Bellion Spirits, LLC v. United States ( 2021 )

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued September 11, 2020 Decided August 6, 2021
No. 19-5252
BELLION SPIRITS, LLC AND CHIGURUPATI TECHNOLOGIES
PRIVATE LTD.,
APPELLANTS
v.
UNITED STATES OF AMERICA, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:17-cv-02538)
Jonathan W. Emord argued the cause for appellants. With
him on the briefs was Peter A. Arhangelsky.
Leif Overvold, Attorney, U.S. Department of Justice,
argued the cause for appellees. With him on the brief were
Joseph H. Hunt, Assistant Attorney General, and Daniel Tenny,
Attorney.
Before: SRINIVASAN, Chief Judge, KATSAS, Circuit Judge,
and GINSBURG, Senior Circuit Judge.
Opinion for the Court filed by Chief Judge SRINIVASAN.
2
SRINIVASAN, Chief Judge: Bellion Spirits, LLC produces
and distributes vodka. Bellion infuses its vodka with NTX, a
proprietary blend that Bellion contends mitigates alcohol’s
damage to a person’s DNA.
In 2016, Bellion filed a petition with the Alcohol and
Tobacco Tax and Trade Bureau (TTB), the agency that
regulates alcoholic beverage labeling and advertising. The
petition sought to determine whether Bellion could lawfully
make certain claims on labels and in advertisements about the
alleged health benefits of NTX. TTB denied the petition on the
grounds that the claims were scientifically unsubstantiated and
misleading. TTB thus concluded that including the claims on
vodka labels and in advertisements would violate the Federal
Alcohol Administration Act and TTB’s regulations.
Bellion then brought this suit in the district court. Bellion
contends, among other things, that TTB’s denial of the petition
violates Bellion’s First Amendment rights and that the
standards under which TTB rejected the proposed claims about
NTX are unconstitutionally vague. The district court granted
TTB’s motion for summary judgment. Because we agree with
the district court that Bellion’s various challenges lack merit,
we affirm.
I.
A.
The Federal Alcohol Administration Act regulates the
production, sale, labeling, and advertising of alcoholic
beverages. See 27 U.S.C. §§ 201–219a. The Act requires
product labels and advertisements for alcoholic beverages to
comply with regulations issued by the Secretary of the
Treasury. Id. § 205(e), (f). And the Act calls for those
3
regulations to prevent “deception of the consumer” and to
“prohibit, irrespective of falsity, such statements relating to
age, manufacturing processes, analyses, guarantees, and
scientific or irrelevant matters as the Secretary of the Treasury
finds to be likely to mislead the consumer.” Id. The
regulations also must “prohibit statements” in labeling or
advertising that are “false, misleading, obscene, or indecent.”
Id. The Secretary of the Treasury has delegated responsibility
for issuing those regulations to the Administrator of TTB. U.S.
Dep’t of Treasury, Treasury Order 120-01 (Dec. 10, 2013),
https://home.treasury.gov/about/general-information/orders-
and-directives/treasury-order-120-01.
TTB’s regulations addressing alcoholic beverage labels
and advertisements prohibit statements that are “false or untrue
in any particular, or that, irrespective of falsity, directly, or by
ambiguity, omission, or inference, or by the addition of
irrelevant, scientific or technical matter, tend[] to create a
misleading impression.” 27 C.F.R. § 5.42(a)(1); see id.§ 5.65(a)(1). The regulations also specifically address claims
made on labels and in advertisements about the relationship
between alcohol consumption and human health. Those
regulations address two categories of claims about alcohol’s
effects on health.
First, the broader category of “[h]ealth-related statements”
encompasses “any statement related to health,” including
“statements of a curative or therapeutic nature that, expressly
or by implication, suggest a relationship between the
consumption of alcohol, distilled spirits, or any substance
found within the distilled spirits, and health benefits or effects
on health.” Id. § 5.65(d)(1)(i). TTB’s regulations pertaining
to health-related statements state that an alcoholic-beverage
label or advertisement “may not contain any health-related
statement that is untrue in any particular or tends to create a
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misleading impression as to the effects on health of alcohol
consumption.” Id. §§ 5.42(b)(8)(ii)(A); 5.65(d)(2)(i). TTB
evaluates health-related statements “on a case-by-case basis,”
and the agency may require “a disclaimer or some other
qualifying statement to dispel any misleading impression”
created by health-related statements. Id. § 5.65(d)(2)(i).
