The opinion
FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
MICHELLE PRZYBOCKI; KETAN No. 24-7174
VAKIL; GOURMEND FOODS,
D.C. No.
LLC,
2:23-cv-00455-
ART-DJA
Plaintiffs - Appellants,
v. OPINION
UNITED STATES DEPARTMENT
OF AGRICULTURE; BROOKE L.
ROLLINS; UNITED STATES
DEPARTMENT OF
AGRICULTURE FOOD SAFETY
AND INSPECTION SERVICE;
TREY FORSYTH; UNITED
STATES FOOD AND DRUG
ADMINISTRATION; KYLE
DIAMANTAS, Acting
Commissioner, U.S. Food and Drug
Administration,
Defendants - Appellees.
As required by Federal Rule of Appellate Procedure 43(c)(2), Brooke
L. Rollins, Trey Forsyth, and Kyle Diamantas are automatically
substituted for Thomas J. Vilsack, Sandra Eskin, and Robert Califf,
respectively.
2 PRZYBOCKI V. USDA
Appeal from the United States District Court
for the District of Nevada
Anne R. Traum, District Judge, Presiding
Argued and Submitted November 14, 2025
San Francisco, California
Filed August 3, 2026
Before: Michelle T. Friedland and Jennifer Sung, Circuit
Judges, and P. Casey Pitts, District Judge.**
Opinion by Judge P. Casey Pitts
SUMMARY***
Standing / First Amendment
In an action brought by Michelle Przybocki, Ketan Vakil
and his food company, Gourmend LLC, challenging United
States Department of Agriculture and Food and Drug
Administration statutes and regulations governing the
inclusion of information regarding sugars known as
“FODMAPs” on product labels, the panel (1) reversed the
district court’s dismissal for lack of standing of plaintiffs’
The Honorable P. Casey Pitts, United States District Judge for the
Northern District of California, sitting by designation.
***
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
PRZYBOCKI V. USDA 3
claims against the FDA and Przybocki’s claims against the
USDA; and (2) in a separate memorandum disposition,
affirmed the district court’s dismissal for failure to exhaust
administrative remedies of Vakil and Gourmend’s claims
against the USDA.
Przybocki, who struggles to digest FODMAPs and wants
FODMAP levels to be included on food labels, and Vakil,
who wishes to sell foods that include FODMAP levels on
their labels through his company Gourmend, alleged that
federal law prohibiting food companies from including
FODMAP information on product labels violates their First
Amendment rights to speak and to receive information.
The panel held that Przybocki adequately pleaded
standing to sue as a listener based on her needs as a consumer
of low-FODMAP foods and her allegation that food
producers, including but not limited to Gourmend, would be
reasonably likely to include FODMAP-related information
on food labels in the absence of the challenged FDA and
USDA regulations.
The panel also held that Vakil and Gourmend
sufficiently pleaded Article III standing as speakers to
pursue a pre-enforcement challenge against the FDA based
on the government’s threatened enforcement of the
applicable food-labeling laws.
In a separate memorandum disposition, the panel
affirmed the district court’s dismissal of Vakil and
Gourmend’s claims against the USDA for failure to exhaust
available administrative remedies.
4 PRZYBOCKI V. USDA
COUNSEL
Justin M. Pearson (argued), Institute for Justice, Miami,
Florida; Paul M. Sherman and Elizabeth L. Sanz, Institute
for Justice, Arlington, Virginia; Joel Z. Schwarz and
Matthew T. Dushoff, Saltzman Mugan Dushoff, Las Vegas,
Nevada; for Plaintiffs-Appellants.
Laura E. Myron (argued) and Gerard Sinzdak, Attorneys,
Appellate Staff, Civil Division; Yaakov M. Roth, Acting
Assistant Attorney General; United States Department of
Justice, Washington, D.C.; Nicole Leibow, Assistant United
States Attorney; Sigal Chattah, United States Attorney;
Office of the United States Attorney, United States
Department of Justice, Las Vegas, Nevada; for Defendants-
Appellees.
OPINION
PITTS, District Judge:
Millions of people suffer from digestive issues,
including the inability to digest sugars called “FODMAPs.”1
Plaintiff Michelle Przybocki has this condition and wants
FODMAP levels to be included on the labels of the food she
buys so that she can avoid foods high in FODMAPs and
instead choose low-FODMAP foods. Plaintiff Ketan Vakil
also avoids FODMAPs on the advice of his doctor. Through
1
“FODMAPs” is an acronym for fermentable oligosaccharides,
disaccharides, monosaccharides, and polyols.
