DC DISTRICT COURT

Gallagher v. FDA, 18-2154

Motion for RULE 5.1 Hearing & Jurisdiction Response

I would first like to point out that the Defendant Completely ignored the CDER and other aspects of this
Case, involving Marijuana as an Investigational New Drug and the NIDA contract with the University of
Mississippi.

But...

This is a Statement of Jurisdiction, Standing, and a Motion for a Rule 5.1 Hearing. The issue at hand is
that the FDA and DEA are treating 4-OH-MiPT, Miprocin, when ingested by Humans, as if it is a Schedule
I Substance. But when not for Human Ingestion, it is being Treated as a Regular Molecule for Buy, Sell,
Trade and Give-Away, as if it is not a Scheduled Substance. For example, if I wanted to use it to create a
New Paint, I could Legally do that under Federal Law, or if I wanted to add it to an Ant Poison, or if I
wanted to use it as an Ingredient in Plant Food, and many people use these Method of Sales as
Disguises. That is not what I am trying to do, I am not looking for a Loop Hole, I am saying 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. Sasha Shulgin is the Inventor of this Substance, and
he is the Saint, or Dead Guru of our Temple. He is the Founder, we are his Prophets.

We ask that Religious use of this Substance be treated no differently than the other forms of use, not for
Human Consumption, provided by Federal Law. We ask that we be allowed to Manufacture and
Transport this NON-SCHEDULED SUBSTANCE, and we ask that we be able to use it in Ritual and
Ceremony.

I am not asking for a Medical, or Clinical License, in fact I argue that Religion can not be forced to
retrieve licenses.

I further argue that Standing is proven by the Document Attached to the Complain, in which Stephen D
Hardeman denies me a Religious Exemption, says the “FDA Doesn’t do that” and then has an email
discussion with me about it. That is my Standing, I already asked the DEA to do this. The DEA was
FORCED to create an Exemption Process after Gonzales v. O Centro.

Gonzales v. O Centro Espírita Beneficente União do Vegetal​, 546 U.S. 418 (2006), was a ​United
States Supreme Court​ case in which the Court held that, under the ​Religious Freedom Restoration
Act​, the government had failed to show a compelling interest in prosecuting religious adherents for
drinking a sacramental tea containing a ​Schedule I controlled substance​. After the federal
government seized its sacramental tea, the ​União do Vegetal​ (UDV), the ​New Mexican​ branch of a
Brazilian church that imbibes ​ayahuasca​ in its services, sued, claiming the seizure was illegal, and
sought to ensure future importation of the tea for religious use. The church won a preliminary
injunction from the ​United States District Court for the District of New Mexico​, which was affirmed
on appeal.
The Supreme Court affirmed. The Court also disagreed with the government's central argument that
the uniform application of the ​Controlled Substances Act​ (CSA) does not allow for exceptions for
the substance in this case, as ​Native Americans​ are given exceptions to use ​peyote​, another
Schedule I substance.
 21 U.S. Code § 813 - Treatment of controlled
substance analogues
(a)In general

A ​controlled substance​ analogue shall, to the extent intended for human

consumption, be treated, for the purposes of any Federal law as a ​controlled
substance​ in schedule I.

(b)DeterminationIn determining whether a ​controlled substance​ analogue was

intended for human consumption under subsection (a), the following factors may be
considered, along with any other relevant factors:

(1)The marketing, advertising, and labeling of the substance.

(2)The known efficacy or usefulness of the substance for the marketed, advertised,
or labeled purpose.

(3)The difference between the price at which the substance is sold and the price at
which the substance it is purported to be or advertised as is normally sold.

(4)The diversion of the substance from legitimate channels and the clandestine
importation, ​manufacture​, or distribution of the substance.

(5)Whether the defendant knew or should have known the substance was intended
to be consumed by injection, inhalation, ingestion, or any other immediate means.

(6)Any ​controlled substance​ analogue that is manufactured, formulated, sold,

distributed, or marketed with the intent to avoid the provisions of existing​ drug
laws.

(c)Limitation

For purposes of this section, evidence that a substance was not marketed, advertised,
or labeled for human consumption, by itself, shall not be sufficient to establish that
the substance was not intended for human consumption.

Ashcroft v. Iqbal, 556 U.S. 662 (2009)- 28 USC 1915 ​STATE CLAIM

Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007)​ - ​28 USC 1915​ STATE CLAIM

Watson v. Ault, 525 F.2d 886 (5th Cir 1976) – Judge's ​QUESTIONNAIRE

Bivens v. Six Unknown Agents, 403 U.S. 388 (1971) – Federal DEFENDANTS

Spears v. Mccotter, Et al, 766 F.2d 179 (5th Cir. 1985) – Factual ​ALLEGATIONS

US v Baucum, 94-3040 (DC Cir 1996) – Case involving use of Marijuana in a School Zone, Activation of
RULE 5.1

Leary v. US, 395 US 6 (1969) – Arrested at US Border with Marihuana, in violation of the Marihuana Tax
Act, Activation of​ RULE 5.1

​ bbie Hoffman
National Mob. Com. to End the War in Viet Nam v. Foran, 411 F.2d 934 (7th Cir. 1969) – A
and others Challenging the Federal Riot Act​, Federal JURISICTION

US v. Ballard, 322 U.S. 78 (1944) – FBI wanted to charge the Dead Founder of the “I AM” Movement with
Mail Fraud, Government putting ​RELIGION ON TRIAL

Washington v. Sessions, 1:17cv05625 (SDNY 2018) – Lexi, a Little Girl from Texas, moved to Colorado to
have her Medicine for Epilepsy, Religious ​REFUGEE

