                             UNITED STATES DISTRICT COURT
                             FOR THE DISTRICT OF COLUMBIA


REV. RYAN “SASHA” GALLAGHER,

               Plaintiff,
       v.
                                                      Civil Action No. 18-2154 (TJK)
FOOD AND DRUG ADMINISTRATION et
al.,

               Defendants.


                                  MEMORANDUM OPINION

       Plaintiff Rev. Ryan “Sasha” Gallagher, proceeding pro se, sues the Food and Drug

Administration (FDA) and Dr. Stephen D. Hardeman, a senior official at its Center for Drug

Evaluation and Research. Before the Court is Defendants’ motion to dismiss. Because

Gallagher’s complaint does not include a short and plain statement showing why he is entitled to

relief, the Court will grant the motion and dismiss the case without prejudice for failure to

comply with Federal Rule of Civil Procedure 8(a).

                                   *              *             *

       Pleadings prepared by pro se litigants are held to less stringent standards than those that

apply to pleadings prepared by lawyers. See Haines v. Kerner, 404 U.S. 519, 520 (1972).

However, pro se litigants must follow the Federal Rules of Civil Procedure. Jarrell v. Tisch, 656

F. Supp. 237, 239 (D.D.C. 1987). Rule 8(a) requires a complaint to include “a short and plain

statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a). “The

purpose of the rule is to give fair notice of the claim being asserted so as to permit the adverse

party the opportunity to file a responsive answer, prepare an adequate defense and determine

whether the doctrine of res judicata is applicable.” Brown v. Califano, 75 F.R.D. 497, 498
(D.D.C. 1977). “Where a complaint is insufficiently focused, it places an undue burden on the

defendant to answer or move and it invites unnecessary delay and confusion in the proceedings.”

Achagzai v. Broad. Bd. of Governors, 109 F. Supp. 3d 67, 71 (D.D.C. 2015).

                                   *             *             *

       Even liberally construed, Gallagher’s complaint and his subsequent pleadings do not

contain a short and plain statement explaining why he is entitled to relief. 1 Gallagher’s

complaint focuses on the substance 4-Hydroxy-N-methyl-N-isopropyltryptamine (“4-OH-

MiPT”). According to Gallagher, it is central to his religious beliefs:

       Within the Shaivite Temple, we do believe that Dr. Sasha Shulgin performed
       Miracles in his life, we do believe Shaivism, created in the Bronze age, is the
       Religion of the Atomic Age. We believe 4-OH-MiPT to be the Lord God Soma.
       AN UNSCHEDULED SUBSTANCE. 4-OH-MiPT is a Sacred Food, not a Drug.

ECF No. 1 (“Compl.”) at 2. Gallagher alleges that he wrote to the FDA about “a Religious

Exemption for 4-OH-MiPT use within the practices of the Shaivite Temple.” Id. at 1. Hardeman

responded. Id. at 4. The FDA interpreted Gallagher’s letter as a request for an exemption from

the requirement to submit an Investigational New Drug Application (IND) to conduct a clinical

investigation of 4-OH-MiPT. Id.; see also 21 C.F.R. § 312.2(b). Hardeman listed the

requirements for an exemption, but informed Gallagher that he did not appear to qualify for one.

Compl. at 4. Hardeman informed Gallagher that, as a result, he would have to submit an IND if

he wished to conduct a clinical investigation of 4-OH-MiPT. Id. Gallagher further alleges that

Hardeman told him in a later email that the FDA “does not consider Religiousity [sic] when

evaluating the safety of proposed clinical experimentation on Humans.” Id. at 2.




1
 The Court considers a pro se plaintiff’s pleadings “in toto” when determining whether to
dismiss. See Brown v. Whole Foods Mkt. Grp., Inc., 789 F.3d 146, 151 (D.C. Cir. 2015).



                                                 2
        In his complaint, Gallagher alleges that the FDA’s “IND program is in violation of the

First Amendment,” and cites a case in which the D.C. Circuit held that the Drug Enforcement

Administration (DEA) was not required to provide a religious-use exemption from federal laws

proscribing marijuana. Id. at 2 (citing Olsen v. Drug Enf’t Admin., 878 F.2d 1458 (D.C. Cir.