TTB describes the second, narrower type of claims about
alcohol and human health as “specific health claims.” Id.
§ 5.65(d)(1)(ii). A specific health claim is “a type of health-
related statement that, expressly or by implication,
characterizes the relationship of the distilled spirits, alcohol, or
any substance found within the distilled spirits, to a disease or
health-related condition.” Id. A specific health claim must
comply with the more general regulations applicable to health-
related statements. See id. In addition, a specific health claim
will be approved only if it is supported by scientific or medical
evidence, contains appropriate qualifiers, and discloses
relevant health risks. See id. §§ 5.42(b)(8)(ii)(B)(2);
5.65(d)(2)(ii). If a specific health claim is accompanied by a
qualifier or disclaimer, that information “must appear as part of
the specific health claim.” Id.
B.
TTB provides an avenue for regulated entities to seek
advisory rulings on matters relating to the Act and its
implementing regulations. “Any person who is in doubt as to
any matter arising in connection with the [Act] may request a
ruling thereon by addressing a letter to the appropriate TTB
officer.” Id. § 70.471(a). There is no requirement for a
regulated entity to seek such a ruling before including a health-
related statement or a specific health claim in advertisements.
See 27 U.S.C. § 205(e), (f).
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While regulated entities thus need no preapproval to make
health-related statements or specific health claims in
advertisements, they generally do need preapproval to make
such statements or claims on labels. In particular, before
bottlers and importers introduce alcoholic beverages into
interstate or foreign commerce, they generally must obtain a
certificate of label approval (COLA) from TTB. Id. § 205(e).
As part of that process, TTB reviews statements made on an
alcoholic-beverage label—including health-related statements
and specific health statements—to determine whether the
proposed label “complies with applicable laws and
regulations.” 27 C.F.R. § 13.21(a). TTB has 90 days after
receiving a COLA application to “notify the applicant whether
the application has been approved or denied,” unless TTB
extends that period by 90 days under “unusual circumstances.”
Id. § 13.21(b). When TTB denies a COLA application, it must
issue a notice setting forth the reasons for the denial. Id.
§ 13.23. The applicant may then submit a new amended
application or file up to two administrative appeals. See id.
§§ 13.25, 13.27.
Although TTB has primary responsibility for regulating
the labeling and advertising of alcoholic beverages, the Food
and Drug Administration (FDA) also plays a role. For instance,
the rulemaking that led to the regulations concerning health-
related statements noted that TTB’s predecessor agency had
“always utilized, as TTB does now, the scientific and public
health expertise of FDA in approving ingredients in alcohol
beverages, requiring label disclosure of certain substances, and
identifying adulterated alcohol beverages that are deemed
mislabeled.” Health Claims and Other Health-Related
Statements in the Labeling and Advertising of Alcohol
Beverages, 68 Fed. Reg. 10,076, 10,078 (Mar. 3, 2003).
Consistent with that recognition, TTB’s regulations addressing
specific health claims state that “TTB will consult with [FDA],
6
as needed, on the use of a specific health claim on a distilled
spirits label.” 27 C.F.R. § 5.42(b)(8)(ii)(B)(1).
C.
In April 2016, Bellion Spirits, LLC, and Chigurupati
Technologies Private Ltd. filed a petition with TTB. Bellion
Spirits is the producer and distributor of Bellion brand vodka.
Chigurupati Technologies is a research and development
institution that developed a proprietary blend of ingredients
known as NTX, which Bellion includes in its vodka. Bellion’s
petition inquired about whether it could lawfully make certain
statements about the health benefits of NTX on its vodka labels
and in its advertising.
The petition asked TTB to review eight proposed
statements, two of which are in issue here. Those two proposed
statements are: (i) “NTX helps protect DNA from alcohol-
induced damage,” and (ii) “NTX reduces alcohol-induced
DNA damage.” Bellion Petition for Health Claims, J.A. 426.
