HISTORY

1996: Medical Use Begins (California and Arizona)

June 14, 2000: Hawaii Act 228 (personal cultivation authorized) 1

June 6, 2005: Gonzales v. Raich, 545 U.S. 1, 19 (2005) (comparing individual growing wheat for personal consumption with individual growing marijuana for personal consumption) 2

The parallel concern making it appropriate to include marijuana grown for home consumption in the CSA is the likelihood that the high demand in the interstate market will draw such marijuana into that market.

While the diversion of homegrown wheat tended to frustrate the federal interest in stabilizing prices by regulating the volume of commercial transactions in the interstate market, the diversion of homegrown marijuana tends to frustrate the federal interest in eliminating commercial transactions in the interstate market in their entirety.

Raich, at 22:

distinguishing between marijuana cultivated locally and marijuana grown elsewhere

concerns about diversion

Raich, at page 28, n.37:

all homegrown medical substances

October 19, 2009: DOJ Ogden Memo 3

should not focus federal resources … on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of marijuana

June 29, 2011: DOJ Cole Memo 4

the business of cultivating, selling or distributing marijuana, and those who knowingly facilitate such activities, are in violation of the Controlled Substances Act, regardless of state law

2012: Adult Use Begins (Colorado and Washington)

August 29, 2013: DOJ Cole Memo 5

the existence of a strong and effective state regulatory system, and an operation’s compliance with such a system, may allay the threat than an organization’s size poses to federal enforcement

July 1, 2015: Hawaii Act 241 (dispensary system added to personal cultivation) 6

July 1, 2016: Hawaii Act 230 (bring dispensary system into compliance with 2013 Cole Memo) 7

May 12, 2017: Iowa Act 162 (dispensary system without personal cultivation) 8

January 4, 2018: DOJ Sessions Memo (rescinding Ogden and Cole memos) 9

2016-2020: President Trump – Medical marijuana is okay and other use should be a state decision (meaning the Sessions Memo did not have any effect).  Trump did say he was not bound by language in the annual budget limiting funding for federal enforcement against state marijuana programs, but that had no effect because he wasn’t in favor of federal enforcement regardless of that language in the annual budget.

December 1, 2018: Iowa over the counter sales begin.

EXEMPTION

January 28, 2019: Iowa citizen petition under 21 C.F.R. § 1307.03 for a federal exemption for state authorized use of marijuana. 10

The listing of marihuana as a controlled substance in Schedule I does not apply to the authorized medical use of marihuana authorized by or under any State statute or by any State agency.

August 2, 2019: Iowa Medical Cannabidiol Board requests IDPH consider obtaining a federal exemption. 11

January 1, 2020: Iowa Medical Cannabidiol Board requests the Iowa legislature consider obtaining a federal exemption or federal funding guarantees. 12

June 29, 2020: Iowa legislature instructs IDPH to obtain federal funding guarantees. 13

September 4, 2020: Iowa Department of Public Health determines federal funding guarantees require a federal exemption under 21 C.F.R. § 1307.03. 14

November 10, 2020: DEA denies citizen petition under 21 C.F.R. § 1307.03. 15

Notably, your proposed rule does not seek to alter the federal scheduling of marijuana, but rather to exempt the application of the CSA’s controls to marijuana.  But exempting the foregoing controls over marijuana would be inconsistent with United States obligations under the Single Convention, as noted above.  See also 81 FR at 53767-68 (noting that U.S. obligations under the Single Convention are carried out by applying the controls specified in schedules I or II of the CSA to marijuana).  Moreover, although DEA’s Administrator is authorized by 21 CFR 1307.03 to grant an exception to the application of any regulatory provision contained in 21 CFR part 1300 to end, the Administrator does not have the authority to grant exceptions to requirements enacted by Congress in the text of the CSA, including the eight categories of control listed above that are required by statute for all schedule I controlled substances.  Because your proposed rule would override the statutory requirements of the CSA enacted by Congress, it is beyond DEA’s authority to enact.  Additionally, your proposed rule would result in far fewer controls on marijuana than rescheduling marijuana to schedule II and would lead to the presence of marijuana in the market without the many controls designed to limit the abuse of both schedule I and schedule II drugs.