PRZYBOCKI V. USDA 5
his company, plaintiff Gourmend Foods, LLC, he wishes to
sell foods that include FODMAP levels on their labels.
According to the plaintiffs, federal law prohibits food
companies like Gourmend from including FODMAP
information on their products’ labels. Indeed, the United
States Department of Agriculture’s Food Safety and
Inspection Service (FSIS) rejected Gourmend’s proposed
beef broth label precisely because it included the broth’s
FODMAP levels. Soon thereafter, Przybocki, Vakil, and
Gourmend sued the Food and Drug Administration and the
USDA, alleging violations of their First Amendment rights
to speak and to receive information. The district court
dismissed the suit, concluding that the plaintiffs failed to
plead Article III standing and failed to exhaust their
administrative remedies.
We reverse in part. Przybocki adequately pleaded
standing to sue as a listener based on her needs as a consumer
of low-FODMAP foods and her allegation that food
producers, including but not limited to Gourmend, would be
reasonably likely to include FODMAP-related information
on food labels in the absence of the challenged FDA and
USDA regulations. Vakil and Gourmend also sufficiently
pleaded Article III standing to pursue claims against the
FDA based on the government’s threatened enforcement of
the applicable food-labeling laws. For the reasons set forth
in a separate memorandum disposition filed simultaneously
herewith, however, we affirm the district court’s dismissal
of Vakil and Gourmend’s claims against the USDA for
failure to exhaust available administrative remedies.
REGULATORY FRAMEWORK
Two different federal agencies, the FDA and the USDA
(with the assistance of its subagency the FSIS), administer
6 PRZYBOCKI V. USDA
and enforce federal food-labeling laws. Under the Food,
Drug, and Cosmetic Act, the FDA regulates false or
misleading statements on most nonmeat food labels. See 21
U.S.C. §§ 321, 343. The applicable statutes and regulations
mandate disclosures regarding certain nutrients, such as the
number of calories and the amount of protein and
carbohydrates. See 21 U.S.C. § 343(q); 21 C.F.R.
§§ 101.9(c), 101.13(b). For example, a food label must
disclose the “[t]otal fat, saturated fat, cholesterol, sodium,
total carbohydrates, complex carbohydrates, sugars, dietary
fiber, and total protein” in that food. 21 U.S.C.
§ 343(q)(1)(D). Federal regulations also permit companies
to make certain “nutrient content claims” on food labels. 21
C.F.R. § 101.13. A nutrient content claim describes the level
of a specific nutrient in a food, such as “low sodium.” Id. But
a food company may not make nutrient content claims other
than those specifically defined and permitted by statute or
FDA regulations. See id. § 101.13(b); 21 C.F.R. pt. 105
(establishing regulations for “special dietary use” foods
without including FODMAPs); 21 C.F.R. pt. 107
(establishing regulations for infant formula labels); 21
C.F.R. §§ 101.54–69 (establishing additional regulations for
“nutrient content claims”). The regulations define nutrient
content claims for various nutrients, including “fat,” “sugar”
and “cholesterol,” but they do not define nutrient content
claims for FODMAPs. 21 C.F.R. §§ 101.54–67. If an entity
wishes to make a nutrient content claim that is not already
defined by the regulations, the entity may petition the FDA
for approval of the new nutrient-content claim. Id. § 101.69.
The USDA, rather than the FDA, regulates the labeling
of certain other meat, poultry, and egg products. See 21
U.S.C. § 602; Formal Agreement Between USDA and FDA
Relative to Cooperation and Coordination, Food & Drug
PRZYBOCKI V. USDA 7
Admin. (Jan. 30, 2018),
https://www.fda.gov/food/international-interagency-
coordination/formal-agreement-between-usda-and-fda-
relative-cooperation-and-coordination
[https://perma.cc/RTN6-TKDY]. As with the FDA’s
regulatory regime, the statutes and regulations enforced by
the USDA require nutritional labeling. See, e.g., 9 C.F.R.
§ 317.300(a) (“Nutrition labeling must be provided for all
meat and meat food products intended for human
consumption and offered for sale ….”); see also id.
§ 317.309(c). Also like the FDA, the USDA regulates
additional nutrient-content claims, see id. § 317.313(a)–(b),
(e), and provides an application process for those seeking to
make new nutrient-content claims, id. § 317.369.
