[J-57-2024] IN THE SUPREME COURT OF PENNSYLVANIA MIDDLE DISTRICT
TODD, C.J., DONOHUE, DOUGHERTY, WECHT, MUNDY, BROBSON, McCAFFERY, JJ.
GREEN ANALYTICS NORTH, LLC D/B/A : No. 76 MAP 2023 STEEP HILL PA, HANGING GARDENS, : LLC, PENNSYLVANIA MEDICAL : Appeal from the Order of the SOLUTIONS, LLC, CURALEAF PA, LLC, : Commonwealth Court at No. 104 AES COMPASSIONATE CARE, LLC, : MD 2023 dated June 29, 2023 STANDARD FARMS, LLC, AND PAREA : BIOSCIENCES, LLC, : ARGUED: September 10, 2024 : Appellees : : : v. : : : PENNSYLVANIA DEPARTMENT OF : HEALTH, : : Appellant :
OPINION
JUSTICE McCAFFERY DECIDED: September 25, 2025 With the enactment of Act 16 of 2016, known as the Medical Marijuana Act (the Act
or the MMA), Pennsylvania became the 24th state to legalize medical marijuana. The Act
created a medical marijuana program and tasked Appellant, the Pennsylvania
Department of Health, with implementing and regulating the program. In turn, the
Department required growers and processors (in the parlance of the Act,
“growers/processors”) of medical marijuana to employ one independent laboratory for
testing harvest lots, and a second, distinct, independent laboratory for testing lots after
processing. This is known as the “two-lab requirement.” Appellees, entities approved by the Department to engage in the business of
medical marijuana, 1 contend the two-lab requirement exceeds the powers granted to the
Department under the Act. Specifically, Appellees argue the two-lab requirement
contradicts the Act’s command that growers/processors use “one or more independent
laboratories” to test lots at harvest and final processing. See 35 P.S. § 10231.704
(Section 704). The Commonwealth Court agreed with Appellees, concluding Section 704
granted growers/processors a right to decide how many independent laboratories to use.
We disagree. The primary goal of the Act is to alleviate the suffering of seriously
ill patients. This goal necessarily relies upon a focus on patient safety – unsafe medical
marijuana, by definition, will only increase the suffering of such patients. Since the
Commonwealth Court engaged in an acontextual analysis of Section 704 of the Act with
no consideration of patient safety, we reverse and remand to the Commonwealth Court
for further consideration.
I. The Medical Marijuana Act
The Act legalized marijuana for medical purposes under Pennsylvania law, but
marijuana otherwise remains illegal. 2 See 35 P.S. §§ 10231.303-10231.304. Through
the MMA, the Legislature acknowledged that there is scientific evidence suggesting that
medical marijuana “may mitigate suffering in some patients and also enhance quality of
life.” 35 P.S. § 10231.102(1).
The Legislature also indicated that it is “committed to patient safety.” 35 P.S. §
10231.102(2). Indeed, the Act references patient safety three separate times in setting
1 Green Analytics North, LLC (d/b/a Steep Hill Pa.) is an approved laboratory under the
Act. Hanging Gardens, LLC, Pennsylvania Medical Solutions, LLC, Curaleaf, Pa, LLC, AES Compassionate Care, LLC, Standard Farms, LLC, and Parea BioSciences, LLC, are approved growers/processors under the Act. 2 Marijuana is still classified as a schedule I narcotic under federal law. See 21 U.S.C. § 812.
[J-57-2024] - 2 forth its explicit policy goals. See 35 P.S. § 10231.102(2), (3)(i), (3)(ii). The Legislature
also sought to incentivize research into the effectiveness and safety of medical marijuana.
See 35 P.S. § 10231.102(2), (3)(iii).
Through the Act, the Legislature created a tightly regulated market with limited
participants. Only growers/processors approved by the Department are permitted to grow
or process medical marijuana. See 35 P.S. § 10231.601; 35 P.S. § 10231.101.
Growers/processors may sell their product to dispensaries who have been approved by
the Department. See 35 P.S. § 10231.616(7). Dispensaries act as retailers — selling
medical marijuana to patients — and must obtain marijuana only from approved
growers/processors. See 35 P.S. § 10231.101 (defining “Dispensary”); § 10231.616(6)
(requiring dispensaries to only purchase medical marijuana from a grower/processor).
Dispensaries are subject to multiple statutory requirements, including packaging
and labeling obligations. Package labels must include: (1) dispensing information; (2)
the packaging date; (3) any applicable expiration date; (4) warnings about side effects;
(5) the amount of doses, the species of marijuana, the percentage of
tetrahydrocannabinol [THC]; and the percentage of cannabidiol [CBD]; 3 (6) a warning that
the medical marijuana must remain in the package as dispensed; (7) a warning that
unauthorized use is subject to criminal penalties; and (8) “[a]ny other information required
by the department.” 35 P.S. § 10231.801(i).
The Department is tasked with creating and maintaining an electronic database
capable of tracking virtually all activities in the medical marijuana program. See 35 P.S.
3 “THC is delta-9-tetrahydrocannabinol, the main psychoactive ingredient in the cannabis
plant. It’s what makes you feel ’high’ when you smoke marijuana or eat an edible. … CBD is short for cannabidiol. It’s also made from the cannabis plant. CBD is related to THC, but it’s not psychoactive, so it doesn’t make you ’high’ like THC does.” See https://www.webmd.com/pain-management/cbd-thc-difference (last visited September 19, 2025).
[J-57-2024] - 3 § 10231.301(a)(4). This database is to aid the Department in ensuring that “medical
marijuana is not diverted or otherwise used for unlawful purposes[.]” 35 P.S. §
10231.301(a)(4)(i). Further, the Department’s database must “[m]onitor[] all growth,
transfer, possession, processing, testing and dispensing of medical marijuana” in
Pennsylvania. 35 P.S. § 10231.301(a)(4)(iv). The database must be capable of providing
this information in real time. See 35 P.S. § 10231.301(a)(4)(v).
II. The MMA’s Independent Laboratory Requirement
As initially enacted, the Act required growers/processors to contract with an
independent laboratory to test batches of product:
A grower/processor shall contract with an independent laboratory to test the medical marijuana produced by the grower/processor. The department shall approve the laboratory and require that the laboratory report testing results in a manner as the department shall determine, including requiring a test at harvest and a test at final processing. The possession by a laboratory of medical marijuana shall be a lawful use.
35 P.S. § 10231.704 (Act 16 of 2016). However, the legislature subsequently amended
Section 704:
A grower/processor shall contract with an independent laboratory one or more independent laboratories to test the medical marijuana produced by the grower/processor. The department shall approve the a laboratory under this subsection and require that the laboratory report testing results in a manner as the department shall determine, including requiring a test at harvest and a test at final processing. The possession by a laboratory of medical marijuana shall be a lawful use.
35 P.S. § 10231.704 (Act 44 of 2021). 4
4 One consequence of marijuana remaining a prohibited narcotic under federal law is that
any such “independent” laboratory is currently ineligible to contract with the federal government or receive a federal grant. See 41 U.S.C. § 701. These laboratories thus face a constricted market for their services.
[J-57-2024] - 4 III. The Department’s “Two-Lab Requirement”
Several months after enactment, the Department published temporary regulations
to implement, among other things, the testing referenced under Section 704. One
temporary regulation identified the minimum sampling points for testing a lot of medical
of marijuana: (1) after harvest but before any further processing (“harvest lot”); and (2)
after processing but before marketing of the batch (“process lot”). See 46 Pa.B. 8036
(proposed 28 Pa.Code § 1171.29(c)). The Department simultaneously required that
laboratories test samples for: “(1) Pesticides[;] (2) Solvents[;] (3) Water activity and
moisture content; (4) THC and CBD concentration[; and] (5) Microbiological
contaminants.” Id. (proposed 28 Pa.Code § 1171.29(d)). Further, all testing was required
to comply with scientific and Department standards. Id. (proposed Pa.Code § 1171.29(e),
(f)).
In February 2021, the Department provided notice of its intent to update the
testing regulations. The proposed update would still require, as a minimum, sampling of
a harvest lot and a process lot. See 51 Pa.B. 1201 (proposed 28 Pa.Code § 1171a.29(c)).
However, the updated regulation included the two-lab requirement:
(c) At a minimum, testing, as prescribed by the Department, shall be performed as follows:
(1) An approved laboratory shall test samples from a harvest batch or harvest lot prior to using the harvest batch or harvest lot to produce a medical marijuana product.
(2) An approved laboratory other than the one that tested the harvest batch or harvest lot shall test samples from each process lot before the medical marijuana is sold or offered for sale to another medical marijuana organization.
[J-57-2024] - 5 Id. 5 The two-lab requirement went into effect on March 4, 2023, when the Department
published the regulation in its final form:
(c) Testing shall be performed as follows:
(1) An approved laboratory shall test samples from a harvest batch or harvest lot prior to using the harvest batch or harvest lot to produce a medical marijuana product.