1989). He also asserts that “they are refusing to create processes similar to the DEA’s” and cites

a case in which the Supreme Court held that the Department of Justice had not shown, under the

Religious Freedom Restoration Act (RFRA), 42 U.S.C. § 2000bb–1 et seq., a compelling interest

in barring a religious sect’s sacramental use of a substance regulated under Schedule I of the

Controlled Substances Act (CSA), 21 U.S.C. § 812(c). Id. at 3 (citing Gonzales v. O Centro

Espirita Beneficente Uniao do Vegetal, 546 U.S. 418 (2006)).

        The complaint also includes several unexplained references to marijuana. For example,

Gallagher references “Federal Marijuana Patients, [sic] and GW Pharma THCv,” and says he

told Hardeman that “[w]e consider THCv to be the non-Marijuana form of Lord Shiva.” Id. at 1.

And he alleges that “Synthetic THCv is not Scheduled” and cites a case from outside this Circuit

holding that “the DEA’s relevant rules and regulations may be enforced only insofar as they ban

the presence of marijuana or synthetic THC.” Id. at 7 (quoting Hemp Indus. Ass’n. v. Drug Enf’t

Admin., 357 F.3d 1012, 1013 (9th Cir. 2004)). But he never explains how marijuana or THC

bear on the instant case. 2



2
  Gallagher briefly revisits marijuana in his “Motion for Rule 5.1 Hearing & Jurisdiction
Response,” which the Court construes as an opposition to the motion to dismiss. ECF No. 15 at
1 (“I would first like to point out that the Defendant Completely ignored the [Center for Drug
Evaluation and Research] and other aspects of this case, involving Marijuana as an Investigative
New Drug and the [National Institute on Drug Abuse] contract with the University of
Mississippi.”). Again, he fails to explain how marijuana is relevant to any claim in this case. To
the extent he seeks to relitigate his past marijuana-related claims that have already been
adjudicated, res judicata bars him from doing so. See, e.g., Gallagher v. DEA, No. 3:18-CV-



                                                3
        These allegations in the complaint do not constitute “a short and plain statement of the

claim” showing that Gallagher “is entitled to relief.” Fed. R. Civ. P. 8(a). An IND is the start of

the process through which pharmaceutical drug sponsors seek FDA approval to test proposed

new pharmaceutical drugs for safety and efficacy, before they are approved for sale and

marketing. See 21 U.S.C. § 355(i); 21 C.F.R. § 312.1. But Gallagher does not allege that he

seeks to test, sell, or market a pharmaceutical drug. See generally Compl. Nor does he allege

that his intended use of 4-OH-MiPT—whatever that may be—would cause that substance to be

subject to the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq. See 21

U.S.C. § 321(g)(1) (defining the term “drug”). 3 In sum, he does not explain how the “IND

program” or any part of the FDCA even applies to him, let alone violates his First Amendment

rights or burdens the practice of his religion. 4

        Gallagher’s subsequent filings only further muddy the waters, as he appears to shift the

basis for his claim away from the allegations in the complaint. In his Opposition, he reiterates



263-NBB-DAS, 2019 WL 1997481 (N.D. Miss. Apr. 16, 2019), R. & R. adopted, 2019 WL
1996675 (N.D. Miss. May 6, 2019); Gallagher v. Drug Enforcement Administration, No. 1:18-
CV-2439-UNA (D.D.C. Dec. 3, 2018).
3
 As Defendants point out, 4-OH-MiPT does not appear in the official U.S. Pharmacopeia. ECF
No. 12 at 3 n.2. Therefore, to be subject to the FDCA, it must fall within one of the statute’s
conduct-based definitions. See 21 U.S.C. § 321(g).
4
  Because the complaint fails to allege how Gallagher was injured by the “IND program,” it also
warrants dismissal for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).
See Henthorn v. Dep’t of Navy, 29 F.3d 682, 684 (D.C. Cir. 1994) (noting that, despite the
lenient standard applied to pro se pleadings, “the district court ‘need not accept inferences drawn
by plaintiffs if such inferences are unsupported by the facts set out in the complaint’”). And to
the extent Gallagher alleges an injury solely based on the government’s abstract failure to follow
the law, he lacks standing, and the complaint warrants dismissal for lack of subject-matter
jurisdiction as well. Valley Forge Christian Coll. v. Americans United for Separation of Church
& State, Inc., 454 U.S. 464, 485 (1982) (finding no standing where a plaintiff did not “identify
any personal injury suffered by them as a consequence of the alleged constitutional error”).



