United States District Court, District of Columbia
E. BOASBERG, UNITED STATES DISTRICT JUDGE.
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 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 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).
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.
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 (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.
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.
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.
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
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.
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. 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.
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. MS, 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
Plaintiffs' claims arising under the APA and the
Constitution implicate distinct considerations, the ...