While product marketers do not need advance approval
for products whose labels are regulated by the FDA, a meat
or meat-product label subject to the USDA’s jurisdiction
cannot be used until the USDA, through the FSIS, has
granted it approval. See 21 U.S.C. § 607(e); 9 C.F.R.
§§ 412.1(a), 500.8. As a result, any proposed product label
making “nutrient content claims” and subject to the USDA’s
regulatory jurisdiction must receive affirmative approval
from USDA before it can be used. See 9 C.F.R.
§ 317.313(a)–(b). If the USDA rejects a labeling application,
the applicant has an “opportunity for a hearing,” and the
USDA’s decision is subject to judicial review. See 21 U.S.C.
§ 607(e); 9 C.F.R. § 500.8(c); 7 C.F.R. § 1.145(i).
FACTUAL AND PROCEDURAL BACKGROUND
Plaintiff Michelle Przybocki alleges that she is one of
tens of millions of people who struggle to digest FODMAPs.
Przybocki is a speech therapist in Las Vegas, Nevada, who
suffers from irritable bowel syndrome so severe that she
8 PRZYBOCKI V. USDA
reported “debilitating pain” every time she ate. Przybocki’s
doctor told her to follow a low-FODMAP diet to manage her
symptoms. To follow her doctor’s recommendation,
Przybocki wants information about FODMAP levels to be
displayed on the labels of the food she buys. Przybocki
believes, however, that many food companies do not list
information about FODMAP levels on their products out of
fear that doing so would violate federal food-labeling
regulations regarding nutrient content claims.
Plaintiff Ketan Vakil runs a food company, Gourmend
LLC, that produces low-FODMAP foods. Like Przybocki,
Vakil follows a low-FODMAP diet on the advice of his
doctor. Vakil founded Gourmend in 2018 to serve the
potentially millions of consumers who seek reliably low-
FODMAP foods.
Gourmend sells four low-FODMAP spice blends and
one low-FODMAP chicken broth. Vakil and Gourmend
have worked with Monash University in Australia to obtain
Monash’s low-FODMAP certification for the five offerings.
The labels for the five products state that the products are
low-FODMAP, are certified by Monash University as such,
and are “deliciously digestible” and “gut loving.” The parties
agree that all five products fall within the FDA’s regulatory
jurisdiction.
Gourmend has also developed a low-FODMAP beef
broth. Unlike Gourmend’s other products, that product’s
labeling is regulated by the USDA. Accordingly, in July
2022, Gourmend submitted a proposed beef broth label to
the USDA and the FSIS for approval. Though the FDA had
not previously raised concerns about Gourmend’s spice or
chicken broth labels, the FSIS told Gourmend that it had to
“remove all references to digestible, gut loving, and fodmap”
PRZYBOCKI V. USDA 9
from the label or its application would not be approved. FSIS
Deputy Director of Labeling and Program Delivery Jeffrey
Canavan told Gourmend that the USDA and the FSIS had
discussed Gourmend’s proposed label with the FDA, and
that the FDA agreed that the label’s FODMAP content claim
constituted an impermissible nutrient-content claim.
Gourmend then applied for approval of a label that did not
include “digestible,” “gut-loving,” “low FODMAP,” “safely
delicious,” “triggers,” or a heart. The FSIS approved the
revised label with two unrelated modifications.
After the FSIS instructed Gourmend to remove the
references to FODMAP levels from its beef broth label in
order to receive approval, Przybocki, Vakil, and Gourmend
sued the USDA, the FSIS, the FDA, and agency officials in
the U.S. District Court for the District of Nevada. They
alleged that the government’s actions violated Przybocki’s
First Amendment right to receive information and Vakil’s
and Gourmend’s First Amendment right to speak. The
plaintiffs sought a declaratory judgment that the USDA and
FDA statutes and regulations governing the use of FODMAP
claims on product labels violate the First Amendment as well
as injunctive relief prohibiting continued enforcement of
those statutes and regulations.
The district court dismissed the plaintiffs’ suit on two
grounds relevant here.
First, the court held that Vakil and Gourmend had failed
to plead an injury in fact arising from the FDA’s conduct
because they were selling FODMAP-labeled products and
10 PRZYBOCKI V. USDA
had not received “any warning letters or threats from the
FDA.”2
Second, the court held that Przybocki had not alleged an
injury in fact arising from the government’s restriction on
her right to receive information. The court concluded that
Przybocki failed to plead that there were other speakers
willing to convey FODMAP information who would do so
in the absence of the USDA and FDA regulations. And the
court concluded that Przybocki had not alleged an injury
arising from the chilling of Gourmend’s speech because the
plaintiffs had not alleged that Gourmend sells food in any
store Przybocki frequents, because Gourmend’s products
except its beef broth still carry the “low-FODMAP” labels,
and because Przybocki can find information about
Gourmend’s beef broth on its website.
The district court granted the government’s motion to
dismiss without prejudice and with leave to amend. After the
plaintiffs notified the district court that they would not be
filing an amended complaint, the court entered final
judgment. We have jurisdiction pursuant to 28 U.S.C.
§ 1291.
DISCUSSION
We address two issues in this opinion. We first consider
whether Przybocki adequately pleaded standing to challenge
the FDA and USDA regulations as a listener allegedly
denied access to speech regarding FODMAP levels. Second,
we consider whether Vakil and Gourmend adequately
2
The court dismissed Vakil and Gourmend’s claims against the USDA
for failure to exhaust available administrative remedies. We address that
issue in a separate memorandum disposition and do not address any legal
questions relating thereto in this opinion.
PRZYBOCKI V. USDA 11
pleaded standing as speakers sufficient to allow them to
pursue a pre-enforcement challenge against the FDA.3 We
address a third issue, related to lack of administrative
exhaustion of Vakil and Gourmend’s claims against the
USDA, in a memorandum disposition filed simultaneously
herewith.
We review de novo the issues of Article III standing,
ripeness, and administrative exhaustion. See Stockton v.
Brown, 152 F.4th 1124, 1135 (9th Cir. 2025); VHT, Inc. v.
Zillow Grp., Inc., 69 F.4th 983, 987 (9th Cir. 2023).
I. Przybocki’s Standing as a Listener
To establish Article III standing, a plaintiff must show
“(i) that she has suffered or likely will suffer an injury in fact,
(ii) that the injury likely was caused or will be caused by the
defendant, and (iii) that the injury likely would be redressed
by the requested judicial relief.” FDA v. All. for Hippocratic
Med., 602 U.S. 367, 380 (2024). Where, as here, a defendant
raises a facial challenge to plaintiff’s standing, we
“[a]ccept[] the plaintiff’s allegations as true and draw[] all
reasonable inferences in the plaintiff’s favor,” then
“determine[] whether the allegations are sufficient as a legal
matter to invoke the court’s jurisdiction.” Leite v. Crane Co.,
749 F.3d 1117, 1121 (9th Cir. 2014).
Listeners generally have a First Amendment right to
receive information. Va. State Bd. of Pharmacy v. Va.
Citizens Consumer Council, 425 U.S. 748, 756 (1976). But
3
In light of the USDA’s rejection of Vakil and Gourmend’s low-
FODMAP beef broth label, we conclude that Vakil and Gourmend have
Article III standing to challenge that rejection and the underlying
regulations. See Cal. Pro-Life Council, Inc. v. Getman, 328 F.3d 1088,
1095 (9th Cir. 2003).
12 PRZYBOCKI V. USDA
“[t]o establish actual injury from a restriction of the right to
receive information, there must be a speaker who is willing
to convey the information.” Johnson v. Stuart, 702 F.2d 193,
195 (9th Cir. 1983) (citing Va. State Bd. of Pharmacy, 425
U.S. at 756–57). And even if there is a willing speaker, a
plaintiff alleging standing as a prospective listener based on
“someone else’s censorship” must have a “concrete, specific
connection to the speaker.” Murthy v. Missouri, 603 U.S. 43,
75 (2024).
The Supreme Court most recently addressed the
requirements for listener standing in Murthy v. Missouri. In
that case, the plaintiffs were states and social media users
suing federal agencies and officials for allegedly pressuring
social media companies to censor other users’ speech. Id. at
49. The plaintiffs argued that they had a “right to listen” to
other users who had allegedly been censored. Id. at 74–75.
The Supreme Court rejected the plaintiffs’ theory of
standing, explaining that the plaintiffs’ “startlingly broad”
theory “would grant all social-media users the right to sue
over someone else’s censorship—at least so long as they
claim an interest in that person’s speech.” Id. at 75. Rather
than accept that “boundless” theory, the Court held that
listener standing exists only where the listener has “a
concrete, specific connection to the speaker” and can
“identif[y] any specific speakers or topics that they have
been unable to hear or follow.” Id. The Court distinguished
the Murthy plaintiffs, who failed to identify any censored
speaker to whom they had a concrete and specific
connection, from two other groups of listeners whom the
Court had previously found to have listener standing:
professors challenging the denial of their academic invitee’s
visa, and prescription-drug consumers challenging rules
prohibiting pharmacists from advertising prescription drug
PRZYBOCKI V. USDA 13
prices. Id. (discussing Kleindienst v. Mandel, 408 U.S. 753,
762 (1972), and Va. State Bd. of Pharmacy, 425 U.S. at 756–
57).