                                                    4
that “our Temple, the Shaivite Temple, believes that 4-OH-MiPT, Miprocin, is a Soma, a Sacred

Drink, a Sacred Substance, used by and given to us by the Gods.” ECF No. 15 at 1. He requests,

with more specificity than in the complaint, that he “be allowed to Manufacture and Transport

this NON-SCHEDULED SUBSTANCE” and that he “be able to use it in Ritual and Ceremony.”

Id. And he suggests that he is barred from doing so under the Controlled Substance Analogue

Enforcement Act (“Analogue Act”), see 21 U.S.C. § 813, because “the FDA and DEA are

treating 4-OH-MiPT, Miprocin, when ingested by Humans, as if it is a Schedule I substance.”

Id. But once again, Gallagher does not allege that he seeks to test, sell, or market a

pharmaceutical drug such that he would need an IND, the focus of his complaint and the letter he

received from Defendants. Moreover, he does not plead facts that suggest that the government

is, in fact, treating 4-OH-MiPT as a Schedule I substance. And even assuming it is, this

allegation hardly clarifies his claim—because he also asserts that the FDA informed him that the

Analogue Act “has no bearing on the applicability of” an IND exemption. See Compl. at 2. As

Defendants point out, “[t]he laws regulating scheduled substances are separate and distinct from

the new drug provisions of the FDCA.” 5 ECF No. 12 at 4.

       Finally, in a subsequent “Motion to Deny Defendant,” Gallagher argues—for the first

time—that “this is an Administrative Procedure Act (APA) case, regarding the FDA.” ECF No.




5
 To the extent that Gallagher’s claim is grounded in a concern that the CSA will be enforced
against him in the future, he does not plead facts suggesting that such enforcement is imminent
or even likely, especially given that he concedes that 4-OH-MiPT is not a controlled substance.
Therefore, he lacks standing to assert a claim based on future enforcement, and his complaint
warrants dismissal for lack of subject-matter jurisdiction. See Seegars v. Gonzales, 396 F.3d
1248, 1255 (D.C. Cir. 2005) (holding that plaintiffs who “allege no prior threats against them or
any characteristics indicating an especially high probability of enforcement against them” lacked
pre-enforcement standing).




                                                 5
20 at 1. But he does not identify any allegedly unlawful final agency action that caused him

harm. See 5 U.S.C. § 704. 6

                                   *              *             *

       As explained above, nowhere in Gallagher’s complaint or subsequent pleadings does he

provide a short and plain statement of why he is entitled to relief. Therefore, he has failed to

comply with Rule 8(a). Accordingly, the Court will grant Defendants’ motion and dismiss the

case without prejudice. A separate order will issue.



                                                              /s/ Timothy J. Kelly
                                                              TIMOTHY J. KELLY
                                                              United States District Judge

Date: November 25, 2019




6
  To the extent that Gallagher suggests that the letter he received from Hardeman is final agency
action, he has pled no facts that suggest that this is so. To the contrary, Hardeman noted that
Gallagher’s original letter to the FDA had “reference[d] the Religious Freedom Restoration Act
(RFRA)” but clarified that the FDA’s response was “limited to the issues raised in [his] letter
related to the Federal Food, Drug, and Cosmetic Act.” Compl. at 4. Therefore, it appears the
letter did not reflect agency action of any kind concerning Gallagher’s request as it related to his
religious beliefs. Cf. Holistic Candlers & Consumers Ass’n v. Food & Drug Admin., 664 F.3d
940, 944 (D.C. Cir. 2012) (holding that a letter from the FDA warning of potential enforcement
action in the future did not constitute final agency action under the APA).



                                                  6
