Comments on Proposed Rules

Comments on Proposed Amendments to
641 Iowa Administrative Code 154
“Medical Cannabidiol Act Registration Card Program”
July 25, 2017

The Medical Cannabidiol Act, 2017 Iowa Acts 451, Chapter 162 (H.F. 524), was signed into law on May 12, 2017, by Governor Terry E. Branstad.

Section 7(1) of the Act, Iowa Code § 124E.4(1) (2017), authorizes the Iowa Department of Public Health to issue a registration card to a “patient” which then provides that patient with an “affirmative defense” for the possession of cannabidiol products in Iowa.  See Section 15(4)(a) of the Act, Iowa Code § 124E.11(4)(a) (2017).

Section 7(3) of the Act, Iowa Code § 124E.4(3) (2017), authorizes the Iowa Department of Public Health to issue a registration card to a “primary caregiver” which then provides that primary caregiver with an “affirmative defense” for the possession of cannabidiol products in Iowa.  See Section 15(4)(b) of the Act, Iowa Code § 124E.11(4)(b) (2017).

Federal Regulations

The Iowa Medical Cannabidiol Act of 2017 does not explain how possession of cannabidiol products is consistent with existing federal regulations.

The Drug Enforcement Administration (DEA) has recently published a notice in the Federal Register clarifying that cannabidiol products are federal schedule 1 controlled substances.[1]  The DEA has further clarified that cannabidiol products are federal schedule 1 controlled substances on its website.[2]

Attached to this document are two letters from the Iowa Board of Pharmacy dated May 31, 2017, and June 7, 2017, confirming that cannabidiol products are both federal and state schedule 1 controlled substances.

There are no federally approved cannabidiol products.  Without an explanation in the rules the Iowa Department of Public Health is proposing, Iowa patients are left facing a potential hazard.

This document explains why the Iowa Department of Public Health must resolve any inconsistency or doubt by administrative rule.

Federal Penalties

The Federal penalties for possessing cannabidiol products are quite severe, with penalties ranging from 1 to 3 years in federal prison and fines ranging from $1,000 to $5,000.[3]

Federal Enforcement Policy

While Iowa House Speaker Linda Upmeyer has suggested that federal enforcement policy might continue to overlook state medical marijuana programs, recent statements from the United States Attorney General, Jeff Sessions, have indicated otherwise.[4]

Disabled Americans have been Negatively Impacted

Because of the consistent failure of state laws and regulations to address federal regulations appropriately, disabled Americans have been severely and negatively impacted.

The Supreme Court of Colorado recently rejected an employment discrimination claim by a severely disabled person.  Coats v. Dish Network, 350 P.3d 849, 850 (Colorado 2015) (“an activity such as medical marijuana use that is unlawful under federal law is not a ‘lawful’ activity under section 24-34-402.5”); People v. Crouse, 388 P.3d 39, 43 (Colorado 2017) (“Consistent with our holding in Coats, then, we again find that conduct is ‘lawful’ only if it complies with both federal and state law.”)

And see Gonzales v. Raich, 545 U.S. 1 (2015) (possession of marijuana for medical use under state program unlawful under federal classification), while noting marijuana’s federal schedule 1 classification may be invalid, 545 U.S., at 28 n.37; and see Casias v. Walmart, 695 F.3d 428 (6th Cir. 2012) (discrimination in employment allowed against participant in state medical marijuana program); and see James v. Costa Mesa, 700 F.3d 394 (9th Cir. 2012) (Americans with Disabilities Act does not protect participation in state medical marijuana program).

The Iowa Medical Cannabidiol Act of 2017 gives the Iowa Department of Public Health sufficient authority to resolve this potential hazard by administrative rule.   State medical marijuana programs are lawful under federal law.  The federal drug act was never intended to prevent the medical use of controlled substances.  The federal drug act is intended to prevent the abuse, not the authorized medical use, of controlled substances.

As we have noted before, the CSA “repealed most of the earlier antidrug laws in favor of a comprehensive regime to combat the international and interstate traffic in illicit drugs.” Raich, 545 U.S., at 12.  In doing so, Congress sought to “conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.”  Ibid.  It comes as little surprise, then, that we have not considered the extent to which the CSA regulates medical practice beyond prohibiting a doctor from acting as a drug “‘pusher’” instead of a physician.  Moore, 423 U.S., at 143.

Gonzales v. Oregon, 546 U.S. 243, 269 (2006).

Federal Law

States do not surrender their sovereignty when they become members of the union (“united states”).