Bellion also submitted a proposed disclaimer that would
accompany those claims. The disclaimer states:
NTX does not protect against all health risks associated
with moderate and heavy levels of alcohol consumption,
including, but not limited to, motor vehicle accidents, high
blood pressure, stroke, cancer, birth defects, psychological
problems, and alcohol dependency. Do not consume
alcohol if: you are younger than the legal drinking age;
you are pregnant or may become pregnant; you are taking
medicine that can interact with alcohol; you have a
medical condition for which alcohol is contraindicated;
you plan to drive; or you cannot restrict your drinking to
moderate levels. If you consume alcohol, only consume it
7
in moderation. “Moderation” means up to one drink per
day for women and up to two drinks per day for men.
Id. at 427.
Bellion did not file a COLA application. And its petition
stated that “[p]etitioners are not requesting the use of specific
health-related statements on a specific label.” Id. at 433.
Rather than make use of the preapproval process for labels,
Bellion sought advisory guidance from TTB under 27 C.F.R.
§ 70.471(a) about whether its claims would comply with the
Act and the agency’s regulations. Shortly after Bellion filed its
petition, Frank-Lin Distillers Products, Ltd.—a separate entity
that is not a party to this litigation—submitted nine COLA
applications for Bellion vodka labels that also included the
specific health claims listed in Bellion’s petition.
TTB acknowledged receipt of Bellion’s petition in May
2016. The agency stated that, consistent with its regulations, it
had forwarded the petition and accompanying exhibits to FDA.
After corresponding with TTB, Bellion supplemented its
petition. In total, Bellion submitted 112 scientific articles or
studies in support of its petition.
In May 2017, TTB denied Bellion’s petition in a 47-page
ruling letter. The agency explained that the proposed
statements about NTX’s effects on DNA are both “health-
related statements” and “specific health claims.” TTB found
that the claims failed to comply with the regulations governing
either category. TTB concluded that the claims, even with the
proposed disclaimer, “would violate the [Act] and its
implementing regulations by making specific health claims that
are not adequately substantiated, and by misleading consumers
as to the serious health consequences of both moderate and
8
heavy levels of consumption of alcohol beverages containing
NTX.” TTB Ruling Letter at 2, J.A. 1056.
TTB further explained that it had “consulted with FDA”
and “drawn on that agency’s substantial expertise in assessing
scientific studies.” Id. at 1070. Based on its review of FDA’s
analysis of the materials submitted by Bellion, TTB concluded
that “there is no credible evidence to support these proposed
claims.” Id. at 1089. TTB also stated that “the proposed
disclaimer does not characterize the level of evidence to
support the claims, and it reinforces the most misleading
aspects of the claims.” Id. at 1097. And TTB explained that it
had “considered but rejected use of a different disclaimer to
accompany the proposed claims,” because any disclaimer
would need to “effectively characterize[] the claim as
baseless.” Id.Bellion then filed suit in the district court. Bellion
challenged TTB’s ruling letter on a number of grounds,
bringing both statutory and constitutional claims. Bellion later
moved to add evidence outside the administrative record,
including testimony from expert witnesses that was not before
TTB when it made its decision. The court denied that motion.
Bellion Spirits, LLC v. United States, 335 F. Supp. 3d 32, 36
(D.D.C. 2018).
The parties both moved for summary judgment, and the
court granted the government’s motion. Bellion Spirits, LLC v.
United States, 393 F. Supp. 3d 5, 9 (D.D.C. 2019). With regard
to Bellion’s statutory challenge, the court concluded that TTB
permissibly consulted with FDA. Id. at 17. The court then
determined that TTB’s ruling letter did not impermissibly
proscribe commercial speech under the First Amendment. Id.
at 24. The court next held that TTB’s regulations did not
impose an unconstitutional prior restraint. Id. at 32. Last, the
9
court concluded that TTB’s regulations were not
unconstitutionally vague. Id. at 34.
II.