(2) An approved laboratory other than the one that tested the harvest batch or harvest lot shall test samples from each process lot before the medical marijuana is sold or offered for sale to another medical marijuana organization. 53 Pa.B. 1275.
On that same day, Appellees filed a joint Petition for Review in the Commonwealth
Court, contending the “two-lab requirement” contained in Section 1171a.29(c)(2)
exceeded the Department’s authority under the Act. 6 The Department subsequently
agreed to suspend enforcement of the two-lab requirement pending litigation of Appellees’
petition.
IV. The Commonwealth Court’s Decision
On June 29, 2023, a divided en banc panel of the Commonwealth Court held that
the regulation’s two-lab requirement is inconsistent with Section 704 of the Act and
declared the two-lab requirement unenforceable. See Green Analytics North, LLC v. Pa.
Dep’t of Health, 298 A.3d 181 (Pa. Cmwlth. 2023) (en banc). The Court applied what is
often called the “Tire Jockey test.” See id. at 186 (referencing Tire Jockey Serv. Inc. v.
5The proposed update of Section 1171a.29(c) was approved by the Independent Regulatory Review Commission on October 20, 2022. Notably, the legislature’s amendment of Section 704 of the Act occurred in the interim — on June 30, 2021. 6 The petition alleged Section 1171a.29(c) was invalid because: (1) it exceeds the Department’s statutory authority; (2) it violates the non-delegation doctrine; and (3) it violates the Contracts Clauses of the Pennsylvania and U.S. Constitutions. The petition sought to temporarily and permanently enjoin the Department from enforcing Section 1171a.29(c).
[J-57-2024] - 6 Dep’t of Env’t Prot., 915 A.2d 1165, 1186 (Pa. 2007)). Under that test, a regulation is
binding upon courts if (a) a statute empowers the agency to adopt it; (b) the agency
followed proper procedure in issuing it; and (c) the regulation is reasonable. See id.
In granting summary relief, the Commonwealth Court majority reached only the
first step — whether the two-lab requirement was adopted pursuant to a statutory grant
of authority. See Green Analytics North, 298 A.3d at 187. The Commonwealth Court
identified the issue before it as “whether [the two-lab requirement] is in conflict with the
Act which mandates that growers/processors contract with one or more [labs] for testing.”
Green Analytics North, 298 A.3d at 187. The Court emphasized that the plain language
of Section 704(a) of the Act utilized “or” in the phrase “one or more independent
laboratories[.]” See id. “Thus, the plain meaning of Section 704(a) of the Act is that
growers/processors may contract with only one Lab if they so choose.” Id. (emphasis in
original). As a consequence, the Court ruled that the two-lab requirement was invalid and
unenforceable. See id. at 188. Once it concluded that the two-lab requirement conflicted
with the explicit terms of the Act, the majority went no further.
President Judge Cohn Jubelirer dissented, joined by Judge McCullough. Judge
Cohn Jubelirer focused on the breadth of regulatory power granted to the Department
under Section 301 of the Act. See Green Analytics North, 298 A.3d at 189. She noted
that Section 301(a)(1) established a medical marijuana program in Pennsylvania and
requires the Department to implement and administer the program. See id. In her view,
Section 301(a)(3) provides additional enlightenment, declaring that the Department “shall
have regulatory and enforcement authority over the growing, processing, sale and use of
medical marijuana[.]” Id. (citation, emphasis, and brackets omitted). Judge Cohn
Jubelirer also highlighted that Section 301(b) directed the Department to “promulgate all
regulations necessary to carry out the provisions of the Act.” Id. (citation, emphasis, and
[J-57-2024] - 7 brackets omitted). She also observes the Act repeatedly references a concern for patient
safety. See id. at 190.
Judge Cohn Jubelirer thus concluded that “the General Assembly broadly charged
the Department with regulating and enforcing the Act’s provisions and required the
Department to adopt all regulations necessary to carry out its responsibility.” Green
Analytics North, 298 A.3d at 190. Accordingly, the Act’s language “evinces that the
General Assembly authorized the Department to implement testing requirements through
more than one Lab as the Department may deem appropriate in furtherance of the stated
obligations and broad authority the Act grants the Department[.]” Id. at 190-191.
The Department appealed to this Court, challenging the Commonwealth Court
Majority’s conclusion that the Department lacks authority under the Act to impose the two-
lab requirement. 7
V. Standard of Review
The Commonwealth Court did not identify any dispute of material fact in granting
summary relief. No party before this Court has done so either. Accordingly, in reviewing
the Commonwealth Court’s grant of summary relief, we simply determine whether the
court committed an error of law. See Pa. Med. Soc. v. Dep’t of Pub. Welfare of Com., 39
A.3d 267, 277 (Pa. 2012). Here, the Commonwealth Court determined that the two-lab
requirement imposed by the Department exceeded the Department’s authority under the
Act. We therefore begin by reviewing agency law principles.
VI. Agency Law
Commonwealth agencies have no power to impose regulations in the absence of
authorization by the Legislature. See Marcellus Shale Coalition v. Dep’t of Evntl. Prot.,
7 As this matter was initiated in the Commonwealth Court’s original jurisdiction, we have
direct appellate jurisdiction. See 42 Pa.C.S. § 723(a).
[J-57-2024] - 8 292 A.3d 921, 927 (Pa. 2023) (“MSC II”). Agencies are authorized to impose regulations
by complying with various statutes. 8 See id. Compliance with these statutes requires,
pursuant to the Tire Jockey test, agencies to establish their regulations are: (a) adopted
pursuant to a statutory grant of power; (b) issued using proper procedures; and (c)
reasonable. See id. (citing Tire Jockey, 915 A.2d at 1186).
As the Department “is a creature of statute, it has only those powers which are
expressly conferred upon it by the Legislature and those powers which arise by necessary
implication.” Feingold v. Bell of Pa., 383 A.2d 791, 794 (Pa. 1977). Thus, our analysis
begins with the Department’s identification of an enabling statute. See MSC II, 292 A.3d
at 938 (observing that a broad grant of power in an enabling statute lessens the need to
scrutinize other sections of the statute that do not explicitly address regulatory authority).
An enabling statute is a statute that “permits what was previously prohibited or that
creates new powers; esp., a congressional statute conferring powers on an executive
agency to carry out various delegated tasks.” BLACK’S LAW DICTIONARY (12th ed. 2024).
As in all cases involving the interpretation of a statute, our foundational premise is
to bring about the Legislature’s intent in enacting the statute. See Crown Castle NG East
LLC v. Pa. Pub. Util. Comm’n, 234 A.3d 665, 674 (Pa. 2020). While “the best indication
of legislative intent is the plain language of the statute[,]” we identify the plain meaning by
considering “the statutory language in context and give words and phrases their common
and approved usage.” Id. (citations and internal quotation marks omitted).
There is an often-unstated tension between the command to consider the statute
in context and the command to give words their common meaning. Yet neither are
elevated above our goal of accomplishing Legislative intent. Indeed, both commands are
8 The Commonwealth Documents Law, 45 P.S. §§ 901 - 907; the Regulatory Review Act,
71 P.S. §§ 745.1 - 745.15; and the Commonwealth Attorneys Act, 71 P.S. §§ 732-101 – 732-506.
[J-57-2024] - 9 mere tools in service of identifying such intent. For example, when a different section of
a statute provides an explicit definition for a word in a statute, we do not ignore the context
in favor of giving the word its common meaning. See 1 Pa.C.S. § 1903(a). Nor do we
give a word its common meaning when it is clear the word is used in a specialized,
technical fashion. See id.
VII. Identifying the Parties’ Duties and Rights Under the MMA
A. The Plain Language of the Act
As noted previously, the Commonwealth Court decided this case purely on the first
step of the Tire Jockey test. It did not reach the issue of the procedures used by the
Department in issuing the two-lab requirement, nor did it address whether the two-lab
requirement is reasonable. Thus, the only issue before this Court at this time is whether
the Commonwealth Court was correct in its conclusion that the Act prohibits the two-lab
requirement.
Here, the Department points to several enabling statutes. First, it notes that
Section 301(a) of the Act requires the Department to implement and enforce the medical
marijuana program in Pennsylvania. See 35 P.S. § 10231.301(a). Section 301(a)(3) links
that command to the Department having “regulatory and enforcement authority over the
growing, processing, sale, and use of medical marijuana” in Pennsylvania. 35 P.S. §
10231.301(a)(3). According to the Department, this is a broad grant of regulatory
discretion limited only by constitutional concerns and the reasonableness prong of the
Tire Jockey test.
The Department also highlights that the Act requires the Department to issue
regulations “necessary to carry out the provisions” of the Act. 35 P.S. § 10231.302.
According to the Department, Section 302 imposes a duty upon the Department to issue
regulations that accomplish the purposes of the Act.
[J-57-2024] - 10 In contrast, Appellees — and the Commonwealth Court below — focus entirely on
Section 704 of the Act. They skip over the question of what the Legislature intended to
accomplish with the enabling statutes, and instead read Section 704 as the only part of
the Act that is relevant to the question before us.
We note that Appellees’ position is immediately dubious. When interpreting a
statute, we should not read the provisions in isolation, but instead understand each
provision in the context of the statute as a whole. See A.S. v. Pa. State Police, 143 A.3d
896, 906 (Pa. 2016). Appellees’ argument asks us to blind ourselves to the rest of the
Act, including the provisions that explicitly address the question of the Department’s
power to regulate. We decline to accept that invitation.
While not completely equivalent, Appellee’s argument is a variation on the concept
of ignoring context through an obsessive focus on individual words. The question before
us is not simply “what does Section 704 mean?” Rather, it is “who did the Legislature
intend to empower to determine how many labs a grower/processor must use in testing
its product?”
Through the first sentence of Section 704, the Legislature clearly imposes a duty
upon growers/processors to use an independent laboratory to test harvest and process
lots of medical marijuana: “A grower/processor shall contract with one or more
independent laboratories to test the medical marijuana produced by the
grower/processor.” 35 P.S. § 10231.704(a). This sentence imposes a duty, not a right,
on growers/processors using the word “shall.” See In re Canvass, 241 A.3d 1058, 1087
(Pa. 2020) (Wecht, J., concurring) (declaring that “shall” can only be read as mandatory
and stating “we must prefer the sometimes-unsatisfying clarity of interpreting mandatory
language as such over the burden of seeking The Good in its subtext.”); see also Antonin
[J-57-2024] - 11 Scalia and Brian A. Garner, Reading Law: The Interpretation of Legal Texts, (2012), at
112 (“Mandatory words impose a duty; permissive words grant discretion.”).
Further, there are no permissive verbs in the first sentence. The Legislature clearly
understood how to grant rights to growers/processors under the Act through the use of
permissive language. For example, in another section the Legislature provided that
growers/processors “may … [o]btain and transport seed and immature plant material from
outside this Commonwealth during at least one 30-day period per year[.]” 35 P.S. §
10231.702(a)(1) (emphasis added). This a clear expression of a right granted to
growers/processors. Section 702 thus clearly limits the Department’s power to regulate.
For example, the Department may not impose a regulation that completely prohibits
growers/processors from obtaining marijuana seeds from outside the Commonwealth.
Yet even the rights granted to growers/processors under Section 702(a) are explicitly
conditioned on compliance with Department regulations. See id.
If the Legislature intended to grant growers/processors the right to choose the
number of laboratories to employ in testing their product, the Legislature would have
identified this right in Section 702(a). In the alternative, the Legislature could have
granted this right to growers/processors in Section 704 through a clear expression of its
intent to do so by using permissive language. The plain language of the Act includes
neither of these options.
A similar analysis leads us to conclude that the plain language of Section 704 in
isolation does not explicitly grant the Department the discretion to choose how many labs
must be employed by growers/processors. The second sentence of Section 704 imposes
duties upon the Department through use of the verb “shall.” The plain language does not
[J-57-2024] - 12 grant the Department discretion. 9 We therefore cannot construe Section 704 as explicitly
granting discretion to either growers/processors or the Department. Notably, the plain
language of Section 704, viewed in isolation, does not answer the question of who is
granted discretion in deciding the number of labs to use.
Appellees argue that the two-lab requirement “deletes” the word “one” from Section
704. This is simplistic sophistry. Section 704 clearly envisions a choice between “one”
and “more than one.” That someone gets to choose between those options does not
“delete” the other option. Indeed, the very presence of the choice indicates that someone
has the power to choose between the options; neither option is statutorily superior. As
noted previously, our task is merely to determine to whom the Legislature intended to
grant the discretion to decide between the options of “one” or “more.”
In that vein, viewing Section 704 in context of the Act as a whole is necessary to
answer the question of who gets to decide. The Act is not garden-variety legislation which
seeks to regulate otherwise lawful behavior. See, e.g., MSC II, 292 A.3d 921 (construing
regulations governing gas wells); Tire Jockey Serv. Inc., supra. (construing regulations
governing the disposal of discarded tires). Instead, the Legislature, through the Act,
intended to repeal the wholesale prohibition of marijuana use under Pennsylvania law.
See 35 P.S. § 10231.303(a) (“Notwithstanding any provision of the law to the contrary,
use or possession of medical marijuana as set forth in this act is lawful within this
Commonwealth.”). Absent compliance with the Act, marijuana — medical or not —
9 The second sentence of Section 704 highlights some of the difficulties created by an
excessive focus on the common definitions of words used in a statute: “The Department shall approve a laboratory under this subsection and require that the laboratory report testing results in a manner as the department shall determine, including requiring a test at harvest and a test at final processing.” 35 P.S. § 10231.704(a). The sentence contains the word shall twice and clearly imposes duties upon the Department. The sentence does not contain the verb “may” or any other verb that indicates discretion. Nonetheless, there can be no doubt that, read in context of the whole Act, the Legislature intended to grant the Department discretion to determine the form and substance of testing reports.
[J-57-2024] - 13 remains illegal under Pennsylvania law. See 35 P.S. § 10231.304(a). Thus, the Act
enables not only the Department to regulate, but also enables growers/processors to
engage in, the business of medical marijuana. 10
Under these circumstances, we must determine not only what rights, powers, and
duties the Act grants or imposes on the Department, but also what rights, powers, and
duties the Act grants or imposes on growers/processors.
B. Contextual Considerations
We have already demonstrated the plain language of Section 704(a) does not
identify to whom the Legislature is granting discretion. We therefore must look to the rest
of the Act, and especially (1) the explicit declaration of policies and (2) the explicit enabling
statutes included in the Act.
Here, the Legislature provides an explicit list of its policies in Section 102 of the
Act. As noted previously, the Legislature acknowledged that there is scientific evidence
10 This Court has historically recognized that under similar circumstances arising from the
legalization of gambling on horse racing, the Legislature is likely to have intended a broader grant of regulatory power:
While the authorizing statute removed the stigma of illegality from the operation, it did not remove all of the many perils, pitfalls, temptations and traps for the unwary, nor the occasions for corruption for the participants, all of which are inherent in any gambling operation of such proportions. The Legislature recognized the existence of these dangers unless the racing meetings were strictly governed and controlled by rules covering the many details which the statute did not cover. It is contemplated that the Commission would be best equipped to supervise the racing operations, and it gave the Commission the very broad powers necessary to accomplish the purpose.
Gilligan v. Pa. Horse Racing Comm’n, 422 A.2d 487, 490 (Pa. 1980) (internal parentheses omitted) (quoting Colella v. State Racing Comm’n, 274 N.E.2d 331, 334-336 (Mass. 1971)). While we believe this “thumb on the scale” approach is not consistent with our duty to effectuate the intent of the legislature, Gilligan demonstrates that there is a qualitative difference between the Act and a common regulatory scheme.
[J-57-2024] - 14 suggesting that medical marijuana “may mitigate suffering in some patients and also
enhance quality of life.” 35 P.S. § 10231.102(1). Thus, the Legislature explicitly sought
to alleviate the suffering of seriously ill patients and improve their quality life.
Next, the Legislature stated that it is “committed to patient safety.” 35 P.S. §
10231.102(2). As such, “[c]arefully regulating the program which allows access to
medical marijuana will enhance patient safety while research into its effectiveness
continues.” Id. Through this provision, the Legislature identified “patient safety” as a
concern, perhaps the primary concern, of the Act. Further, the Legislature recognized
that “careful regulation” of the medical marijuana program serves the purpose of patient
safety. When read in conjunction with subsection (1), it is clear the Legislature desired to
provide the Department with sufficient regulatory power to avoid unsafe medical
marijuana products that could increase the suffering of seriously ill patients. Thus, a focus
on patient safety serves both of the first two policies explicitly identified by the Legislature.
Two of the remaining three policies identified by the Legislature in Section 102 also
explicitly reference patient safety:
(3) It is the intent of the General Assembly to: a. Provide a program of access to medical marijuana which balances the need of patients to have access to the latest treatments with the need to promote patient safety. b. Provide a safe and effective method of delivery of medical marijuana to patients. c. Promote high quality research into the effectiveness and utility of medical marijuana. 35 P.S. § 10231.102(3) (emphasis added).
Accordingly, patient safety is explicitly mentioned in three of the five goals set forth
in Section 102. Of the remaining two goals, patient safety is clearly related to the
Legislature’s desire to mitigate the suffering of seriously ill patients.
What other policies are set forth in Section 102? Three of the six subsections
indicate that the Legislature desired to increase knowledge about the benefits of medical
[J-57-2024] - 15 marijuana. First, subsection (1) indicates that “scientific evidence suggests” that medical
marijuana can be a useful treatment for some patients. 35 P.S. § 10231.102(1) (emphasis
added). This implies the Legislature did not believe that such usefulness had already
been scientifically established. Rather, the Legislature’s statement opines that there is
reason to believe marijuana has medical value, but that more research is necessary.
Subsection (2) declares that regulation of the medical marijuana program “will enhance
patient safety while research into its [medical marijuana’s] effectiveness continues.”
35 P.S. § 10231.102(2) (emphasis added). Again, this statement reveals a legislative
preference for more scientific evidence regarding marijuana’s effectiveness for treating
ailments. Finally, Subsection (3)(iii) clearly sets forth a desire to “[p]romote high quality
research into the effectiveness and utility of medical marijuana.” 35 P.S. §
10231.102(3)(iii). 11
Finally, we note that subsection (3)(i) provides a limiting principle for patient safety
(and arguably research promotion): “It is the intent of the General Assembly to …
[p]rovide a program of access to medical marijuana which balances the need of patients
to have access to the latest treatments with the need to promote patient safety.” 35 P.S.
§ 10231.102(3)(i). Thus, the legislative intent is to prevent a situation where an excessive
11 It is important to note that in pharmaceutical research, “effectiveness” can have a
slightly specialized meaning. “Efficacy can be defined as the performance of an intervention [such as the administration of a pharmaceutical] under ideal and controlled circumstances, whereas effectiveness refers to its performance under ‘real world’ conditions.” https://pmc.ncbi.nlm.nih.gov/articles/PMC3912314. (last visited September 19, 2025). Pharmaceutical effectiveness is directly correlated with dosage, while pharmaceutical safety is generally inversely correlated with dosage. See, e.g., Mayo Collaborative Svcs. v. Prometheus Labs., Inc., 566 U.S. 66, 73 (2012) (noting that “[b]ecause the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective.”)
[J-57-2024] - 16 focus on patient safety renders medical marijuana inaccessible to patients who might
benefit from it.
With these goals in mind, we note the Legislature could have chosen to allow
growers/processors to test their raw materials or product in-house, or through an
otherwise dependent laboratory such as a wholly owned subsidiary. It clearly chose not
to. The obvious purpose of requiring the use of an independent laboratory is to avoid
conflicts of interest in generating accurate test results, since accurate and independent
test results serve the clearly expressed statutory goals of patient safety.
Accurate test results serve another explicit statutory goal: the promotion of “high
quality research into the effectiveness and utility of medical marijuana.” See 35 P.S. §
10231.102(3)(iii). Needless to say, high quality research requires high quality, accurate
testing. As but one example of many, consider whether clinical trials can support any
meaningful scientific conclusions if clinicians cannot accurately determine how much THC
they are administering to patients enrolled in the trial.
We cannot identify any rationale whereby granting growers/processors the
discretion to choose the number of independent laboratories employed effectuates the
Act’s explicit goal of patient safety. Nor can we see how granting this power to
growers/processors enhances the goal of high-quality research.
Arguably, the desire to maintain access to medical marijuana might support giving
discretion to growers/processors as a method of cost containment. However, that policy
is mentioned only as a factor to be balanced against patient safety; in other words, it
imposes a reasonableness limit upon how much emphasis can be placed on patient
safety. Since it is an explicit balancing test, it has less to do with the Department’s or
growers/processers’ statutory authority to make a decision, and more to do with ensuring
that decision is reasonable in light of the goals of the Act. As such, applying this policy to
[J-57-2024] - 17 the two-lab requirement is consigned to the third step of the Tire Jockey test – whether
the regulation is reasonable.
With the goals of patient safety and high quality research in mind, we turn to the
MMA’s enabling statutes. Section 301 of the Act declares that the medical marijuana
program “shall be implemented and administered by the [D]epartment.” 35 P.S. §
10231.301(a). Further, the Department “shall promulgate all regulations necessary to
carry out the provisions of” the Act. 35 P.S. § 10231.301(b). Section 1102 of the Act
directs medical marijuana organizations to “periodically” file reports with the Department
summarizing their “activities.” 35 P.S. § 10231.1102. The Department “shall determine
the information required in and the frequency of filing the reports.” Id. Further, the second
sentence of Section 704 contains enabling language, explicitly granting the Department
discretion over the format and substance of laboratory testing reports. See 35 P.S. §
10231.704.
Taken as a whole, these provisions of the Act evince a comprehensive grant of
regulatory power to the Department. While the Legislature set forth the broad outlines
and goals of the medical marijuana program in the Commonwealth, it clearly intended to
leave many of the details of accomplishing the goals of the program to the Department’s
discretion.
In turn, we must examine the duties imposed on the Department by the Act. Many,
but not all, of these duties are located in Section 301. The first duty imposed is one to
issue permits “to medical marijuana organizations … and ensure their compliance with
this act.” 35 P.S. § 10231.301(a)(1). 12 Further, the Department is tasked with “regulatory
and enforcement authority over the growing, processing, sale and use of medical
12 “Medical marijuana organization” is defined as “[a] dispensary or a grower/processor.”
35 P.S. § 10231.103.
[J-57-2024] - 18 marijuana in this Commonwealth.” 35 P.S. § 10231.301(a)(3). Elsewhere, the Act
declares the lawful use of medical marijuana requires that “[p]roducts packaged by a
grower/processor or sold by a dispensary shall only be identified by,” among other
requirements, “the percentage of [THC] and [CBD] contained in the product and any other
labeling required by the [D]epartment.” 35 P.S. § 10231.303(b)(8). Thus, the Department
is explicitly charged with the duty of enforcing a requirement that medical marijuana
products be labeled with the percentage of active ingredients contained in the products.
While it is possible to imagine that the Legislature did not desire accurate percentages
on the label, it strains credulity to call such an attribution reasonable. As noted above in
fn. 11, dosage amounts are correlated not only with effectiveness of a drug, but also
safety. Accurate results therefore contribute to two of the explicit goals for the Act as set
forth by the Legislature in Section 102.
Similarly, the Act requires the Department to ensure that “medical marijuana is not
diverted or otherwise used for unlawful purposes by a practitioner or medical marijuana
organization.” 35 P.S. § 10231.301(a)(4)(i). A medical marijuana organization commits a
first degree misdemeanor if it intentionally distributes medical marijuana “to a person who
is not lawfully permitted to receive medical marijuana[.]” 35 P.S. § 10231.1302(1).
Accurate test results of harvest batches and final processing are reasonably necessary
to ensure that a grower/processor is not diverting medical marijuana for unlawful
purposes. Perhaps even more importantly, the Act similarly criminalizes the diversion of
medical marijuana by a “laboratory utilized to test medical marijuana under section 704.”
35 P.S. § 10231.1302(4). And it is inescapable that having a second independent
laboratory involved in testing would help detect and deter such illegal diversions by
laboratories. In fact, it may be the only way to do so.
[J-57-2024] - 19 The Department also is required to establish “the procedure to be used by a health
care medical marijuana organization that grows and processes medical marijuana” when
recalling “defective medical marijuana.” 35 P.S. § 10231.907(4). This duty is reiterated
under Section 1903(a)(3). See 35 P.S. § 10231.1903(a)(3). “Defective medical
marijuana” is not defined in the Act. In the absence of an explicit definition, it is
necessarily implied that the Legislature intended the Department to have a significant role
in defining “defective” and how to determine whether a lot of medical marijuana (either
pre- or post-processing) is “defective.” By any reasonable construction, accurate test
results are necessary to determine whether a lot of medical marijuana is “defective.” The
explicit language of Section 1903 demonstrates the Legislature intended to impose the
duty of comprehensively regulating testing of medical marijuana on the Department. The
two-lab requirement is one such regulation that serves multiple explicit purposes of the
Act. Thus, the Department has the authority to enforce the two-lab requirement.
VIII. Conclusion
Under the Act, the Department has discretion in determining the number of
laboratories necessary to achieve the explicit goals of the Act. Thus, contrary to the
Commonwealth Court’s analysis, the two-lab requirement does not exceed the regulatory
authority granted to the Department by the Act. We therefore remand this matter to the
Commonwealth Court to apply the remaining steps of the Tire Jockey test. 13
13 While our discussion touches on the reasonableness of the Department’s authority to
require multiple labs under the Act, we do not pass any judgment on whether the two-lab requirement itself is “reasonable” under the third step of the Tire Jockey test. In other words, the Department has the statutory authority to regulate testing, but its regulation must not be “made in bad faith, … arbitrarily executed, or constitute a manifest abuse of discretion.” Tire Jockey, 915 A.2d at 1190. As but one example, the two-lab requirement could still be unreasonable if growers/processors establish that the costs of the two-lab requirement unreasonably exceeded the purported benefits such that the requirement constitutes a flagrant abuse of the Department’s discretion. The third step of the Tire Jockey test allows for the balancing test envisioned in 35 P.S. § 10231.102(3)(i).
[J-57-2024] - 20 Chief Justice Todd and Justices Donohue, Dougherty and Mundy join the opinion.
Justice Wecht files a dissenting opinion in which Justice Brobson joins.
[J-57-2024] - 21