 (“[I]t is generally ‘not for the judicial branch to
undertake comparative evaluations of conflicting scientific evidence.’”) (quoting NRDC v. EPA,
824 F.2d 1211, 1216 (D.C. Cir. 1987)).
Said otherwise, the gravamen of Bellion’s constitutional complaint in Count I faults a
decision made by an administrative agency — namely, its conclusion that Bellion’s health claims
are misleading. The Court’s evaluation of the agency’s decision is not aided by considering
evidence to which the agency was not privy. The nature of Bellion’s assertion and the method in
which the Court is obligated to review the agency’s scientific conclusions in this case, buttressed
by practical considerations, thus militate in favor of treating Bellion’s first First Amendment
13 claim (Count I) in the same manner as a similar challenge brought under the APA — i.e.,
For these and similar reasons, district courts have been hesitant to permit a plaintiff
asserting a constitutional challenge to agency action to avoid the APA’s bar on extra-record
evidence. For example, one court bound a plaintiff’s First Amendment claim to the APA’s
procedural provisions because the case was “an appeal of an agency action in every respect” and
permitting a broader record on judicial review for a constitutional claim would “incentivize
every unsuccessful party to agency action to allege bad faith, retaliatory animus, and
constitutional violations to trade in the APA's restrictive procedures for the more even-handed
ones of the Federal Rules of Civil Procedure.” Jarita Mesa Livestock Grazing Ass’n v. U.S.
Forest Serv., 58 F. Supp. 3d 1191, 1237–38 (D.N.M. 2014). Other courts have followed similar
reasoning. See Chiayu Chang, 254 F. Supp. 3d at 161–62; Harvard Pilgrim Health Care of New
England v. Thompson, 318 F. Supp. 2d 1, 10 (D.R.I. 2004) (“The APA’s restriction of judicial
review to the administrative record would be meaningless if any party seeking review based on
statutory or constitutional deficiencies was entitled to broad-ranging discovery.”); Ketcham v.
U.S. Nat’l Park Serv., No. 16-17, 2016 WL 4268346, at *1–2 (D. Wyo. Mar. 29, 2016) (holding
that court was “obligated” to analyze a suit asserting constitutional claims under “the procedures
set forth under the APA” because “distinguish[ing] between a ‘stand-alone constitutional
challenge’ and an ‘APA challenge,’ . . . would run afoul of Congress’s intent”); Alabama-
Tombigbee Rivers Coal. v. Norton, 2002 WL 227032, at *5–6 (N.D. Ala. Jan. 29, 2002) (denying
plaintiff’s request for discovery for its constitutional claim because “when there is a
contemporaneous explanation of the agency decision, the validity of that action must stand or fall
on the propriety of that finding” and whether it is “sustainable on the administrative record
14 made”) (quoting Vermont Yankee Nuclear Power Corp. v. NRDC, Inc., 435 U.S. 519, 549
(1978)).
There appears to be a common thread running through these cases: when a constitutional
challenge to agency action requires evaluating the substance of an agency’s decision made on an
administrative record, that challenge must be judged on the record before the agency. In fact, the
one case cited by Bellion in which a court permitted extra-record evidence for a constitutional
claim accords with this principle. See Rydeen v. Quigg, 748 F. Supp. 900, 906 (D.D.C. 1990).
In Rydeen, the constitutional challenge – under the Due Process Clause – did not require the
court to review the substance of an agency’s decision. Rather, it challenged the procedures by
which the agency reached its conclusion. Id.
So here is the bottom line: Given the dearth of caselaw on point in this circuit, the Court
declines to adopt any bright line or categorical rule. It finds that in this particular case, Bellion is
not entitled to supplement the administrative record for any constitutional claim that requires the
Court to analyze the substance of an agency’s decision that is, in turn, based on an evaluation of
that record. This conclusion disposes of Plaintiffs’ Motion with respect to its First Amendment
claim challenging the agency’s conclusion that Bellion’s health claims are misleading or
inadequately substantiated (Count I).
In Counts II and IV, however, Plaintiffs challenge the agency’s procedures rather than the
substance of its decision. Bellion contends in Count II that TTB’s procedures amount to an
unconstitutional prior restraint in violation of the protections afforded by the First Amendment.