Before addressing the merits of Bellion’s challenges, we
consider as a threshold matter whether the dispute is ripe for
our review, and, relatedly, whether TTB’s ruling letter
constituted final agency action. Under the Administrative
Procedure Act (APA), an agency’s challenged decision is
subject to judicial review if it constitutes final agency action.
5 U.S.C. § 704. While TTB has not argued that its ruling letter
fails to qualify as final agency action, satisfaction of that
requirement is a prerequisite to ripeness in an APA case: “a
dispute is not ripe if it is not fit, and (at least in an APA case)
it is not fit if it does not involve final agency action.” Holistic
Candlers & Consumers Ass’n v. FDA, 664 F.3d 940, 943 n.4
(D.C. Cir. 2012) (citations omitted). We take up the question
of ripeness on our “own motion,” Nat’l Park Hosp. Ass’n v.
Dep’t of Interior, 538 U.S. 803, 808 (2003), which, in the
context of this case, necessarily requires us to examine whether
the ruling letter amounted to final agency action.
Agency action is final “if two independent conditions are
met: (1) the action mark[s] the consummation of the agency’s
decisionmaking process and is not of a merely tentative or
interlocutory nature; and (2) it is an action by which rights or
obligations have been determined, or from which legal
consequences will flow.” Soundboard Ass’n v. FTC, 888 F.3d
1261, 1267 (D.C. Cir. 2018) (internal quotation marks
omitted). TTB’s ruling letter satisfies both conditions.
First, the ruling letter marks the consummation of TTB’s
decisionmaking process with respect to Bellion’s petition. The
letter puts forth the agency’s official position about how the
10
Act and its regulations apply to the facts described in the
petition. The letter was not “informal, or only the ruling of a
subordinate official, or tentative.” Abbott Labs. v. Gardner,
387 U.S. 136, 151 (1967) (citations omitted). In addition, the
letter did not provide any other “avenue for [Bellion] to
affirmatively seek relief” through additional procedures. See
Ipsen Biopharmaceuticals, Inc. v. Azar, 943 F.3d 953, 958
(D.C. Cir. 2019). Regardless of whether Bellion could submit
a COLA application or additional petitions for review, the
ruling letter concluded the agency’s decisionmaking process
with regard to the petition Bellion filed.
Second, the ruling letter is an agency action from which
legal consequences will flow. It is true that the ruling letter is
an advisory guidance and does not itself expose Bellion to
additional civil or criminal liability above what it would
already face for violating the Act or TTB’s regulations. But
legal consequences nonetheless attach to the letter because it
has the effect of extinguishing any willfulness defense Bellion
otherwise might assert in an administrative proceeding
involving its basic permit.
Under the Act, the Secretary of the Treasury must suspend
or revoke an alcoholic beverage distributor’s basic permit for
violating the permit’s conditions. 27 U.S.C. § 204(d), (e).
Those conditions include compliance with the Act’s labeling
and advertising requirements. See id. § 204(d). But the
Secretary can suspend or revoke a permit only upon finding
“that the permittee has wilfully violated any of the conditions
thereof.” Id. § 204(e) (emphasis added). When, as here, a
ruling letter concludes that the regulated entity’s proposed
statements would contravene the governing regulations, TTB
could use that letter as evidence of willfulness to suspend a
basic permit. TTB’s ruling letter thus had a concrete legal
effect on Bellion’s ability to make the challenged statements
11
without jeopardizing its basic permit. See Ipsen, 943 F.3d at
957 (letter expressing agency’s position was final because it
“refute[d] any colorable argument [the plaintiff] might have in
an enforcement action that it was acting without knowledge of
[the agency’s] position”); accord Rhea Lana, Inc. v. Dep’t of
Labor, 824 F.3d 1023, 1028–30 (D.C. Cir. 2016); Unity08 v.
FEC, 596 F.3d 861, 865 (D.C. Cir. 2010).
Having concluded that the ruling letter constituted final
agency action, we also hold that the dispute is ripe. The
ripeness inquiry encompasses “both the fitness of the issues for
judicial decision and the hardship to the parties of withholding
court consideration.” Marcum v. Salazar, 694 F.3d 123, 129
(D.C. Cir. 2012) (quoting Abbott Labs., 387 U.S. at 149).
