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/ordersand-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 
4

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 healthrelated 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 healthrelated 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 healthrelated statement or a specific health claim in advertisements. 

See 27 U.S.C. § 205(e), (f).
5

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 healthrelated 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 alcoholinduced 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 “healthrelated 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.