We applied this rule in Stockton v. Brown, which
considered whether certain doctors and individual citizens
had standing to challenge state medical commission
investigations and charges targeting physicians who were
allegedly spreading COVID-19 misinformation. 152 F.4th at
1132. We held that plaintiff John Stockton, a podcast host
interested in COVID-19 (as well as the NBA’s all-time
assists leader), did not suffer an injury-in-fact as a listener
where he pleaded only that he had “an avid interest in, and
affection for,” one of the doctors’ speech, and did not plead
that he “was prevented from” having the doctor on his
podcast because of the state proceedings. Id. at 1134, 1146.
We explained that Stockton and other plaintiffs who
described themselves as “consumers of information” were
unlike the prescription drug consumers in Virginia State
Board of Pharmacy because that decision “h[eld] only that
consumers of a product can challenge restrictions on the
dissemination of information about that product.” Id. at 1148
(emphasis added). Nor were the plaintiffs similar to the
professors in Mandel, who challenged the government’s
refusal to allow their invited speaker to enter the United
States. The professors had “specifically invited the third-
party speaker to conferences for the purpose of making
speeches and debating,” so they plainly had a “concrete
connection” to the speaker. Id. at 1147. We further explained
that Stockton’s theory of standing “would seemingly give
any listener who has an interest in a speaker’s work standing
to challenge laws that purportedly restrict the speaker’s
speech,” and concluded that this was the kind of “startlingly
14 PRZYBOCKI V. USDA
broad” theory of standing that had been rejected in Murthy.
Id. at 1146.
Applying the principles set forth in Murthy and Stockton,
we conclude that Przybocki pleaded a sufficiently “concrete
[and] specific connection” to identified speakers who would
like to include FODMAP-related claims on their products’
labels but refrain from doing so as a result of the challenged
USDA and FDA regulations. Murthy, 603 U.S. at 75. Unlike
the plaintiffs in Stockton who expressed a general interest in
“hear[ing] information about COVID-19,” Przybocki does
not have merely an “avid interest in, and affection for”
FODMAP labeling. 152 F.4th at 1145–46. Instead, she is a
prospective consumer who must identify foods’ FODMAP
levels in order to plan a diet consistent with her doctor’s
recommendation. Like the drug consumers in Virginia State
Board of Pharmacy, she is a “consumer[] of a product …
challeng[ing] restrictions on the dissemination of
information about that product.” Id. at 1148. Przybocki also
identifies Vakil and Gourmend as willing speakers.
According to the complaint, Vakil and Gourmend would like
to sell products labeled as low-FODMAP, but they currently
refrain from labeling Gourmend’s beef broth as low-
FODMAP and are not developing new products with low-
FODMAP labels due to the USDA and FDA regulations. In
addition to those speakers, Przybocki alleges that other food
companies would include FODMAP-related claims on their
labels but for the challenged USDA and FDA regulations.
As to Gourmend, it is undisputed that Vakil has wanted
to expand the company’s product offerings to include a low-
FODMAP-labeled beef broth since 2022. Vakil and
Gourmend submitted the proposed label to the FSIS, which
required Vakil and Gourmend to “remove all references to
digestible, gut loving, and fodmap.” As a result, Gourmend
PRZYBOCKI V. USDA 15
used a beef-broth label that did not disclose the low-
FODMAP information Vakil wanted, and Przybocki is
unable to purchase a Gourmend beef broth that includes
information about its FODMAP levels on the label. The
plaintiffs also allege that Vakil and Gourmend “intend to sell
additional low-FODMAP products with this labeling
information, but the [USDA and FDA] [b]an has delayed
them from doing so.” Because of these limitations on
Gourmend’s labeling, Przybocki has been denied access to
specific labeling information of significant and concrete
interest to her.