Count IV raises a challenge under the Fifth Amendment — namely, that TTB regulations are
unconstitutionally vague. Because these claims do not require the Court to evaluate the
substance of the existing administrative record, the prior analysis does not necessarily apply.
15 Rather, the question here is whether Plaintiffs’ proposed evidence is relevant to their allegations.
It would be an exercise in futility to permit extra-record evidence that has no bearing on
Bellion’s claims.
The Court would forgive a careful reader for being confused by Bellion’s assertion that
its evidence is relevant to its procedural claims. Plaintiffs conceded, as earlier mentioned, that
“[n]one of Bellion’s proposed extra-record evidence is relevant to Bellion’s APA claim,” which,
like the constitutional claims, attacks the procedures employed by TTB. See Pl. Reply at 5.
Similarly, nowhere in Bellion’s Motion do they connect their extra-record evidence to their
procedural arguments. On the other hand, they explicitly assert that the declarations and peer-
reviewed articles attack the substance — rather than procedure — of FDA’s conclusion. They
say, for example, that the Blumberg declaration is “probative of whether [the] DNA Claims are
substantiated by credible evidence” and “challenge[s] the scientific deficiencies that were
overlooked by the TTB in its Decision.” Pl. Motion at 13–14.
After the Government pointed out this logical disconnect, Bellion changed tack in their
Reply. There, Plaintiffs contend that “each of the items Bellion seeks to add to the record are
relevant to the issue of whether TTB’s procedural process was valid.” Pl. Reply at 12. Bellion
says that the Chigurupati declaration — which “respond[s] to a specific critique of TTB” —
“proves that if TTB provided Bellion with sufficient notice of the standards upon which it would
adjudge Bellion’s substantiation, Bellion could have quickly included the . . . declaration in the
record below.” Id. Similarly, Bellion contends that the two expert declarations “support
Bellion’s argument that TTB’s procedure is invalid” because, had TTB “provided Bellion with a
trial-like process, Bellion would have offered” the testimony in rebuttal. Id. at 14.
16 As an initial matter, the Court is skeptical that these substantive declarations can prove
that Bellion was afforded a constitutionally inadequate process in the manner asserted in Counts
II and IV. Such a ruling, however, might dance too close to the merits of Plaintiffs’ claim, which
will be the subject of future merits briefing. The Court thus grants for now the premise that
Bellion’s inability to respond to the agency’s conclusion could be relevant to Counts II and IV.
The question then becomes whether Plaintiffs need to supplement the record in order to
demonstrate this connection. They do not. On the existing record, they are free to assert in
future briefing, for instance, that TTB never offered them a chance to respond. Should the
Government argue that such response would not change the outcome, Bellion is similarly free to
outline the contours of the evidence they would have presented. For this, they also need not
supplement the record. Plaintiffs thus do not explain, nor does the Court discern any reason,
why admitting the declarations now would help them in making their case for Counts II and IV.
Said otherwise, admitting the extra-record evidence does not advance the ball for Plaintiffs
beyond their current position. On the briefing before it, the Court thus concludes that Bellion
cannot bootstrap in evidence attacking the substance of the agency’s decision merely by
asserting that they would have submitted this evidence had the procedures been as they desired.
This is not to say, however, that Bellion is without remedy. If Plaintiffs believe that the
administrative record is too incomplete to give them a fair shake, their request should be directed
to the agency to consider the evidence in the first instance, not this Court. See CTS Corp., 759
F.3d at 65 (noting similarly). The Government posits, and this Court has no reason to doubt, that
Bellion could submit a motion for reconsideration of the agency’s decision or file a new petition
in which they incorporate their additional evidence. See Def. Opp. at 15. Similarly, Bellion
17 remains free to criticize the merits of TTB’s decision. It must do so, however, without resort to
extra-record evidence.
IV. Conclusion
For these reasons, the Court will deny Plaintiffs’ Motion to File Extra-Record Evidence.
A separate Order so stating will issue this day.
/s/ James E. Boasberg JAMES E. BOASBERG United States District Judge Date: September 27, 2018