Texas Department of State Health Services and Dr. Jennifer A. Shuford, in Her Official Capacity as Commissioner of the Texas Department of State Health Services v. Sky Marketing Corp., D/B/A Hometown Hero; Create a Cig Temple, LLC; Darrell Surif; And David Walden

Supreme Court of Texas
                           ══════════
                            No. 23-0887
                           ══════════

       Texas Department of State Health Services and
     Dr. Jennifer A. Shuford, in Her Official Capacity as
Commissioner of the Texas Department of State Health Services,
                              Petitioners,

                                   v.

    Sky Marketing Corp., d/b/a Hometown Hero; Create a Cig
        Temple, LLC; Darrell Surif; and David Walden,
                             Respondents

   ═══════════════════════════════════════
              On Petition for Review from the
       Court of Appeals for the Third District of Texas
   ═══════════════════════════════════════

                      Argued January 14, 2026

      JUSTICE YOUNG delivered the opinion of the Court.

      Justice Sullivan did not participate in the decision.

      The legislature has charged the commissioner of the Texas
Department of State Health Services with primary responsibility for
overseeing the civil schedules of controlled substances. The statutory
framework consciously, purposefully, and expressly authorizes her—
indeed requires her—to undertake this task with a substantial and
unusual degree of discretion. That legislative choice is at least in part
explained by the need for the executive branch to be capable of responding
rapidly and authoritatively to emerging threats to public safety from the
development of illicit and harmful substances.
       One such substance is manufactured delta-8 THC. Delta-8 THC is a
naturally occurring psychoactive compound found in exceedingly trace
amounts in the cannabis plant (and therefore unable to produce any real or
measurable psychoactive effect if consumed in its natural form).
Technological developments now make it possible, however, to create
artificial products containing a high concentration of manufactured delta-8
THC—more than enough to create the “high” experienced by users of
marijuana (or “marihuana,” as it is often spelled in government documents).
       Businesses that have developed these products claim that the
legislature opened the market for them in 2019. So when the commissioner
attempted to clarify that, in fact, the legislature did not greenlight potent
levels of manufactured delta-8 THC in consumable hemp products, a group
of businesses and consumers asked a court to order her and the department
to rewrite the schedules of controlled substances, primarily on the
ground that the legislature legalized delta-8 THC in 2019, making the
commissioner’s actions impermissible and ultra vires.
       The trial court granted this relief in the form of a temporary
injunction, which the court of appeals affirmed. We now conclude that the
lower courts exceeded their authority.
       If the legislature desires to legalize powerful drugs, it has every tool it
needs to do so—and to do so unmistakably, as we expect for such a major
change to social policy. The role of the courts is merely to assess the state of




                                        2
the law as it is. That task is complex in this case because the law governing
controlled substances is itself complex, both procedurally and substantively.
The textual arguments pressed by respondents and adopted by the lower
courts are forceful and warrant respect. But those arguments are adequately
addressed by the text, structure, and history of the Texas Controlled
Substances Act, which has not divested the commissioner of discretion to
include manufactured delta-8 THC as a controlled substance. Those seeking
a different result must look to the other branches of government.
      The judgment of the court of appeals is affirmed as to respondents’
standing and otherwise reversed. We render judgment reversing the trial
court’s order granting the temporary injunction.

                                     I

                                     A
      Both federal and state law historically have treated all parts of
the cannabis plant as “marihuana,” a Schedule I controlled substance.
Cannabidiol (CBD) and tetrahydrocannabinols (THC) are compounds
found in the cannabis plant. THC, which creates the “high” marijuana
users feel, exists in the form of isomers, including delta-8 THC. Delta-8
THC is present in exceedingly trace amounts in the cannabis plant.
      Congress enacted the 2018 Farm Bill, which amended the federal
Controlled Substances Act to exclude “hemp” from the definition of
“marihuana” and to exclude “[THC] in hemp” from Schedule I. Agriculture
Improvement Act of 2018, Pub. L. No. 115–334, 132 Stat. 4490, 5018 (2018).
The 2018 Farm Bill defined “hemp” as
      the plant Cannabis sativa L. and any part of that plant,
      including the seeds thereof and all derivatives, extracts,
      cannabinoids, isomers, acids, salts, and salts of isomers,




                                     3
       whether growing or not, with a delta-9 [THC] concentration
       of not more than 0.3 percent on a dry weight basis.
Id. at 4908.
       Shortly thereafter, the legislature enacted the 2019 Texas Farm
Bill, which adopted a near-identical definition of “hemp” and deleted hemp
and the THC in hemp from the list of controlled substances under the
Texas Controlled Substances Act. Act of May 26, 2019, 86th Leg., R.S.,
ch. 764, §§ 2, 8, 2019 Tex. Gen. Laws 2085, 2086, 2100–01. The term
“marihuana” now “does not include . . . hemp,” Tex. Health & Safety Code
§ 481.002(26)(F), and the term “controlled substance” now “does not include
hemp, . . . or the [THC] in hemp,” id. § 481.002(5) (emphasis added). Under
Texas law, “hemp” means
       the plant Cannabis sativa L. and any part of that plant,
       including the seeds of the plant and all derivatives, extracts,
       cannabinoids, isomers, acids, salts, and salts of isomers,
       whether growing or not, with a delta-9 [THC] concentration
       of not more than 0.3 percent on a dry weight basis.
Tex. Agric. Code § 121.001. The Texas Farm Bill did not itself amend the
THC or “marihuana extract” definitions in the list of Schedule I controlled
substances, but the commissioner subsequently amended the THC and
“marihuana” definitions to conform the 2019 and 2020 Schedules to the
2019 Texas Farm Bill. See 44 Tex. Reg. 2514, 2516–17 (2019); 45 Tex. Reg.
2249, 2251 (2020).
       In August 2020, the federal Drug Enforcement Administration
issued an interim final rule that “amend[ed] the scope of substances falling
within” the federal definition of Schedule I “marihuana extract” and clarified
that “hemp-derived extracts containing less than 0.3%-THC content are
also decontrolled along with the [hemp] plant itself.” Implementation of