The government argues that any restrictions on
Gourmend’s labels do not harm Przybocki’s interests as a
listener because “Gourmend is already speaking to”
Przybocki through its website, which labels Gourmend’s
beef broth as “low FODMAP.” But that argument ignores
that the plaintiffs’ challenge involves more than just the beef
broth label. According to the complaint, Gourmend would
like to expand and sell new products with low-FODMAP
labels but development is delayed or prevented because of
the regulations. Thus, whether or not Gourmend is already
speaking to Przybocki about the beef broth via its website,
Przybocki is injured by the regulations because they are
causing Gourmend to refrain from developing and speaking
about new products.
Moreover, Przybocki’s injury as a listener is not
alleviated by the fact that Gourmend could provide
FODMAP information on its website about those products.
Other than in the context of content-neutral regulations of
the time, place, or manner of speech, we generally will not
consider restrictions on speech to be permissible simply
because other means of communicating that information are
available. Indeed, in Virginia State Board of Pharmacy, the
16 PRZYBOCKI V. USDA
state had stipulated that the challenged statute “d[id] not
prohibit anyone from receiving [prescription drug pricing]
information either in person or by phone” and that it
“forb[ade] ‘only publish(ing), advertis(ing), or promot(ing)’
prescription drugs.” 425 U.S. at 782 (Rehnquist, J.,
dissenting); see also id. at 750 & n.2. Nonetheless, the
Supreme Court concluded that the consumers challenging
the state law had standing based on their right to receive
information. See id. at 781–82 (Rehnquist, J., dissenting).
Just as the plaintiffs in Virginia State Board of Pharmacy
had standing despite their access to the pricing information
through other channels, the fact that Przybocki can learn
about the FODMAP levels of Gourmend’s products through
Gourmend’s website does not remedy the First Amendment
injury resulting from the government’s restriction of the
products’ labeling. Indeed, Przybocki’s injury may well be
more substantial than that of the consumers in Virginia State
Board of Pharmacy. Although a prescription drug
consumer’s interest in pricing information likely recedes
once a purchase has been made, consumers of food products
often have a continuing interest in the nutritional information
that is provided on the products’ labels, given that their use
of the products may occur long after the time of purchase.
In addition to alleging that Vakil and Gourmend are
willing speakers, Przybocki also plausibly alleges that there
are other food companies that would like to label their
products with FODMAP levels but refrain from doing so due
to the challenged regulations. The government nonetheless
argues that Przybocki’s allegation regarding other food
companies is “too ‘conjectural or hypothetical’ to establish
injury in fact” because it is contingent on food producers
choosing to provide more FODMAP information on their
labels in the absence of the challenged regulations. See Lujan
PRZYBOCKI V. USDA 17
v. Defs. of Wildlife, 504 U.S. 555, 560 (1992). In the
government’s view, there is no guarantee that other food
sellers would begin labeling their products as low-FODMAP
absent the challenged regulations, so Przybocki has not
shown that setting aside those regulations would redress her
injury.
The government is certainly correct that “when the
plaintiff is not [her]self the object of the government action
or inaction [s]he challenges” and the government is instead
regulating third parties, “standing is not precluded, but it is
ordinarily substantially more difficult to establish.” Id. at
562 (citation modified). Plaintiffs generally must show that
“third parties will likely react to the government regulation
(or judicial relief) in predictable ways that will likely cause
(or redress) the plaintiff’s injury.” Diamond Alt. Energy,
LLC v. EPA, 606 U.S. 100, 112 (2025) (citation modified).
But making such a showing does not require declarations
from expert economists or “directly regulated third parties.”
Id. at 120. Instead, the plaintiff “must simply ‘show a
predictable chain of events’ that would likely result from
judicial relief and redress [their] injury.” Id. at 121 (quoting
All. for Hippocratic Med., 602 U.S. at 385). In evaluating
whether such circumstances exist, courts may consider
“commonsense economic realities,” especially “[w]hen third
party behavior is predictable.” Id. at 116, 121. For example,
“[w]hen redress for a plaintiff’s injury depends on a third
party’s independent action and the third party stands to profit
by doing as the plaintiff hopes,” we may conclude that “the
third party’s ‘pecuniary interests’ and the basic dynamic of
‘naked capitalism’ are enough to satisfy the redressability
requirement.” Teton Historic Aviation Found. v. U.S. Dep’t
of Def., 785 F.3d 719, 728 (D.C. Cir. 2015) (quoting Abigail
18 PRZYBOCKI V. USDA
All. for Better Access to Developmental Drugs v.
Eschenbach, 469 F.3d 129, 135 (D.C. Cir. 2006)).