Bellion’s challenges are fit for judicial decision because they
involve final agency action and because “judicial intervention”
would not “inappropriately interfere with further
administrative action.” Ohio Forestry Ass’n, Inc. v. Sierra
Club, 523 U.S. 726, 733 (1998). As for hardship to the parties,
if we were to withhold review, then Bellion could obtain
judicial review of TTB’s position only by flouting the ruling
letter and publishing the statements, thereby risking the
imposition of civil and potentially criminal penalties. See 27
U.S.C. § 207. The ripeness requirement does not require
parties to subject themselves to that kind of jeopardy. See
Unity08, 596 F.3d at 866.
III.
Proceeding to the merits of Bellion’s challenges, we first
address Bellion’s non-constitutional arguments before turning
to its constitutional claims. See POM Wonderful, LLC v. FTC,
777 F.3d 478, 490 (D.C. Cir. 2015).
12
A.
Bellion first contends that the district court abused its
discretion by declining to supplement the administrative record
with additional evidence. We disagree.
It is “black-letter administrative law that in an APA case,
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. FDA, 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)). “We do not allow parties to
supplement the record ‘unless they can demonstrate unusual
circumstances justifying a departure from this general rule.’”
Am. Wildlands v. Kempthorne, 530 F.3d 991, 1002 (D.C. Cir.
2008) (quoting Tex. Rural Legal Aid, Inc. v. Legal Servs. Corp.,
940 F.2d 685, 698 (D.C. Cir. 1991)).
Bellion challenges administrative action in the form of
TTB’s ruling letter. And Bellion identifies no circumstances
that would warrant departing from the ordinary rule against
admitting evidence not before the agency when it made its
challenged decision. For instance, there is no reason to think
that TTB deliberately excluded evidence from the record. See
City of Dania Beach v. FAA, 628 F.3d 581, 590 (D.C. Cir.
2010). Rather, Bellion simply did not submit the additional
evidence to TTB and then sought to have the district court
consider it in the first instance. The district court appropriately
exercised its discretion in declining to supplement the
administrative record. See Bellion Spirits, LLC, 335 F. Supp.
3d at 45.
13
B.
Bellion next argues that TTB improperly delegated its
statutory authority to FDA. We again disagree.
The Federal Alcohol Administration Act does not preclude
TTB from involving FDA in TTB’s evaluation of scientific
evidence. To the contrary, the Act empowers the Secretary of
the Treasury to “utilize the services of any department or other
agency of the Government to the extent necessary to carry out
his powers and duties under this chapter.” 27 U.S.C. § 202(f).
And TTB’s regulations expressly authorize TTB to “consult
with [FDA], as needed, on the use of a specific health claim on
a distilled spirits label.” 27 C.F.R. § 5.42(b)(8)(ii)(B)(1).
TTB acted in accordance with that scheme. TTB
explained in the ruling letter that it “consulted with FDA and
[drew] on that agency’s substantial expertise in assessing
scientific studies” to determine whether the petition satisfied
TTB’s requirements for specific health claims. TTB Ruling
Letter at 16, J.A. 1070. But “FDA did not recommend any
decision with regard to the ultimate issue of whether to approve
the eight claims in the petition.” Id. at 1077. Based on its
examination of FDA’s analysis, TTB “determined that none of
the eight claims is supported by credible scientific or medical
evidence” and that the claims thus did not satisfy TTB’s
standards for specific health claims or health-related
statements. Id. at 1070.
TTB did not rubberstamp FDA’s analysis of the scientific
evidence or delegate final decisionmaking authority to FDA.
Rather, TTB systematically evaluated and explained its reasons
for agreeing with FDA’s analysis of each scientific study. TTB
then made its own determinations about whether the proposed
claims complied with its standards for health-related
14
statements and specific health claims. In short, TTB consulted
with FDA on a matter implicating FDA’s expertise and then
considered that expertise in reaching its own final decision.
IV.
We next turn to Bellion’s constitutional arguments.
Bellion challenges TTB’s ruling letter on both First
Amendment grounds and Fifth Amendment vagueness
grounds. We reject those challenges.
A.
Bellion first contends that TTB’s position on the proposed
claims about NTX is inconsistent with the First Amendment.
We conclude that Bellion’s claims are unprotected by the First
Amendment because they constitute inherently misleading
commercial speech.
Bellion seeks to include its proposed claims about the
alleged health benefits of NTX on vodka labels and in vodka
advertisements. The speech at issue, then, amounts to
commercial speech. See Rubin v. Coors Brewing Co., 514 U.S.
476, 481 (1995) (“Both parties agree that the information on
beer labels constitutes commercial speech.”).
“For commercial speech to come within [the First
Amendment], it at least must concern lawful activity and not
be misleading.” Cent. Hudson Gas & Elec. Corp. v. Pub. Serv.
Comm’n of N.Y., 447 U.S. 557, 566 (1980). Consequently,
“[m]isleading advertising may be prohibited entirely.” In re
R.M.J., 455 U.S. 191, 203 (1982).
In its ruling letter, TTB found that Bellion’s proposed
statements about NTX may be barred consistent with the First
15
Amendment because they are inherently misleading. The
parties debate the standard of review under which we should
examine that determination. TTB, relying on our decision in
POM Wonderful, 777 F.3d at 499, contends that we should
apply deferential, substantial-evidence review to the agency’s
determination that the proposed speech is misleading. Bellion
submits that we must apply de-novo review to TTB’s
conclusion that the proposed speech is misleading. See Peel v.
Att’y Registration & Disciplinary Comm’n of Ill., 496 U.S. 91,
108 (1990) (plurality opinion).
We need not resolve whether de-novo review or
substantial-evidence review applies in the circumstances of this
case. Even assuming that de-novo review governs, and
applying that standard, we agree with TTB that Bellion’s
proposed claims are misleading and thus can be proscribed
consistent with the First Amendment.
Consider the scientific studies Bellion submitted to TTB.
In total, Bellion submitted 112 scientific articles or studies in
support of its petition. Aided by FDA’s analysis, TTB
systematically considered and assessed the probative value of
those materials. And based on its review, TTB concluded that
the studies provided no credible evidence supporting the
proposed claims.
Our independent review yields a similar assessment of the
evidence. Of the 112 articles or studies, we see no basis to
disagree with TTB’s conclusion that 106 of them do “not allow
scientific conclusions to be drawn about the claims.” TTB
Ruling Letter at 30, J.A. 1084. For example, many of the
studies were conducted only on animals or in vitro, while
others included only one component of NTX rather than the
full compound. Additionally, some of the submitted materials
were written in foreign languages or were simply book chapters
16
or review articles that discussed a number of studies at a high
level of generality. Like TTB, we are “unable to evaluate data
provided in articles published in a foreign language unless an
accurate and complete English translation is provided.” Id. at
1081. And we agree with TTB that the book chapters and
review articles do not provide sufficient information about
individual studies to evaluate Bellion’s claims.
Nonetheless, out of an abundance of caution, TTB asked
FDA to review studies that included only a single ingredient of
NTX and were not otherwise excluded for one of the above
reasons. But FDA and TTB still correctly determined that
“scientific conclusions cannot be drawn” from those studies
because they did not address how NTX interacts with alcohol.
Id. at 1082.
With regard to the six remaining articles or studies
submitted by Bellion, we agree with TTB’s conclusion that
Bellion’s proposed claims “are not adequately substantiated by
the evidence presented” because the materials “do not provide
credible evidence to support” the claims. Id. at 1095–96. For
example, one of the studies (referred to as the first Pandit study)
“did not include information on the study, such as study
subjects (e.g., health status) and study design (e.g., provision
of the control and test (NTX Products), dose of NTX provided,
appropriateness of control group).” Id. at 1084. Two of the
studies were merely “the findings of the same study with one
being a published version of the other.” Id. at 1085. And
neither that study nor the three remaining studies provided
credible support for Bellion’s proposed claims. For instance,
none of those four studies “includes information about the
dosage of NTX consumed by the study subjects.” Id. at 1086.
We concur with TTB’s assessment that studies lacking dosage
information cannot support valid scientific conclusions.