                                      4
the Agriculture Improvement Act of 2018, 85 Fed. Reg. 51639, 51641–42,
51644 (Aug. 21, 2020) (codified at 21 C.F.R. pts. 1308, 1312).
      Back in Texas, the commissioner objected to those DEA modifications
“to the extent that the definitions allow for the presence or addition of
[THC] aside from the presence of delta-9-[THC].” 45 Tex. Reg. 6613, 6614
(2020). Her objection was specifically authorized by Health & Safety Code
§ 481.034(g), under which federal actions are automatically incorporated
into Texas law unless the commissioner timely objects. Her notice of
objection was posted to the department’s website in September 2020, and
she held a public hearing the next month, but the department received no
comments at the hearing or in writing.
      Accordingly, in January 2021, the commissioner issued a final
decision declining to adopt the DEA’s modifications. See 46 Tex. Reg. 873,
873–74 (2021). She then updated Schedule I’s THC and “marihuana
extract” definitions to comport with the objection and to clarify Texas law
in light of the change in federal law that had occasioned her objection:
            *(31) Tetrahydrocannabinols, meaning [THC]
      naturally contained in a plant of the genus Cannabis
      (cannabis plant), except for up to 0.3 percent delta-9-
      [THC] in hemp (as defined under Texas Agriculture Code
      121Section 297A(1) of the Agricultural Marketing Act of
      1946), as well as synthetic equivalents of the substances
      contained in the cannabis plant, or in the resinous
      extractives of such plant, and/or synthetic substances,
      derivatives, and their isomers with similar chemical
      structure and pharmacological activity to those substances
      contained in the plant, . . . ;
             ...
            *(58) Marihuana extract, meaning an extract
      containing one or more cannabinoids that has been derived
      from any plant of the genus Cannabis, except for extracts



                                    5
      derived from hemp (as defined under Texas
      Agriculture Code 121) containing up to 0.3% delta-9-
      [THC] on a dry weight basis, other than the separated
      resin (whether crude or purified) obtained from the plant[.]
Compare 46 Tex. Reg. 1763, 1768, 1770 (2021), with 45 Tex. Reg. at
2251–52 (amendments bolded and struck through). In October 2021,
the department announced on its website that
      Texas Health and Safety Code Chapter 443 (HSC 443),
      established by House Bill 1325 (86th Legislature), allows
      Consumable Hemp Products in Texas that do not exceed
      0.3% Delta-9 [THC]. All other forms of THC, including
      Delta-8 in any concentration and Delta-9 exceeding 0.3%,
      are considered Schedule I controlled substances.
(Emphasis added.)

                                    B
      The plaintiffs below, who are respondents in this Court, are a group
of licensed manufacturers, registered retailers, and individual consumers—
collectively, the “vendors.” The vendors sued the department and the
commissioner, seeking temporary and permanent injunctions and
declaratory relief. They allege that the 2018 Farm Bill and 2019 Texas
Farm Bill opened a market for consumable hemp products containing
manufactured delta-8 THC, which is converted from hemp-derived CBD
through a variety of processes. These products contain higher delta-8-THC
concentrations than could ever naturally occur in the hemp plant. The
vendors entered this burgeoning delta-8-THC market, and the department
issued licenses to some of the vendors and similarly situated businesses.
      Businesses and consumers thus operated under the assumption
that only products with a delta-9-THC concentration over 0.3% were
illegal. But when the commissioner published the 2021 Schedules and




                                    6
purported to control manufactured delta-8-THC products, hemp
businesses scrambled to “pull products from the shelves, abruptly halt
sales, [and] destroy significant amounts of inventory.”
      The vendors asserted ultra vires claims against the commissioner,
alleging that she lacked discretion to modify the 2021 Schedules pursuant
to Health & Safety Code § 481.034(g) and was instead required to, but did
not, comply with other procedures enumerated in §§ 481.034–.035. The
vendors also brought a claim against the department under the Texas
Administrative Procedure Act, asserting that the 2021 amendments and
the October 2021 statement on the department’s website were invalid
“rules.” The vendors further alleged that the department’s website
statement and the commissioner’s modifications to the THC and
“marihuana extract” definitions purported to control hemp products that
the 2019 Texas Farm Bill expressly legalized. The vendors therefore
sought, among other relief, a temporary injunction “enjoin[ing] the
effectiveness going forward of the amendments to the definitions for the
terms ‘[THC]’ and ‘[m]arihuana extract’ ” in the 2021 Schedules.
      The department and commissioner responded with a plea to the
jurisdiction, asserting sovereign immunity and challenging the vendors’
standing. The commissioner and department first argued that the vendors
lack standing because the department possesses only civil-enforcement
authority and cannot criminally enforce the Texas Controlled Substances
Act. And because the vendors’ alleged injury arises from threat of criminal
enforcement, that injury is not redressable by an injunction against the
commissioner and department.




                                    7
      The commissioner further asserted that the vendors failed to allege
a viable ultra vires claim because she acted within her § 481.034(g)
authority to reject federal modifications to the THC and “marihuana
extract” definitions. THC, including delta-8 THC, has been a Schedule
I controlled substance for over forty years, and the 2019 Texas Farm Bill
created a limited exception for up to 0.3% concentration of delta-9 THC
naturally contained in the cannabis plant. Delta-8 THC occurs in almost
undetectably trace amounts in hemp, but it can be derived synthetically
from CBD to produce a dramatically higher concentration than that which
occurs naturally in the cannabis plant. Texas law considers such synthetic
THC to be a Schedule I controlled substance. See 46 Tex. Reg. at 1768
(listing “synthetic equivalents of the substances contained in the cannabis
plant, . . . and/or synthetic substances, derivatives, and their isomers
with similar chemical structure and pharmacological activity to those
substances contained in the plant” as Schedule I controlled substances).
      After a hearing, the trial court denied the plea to the jurisdiction
and granted a temporary injunction preserving what it termed “the status
quo that existed prior to” the allegedly ultra vires conduct and APA
violation. The court purported to enjoin “the effectiveness going forward of
amendments to the terms ‘[THC]’ and ‘[m]arihuana extract’ in” the 2021
Schedules and ordered the department to “remove from its currently
published Schedule of Controlled Substances the most recent modifications
of the definitions,” as well as “any subsequent publications of the same (if
any).” The court also purported to enjoin the “effectiveness going forward
of the rule stated on [the department]’s website that Delta-8 THC in any
concentration is considered a Schedule I controlled substance.”