Given the prevalence of FODMAP-related digestive
disorders today, one can plausibly infer that consumers,
perhaps numbering in the tens of millions, want food labels
to contain information about FODMAP levels. And given
this consumer demand, the plaintiffs plausibly allege that
food sellers “want to convey [] low-FODMAP information
to Michelle [Przybocki] and other customers” because those
food sellers would “stand[] to profit” by doing so. Id. at 728.
We can also reasonably infer that food producers are not
currently labeling their products with FODMAP information
because they understand the regulations to prohibit such
labels. On the basis of these allegations, the plaintiffs
plausibly alleged that there are speakers other than
Gourmend who are willing to convey FODMAP information
to Przybocki and would do so in the absence of the
regulations, and that she has a sufficiently close connection
to those speakers to establish her Article III listener standing.
Stuart, 702 F.2d at 195.
In sum, Przybocki has alleged facts from which we can
infer the existence of speakers, including Gourmend and
other food companies, who would include FODMAP-related
information on their labels in the absence of the challenged
regulations, and that Przybocki has a concrete and specific
connection to those speakers. Przybocki therefore
adequately pleaded Article III standing to challenge the FDA
and USDA regulations at issue here.
II. Vakil and Gourmend’s Standing to Pursue
Claims Against the FDA
We next consider whether Vakil and Gourmend
adequately pleaded standing to sue the FDA based on the
PRZYBOCKI V. USDA 19
alleged chilling of their own speech. We conclude that they
did.
To establish their standing to pursue a pre-enforcement
First Amendment challenge targeting the FDA’s regulations,
Vakil and Gourmend must plead “[1] an intention to engage
in a course of conduct arguably affected with a constitutional
interest, but [2] proscribed by a statute, and [3 that] there
exists a credible threat of prosecution thereunder.” Susan B.
Anthony List v. Driehaus, 573 U.S. 149, 159 (2014) (quoting
Babbitt v. United Farm Workers Nat’l Union, 442 U.S. 289,
298 (1979)). First Amendment pre-enforcement lawsuits
“present unique standing considerations such that the inquiry
tilts dramatically toward a finding of standing.” Libertarian
Party of L.A. Cnty. v. Bowen, 709 F.3d 867, 870 (9th Cir.
2013) (citation modified). As noted already, Vakil and
Gourmend currently sell products regulated by the FDA that
include FODMAP-related information on their labels and
have not yet been the subject of any FDA enforcement
action. We must therefore determine whether they
nonetheless allege a “credible threat of prosecution” arising
from the inclusion of FODMAP-related information in
Gourmend’s labels sufficient to plead Article III standing.
Susan B. Anthony List, 573 U.S. at 159.
A mere possibility of prosecution does not establish
injury in fact, Thomas v. Anchorage Equal Rts. Comm’n, 220
F.3d 1134, 1139 (9th Cir. 2000) (en banc), nor does a threat
that is dependent upon a “highly attenuated chain of
possibilities,” Clapper v. Amnesty Int’l USA, 568 U.S. 398,
410 (2013). In determining whether Vakil and Gourmend
face a “credible threat of prosecution,” we consider, first,
“whether the plaintiffs have articulated a concrete plan to
violate the law in question”; second, “whether the
prosecuting authorities have communicated a specific
20 PRZYBOCKI V. USDA
warning or threat to initiate proceedings”; and third, “the
history of past prosecution or enforcement under the
challenged statute.” Clark v. City of Seattle, 899 F.3d 802,
813 (9th Cir. 2018) (citation modified); see also Cal. Pro-
Life Council, Inc. v. Getman, 328 F.3d 1088, 1094 (9th Cir.
2003) (applying these factors from Thomas to determine
standing and explaining that Thomas did not overrule long-
standing precedent “recognizing the validity of pre-
enforcement challenges to statutes infringing upon
constitutional rights”); Imperial Sovereign Court of
Montana v. Knudsen, 170 F.4th 820, 835 (9th Cir. 2026)
(explaining circumstances in which a plaintiff can show a
credible threat of enforcement “even in the absence of any
investigation or warning of prosecution”); Matsumoto v.
Labrador, 122 F.4th 787, 797–98 (9th Cir. 2024) (same).
Here, the first two factors clearly favor finding a credible
threat of prosecution, while the third factor weakly favors
such a finding.
First, Vakil and Gourmend have a “concrete plan to
violate the law in question.” Clark, 899 F.3d at 813.
Gourmend continues to market its four spice blends and its
chicken broth with labels that communicate low FODMAP
levels, as it has since 2022. In other words, Gourmend has
been labeling products in potential violation of the FDA’s
regulations for years. The complaint also alleges that the
challenged regulations “ha[ve] further chilled [Vakil] and
Gourmend’s speech by causing them to delay plans for
additional speech and additional low-FODMAP food
products.” Thus, Gourmend either already offers or has a
“concrete plan” to offer products that violate the applicable
food-labeling laws through the inclusion of FODMAP-
related information on their labels. Id.
PRZYBOCKI V. USDA 21
Second, the government has provided Vakil and
Gourmend with a “specific warning or threat to initiate
proceedings.” Id. After Gourmend submitted its proposed
beef broth label for approval, the FSIS rejected it and an
FSIS official told Gourmend that “[a]ll of the references to
gut loving, digestibility and fodmap must be removed.”
Crucially, FSIS Deputy Director Jeffrey Canavan also told
Gourmend that FSIS had discussed the application with FDA
and that “both agencies view” the beef broth label’s claims
as “undefined nutrient content claims.” We have previously
explained that a First Amendment plaintiff faces a credible
threat of enforcement “if the plaintiff’s intended speech
arguably falls within the statute’s reach,” and quoted
approvingly the Seventh Circuit’s explanation that “the
threat [of prosecution] is latent in the existence of the
[allegedly unconstitutional] statute.” Cal. Pro-Life Council,
Inc., 328 F.3d at 1095 (quoting Majors v. Abell, 317 F.3d
719, 721 (7th Cir. 2003)). Here, the government agencies’
own correspondence demonstrates that Vakil and
Gourmend’s proposed speech “arguably falls within the
statute’s reach,” such that the threat of prosecution is “latent
in the existence of” the regulations. Id. And although the
FDA has not issued warning letters to Vakil or Gourmend,
“the government’s failure to disavow enforcement of [a]
law … weigh[s] in favor of standing.” Tingley v. Ferguson,
47 F.4th 1055, 1068 (9th Cir. 2022), abrogated on other
grounds by Chiles v. Salazar, 146 S. Ct. 1010 (2026). At oral
argument, the government confirmed that it could not
provide any assurance that the FDA will not pursue an
enforcement action against Vakil and Gourmend based on
Gourmend’s existing labels.
Third, the government’s “history of past prosecution or
enforcement” weakly favors Vakil and Gourmend. Clark,
22 PRZYBOCKI V. USDA
899 F.3d at 813. Although the government has not yet
challenged Gourmend’s FDA-governed labels, the FDA
enforces bans on other unapproved nutrient-content claims,
such as “low lactose content.” See FDA, Warning Letter,
Maine Natural Health, Inc., MARCS-CMS 525870 (Dec.
19, 2017) https://www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/warning-
letters/maine-natural-health-inc-525870-12192017
[https://perma.cc/RE43-PTJE]. And FSIS Deputy Director
Canavan’s letter, which noted the FDA’s agreement with
FSIS that FODMAP content claims are impermissible
nutrient-content claims, constitutes at least a “future warning
of prosecution,” see Unified Data Servs., LLC v. Fed. Trade
Comm’n, 39 F.4th 1200, 1211 (9th Cir. 2022), in the broader
sense in which we have applied that rule in pre-enforcement
challenges under the First Amendment, see Libertarian
Party of L.A. Cnty., 709 F.3d at 871 (holding that the
government had “communicated a specific warning or threat
of enforcement” by posting instructions for complying with
the statute on its website). In any event, when the first two
factors have been met, an imminent threat of prosecution
may be found even where the third factor is neutral. See, e.g.,
Project Veritas v. Schmidt, 125 F.4th 929, 941–42 (9th Cir.
2025) (en banc).
Under these circumstances, Vakil and Gourmend alleged
a “genuine threat of imminent prosecution” sufficient to
establish their Article III standing to sue the FDA. Clark, 899
F.3d at 813.
CONCLUSION
For the foregoing reasons, we reverse the district court’s
judgment as to Przybocki, Vakil, and Gourmend’s claims
against the FDA and as to Przybocki’s claims against the
PRZYBOCKI V. USDA 23
USDA. In a separate memorandum disposition, we affirm
the district court’s dismissal of Vakil and Gourmend’s
claims against the USDA for failure to exhaust available
administrative remedies.
AFFIRMED IN PART, REVERSED IN PART. The
parties shall bear their own costs on appeal.