17
Despite the facially evident shortcomings of those four
studies, TTB analyzed their findings in greater depth. Our
review confirms that the studies provide no credible evidence
supporting Bellion’s proposed claims. For example, one of the
studies “show[ed] no effect on protecting DNA.” Id. at 1094.
And the study that came the closest to providing a modicum of
support for Bellion’s claims was the second Pandit study,
which provided, at best, “weak evidence tangentially related
to” to Bellion’s DNA protection claims. Id. at 1092. The study
showed a “reduction in certain measures of DNA damage at
some but not all time points after administration of NTX.” Id.
at 1094. Meanwhile, none of the four studies purported to
assess the long-term effects of NTX on DNA. For those
reasons—and because the studies, as noted, lack information
about the dosages of NTX administered—we agree with TTB
that the studies do not permit “valid scientific conclusions
regarding the health effects of consumption of alcohol
beverages containing NTX in the quantities in which such an
ingredient would be allowed in alcohol beverages.” Id. at
1086.
In light of the absence of scientific support for Bellion’s
proposed claims concerning NTX’s effect on DNA, we
conclude that the claims are inherently misleading.
Specifically, Bellion’s claims that “NTX helps protect DNA
from alcohol-induced damage” and that “NTX reduces
alcohol-induced DNA damage,” Bellion Petition for Health
Claims, J.A. 426, are misleading because none of the studies
reliably support those assertions.
Our precedents confirm that commercial speech lacking
any reliable support is properly characterized as misleading and
thus may be proscribed consistent with the First Amendment.
In Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999), we
explained that, “where evidence in support of a claim is
18
outweighed by evidence against the claim, the FDA could
deem it incurable by a disclaimer and ban it outright.”
Similarly, there would be “no problem with the FDA imposing
an outright ban on a claim where evidence in support of the
claim is qualitatively weaker than evidence against the claim—
for example, where the claim rests on only one or two old
studies.” Id. at 659 n.10. And in POM Wonderful, we
described claims as “misleading speech unprotected by the
First Amendment” because they had “insufficient support.”
777 F.3d at 500.
The same is true here. At best, one study provided “weak
evidence tangentially related” to the proposed claims. TTB
Ruling Letter at 38, J.A. 1092. And the remaining studies
either provided no evidence about the proposed claims or
tended to undercut them. In those circumstances, the proposed
claims are misleading because they are not backed by credible
scientific findings.
B.
Bellion next contends that TTB subjected it to an
unconstitutional prior restraint on speech. We have previously
left open whether the prior-restraint doctrine applies in the
context of commercial speech, see Pearson, 164 F.3d at 660 &
n.11, and we do so again here. Even assuming the applicability
of prior-restraint principles, Bellion fails to demonstrate an
unconstitutional prior restraint.
Under the Act, regulated entities do not need TTB’s
preapproval to make health claims in alcohol-related
advertising. See 27 U.S.C § 205(f). Insofar as Bellion wishes
to make its health claims in advertisements, then, there is no
prior restraint limiting its ability to do so. Preapproval is
required only when entities seek to put health claims on
19
alcoholic beverage labels. See id. § 205(e). That preapproval,
as explained, is obtained through a COLA, and TTB
regulations spell out the procedural requirements for applying
for a COLA. See 27 C.F.R. § 5.55. For its part, Bellion did not
make use of the procedures for obtaining a COLA, and instead
opted to pursue non-mandatory, advisory guidance under 27
C.F.R. § 70.471(a). In fact, Bellion’s petition to TTB expressly
disavowed that it was seeking authorization for the “use of
specific health-related statements on a specific label.” Bellion
Petition for Health Claims, J.A. 433.