                                     8
       The department appealed, see Tex. Civ. Prac. & Rem. Code
§ 51.014(a)(4), (8); Tex. R. App. P. 28.1(a), and the court of appeals
affirmed, 711 S.W.3d 227 (Tex. App.—Austin 2023). The court held that
the vendors have standing; the trial court did not err in denying the plea
to the jurisdiction as to the vendors’ ultra vires and APA claims; and the
trial court did not abuse its discretion in granting a temporary injunction.
We granted the department’s ensuing petition for review.

                                        II
       As always, our first obligation is to confirm the subject-matter
jurisdiction of this Court and the lower courts. Two justiciability doctrines
are central to that inquiry here: standing and ripeness.
       Standing is about who can sue.            It concerns the nature and
sufficiency of the plaintiff’s connection with the litigation’s subject matter,
so that courts are not tempted to resolve legal issues at the request of
someone lacking the requisite interest in the outcome. That is why at least
one named plaintiff must have a “personal stake” in a case and “be able to
answer a basic question: ‘What’s it to you?’ ” Bost v. Ill. State Bd. of Elections,
607 U.S. 71, 76 (2026) (quoting Antonin Scalia, The Doctrine of Standing
as an Essential Element of the Separation of Powers, 17 Suffolk U. L. Rev.
881, 882 (1983)); see also Heckman v. Williamson County, 369 S.W.3d 137,
152 (Tex. 2012). To answer this question, a plaintiff “must show (1) an
‘injury in fact’ that is (2) ‘fairly traceable’ to the defendant’s challenged
action and (3) redressable by a favorable decision.” Abbott v. Mex. Am.
Legis. Caucus, 647 S.W.3d 681, 690 (Tex. 2022).
       Ripeness, on the other hand, is about when a plaintiff—even one
with a sufficient personal stake—may bring suit. It probes whether the




                                        9
dispute is one that is ready for judicial review. Waco ISD v. Gibson, 22
S.W.3d 849, 851–52 (Tex. 2000). The touchstone of ripeness is “whether,
at the time a lawsuit is filed, the facts are sufficiently developed ‘so that an
injury has occurred or is likely to occur, rather than being contingent or
remote.’ ” Id. (quoting Patterson v. Planned Parenthood of Houston & Se.
Tex., Inc., 971 S.W.2d 439, 442 (Tex. 1998)). And if a plaintiff’s claimed
injury-in-fact “is based on ‘hypothetical facts, or upon events that have not
yet come to pass,’ then the case is not ripe[.]” Sw. Elec. Power Co. v. Lynch,
595 S.W.3d 678, 683 (Tex. 2020) (quoting Gibson, 22 S.W.3d at 852).
Plaintiffs, therefore, may not invoke the judicial process merely because
they contend that a law or other governmental action is unconstitutional
or otherwise illegal, or even because they anticipate eventual harmful
effects from such governmental conduct. Reaching the merits of an unripe
controversy constitutes issuing an advisory opinion, which is not within
the authority that the Texas Constitution confers on the courts. See Tex.
Dep’t of Fam. & Protective Servs. v. Grassroots Leadership, Inc., 717 S.W.3d
854, 872 (Tex. 2025). As with all the justiciability doctrines, ripeness helps
ensure that the judiciary’s work always constitutes enforceable resolutions
of genuine and live disputes. See id. at 866–67.
       Ripeness and standing are distinct but have considerable overlap.
Both doctrines “emphasize[] the need for a concrete injury for a justiciable
claim to be presented.” Lynch, 595 S.W.3d at 683 (quoting Patterson, 971
S.W.2d at 442). All justiciability doctrines “work together to ensure that
at every stage of litigation, a live dispute exists that is proper for judicial
resolution[.]” Grassroots Leadership, 717 S.W.3d at 867. A case failing one
of the tests “often will fail” another. Id. Or, as here, a case passing one of




                                      10
the tests often will pass the other.
       Our standing inquiry begins with the alleged injury-in-fact, which
“must be concrete and particularized, actual or imminent, not hypothetical.”
Heckman, 369 S.W.3d at 155 (quoting DaimlerChrysler Corp. v. Inman,
252 S.W.3d 299, 304–05 (Tex. 2008)). We assess whether a plaintiff has
“plead[ed] facts demonstrating that he, himself (rather than a third party
or the public at large), suffered the injury.” Id.
       The vendors have met that burden. According to their second
amended petition, Sky Marketing Corporation, doing business as
Hometown Hero, is a Texas business that openly sold delta-8-THC
products in the wake of the 2019 Texas Farm Bill. The business applied
for a Texas Hemp License in September 2020, which the department
issued in September 2021. When the commissioner issued the 2021
Schedules, Sky Marketing scrambled to pull its products, halt sales, and
destroy inventory. The alleged result was that Sky Marketing missed out
on revenue previously earned through the sale and distribution of delta-
8-THC products, fired significant portions of its workforce, suffered harm
to its business reputation, and was deprived of a property interest in its
department-issued Texas Hemp License.
       Sky Marketing’s cognizable injury is therefore straightforward. It
allegedly suffered lost sales and revenue resulting in economic and
reputational harm. The “loss of even a small amount of money is ordinarily
an ‘injury’ ” for standing purposes. Mosaic Baybrook One, L.P. v. Simien,
674 S.W.3d 234, 251 (Tex. 2023) (quoting Czyzewski v. Jevic Holding Corp.,
580 U.S. 451, 464 (2017)); accord, e.g., Lexmark Int’l, Inc. v. Static Control
Components, Inc., 572 U.S. 118, 125 (2014) (concluding that a company’s