Mustafaa v. Dutton, 958 F.2d 372 (6th Cir. 1992) – Muslim Petitions for Prayer Oils in Jail, and Court Talks
about use of Wine in Jail, Religious ​MATERIALS

PERKEL v. U.S. DoJ, No. 08-74457 (9​th​ Cir 2010)- Religious Petition to the DEA, Religious ​PETITION

Comptroller v. Ethical Society of Austin, 03-02-00066-CV (TX 3d 2003)​ – ​Questioned if the Ethical Society
of Austin should get Tax Exempt Status since they are not a Religion, The ​SUPREME BEING TEST

HEMP Industries V. USDEA, No. 17-70162 (9th Cir. 2018)- Decided that Seeds of Marijuana did not
contain THC, and were therefore not Marijuana under the Congressionally Written Definition of the word,
Marijuana ​DEFINTIONS

Noramco DE Inc v. DEA, No. 02-1211 (DC Cir. 2004) – Cocain Monopoly headed by the DEA,
Acknowledge by the DOJ, and example of legal Pharmaceutical Applications, DEA ​Form 225

United States v. Forbes, 806 F. Supp. 232 (D. Colo. 1992) – Someone Arrested in Colorado for selling
a-MT as MDMA, but the Court found that a-MT was not an Analogue because it pre-exited MDMA, and
therefore they could not prosecute. The DEA made a-MT schedule I the next day and all Pharmaceutical
Research was halted, Analogue ​DEFINTIONS

Cantwell v. Connecticut, 310 U.S. 296 (1940) - Religions can not be forced to get Licensed, Incorporation
DOCTRINE

US v. ARTICLE OR DEVICE, 333 F Supp 357 (D.D.C. 1971) – Scientology E-Meter is not real Science and
is therefore not Medical, and the church of Scientology has been given Restrictions, these are the kinds
of Restrictions the FDA and DEA should consider, Religion & ​FDA REGULATION

Butz v. Economou, 438 U.S. 478 (1978) – Rights & ​STATE AND FEDERAL AGENTS

U.S. Code: Title 21 - ​FOOD AND DRUGS

81 FR 53846 – ​FEDERAL MARIJUANA REGISTRY

Rule 5.1
Constitution- Article I, Section 9, Clause 3: "No Bill of Attainder ... shall be passed"
US v. Brown, 381 US 437 (1965)- Overturned Law that made it a Crime to be Communist US v. Lovett, 328
US 303 (1946)- Attainder Test
Dent v. West Virginia, 129 US 114 (1889)- A State Law Stating you had to Graduate from a Licensed
Medical School was nearly overturned (Religion can't be Licensed)

28 USC S1331- Federal Question Jurisdiction

28 USC S1337- Commerce and Anti-Trust Regulations; Amount in Controversy, Costs
28 USC S1341- Taxes by States (Fed Courts don't interfere without speedy State remedy)
28 USC S1343- Federal Court Jurisdiction over Conspiracy to interfere with rights under S1985
28 USC S1346- United States as Defendant
28 USC S1351- Court Action Against Diplomats (Foreign and Domestic)
28 USC S1355- Jurisdiction for Fine, Penalty or Forfeiture under an Act of Congress
28 USC S1357- Injury from Act of Congress
28 USC S1365- Actions in Court by Senate (Federal Court Jurisdiction)
28 USC S1367- Supplemental Jurisdiction for Actions brought by Similar Plaintiffs

28 USC Chapter 158- Orders of Federal Agencies; Review

28 USC Chapter 161- United States as Party Generally
28 USC Chapter 163- Fines, Penalties and Forfeitures
28 USC Chapter 165- US Court of Federal Claims Procedure
28 USC Chapter 169- Court of International Trade Procedure
28 USC Chapter 171- Tort Claims Procedure
28 USC Chapter 179- Judicial Review of Certain Actions by Presidential Offices
28 USC Chapter 181- Foreign Judgments

Related Cases
Kerr v. New Orleans PD,2:2013cv00525(ED La 2013)
Gallagher v. Austin PD, 1:2016cv00527 (WD TX 2016)
Gallagher v. DEA, 3:2017cv00734 (ND TX 2017/18)
Gallagher v. Willis, Collin County, 4:2018cv00575 (ED TX 2018)
Gallagher v. FDA, 1:2018cv02154 (DC 2018)
Gallagher v. DEA,18-01352 (10​th​ Cir 2018)
Gallagher v DEA, 1:2018cv02505 (Colorado 2018)
Gallagher v. Colorado Department of Revenue, 1:2018cv02503 (Colorado 2018)
Gallagher v. United States, 1:2018cv02153 (DC 2018)
In Re: Judicial Complaint, 18-10-90033/90034 (10​th​ Cir 2018)

Relevant Amendments
1st Amendment “Congress shall make no law respecting an establishment of religion, or prohibiting the free
exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to
assemble, and to petition the Government for a redress of grievances.”

"It has been objected also against a bill of rights, that, by enumerating particular exceptions to the grant of
power, it would disparage those rights which were not placed in that enumeration; and it might follow by
implication, that those rights which were not singled out, were intended to be assigned into the hands of the
General Government, and were consequently insecure. This is one of the most plausible arguments I have ever
heard against the admission of a bill of rights into this system; but, I conceive, that it may be guarded against."
-James Madison, when Introducing the Bill of Rights

The 9th Amendment "The enumeration in the Constitution, of certain rights, shall not be construed to deny or
disparage others retained by the people."

WHEREBY THE PLAINTIFF PRAYS THE COURT

Grant a Rule 5.1 Hearing as to the Legality of the Federal Analogue Act in this Case.