Notwithstanding Bellion’s disavowal of the COLA
process, we assume Bellion can bring a facial challenge to the
COLA scheme on the basis that it vests undue discretion in the
licensor. See City of Lakewood v. Plain Dealer Publ’g Co.,
486 U.S. 750, 755 (1988). That challenge fails.
By imposing sufficiently “narrow, objective, and definite
standards,” Shuttlesworth v. City of Birmingham, 394 U.S. 147,
151 (1969), the COLA scheme adequately channels TTB’s
discretion. The COLA regulation provides that TTB “will
approve” specific health claims “only if the claim is truthful
and adequately substantiated by scientific or medical evidence;
sufficiently detailed and qualified with respect to the categories
of individuals to whom the claim applies; adequately discloses
the health risks associated with both moderate and heavier
levels of alcohol consumption; and outlines the categories of
individuals for whom any levels of alcohol consumption may
cause health risks.” See 27 C.F.R. § 5.42(b)(8)(ii)(B)(2).
Those conditions of approval are “sufficiently definite to
constrain [TTB] within reasonable bounds.” See Nutritional
Health Alliance v. Shalala, 144 F.3d 220, 228 (2d Cir. 1998).
In addition, the COLA process, contrary to Bellion’s
contention, channels TTB’s decisionmaking through
20
adequately strict deadlines. See Freedman v. Maryland, 380
U.S. 51, 58 (1965). The regulation states that TTB must
respond to an application within 90 days, unless it elects to use
one 90-day extension. See 27 C.F.R. § 13.21(b). Indeed,
applicants who do not receive a decision from TTB within the
specified time period may file an administrative appeal. Id.We find no “unbridled” discretion in that scheme. See City of
Lakewood, 486 U.S. at 757.
We note that, before the district court, Bellion contended
that the COLA process unduly restricts the kinds of evidence
that can be submitted in support of an application. See Bellion
Spirits, LLC, 393 F. Supp. 3d at 31. But Bellion has forfeited
any such argument in our court by suggesting it only in its reply
brief (and even then, only in passing). See Am. Wildlands, 530
F.3d at 1001.
C.
Finally, Bellion contends that TTB’s regulations
addressing specific health claims are unconstitutionally vague
in violation of the Fifth Amendment’s guarantee of due
process. That challenge is similarly without merit.
As noted, the primary regulations at issue state that a
specific health claim will be approved only if it is, among other
things, “truthful and adequately substantiated by scientific or
medical evidence” and “sufficiently detailed and qualified with
respect to the categories of individuals to whom the claim
applies.” 27 C.F.R. §§ 5.42(b)(8)(ii)(B)(2); 5.65(d)(2)(ii).
Because Bellion received a clear response from TTB about
why its proposed claims were denied, Bellion cannot—and
does not purport to—bring an as-applied vagueness challenge
to the regulation. And Bellion’s facial challenge to the
regulation is without merit.
21
“[A] regulation is not impermissibly vague because it is
‘marked by flexibility and reasonable breadth, rather than
meticulous specificity.’” U.S. Telecom Ass’n v. FCC, 825 F.3d
674, 737 (D.C. Cir. 2016) (quoting Grayned v. City of
Rockford, 408 U.S. 104, 110 (1972)). Instead, regulations
withstand a vagueness challenge as long as a “reasonably
prudent person, familiar with the conditions the regulations are
meant to address and the objectives the regulations are meant
to achieve, would have fair warning of what the regulations
require.” Freeman United Coal Mining Co. v. Fed. Mine
Safety & Health Review Comm’n, 108 F.3d 358, 362 (D.C. Cir.
1997). TTB’s regulation satisfies that standard by giving
regulated entities sufficient notice of what kind of evidence
they must present to obtain approval of specific health claims.
Moreover, vagueness concerns are mitigated when
regulated entities “have the ability to clarify the meaning of the
regulation by [their] own inquiry, or by resort to an
administrative process.” Village of Hoffman Estates v.
Flipside, Hoffman Estates, Inc., 455 U.S. 489, 498 (1982).
TTB permits regulated entities to ask for a ruling about whether
statements made on labels would violate its regulations. See
27 C.F.R. § 70.471. Bellion, as noted, made use of that option
here. TTB’s regulations thus provide “[t]he opportunity to
obtain prospective guidance,” which allays “any remaining
concerns about [the regulation’s] allegedly unconstitutional
vagueness.” U.S. Telecom Ass’n, 825 F.3d at 738–39.
* * * * *
For the foregoing reasons, we affirm the district court’s
grant of summary judgment in favor of TTB.
So ordered.