December 16, 2020: Iowa citizen petition under 21 C.F.R. § 1307.03 and 21 C.F.R. § 1308.43 for a federal exemption for state authorized use of marijuana 16

The listing of marihuana as a controlled substance in Schedule I does not apply to the state authorized use of marihuana, and persons using marihuana in compliance with state law are exempt from registration.

Gonzales v. Raich, 545 U.S. 1 (2005) was a direct constitutional challenge to the scheduling of marijuana and not an appeal from a denial of administrative exemption.  Therefore, exemption is a valid request.  Just because no one has ever asked for one does not mean it’s off the table.

Because there is a federal exemption from Schedule I for the ‘non-drug” use of peyote, 21 C.F.R. § 1307.31, a request to exempt some “other” use of marijuana is valid.

2021: President Biden – Same as Trump, but would also move marijuana from Schedule I to Schedule II.  Biden has not reinstated the Ogden or Cole memos.

April 9, 2021: Iowa governor sued for failure to apply for federal funding guarantees. 17

April 23, 2021: Iowa Department of Public Health files for federal funding guarantees with four federal agencies (1) Medicaid and Medicare; (2) Education; (3) FDA; and (4) DEA. 18

April 27, 2021: DEA denies citizen petition under 21 C.F.R. § 1307.03 and 21 C.F.R. § 1308.43, claiming exemptions from Schedule I are forbidden and ignoring the obvious exemption from Schedule I for the “non-drug” use of peyote.  So, we know this is the weak spot in the DEA’s argument.  DEA can’t explain why there is a peyote exemption, if exemptions from Schedule I can’t exist. 19

May 19, 2021: Iowa citizen petition under 21 C.F.R. § 1307.03 and 21 C.F.R. § 1308.43 for a federal exemption for state authorized use of marijuana, focusing on the history of the peyote exemption.  The four April 23, 2021 letters from IDPH requesting federal funding guarantees, and the September 4, 2020 explanation from IDPH that federal funding guarantees require a federal exemption, are attached as exhibits. 20

June 7, 2021: Iowa supplemental argument showing how Iowa’s cannabis program addresses the objections in Gonzales v. Raich about personal cultivation and diversion and how it complies with the requirements of the 2013 Cole memo.  The petitioners ask that the IDPH letters be treated as a request for federal exemption as explained by IDPH on September 4, 2020. 21

§ 814. Removal of exemption of certain drugs

(a) Removal of exemption

The Attorney General shall by regulation remove from exemption under section 802(39)(A)(iv) of this title a drug or group of drugs that the Attorney General finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance.

(b) Factors to be considered

In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption—

(1) the scope, duration, and significance of the diversion;

(2) whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and

(3) whether the listed chemical can be readily recovered from the drug or group of drugs.

(c) Specificity of designation

The Attorney General shall limit the designation of a drug or a group of drugs removed from exemption under subsection (a) to the most particularly identifiable type of drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs.

(d) Reinstatement of exemption with respect to particular drug products

(1) Reinstatement

On application by a manufacturer of a particular drug product that has been removed from exemption under subsection (a), the Attorney General shall by regulation reinstate the exemption with respect to that particular drug product if the Attorney General determines that the particular drug product is manufactured and distributed in a manner that prevents diversion.

(2) Factors to be considered

In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider—

(A) the package sizes and manner of packaging of the drug product;

(B) the manner of distribution and advertising of the drug product;

(C) evidence of diversion of the drug product;

(D) any actions taken by the manufacturer to prevent diversion of the drug product; and

(E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug product.

21 U.S.C. § 814