                                       11
“allegations of lost sales and damage to its business reputation give it
standing under Article III”); Bost, 607 U.S. at 78 (“[R]eputational harms,
as a general matter, are classic Article III injuries.” (alteration in original)
(quotation marks omitted)); see also, e.g., Diamond Alt. Energy, LLC v.
EPA, 606 U.S. 100, 113–14 (2025) (holding that fuel producers’ “decrease
in purchases of gasoline and other liquid fuels resulting from the California
regulations hurt[] their bottom line” and such “monetary costs” were “of
course an injury” (quotation marks omitted)).
       The second prong of our standing inquiry requires that Sky
Marketing’s alleged injury be fairly traceable to the department’s conduct
rather than the result of an “independent action of some third party not
before the court.” Heckman, 369 S.W.3d at 154 (quoting Simon v. E. Ky.
Welfare Rights Org., 426 U.S. 26, 41–42 (1976)). The vendors must show
that there is “a causal connection between the injury and the conduct
complained of.” Id. (quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–
61 (1992)).
       Here too, Sky Marketing has an obvious answer: as a department-
licensed business in a highly regulated industry, it must refrain from
engaging in illegal conduct or else face civil penalties or revocation of its
license and registration. When the commissioner modified the schedules
and announced that delta-8-THC products were banned, Sky Marketing
was required to stop manufacturing and selling such products. Failure to
comply with the department’s regulatory standards meant Sky Marketing
stood to lose its license, which was “valid for one year and may be renewed
annually, provided [it] remains in good standing.” 25 Tex. Admin. Code
§ 300.502(c) (2020) (amended 2026). And losing its license meant Sky




                                      12
Marketing’s operations would cease. Indeed, the “whole point” of the
amendments was to put an end to the very economic activity in which Sky
Marketing was engaged. Diamond Alt., 606 U.S. at 114 (reasoning that
the challenged regulations “likely cause[d]” the plaintiffs’ injuries because
the regulations targeted the plaintiffs’ market).
      To be clear, we are not asked to hold that allegations of vague
consequences that may or may not follow from a general failure to obey the
law can confer standing. Were that enough, standing (and ripeness) would
be a nullity. This case’s context illustrates the kind of individualized
circumstances that distinguish between mere disagreement with a law or
governmental action (no standing) and actual or imminent injury caused
by such an action (standing). Sky Marketing is part of a highly regulated
industry for which a license is affirmatively required to operate, and
maintaining a valid license is expressly conditioned on strict compliance
with the department’s rules and regulations.          As these rules and
regulations change, market participants are bound to adapt expediently.
These conditions transform Sky Marketing’s choice to comply into
compliance based on the government’s coercive power. Like the difference
between money voluntarily paid on a claim of right based upon one’s
independent understanding of his liability under the law and a mandatory
payment made in response to a judgment of a court (even before the
prevailing party has executed that judgment on him), see Miga v. Jensen,
299 S.W.3d 98, 103–04 (Tex. 2009), licensed participants in this uniquely
regulated market do not comply with the regulations voluntarily but
mandatorily, under the shadow of the department’s full enforcement
authority.




                                     13
       Under the circumstances of this case, therefore, Sky Marketing was
not obligated to bet the farm by violating Texas law and risking severe—
potentially fatal—penalties to obtain judicial review. Indeed, its fears were
rationally occasioned: a similarly situated business received a letter from
law enforcement threatening not merely civil but criminal penalties
because manufactured delta-8 THC is a controlled substance. Because
compliance caused Sky Marketing to suffer economic and reputational
harm, and its compliance could in no way be described as voluntary, its
injury is traceable to the department’s actions.
       The final standing element requires that Sky Marketing’s alleged
injury be redressable—i.e., “likely to be redressed by the requested relief[.]”
Heckman, 369 S.W.3d at 155. “When a plaintiff is the ‘object’ of a
government regulation, there should ‘ordinarily’ be ‘little question’ that
the regulation causes injury to the plaintiff and that invalidating the
regulation would redress the plaintiff’s injuries.” Diamond Alt., 606 U.S.
at 114 (quoting Lujan, 504 U.S. at 561).
       That principle applies here. Invalidating the department’s actions
purporting to ban delta-8-THC products would redress at least some of Sky
Marketing’s monetary and reputational injury by allowing it to return to
manufacturing and selling those products. Our confidence in this conclusion
is reinforced by the fact that manufactured delta-8-THC products have
sprung back, and the hemp industry has operated and openly sold them
without fear of department penalty, during the pendency of the trial court’s
temporary injunction.
       Yet the department asserts that because it cannot criminally
enforce the schedules, an injunction would ring hollow. The department is




                                      14
correct that an “injunction is an empty vessel if the enjoined official never
had the power to enforce the law in the first place.” State v. Zurawski, 690
S.W.3d 644, 659 (Tex. 2024). But criminal enforcement is not the only way
the law can have teeth. The department’s civil-enforcement authority is
sharp enough. See Tex. Health & Safety Code § 431.207(a)(7) (empowering
the department to revoke or refuse to issue a license if an applicant or
licensee violates the Texas Controlled Substances Act, which includes the
schedules); id. § 431.021(x) (prohibiting the distribution or manufacturing
of drugs without a department-issued license); id. § 431.058 (“The attorney
general at the request of the department may bring a civil action to recover
an administrative penalty.”). The department has not disclaimed any
intention to civilly enforce the schedules against Sky Marketing should the
temporary injunction be lifted. See In re Abbott, 601 S.W.3d 802, 812 (Tex.
2020) (concluding that plaintiffs had no standing in part because “the State
in its briefing disclaim[ed] any intention by the Governor or the Attorney
General to affirmatively enforce” the challenged law).
       The injunction, therefore, would redress Sky Marketing’s alleged
injury. See Zurawski, 690 S.W.3d at 660 (concluding that plaintiff’s Human
Life Protection Act civil-enforcement claim was redressable by a favorable
injunction against the attorney general because the attorney general could
recover civil penalties for violations of the act).
       For similar reasons, we are also satisfied that this lawsuit is ripe for
judicial review. The coercive nature of this regulatory regime “as a practical
matter require[d]” Sky Marketing “to adjust [its] conduct immediately,”
Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 891 (1990), and its swift
compliance allegedly cost Sky Marketing at least 50% of its revenue




                                      15
stream. Given the coercive nature of the licensing regime that directly and
extensively regulated Sky Marketing’s business, its fears about
department enforcement were concrete, not based on a speculative hunch
about what might occur at some unascertainable time in a future,
hypothetical enforcement scenario. The pocketbook injury, which it alleges
followed directly from compliance, is also sufficiently concrete. See, e.g.,
Abbott Labs. v. Gardner, 387 U.S. 136, 153 (1967) (concluding that there
was “no question” the pre-enforcement challenge was justiciable where the
challenged regulation was “directed at [the plaintiffs] in particular;” the
regulation “require[d] them to make significant changes in their everyday
business practices;” and “if they fail[ed] to observe the [regulation, the
plaintiffs were] quite clearly exposed to the imposition of strong
sanctions”); cf. Abbott, 601 S.W.3d at 812 (“A plaintiff does not need to be
arrested and prosecuted before suing to challenge the constitutionality of
a criminal law.”).
                                 *   *     *
      The vendors allege that at least one named plaintiff, Sky Marketing,
suffered lost sales and revenue resulting in economic and reputational
harm. This alleged injury can be traced directly to the modified schedules,
over which the department exercises civil enforcement authority, and is
redressable by an injunction prohibiting the department from enforcing
certain amendments to the 2021 Schedules. We therefore conclude that
the vendors have standing and the claims are ripe for judicial review.

                                     III
      The vendors’ ultra vires claims can be distilled into two issues.
The first is procedural: they allege that the commissioner exceeded her




                                     16
discretion by modifying the 2021 Schedules in violation of Health &
Safety Code § 481.034, which establishes the procedural avenues through
which the commissioner may modify the schedules.              The second is
substantive: the vendors allege that the commissioner acted beyond her
statutory authority by modifying the 2021 Schedules in a manner contrary
to the 2019 Texas Farm Bill.
       We conclude that the vendors do not allege a valid ultra vires claim,
so sovereign immunity applies. The commissioner lawfully modified the
Schedule I terms THC and “marihuana extract” pursuant to § 481.034(g),
and the amendments do not conflict with the 2019 Texas Farm Bill.

                                      A
       The commissioner’s broad authority to amend the schedules flows
from the Texas Controlled Substances Act, which directs her to “establish
and modify the . . . schedules of controlled substances” in Schedules I–V,
Tex. Health & Safety Code § 481.032(a), subject to certain procedural
safeguards enumerated in § 481.034. The commissioner may modify the
schedules through two procedural avenues outlined in § 481.034.
       First, under subsection (g), “if a substance is designated, rescheduled,
or deleted as a controlled substance under federal law and notice of that
fact is given to the commissioner,” the commissioner “similarly shall
designate, reschedule, or delete the substance, unless the commissioner
objects during the period.” Id. § 481.034(g). If the commissioner objects,
she “shall publish the reasons for the objection,” “give all interested parties
an opportunity to be heard,” and “publish a decision, which is final unless
altered by statute.” Id.
       Second, when the commissioner is not responding to a federal




                                      17
change but has a separate reason for modifying the schedules—such as
responding to new developments in the real world—she must comply with
other procedural obligations. She must, for example, “hold[] a public
hearing on the matter in Austin and obtain[] approval from the executive
commissioner,” id. § 481.034(b); consider eight factors in making her
determination, id. § 481.034(d); make findings with respect to those
factors, id. § 481.034(e); and give written notice to the director and the
relevant state licensing agencies when she designates, deletes, or
reschedules a substance, id. § 481.034(h). She must also modify the
schedules consistent with § 481.035, id. § 481.034(a)(1), and with the
executive commissioner’s approval, id. § 481.034(a)(3).
       The law also imposes substantive limitations on the commissioner’s
authority, but those limitations are strikingly narrow. For example, she
may not modify the schedules to “(1) add a substance to the schedules if
the substance has been deleted from the schedules by the legislature;
(2) delete a substance from the schedules if the substance has been added
to the schedules by the legislature; or (3) reschedule a substance if the
substance has been placed in a schedule by the legislature.” Id. § 481.034(c).
Those express limitations are notable because, in truth, they go without
saying. If a statute authorizes a particular substance, then it is hardly
necessary to say that an administrative agency may not contradict it.
Likewise, if a statute prohibits a substance, who could seriously argue
that an agency could authorize it? The limitations of § 481.034(c) are
meaningful, therefore, primarily by signaling that only such a direct
repudiation of the commissioner’s decisions by the legislature can authorize
the judiciary to set her decisions aside. Section 481.034(c), in other words,




                                     18
confirms that the legislature expected the commissioner to have an
unusually high degree of discretion to modify the schedules and respond
to new developments, which is especially important today, given the
technological capacity to develop new chemicals quickly.
      Indeed, the Texas Controlled Substances Act’s statutory history
confirms that the legislature has provided basic principles as guidance but
charges the department with primary responsibility for determining which
specific substances should be controlled and to what schedule they should
be assigned. The legislature rarely adds or deletes controlled substances in
Schedules I–V. The Court is aware of only two instances in the past twenty
or so years that the legislature has directly scheduled a substance: the 2019
Texas Farm Bill and a 2009 amendment adding carisoprodol to Schedule
IV. See Act of June 1, 2009, 81st Leg., R.S., ch. 774, § 4, 2009 Tex. Gen.
Laws 1961, 1963. By contrast, the legislature has actively amended the list
of controlled substances in the criminal Penalty Groups, which the
department does not control. See, e.g., Act of May 24, 2023, 88th Leg., R.S.,
ch. 910, §§ 2–3, 2023 Tex. Gen. Laws 2898, 2898–2902 (rescheduling
substances from Penalty Group 1 to Penalty Group 1–B); Act of June 1,
2021, 87th Leg., R.S., ch. 584, §§ 2–3, 2021 Tex. Gen. Laws 1174, 1177–78
(creating Penalty Group 1–B and rescheduling various types of fentanyl
from Penalty Group 1 to Penalty Group 1–B); Act of May 27, 2017, 85th
Leg., R.S., ch. 491, §§ 1–2, 2017 Tex. Gen. Laws 1301, 1301–09 (adding six
substances to Penalty Group 1 and three substances to Penalty Group 3).
      Beyond possessing broad discretion and primary regulatory
authority over Schedules I–V, the commissioner’s objections to federal
changes are final—that is, a federal change becomes part of Texas law




                                     19
automatically unless the commissioner objects, and if she does, the
eventual decision is subject only to legislative revision. It is “final unless
altered by statute.” Tex. Health & Safety Code § 481.034(g) (emphasis
added). Again, a statute will always trump agency action. Adding “unless
altered by statute” makes clear that no other basis for a challenge will be
cognizable, so § 481.034(g) is tantamount to announcing that, should the
commissioner’s objection be problematic, the legislature will itself provide
any correction.
       With this statutory framework in mind, we turn to the vendors’
ultra vires claims.

                                      B
       The vendors contend that the commissioner lacked discretion to
modify the 2021 Schedules pursuant to § 481.034(g) because the DEA’s
interim final rule was not a scheduling event; the commissioner’s objection
was improper; the commissioner’s objection did not authorize her to modify
the schedules; and even if the amendments were procedurally authorized,
they substantively conflict with the 2019 Texas Farm Bill. We disagree
with each contention.
       A plaintiff bringing an ultra vires claim must “establish that the
[official] acted beyond [his] lawful authority” to survive a plea to the
jurisdiction. Chambers-Liberty Counties Navigation Dist. v. State, 575
S.W.3d 339, 349 (Tex. 2019). We then “determine whether, based on the
limited record in th[e] interlocutory appeal, we agree with the [plaintiff]
that the [official’s action] conflicts with state law.” Id.
       We have also explained that “the effect of a statute making an
executive determination final is to broaden the executive’s discretion by




                                     20
disallowing challenges to executive decisions,” thereby rendering a
challenge nonjusticiable when it “involve[s] executives acting of their own
volition in making determinations.” Willacy County Appraisal Dist. v.
Sebastian Cotton & Grain, Ltd., 555 S.W.3d 29, 51 (Tex. 2018). So too here.
The commissioner’s § 481.034(g) objections are “final” and therefore binding
“unless altered by statute.” Tex. Health & Safety Code § 481.034(g). The
finality provision inherently reposes substantial discretion in the
commissioner.
       The vendors present significant and forceful arguments that the
2019 Texas Farm Bill protects their chosen conduct, but they have not
established an insoluble conflict between the commissioner’s listing
decision and the express terms of § 481.034(g) or the 2019 Texas Farm Bill.
We accordingly hold that sovereign immunity applies because, as to both
their procedural and substantive challenges, the vendors’ ultra vires
claims fail.
       Start with procedure. The commissioner acted within her discretion
in determining that the federal rule effected a substantive alteration to a
controlled substance under federal law, thereby triggering subsection (g).
By its terms, the federal interim final rule “amend[ed] the scope of
substances falling within” the definition of federal Schedule I “marihuana
extract,” 85 Fed. Reg. 51641 (emphasis added), and “decontrolled” “hemp-
derived extracts containing less than 0.3%-THC content . . . along with the
plant itself,” id. at 51644 (emphasis added).
       It was expressly within the commissioner’s unreviewable,
discretionary authority to object rather than allow the federal changes
to automatically become part of Texas law. We have no jurisdiction to




                                    21
opine on the merits of the objection; as discussed, the legislature reserved
to itself the exclusive authority to review a commissioner’s objection
pursuant to § 481.034(g). See Willacy County, 555 S.W.3d at 51. We do
not understand the vendors to seriously challenge this legal position.
      We further conclude that § 481.034(g) authorized the commissioner
to update Schedule I’s THC and “marihuana extract” definitions to comport
with her objection that the modified federal “definitions allow for the
presence or addition of [THC] aside from the presence of delta-9-[THC],”
45 Tex. Reg. at 6614, and to clarify Texas law in light of the change in
federal law that had prompted her objection. Because the modifications
were made in response to federal law, the other procedures enumerated in
§§ 481.034–.035 that bind the commissioner’s unilateral modifications did
not apply.
      The commissioner therefore complied with all the procedural
requirements that governed her actions. She published the reasons for the
objection on the department’s website. See id. at 6613–14. And she gave
all interested parties an opportunity to be heard at the October 2020 public
hearing (at which the department received no comments). See 46 Tex. Reg.
at 874. Following the hearing, she published a final decision declining to
adopt the DEA’s modifications, see id. at 873–74, and later clarified Texas
law in light of that objection, see id. at 1768, 1770. There can be no real
doubt that, in light of the broad discretion reposed in the commissioner,
she possesses the authority to provide such clarifications about the
legal regime that she is charged with superintending. We hold that
the   commissioner    complied    with    the   procedural   requirements
enumerated in § 481.034(g), which means that the vendors’ procedural




                                    22
ultra vires claim fails and sovereign immunity applies.
      Next, the substantive ultra vires claim. The vendors contend that
the 2019 Texas Farm Bill decontrolled all non-delta-9 THC, including
delta-8 THC at any concentration. They assert that only products with a
delta-9-THC concentration over 0.3% are illegal, so the commissioner’s
2021 modifications contravened the 2019 Texas Farm Bill.
      That view is plausible and indeed rooted in the statutory text. The
2019 Texas Farm Bill removed “hemp” and “the [THC] in hemp” from
Schedule I. Tex. Health & Safety Code § 481.002(26)(F). And hemp is any
part of the cannabis plant “with a delta-9 [THC] concentration of not more
than 0.3 percent on a dry weight basis.” Tex. Agric. Code § 121.001
(emphasis added). The legislature thus imposed a 0.3% delta-9-THC
content limit—all parts of the cannabis plant with a delta-9-THC
concentration of greater than 0.3% are marijuana (a Schedule I controlled
substance), and all parts of the plant with a delta-9-THC concentration less
than or equal to 0.3% are hemp (and therefore decontrolled). Since
manufactured delta-8-THC products are converted from CBD, a substance
below that 0.3% delta-9-THC limit, the 2019 Texas Farm Bill could be read
to authorize manufactured delta-8-THC products.
      But our understanding of and respect for this textual argument does
not entail an ultra vires finding because the argument does not reflect the
most natural interpretation given the Texas Controlled Substances Act’s
text, structure, and statutory history. We have long recognized the
“fundamental principle of statutory construction that words’ meanings
cannot be determined in isolation but must be drawn from the context in
which they are used.” Willacy County, 555 S.W.3d at 39. We therefore




                                    23
“avoid construing a statutory provision in isolation from the rest of the
statute” and instead “consider the act as a whole, and not just single
phrases, clauses, or sentences.” Cities of Austin, Dallas, Fort Worth &
Hereford v. Sw. Bell Tel. Co., 92 S.W.3d 434, 442 (Tex. 2002).
      The legislature went to considerable effort to create a reticulated
legal structure where the commissioner is the primary decisionmaker in
establishing and modifying the schedules. It empowered the commissioner
with broad discretion—subject only to the obvious limitation that her
actions cannot contravene what the legislature itself has decreed by
statute. See Tex. Health & Safety Code § 481.034(c). And if she oversteps
(or understeps), the legislature has made itself the primary entity for
correction. The legislature has rarely disturbed the commissioner’s
decisions, which further justifies regarding the commissioner as exercising
primary regulatory authority; but in those rare instances when the
legislature has spoken in this area, it has done so clearly and
unambiguously.      See, e.g., id. § 481.037 (“Schedule IV includes
carisoprodol.”); id. § 481.002(26)(F) (“ ‘Marihuana’ . . . does not include
hemp”); id. § 481.002(5) (“ ‘Controlled substance’ . . . does not include
hemp, . . . or the [THC] in hemp.”). We would expect such a clear and
unambiguous response in this instance, too, if the commissioner indeed
had exceeded her mandate.
      When the legislature adds, deletes, or reschedules substances,
therefore, it speaks with clarity if it means to upend a historic regulatory
principle. That practice comports with the familiar maxim that legislatures
don’t “hide elephants in mouseholes.” Whitman v. Am. Trucking Ass’ns,
531 U.S. 457, 468 (2001). Absent a clear statement, we decline to imply




                                    24
significant disruptions to the commissioner’s longstanding regulatory
authority. Said differently, if the legislature wishes to eliminate the
commissioner’s discretion in this highly discretion-laden area, it will do
so clearly.
       These principles require us to reject the vendors’ assertion that the
legislature put the elephant of all THC (even THC created wholly
artificially) in the mousehole that governs only the natural plant itself.
The legislature amended the definition of “marihuana” by exempting and
defining “hemp,” which covers only the naturally occurring constituents of
THC in hemp. See Tex. Agric. Code § 121.001. Because the legislature’s
“hemp” exception does not unambiguously include the naturally occurring
hemp plant and a final consumable product containing levels of THC that
substantially exceed those naturally existing in any actual hemp plant, we
must reject the contention that the 2019 Texas Farm Bill itself decontrolled
anything more than the exceedingly trace amounts of delta-8 THC that
naturally occur in hemp. Holding otherwise would require us to accept the
doubtful premise that the legislature decontrols potent substances
(here, THC and marijuana extract) casually or by implication.
       Embracing the vendors’ argument would also require us to conclude
that consumable hemp products containing potent levels of delta-8 THC
cannot be illegal synthetic analogues (as the department treats them). It
would require us to understand the term “all derivatives” in the definition
of “hemp” to encompass not only the plant itself and its naturally occurring
compounds, but also any compound at any potency that theoretically could
be derived from the hemp plant by someone in a lab—even if such a
compound never appears or could appear in nature and even if the final




                                    25
product emulates the THC in marijuana. Again, if the legislature intended
such a massive change to such a significant area of social policy, we would
expect it to speak clearly. Otherwise, we cannot conclude that it intended
so indirectly to remove the commissioner’s discretion to designate
manufactured products with potent THC levels as synthetic equivalents
to marijuana.
      There is one potential conflict between the amended schedules and
the 2019 Texas Farm Bill, but it is one that the government has disclaimed
any intention to enforce—in part because it cannot. The 2019 Texas Farm
Bill excluded “[THC] in hemp” from the definition of “controlled substance,”
Tex. Health & Safety Code § 481.002(5), and it is undisputed that delta-8
THC is naturally present in trace amounts in the hemp plant—so trace, in
fact, that it apparently is almost impossible even to test for it. These
naturally occurring delta-8-THC isomers were decontrolled by statute.
There is therefore at least some theoretical tension between the 2019 Texas
Farm Bill and the 2021 Schedules, which narrowed the THC-in-hemp
exemption by controlling all but one naturally occurring THC isomer in
hemp—delta-9 up to 0.3% dry weight. See 46 Tex. Reg. at 1768 (exempting
“up to 0.3 percent delta-9-[THC] in hemp” from the term THC in Schedule
I (emphasis added)).
      The commissioner, however, has represented to the Court that
delta-8 THC that naturally occurs in the hemp plant is tolerable under the
current legal regime. In light of reality, in which such amounts are not
even detectable, how could she do otherwise? For that same reason,
however, this concession is of no benefit to the vendors. The manufactured
delta-8-THC products the vendors wish to manufacture and sell




                                    26
substantially—dramatically—exceed the delta-8-THC content that
naturally exists in any actual hemp plant. An injunction against the
commissioner, who has disclaimed any intention to enforce the only conflict
between the 2021 Schedules and the 2019 Texas Farm Bill, would
therefore be an “empty vessel” courts lack subject-matter jurisdiction to
issue. Zurawski, 690 S.W.3d at 659.
                                 *   *    *
      The legislature clearly defined “hemp” to encompass the plant itself
and the compounds as found in the plant. The legislature gave that inch,
but the vendors claim a mile—that the legislature exempted all THC, even
in non-naturally-occurring ways. We reject that contention, which would
unsettle the structure of this highly regulated area of law and inject the
judiciary into matters wholly occupied by the other branches. Until there is
a clear withdrawal of the commissioner’s discretion, no court can properly
deem the commissioner’s listing decisions to have been made ultra vires.

                                     IV
      We turn now to the APA claim against the department. This claim
arises out of the department’s October 2021 website announcement that
“[a]ll other forms of THC, including Delta-8 in any concentration and Delta-
9 exceeding 0.3%, are considered Schedule I controlled substances.”
(Emphasis added.)     The vendors allege that this website statement
constitutes an APA “rule” that was published without the required public
notice, opportunity for comment, or reasoned justification. And because
the APA waives sovereign immunity for a claim challenging the validity or
applicability of an agency’s rule “if it is alleged that the rule or its
threatened application interferes with or impairs . . . a legal right or




                                     27
privilege of the plaintiff,” Tex. Gov’t Code § 2001.038(a), they argue the
APA claim survives the department’s plea to the jurisdiction.
      It is not the APA, however, but the Texas Controlled Substances Act
that governs the department’s publication of modifications to the Texas
schedules. Where a “well-established regulatory scheme and the legislation
governing it” provide the procedures agencies must follow in taking specific
actions, APA procedures do not apply. PUC v. RWE Renewables Ams.,
LLC, 691 S.W.3d 484, 492 (Tex. 2024). Section 481.034 and the broader
Texas Controlled Substances Act provide a “well-established regulatory
scheme” for establishing, modifying, and publishing the schedules, so the
APA is the wrong statutory framework to invoke.
      It would make little sense for modification and publication of the
schedules themselves to be subject to § 481.034 procedures but a mere
website-published policy statement purporting to summarize or describe
such modifications and publications be subject to separate APA
procedures. Otherwise, almost any governmental statements about the
government’s understanding of current policy or law in any context
imaginable could be converted into APA “rulemaking” subject to judicial
scrutiny. Cf. TEA v. Leeper, 893 S.W.2d 432, 443 (Tex. 1994) (“Not every
statement by an administrative agency is a rule for which the APA
prescribes procedures for adoption and for judicial review.”). Would a
speech by an executive-branch official—perhaps the governor himself—
describing a view of current law constitute APA “rulemaking”? Why not,
if a website’s comment about public policy would?
      We hold instead that an agency pronouncement purporting to
merely summarize rules promulgated via a non-APA process is not itself




                                    28
an APA rule. The statement did not purport to amend the schedules. Even
if it had, however, it would have been subject not to APA procedures but to
§ 481.034. Moreover, the department acknowledges that the announcement
has no independent legal effect. No one can be civilly penalized for
violating the statement. Cf. El Paso Hosp. Dist. v. Tex. Health & Hum.
Servs. Comm’n, 247 S.W.3d 709, 714 (Tex. 2008) (indicating that APA rules
carry the “effect of law”). Unsurprisingly, the department has disclaimed
any intention to enforce the website statement. An injunction purporting
to invalidate such a statement’s effectiveness would be meaningless, not to
mention an unacceptable intrusion by the judiciary into the work of a
co-equal branch of government. Sovereign immunity bars the vendors’
APA claims.

                                     V
      Because sovereign immunity bars the vendors’ claims, the
temporary injunction must be reversed. Two features of the trial court’s
injunction, however, warrant mention.
      First, the trial court ordered the department to “remove from its
currently published Schedule of Controlled Substances the . . .
modifications of the definitions to the” terms THC and “marihuana
extract,” as well as “any subsequent publications of the same (if any).” The
temporary injunction, in other words, goes beyond vindicating what the
trial court mistakenly understood to be the rights of parties before it, and
actually purports to instruct policymakers in the executive branch to
rewrite the schedules themselves. Such an order aggrandizes judicial
power and transgresses the separation of powers. Cf. Whole Woman’s
Health v. Jackson, 595 U.S. 30, 44 (2021) (“[U]nder traditional equitable




                                    29
principles, no court may ‘enjoin the world at large,’ or purport to enjoin
challenged ‘laws themselves.’ ” (citations omitted)); Jonathan F. Mitchell,
The Writ-of-Erasure Fallacy, 104 Va. L. Rev. 933, 936 (2018) (arguing that
federal courts lack “authority to erase a duly enacted law from the statute
books, and they have no power to veto or suspend a statute”).
       Second, the trial court’s temporary injunction prohibits enforcement
of the amendments against anyone in the State, not just the plaintiffs to
this lawsuit. The U.S. Supreme Court has instructed federal courts that
such “universal injunctions” “likely exceed the equitable authority that
Congress has granted to” those courts. Trump v. CASA, Inc., 606 U.S. 831,
837 (2025). We have held that orders issued pursuant to Texas Rule of
Appellate Procedure 29.3 cannot grant relief to “any and all nonparties who
may find themselves in circumstances similar to the plaintiffs’ ” in a suit. In
re Abbott, 645 S.W.3d 276, 283 (Tex. 2022) (quotation marks omitted). We
need not resolve whether the scope and nature of the trial court’s temporary
injunction here was improper because we reverse it on other grounds, but
we caution Texas courts to ensure that any injunction they issue is no
broader than necessary to protect the rights of the parties before them.
                                  *   *    *
       We affirm the judgment of the court of appeals as to standing and
reverse as to the ultra vires and APA claims. We render judgment
reversing the trial court’s order that granted the temporary injunction.




                                           Evan A. Young
                                           Justice

OPINION DELIVERED: May 1, 2026



                                      30