Congress may not simply “commandeer the legislative processes of the States by directly compelling them to enact and enforce a federal regulatory program.”  Hodel v. Virginia Surface Mining & Reclamation Assn., Inc., 452 U.S. 264, 288 (1981).

New York v. United States, 505 U.S. 144, 161 (1992).  Federal law does not prohibit the state from accepting the medical use of a controlled substance, and federal regulations must maintain that same balance.  What seems like a paradox is a question of balance between state and federal law.

Federal drug law was written to provide flexibility in the classification of controlled substances.  Marijuana is currently classified as a substance with no accepted medical use in the United States.  States have a significant role in federal classification.[5]

See 21 U.S.C. § 903 (2017):

No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.

(Pub. L. 91–513, title II, § 708, Oct. 27, 1970, 84 Stat. 1284.)

Marijuana’s placement in federal schedule 1 depends on whether the DEA’s interpretation of the statutory language “currently accepted medical use in treatment in the United States” is lawful.  The DEA adopted its current interpretation in 1992.  A federal appellate court upheld the DEA’s interpretation of that language in 1994, two years before any state had accepted the medical use of marijuana.  See Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994).

Let that sink in for a moment.  Marijuana’s current placement in federal schedule 1 is based upon a federal administrative decision in 1992, affirmed by a federal appellate court in 1994, determining that marijuana had no accepted medical use in the United States at the time it made the decision, just two years before any state had accepted marijuana for medical use, beginning in 1996.

Initial Classification by Congress

The National Commission on Marihuana and Drug Abuse was created by the Controlled Substances Act of 1970, Public Law 91-513, to study the question of marijuana abuse in the United States.  While the Controlled Substances Act was being drafted in a House committee in 1970, Assistant Secretary of Health Roger O. Egeberg had recommended that marijuana temporarily be placed in schedule I, 21 U.S.C. § 812(c), Schedule 1(c)(10) (1970), the most restrictive category of drugs, pending the Commission’s report.  On March 22, 1972, the Commission’s chairman, Raymond P. Shafer, presented a report to Congress and the public entitled “Marihuana, A Signal of Misunderstanding,” which favored ending marijuana prohibition and adopting other methods to discourage use.  No action was taken on the commission’s report and marijuana has remained in federal schedule 1 since that time.

Duty to Update the Classification

DEA is required to update the classifications annually as necessary.  See 21 U.S.C. § 812(a) (1970).  The Attorney General of the United States, in conjunction with the Secretary of Health and Human Services, may add substances to, transfer substances between, or remove substances from the classifications.  See 21 U.S.C. § 811(a) (1970).  The Drug Enforcement Administration (DEA) has been delegated by the Department of Justice to perform this function for the Attorney General, in conjunction with the Food and Drug Administration which has been delegated by the Department of Health and Human Services to perform its responsibilities under the act.  See 21 U.S.C. § 811(b) (1970).

Contextual Analysis

The Medical Cannabidiol Act of 2017 recognizes and accepts a medical use for the marijuana plant in the state of Iowa.  Section 5(6) of the Act, Iowa Code § 124E.2(6) (2017):

“Medical cannabidiol” means any pharmaceutical grade cannabinoid found in the plant Cannabis sativa L. or Cannabis indica or any other preparation thereof that has a tetrahydrocannabinol level of no more than three percent and that is delivered in a form recommended by the medical cannabidiol board, approved by the board of medicine, and adopted by the department pursuant to rule.

(emphasis added).

A federal regulation (schedule 1) says marijuana has no accepted medical use in the states.  See 21 C.F.R. § 1308.11(d)(22)(2017).  The outdated federal regulation has not been updated since 1994, when marijuana actually had no accepted medical use in any state.  The people of Iowa have now accepted the medical use of marijuana in 2017.  Iowa is a state in the union (“in the United States”).  The state of Iowa is not authorizing the “abuse” of marijuana.  The state of Iowa is authorizing “medical use” of marijuana.

Before marijuana became accepted for medical use in any state, federal courts considering this matter determined that Congress did not define the term “currently accepted medical use,” and that accepted medical use in the United States can be solely intrastate without any federal approval for interstate marketing.  The best evidence of “accepted” medical use in the United States is a state law accepting the medical use of marijuana.  Accepted medical use that is solely intrastate is within the meaning of “currently accepted medical use” under existing federal law.

Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):

We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied).  We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.

Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):

Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate.  Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321 (b), 331, 355(a).  Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.

After the ruling in Grinspoon, the federal courts and the DEA began to address the question of how the DEA determines whether a controlled substance has accepted medical use in the United States.

Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991):

The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term “currently accepted medical use”; therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.

In 1992, the DEA acknowledged that Congress did not authorize the DEA to decide whether the states can or should accept the medical use of marijuana.  The DEA can only acknowledge the decision “others” have made.

Marijuana Scheduling Petition, DEA Docket No. 86-22, 57 Fed. Reg. 10499 (March 26, 1992) 10506:

Clearly, the Controlled Substances Act does not authorize the Attorney General, nor by delegation the DEA Administrator, to make the ultimate medical and policy decision as to whether a drug should be used as medicine.  Instead, he is limited to determining whether others accept a drug for medical use.  Any other construction would have the effect of reading the word “accepted” out of the statutory standard.

It would be strange indeed if “others” did not include states.  We are a nation of laws.  State medical marijuana laws are proof beyond any doubt that marijuana has accepted medical use in the United States.  Opinions don’t matter; but laws do.  It is not reasonable, or lawful, for the DEA to reject state laws as evidence of “accepted” medical use.

Gonzales v. Oregon, 546 U.S. 243, 258 (2006):

The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.

State Law

The Iowa Medical Cannabidiol Act of 2017, H.F. 524, Section 5(6), Iowa Code § 124E.2(6) (2017), defines “medical cannabidiol” as a “pharmaceutical grade cannabinoid found the plant Cannabis.”  The Act specifically authorizes the cultivation and harvesting of marijuana plants to make medical cannabidiol products.  See H.F. 524, Section 9(1)(a), Iowa Code § 124E.5(1)(a) (2017).

Iowa has determined that there is an “accepted” medical use for marijuana and the federal courts have determined that state laws accepting the medical use of a controlled substance are harmonious with the federal Controlled Substances Act.  The Iowa legislature hasn’t included this statement of compliance with existing federal law in the Medical Cannabidiol Act.  A statement of compliance needs to be included in 641 IAC 154 so that patients and their families are not left in doubt about their legal status and personal safety.

The Elephant in the Room

“Congress, we have held, does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions – it does not, one might say, hide elephants in mouseholes.” Whitman v. American Trucking Assns., Inc., 531 U.S. 457, 468 (2001).

Gonzales v. Oregon, 546 U.S. 243, 267 (2006):

H.F. 524 also fails to remove marijuana from Iowa schedule 1.  Iowa schedule 1, like it’s federal counterpart, says marijuana has no accepted medical use in treatment in the United States (unless the Iowa Board of Pharmacy says it does by an administrative rule).  Iowa Code § 124.204(4)(m) (2017); Iowa Code § 124.203(1)(b) (2017).  State law, H.F. 524, now says marijuana does have an accepted medical use in the state.

In 2010, the Iowa Board of Pharmacy, which is authorized by law to make recommendations to the legislature pursuant to Iowa Code § 124.201 (2017), recommended that marijuana be removed from Iowa schedule 1.

Attached to this document is the February of 2010 recommendation from the Iowa Board of Pharmacy, the February of 2010 press release from the Iowa Department of Public Health, and the legislation that was pre-filed in December of 2010 by the department and the board in the 84th General Assembly (2011-2012) of Iowa.

Moving forward without addressing marijuana’s classification in schedule 1 can and will have tragic consequences.

The Iowa Senate bill, S.F. 506, that passed by a vote of 45-5 on April 17, 2017, in the Iowa Senate, included the Iowa Board of Pharmacy’s recommendation from February 17, 2010, recommending the removal of marijuana from schedule 1.  The House version did not include the board’s recommendation.  The House version, H.F. 524, wasn’t made publicly available until 3:00 a.m. on the morning of the day after the legislature was scheduled to adjourn for the year on April 21, 2017.  H.F. 524 passed in the Iowa House at 5:30 a.m. on April 22, 2017, and in the Iowa Senate at 6:30 a.m. on April 22, 2017.  The House version was not carefully vetted.

Comparing Classifications

Both state and federal drugs laws reveal that we do not put plants with medical use in schedule 1.[6]

Marijuana has Medical Use in 46 States

Since 1996, four years after the DEA issued it interpretive rule in 1992, thirty states have accepted the medical use of marijuana, and another sixteen states have accepted the medical use of a marijuana extract (cannabidiol), bringing the total to 46 out of 50 states now depending on marijuana plants for medical use or for making extracts for medical use.  In addition, DC, Puerto Rico, and Guam have accepted the medical use of marijuana.

See National Conference of State Legislatures, July 7, 2017, State Medical Marijuana Laws:

http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx

Conclusion

Regulations must include an explanation of compliance with existing state and federal laws.  This can’t be left to the imagination.  Failure to address classification of marijuana in H.F. 524 leaves Iowa patients and their loved ones at risk of losing access to medical cannabidiol and facing severe federal penalties.  The Iowa Department of Public Health has the authority to take corrective action by administrative rule.  Each medical cannabidiol registration card must include a statement that the card immunizes the patient and/or caregiver from federal prosecution that would result from the false assumption that marijuana is lawfully classified as a schedule 1 substance.  The Iowa Board of Pharmacy has the authority to fix the state classification because it has the authority to reclassify marijuana by administrative rule[7].  H.F. 524 satisfies federal requirements because it nullifies federal schedule 1 (either on its face, or as applied).

Thank you for your prompt attention to this matter.

Carl Olsen, Executive Director
Iowans for Medical Marijuana, Iowa Business No. 334412
Post Office Box 41381, Des Moines, Iowa 50311-0507
http://www.iowamedicalmarijuana.org/

[1] Federal Register
Vol.81, No. 240, Wednesday, December 14, 2016, pp. 90194-90196.

[2] DEA Clarification on Cannabidiol
https://www.deadiversion.usdoj.gov/schedules/marijuana/m_extract_7350.html

[3] Federal Penalties

21 U.S.C. § 844(a) (2017)
First offense
$1,000 fine – up to one year in prison
21 U.S.C. § 844(a) (2017)
Second offense
$2,500 fine – up to two years in prison
21 U.S.C. § 844(a) (2017)
Third and subsequent offense
$5,000 fine – up to three years in prison

[4] Media Reports

March 27, 2017, KGLO Radio, Mason City, Iowa, “Upmeyer says legislators working on medical marijuana issue.”
June 13, 2017, The Cannabist, an edition of the Denver Post, Denver, Colorado, “Jeff Sessions has asked Congress to allow him to prosecute medical marijuana providers.”
June 16, 2017, Globe Gazette, Mason City, Iowa, “Sessions wants flexibility to prosecute Iowa medical marijuana program.”
June 23, 2017, Quad City Times, Davenport, Iowa, “Editorial: Jeff Sessions eyes pot crackdown on Iowa, Illinois.”

[5] Federal Classifications

Schedule 1
21 U.S.C. § 812(b)(1) (2017)
no medical use and high potential for abuse without consideration for physical or psychological dependence.
Schedule 2
21 U.S.C. § 812(b)(2) (2017)
medical use with high potential for abuse with physical dependence and high psychological dependence.
Schedule 3
21 U.S.C. § 812(b)(3) (2017)
medical use with low to moderate physical dependence and high psychological dependence.
Schedule 4
21 U.S.C. § 812(b)(4) (2017)
medical use with physical dependence and psychological dependence less than schedule 3.
Schedule 5
21 U.S.C. § 812(b)(5) (2017)
medical use with physical dependence and psychological dependence less than schedule 4.

[6] Classification Comparisons

Schedule 1
Iowa Code § 124.204(4)(m) (2017) Marijuana
Schedule 2
Iowa Code § 124.206(2)(a)(1) (2017) Raw Opium
Iowa Code § 124.206(2)(a)(7) (2017) Codeine
Iowa Code § 124.206(2)(a)(10) (2017) Hydrocodone
Iowa Code § 124.206(2)(a)(13) (2017) Morphine
Iowa Code § 124.206(2)(c) (2017) Opium Poppy and Poppy Straw
Schedule 3
Iowa Code § 124.208(5)(a)(1) (2017) Codeine
Iowa Code § 124.208(5)(a)(2) (2017) Codeine
Iowa Code § 124.208(5)(a)(3) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(4) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(5) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(7) (2017) Opium
Schedule 5
Iowa Code § 124.212(2)(a) (2017) Codeine
Iowa Code § 124.212(2)(b) (2017) Hydrocodone
Iowa Code § 124.212(2)(e) (2017) Opium

[7] Iowa Board of Pharmacy

Iowa Code § 124.204 (2017)
Schedule I.
4. Hallucinogenic substances.
m. Marijuana, except as otherwise provided by rules of the board for medicinal purposes.

Iowa Code § 124.206 (2017)
Schedule II.
7. Hallucinogenic substances.
a. Marijuana when used for medicinal purposes pursuant to rules of the board.

(emphasis added).  See State v. Bonjour, 694 N.W.2d 511 (Iowa 2005), for the history of this authority.

This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply