Iowa Code Chapter 124E Exempt from Federal Schedules

State law must address fed­er­al sched­ul­ing because of the phrase used in the fed­er­al statute as a pre-con­di­tion for place­ment in sched­ule 1 “cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States.”

The phrase “cur­rent­ly accept­ed med­ical use” is not defined in the fed­er­al statute.

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

nei­ther the statute nor its leg­isla­tive his­to­ry pre­cise­ly defines the term “cur­rent­ly accept­ed med­ical use”

Col­orado has two exam­ples that high­light this sit­u­a­tion very well.

In 2010, Col­orado asked the DEA to resched­ule mar­i­jua­na to sched­ule 2 for phar­ma­ceu­ti­cal pur­pos­es.  See HB1284 at page 9, signed by the Gov­er­nor of Col­orado on June 7, 2010.

See C.R.S. 12–43.3–202(g) (2017):

In recog­ni­tion of the poten­tial med­i­c­i­nal val­ue of med­ical mar­i­jua­na, make a request by Jan­u­ary 1, 2012, to the fed­er­al drug enforce­ment admin­is­tra­tion to con­sid­er resched­ul­ing, for phar­ma­ceu­ti­cal pur­pos­es, med­ical mar­i­jua­na from a sched­ule I con­trolled sub­stance to a sched­ule II con­trolled sub­stance

That request should have demand­ed removal from sched­ule 1 based on “cur­rent­ly accept­ed med­ical use” in the Unit­ed States (Col­orado) as a mat­ter of con­sti­tu­tion­al law (fed­er­al­ism).

In 2015, the Col­orado Supreme Court decid­ed med­ical mar­i­jua­na is not legal in Col­orado because it remains in fed­er­al sched­ule 1.

Coats v. Dish Net­work, 350 P.3d 849, 850 (Col­orado 2015):

There­fore, 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

Please note that Bran­don Coats is a dis­abled para­plegic who thought his employ­ment was pro­tect­ed if he abid­ed by the terms of the state med­ical mar­i­jua­na law which the Col­orado vot­ers added to their state con­sti­tu­tion in 2000.

I’m not sure how much tech­ni­cal accu­ra­cy goes into a direct bal­lot ini­tia­tive amend­ing a state con­sti­tu­tion, but we can do bet­ter in Iowa.  When a state refus­es to claim state accept­ed med­ical use is exempt from sched­ule 1, it cre­ates a con­flict with sched­ule 1 which could have been avoid­ed.  If Col­orado had said state med­ical use is exempt from fed­er­al sched­ule 1, then the Col­orado Supreme Court would have had to deter­mine whether that is so.  Instead, the court just ruled it isn’t legal because the state did not chal­lenge fed­er­al sched­ule 1.  We should not repeat this mis­take here in Iowa.  Col­orado has nev­er includ­ed mar­i­jua­na in its state sched­ule 1, so state sched­ule 1 has nev­er been an issue in Col­orado.

If state med­ical use is exempt from sched­ule 1, then it is legal under both state and fed­er­al law.  If state med­ical use is not exempt, then sched­ule 1 is ille­gal as applied to the “cur­rent­ly accept­ed med­ical use” in the states.

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

Con­gress did not intend “accept­ed med­ical use in treat­ment in the Unit­ed States” to require a find­ing of rec­og­nized med­ical use in every state

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.

Iowa should say both things: (1) state accept­ed med­ical use is exempt from sched­ule 1; and (2) sched­ule 1 is invalid for any sub­stance with accept­ed med­ical use in any state.  Fed­er­al sched­ules are not bind­ing on the states, so a state could place mar­i­jua­na in state sched­ule 1 even if the fed­er­al admin­is­tra­tive agency entire­ly removed mar­i­jua­na from all of the fed­er­al sched­ules.  So, it’s quite easy to make the case that fed­er­al sched­ule 1 is unlaw­ful for mar­i­jua­na if even one state accepts mar­i­jua­na for med­ical use.  It does not deprive any state from find­ing mar­i­jua­na has no med­ical use in that state, although there are only four states that have not accept­ed any form of mar­i­jua­na for med­ical use.

What I am think­ing is that the eas­i­est thing for the Iowa leg­is­la­ture to do would be to add the same lan­guage to the statute that the Iowa Depart­ment of Pub­lic Health has includ­ed on the own­er cer­ti­fi­ca­tion form.

Or, at least start the dis­cus­sion with the lan­guage the Iowa Depar­ment of Pub­lic Health is using and then ask if it is suf­fi­cient.

Here is what the Iowa Depart­ment of Pub­lic Health has writ­ten on the own­er cer­ti­fi­ca­tion form:

any activ­i­ty not sanc­tioned by Iowa Code chap­ter 124E and pro­posed admin­is­tra­tive rules may be a vio­la­tion of state or fed­er­al law and could result in arrest, pros­e­cu­tion, con­vic­tion, or incar­cer­a­tion

https://drive.google.com/file/d/0B-cZdbYdPoLGSnZRQWtBUnFTd2c/view

The com­mon­ly accept­ed argu­ment is that the fed­er­al admin­is­tra­tive agency can inter­pret the mean­ing of “cur­rent­ly accept­ed med­ical use” because that was the court’s rul­ing in 1991/1994.  Alliance for Cannabis Ther­a­peu­tics v. DEA, 930 F.2d 936 (D.C. Cir. 1991); Alliance for Cannabis Ther­a­peu­tics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994).  How­ev­er, the 1994 fed­er­al court rul­ing has nev­er been recon­sid­ered by a fed­er­al court on the con­sti­tu­tion­al law issue of state laws defin­ing “cur­rent­ly accept­ed med­ical use.”  Cal­i­for­nia was the first state to accept the med­ical use of mar­i­jua­na in 1996.  A fed­er­al admin­is­tra­tive agency does not have the pow­er to nul­li­fy a state law with­out the express con­sent of Con­gress, which is total­ly lack­ing here.  The fed­er­al gov­ern­ment has nev­er sued a state for enact­ing a state med­ical mar­i­jua­na pro­gram.  So, how could it be a vio­la­tion of a fed­er­al statute?  Forty-six state have enact­ed laws accept­ing some form of mar­i­jua­na for med­ical use.  It would be absurd to imply those forty-six states intend­ed to autho­rize the vio­la­tion of a fed­er­al law.  When we vote for fed­er­al elect­ed offi­cials, we vote for them at a state vot­ing loca­tion.  There is no fed­er­al vot­ing booth.

A cur­rent Fed­er­al Avi­a­tion Admin­is­tra­tion reg­u­la­tion adopt­ed in 1973 real­ly hits the nail on the head:

https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=03efb7c1b34301bf39ff6d98084cdd45&rgn=div8&view=text&node=14:2.0.1.3.10.1.4.10&idno=14

Title 14: Aero­nau­tics and Space
PART 91—GENERAL OPERATING AND FLIGHT RULES
Sub­part A—General
§91.19  Car­riage of nar­cot­ic drugs, mar­i­hua­na, and depres­sant or stim­u­lant drugs or sub­stances.

(a) Except as pro­vid­ed in para­graph (b) of this sec­tion, no per­son may oper­ate a civ­il air­craft with­in the Unit­ed States with knowl­edge that nar­cot­ic drugs, mar­i­hua­na, and depres­sant or stim­u­lant drugs or sub­stances as defined in Fed­er­al or State statutes are car­ried in the air­craft.

(b) Para­graph (a) of this sec­tion does not apply to any car­riage of nar­cot­ic drugs, mar­i­hua­na, and depres­sant or stim­u­lant drugs or sub­stances autho­rized by or under any Fed­er­al or State statute or by any Fed­er­al or State agency.

Any­one man­u­fac­tur­ing, dis­pens­ing, or con­sum­ing these prod­ucts here in Iowa should be able to sleep at night know­ing they are in full com­pli­ance with all applic­a­ble laws, both state and fed­er­al.  Let’s resolve this mat­ter in Jan­u­ary when the Iowa leg­is­la­ture recon­venes and not leave it for a dis­abled Iowa cit­i­zen to fight it out in court.

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Recognition of Extraordinary Work

Recog­ni­tion of Extra­or­di­nary Work

641 Iowa Admin­is­tra­tive Code 154
Rules 641—154.15(124E) to 641—154.65(124E)

Octo­ber 13, 2017

I would like to com­pli­ment the Iowa Depart­ment of Pub­lic Health for the extra­or­di­nar­i­ly good work it is doing imple­ment­ing the Med­ical Cannabid­i­ol Act.  2017 Iowa Acts 451, Chap­ter 162 (H.F. 524), Iowa Code § 124E (2017).

As I stat­ed in my com­ments on Sep­tem­ber 15, 2017, some­thing should be added to the Iowa statutes or the Iowa reg­u­la­tions (or both) regard­ing com­pli­ance with the exist­ing fed­er­al Con­trolled Sub­stances Act.  Title II of the Com­pre­hen­sive Drug Abuse Pre­ven­tion and Con­trol Act of 1970, Pub­lic law 91–513, 84 Stat. 1236, 1242, 21 U.S.C. ch. 13 §§ 801 et seq.

The U.S. Court of Appeals has clar­i­fied that the fed­er­al act does not define the term “med­ical use,” Alliance for Cannabis Ther­a­peu­tics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (“nei­ther the statute nor its leg­isla­tive his­to­ry pre­cise­ly defines the term ‘cur­rent­ly accept­ed med­ical use’”), and the U.S. Supreme Court has clar­i­fied that the term “med­ical use” under the fed­er­al act is defined by state statute.  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.

The Iowa Depart­ment of Pub­lic Health has flaw­less­ly inter­pret­ed state and fed­er­al law by includ­ing the fol­low­ing state­ment on the “Own­er Cer­ti­fi­ca­tion” form that all Iowa med­ical cannabid­i­ol man­u­fac­tur­ers and dis­pen­saries must sign:

I fur­ther acknowl­edge I have actu­al notice that, notwith­stand­ing any state law, Cannabis is a pro­hib­it­ed Sched­ule I con­trolled sub­stance under Fed­er­al law; any activ­i­ty not sanc­tioned by Iowa Code chap­ter 124E and pro­posed admin­is­tra­tive rules may be a vio­la­tion of state or fed­er­al law and could result in arrest, pros­e­cu­tion, con­vic­tion, or incar­cer­a­tion and that the $7,500 license appli­ca­tion fee is non-refund­able.

http://drive.google.com/file/d/0B-cZdbYdPoLGSnZRQWtBUnFTd2c/view?usp=sharing

This is an extreme­ly impor­tant detail.  This top­ic has come up again and again regard­ing fed­er­al law and state med­ical mar­i­jua­na pro­grams.  Oth­er states have failed to address it. We are clear­ly not autho­riz­ing fed­er­al crim­i­nal activ­i­ty in Iowa.

After sub­mit­ting my com­ments on Sep­tem­ber 15, 2017, I became aware of a fed­er­al trans­porta­tion reg­u­la­tion from 1973 that makes this abun­dant­ly clear.

91.19 Car­riage of nar­cot­ic drugs, mar­i­hua­na, and depres­sant or stim­u­lant drugs or sub­stances.
(a) Except as pro­vid­ed in para­graph (b) of this sec­tion, no per­son may oper­ate a civ­il air­craft with­in the Unit­ed States with knowl­edge that nar­cot­ic drugs, mar­i­hua­na, and depres­sant or stim­u­lant drugs or sub­stances as defined in Fed­er­al or State statutes are car­ried in the air­craft.
(b) Para­graph (a) of this sec­tion does not apply to any car­riage of nar­cot­ic drugs, mar­i­hua­na, and depres­sant or stim­u­lant drugs or sub­stances autho­rized by or under any Fed­er­al or State statute or by any Fed­er­al or State agency.

https://www.ecfr.gov/cgi-bin/text-idx?SID=2f570630a822fec80462ab1f3f4dc714&mc=true&node=se14.2.91_119&rgn=div8

Orig­i­nal­ly, §91.12.  Fed­er­al Reg­is­ter, Vol. 38, No. 126, Mon­day, July 2, 1973, p. 17493 (a copy is attached here­to).

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/

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Comments on Proposed Rules

Com­ments on Pro­posed Amend­ments to
641 Iowa Admin­is­tra­tive Code 154
Rules 641—154.15(124E) to 641—154.65(124E)
Sep­tem­ber 15, 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 9(1) of the Act, Iowa Code § 124E.5(1) (2017), autho­rizes the Iowa Depart­ment of Pub­lic Health to issue a license to a “man­u­fac­tur­er” which allows cul­ti­va­tion and har­vest­ing of cannabis in Iowa.

Sec­tion 10(8) of the Act, Iowa Code § 124E.6(8) (2017), requires a “man­u­fac­tur­er own­er shall not have been con­vict­ed of a dis­qual­i­fy­ing felony offense.”  See, Sec­tion 5(4) of the Act, Iowa Code § 124E.2(4) (2017), ref­er­enc­ing 21 U.S.C. § 802(6).

Sec­tion 11(1) of the Act, Iowa Code § 124E.7(1) (2017), autho­rizes the Iowa Depart­ment of Pub­lic Health to issue a license to a “dis­pen­sary” which allows dis­tri­b­u­tion of cannabis prod­ucts in Iowa.

Sec­tion 12(8) of the Act, Iowa Code § 124E.8(8) (2017), requires a “dis­pen­sary own­er shall not have been con­vict­ed of a dis­qual­i­fy­ing felony offense.”  See, Sec­tion 5(4) of the Act, Iowa Code § 124E.2(4) (2017), ref­er­enc­ing 21 U.S.C. § 802(6).

As recent­ly as Sep­tem­ber 10, 2017, Speak­er of the Iowa House, Lin­da Upmey­er, is quot­ed in the Des Moines Reg­is­ter, stat­ing that the man­u­fac­ture and dis­tri­b­u­tion of cannabid­i­ol in Iowa is a fed­er­al felony offense.  Des Moines Reg­is­ter, Sep­tem­ber 10, 2017, “AG tells agency to halt part of Iowa’s med­ical mar­i­jua­na law.”[Foot­note 1]  Speak­er Upmey­er is quot­ed as stat­ing:

no mat­ter what the Leg­is­la­ture has decid­ed, the state still would have been in vio­la­tion of fed­er­al law

So, as stat­ed by Speak­er Upmey­er, a dis­qual­i­fy­ing offense dis­qual­i­fies some­one from par­tic­i­pat­ing in a dis­qual­i­fy­ing offense.  Accord­ing to Speak­er Upmey­er, the Iowa Depart­ment of Pub­lic Health will be licens­ing indi­vid­u­als to engage in dis­qual­i­fy­ing offens­es (con­tin­u­ing crim­i­nal enter­pris­es) that car­ry up to life in fed­er­al prison and fines of up to $50,000,000.[Foot­note 2]

Fed­er­al Reg­u­la­tions

Although this author dis­agrees with Speak­er Upmeyer’s asser­tion that H.F. 524 vio­lates fed­er­al law, this clear­ly demon­strates what we are about to step into.  The Iowa Med­ical Cannabid­i­ol Act of 2017 doesn’t explain how the intrastate man­u­fac­ture and dis­tri­b­u­tion of cannabid­i­ol prod­ucts is con­sis­tent with exist­ing fed­er­al law.

The Drug Enforce­ment Admin­is­tra­tion (DEA) has recent­ly pub­lished a notice in the Fed­er­al Reg­is­ter clar­i­fy­ing that cannabid­i­ol prod­ucts are fed­er­al sched­ule 1 con­trolled sub­stances.[Foot­note 3]  The DEA has fur­ther clar­i­fied that cannabid­i­ol prod­ucts are fed­er­al sched­ule 1 con­trolled sub­stances on its web­site.[Foot­note 4]

With­out a state­ment of com­pli­ance with exist­ing fed­er­al law, the rules the Iowa Depart­ment of Pub­lic Health is propos­ing will place man­u­fac­tur­ers and dis­trib­u­tors in extreme jeop­ardy, as well as the Iowa patients who will depend on them for their med­i­cine.  Speak­er Upmey­er has clear­ly warned you of the con­se­quences of leav­ing this mat­ter unset­tled.  The fact that she would even put her name on a piece of leg­is­la­tion she thinks vio­lates fed­er­al law is astound­ing.

The Iowa Depart­ment of Pub­lic Health can and must resolve this prob­lem which has been clear­ly artic­u­lat­ed by Speak­er Upmey­er.  The admin­is­tra­tive rules imple­ment­ing this leg­is­la­tion must address the con­cerns she has raised.

Please see this author’s pre­vi­ous com­ments from July 25, 2017, for a com­plete legal analy­sis explain­ing why state med­ical mar­i­jua­na pro­grams are con­sis­tent with exist­ing fed­er­al law and exempt from sched­ule 1.[Foot­note 5]

Con­clu­sion

The reg­u­la­tions imple­ment­ing H.F. 524 must include an expla­na­tion of com­pli­ance with exist­ing state and fed­er­al law.  This can’t be left to the imag­i­na­tion.  The Iowa Depart­ment of Pub­lic Health has the author­i­ty to take cor­rec­tive action by admin­is­tra­tive rule.  Each man­u­fac­tur­er and dis­pen­sary license must include a state­ment that the license immu­nizes the man­u­fac­tur­er or dis­pen­sary from fed­er­al pros­e­cu­tion that would result from the false assump­tion that intrastate med­ical use of mar­i­jua­na is includ­ed in sched­ule 1 of the state and fed­er­al con­trolled sub­stances acts.  H.F. 524 sat­is­fies both state and fed­er­al require­ments because it pro­vides a com­plete exemp­tion from state and fed­er­al sched­ule 1.

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/

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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©, Sched­ule 1©(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)© (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.

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Overlooking the Medical Boards

Rep. Jarad Klein

Rep. Jarad Klein

July 2, 2017

Jarad Klein
Keo­ta, Iowa

Dear Rep. Klein,

Thank you for your work in expand­ing the Iowa Med­ical Cannabid­i­ol Act in 2017.  While Iowans for Med­ical Mar­i­jua­na (Iowa Busi­ness No. 334412) is con­cerned the pro­gram does not go far enough, pro­duc­tion of CBD in Iowa is a huge step for­ward.

As you men­tion in your inter­view with KCII Radio, Wash­ing­ton, IA, on June 30, the new Med­ical Cannabid­i­ol Advi­so­ry Board can rec­om­mend expan­sion of the pro­gram.  Pro­duc­tion in Iowa is the cor­ner­stone that makes it all pos­si­ble.

You also men­tion in your inter­view that the Med­ical Cannabid­i­ol Advi­so­ry Board is often over­looked by crit­ics of the pro­gram.  I would like to point out that the Iowa Board of Phar­ma­cy has also been over­looked through­out this process.  There is a pat­tern here that deserves your atten­tion.

In 2010, the Iowa Board of Phar­ma­cy rec­om­mend­ed the reclas­si­fi­ca­tion of mar­i­jua­na as a sub­stance with accept­ed med­ical use in the Unit­ed States.  The author­i­ty for their rec­om­men­da­tion can be found in Iowa Code § 124.201 (2017), and the require­ment that sub­stances clas­si­fied in sched­ule 1 must have no med­ical use in the Unit­ed States is found in Iowa Code § 124.203 (2017).

I have includ­ed the phar­ma­cy board’s rec­om­men­da­tion from Feb­ru­ary 17, 2010, and the leg­is­la­tion the board filed in 2011, to refresh your mem­o­ry.

It’s cer­tain­ly an emp­ty promise if the phar­ma­cy board’s rec­om­men­da­tions are not tak­en seri­ous­ly.  That could be the rea­son peo­ple are over­look­ing the sig­nif­i­cance of this new board now.  We can keep cre­at­ing boards, but the boards don’t mean much with­out seri­ous con­sid­er­a­tion of their rec­om­men­da­tions.

I do real­ize that pro­duc­tion of CBD in Iowa has been the biggest obsta­cle we’ve had to over­come.  I also real­ize the phar­ma­cy board’s rec­om­men­da­tion may have been pre­ma­ture.

How­ev­er, now that we have agreed on pro­duc­tion of CBD in Iowa, let’s get this plant out of sched­ule 1 so we are not mak­ing med­i­cine from a plant clas­si­fied as hav­ing no med­ical use in the Unit­ed States.  Forty-six states have accept­ed the mar­i­jua­na plant for med­ical use or extracts[1] from the plant as med­i­cine.  Either way, the plant is essen­tial in all forty-six states.

Com­pare this to mor­phine pro­duced from opi­um plants, or cocaine pro­duced from coca plants.  Opi­um plants and coca plants are not in sched­ule 1 and have nev­er been in sched­ule 1, show­ing a leg­isla­tive intent at the time these laws were cre­at­ed to exclude plants with med­ical use from sched­ule 1.

It’s time to fix the clas­si­fi­ca­tion.

Thank you for lis­ten­ing!

Sin­cere­ly,

Carl Olsen
http://iowamedicalmarijuana.org/

[1] CBD is one of many cannabi­noids.  State laws vary on the lev­el of THC that is allowed in a CBD prod­uct, but they don’t spec­i­fy any lev­els for the oth­er cannabi­noids.  These prod­ucts are referred to as “mar­i­jua­na extracts.”

Attach­ments

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The Elephant We Don’t Talk About

Iowans for Med­ical Mar­i­jua­na

The Iowa Med­ical Cannabid­i­ol Act of 2017
(and the ele­phant in the room we don’t want to talk about)

June 26, 2017

On April 22, 2017, the Iowa leg­is­la­ture passed the Med­ical Cannabid­i­ol Act, H.F. 524.  The Med­ical Cannabid­i­ol Act of 2017 was signed into law on May 12, 2017, by Gov­er­nor Ter­ry E. Branstad.

Sec­tion 9(1)(a) of the Act, Iowa Code § 124E.5(1)(a) (2017), autho­rizes the Iowa Depart­ment of Pub­lic Health to license “up to two med­ical cannabid­i­ol man­u­fac­tur­ers to man­u­fac­ture and to pos­sess, cul­ti­vate, har­vest, trans­port, pack­age, process, or sup­ply med­ical cannabid­i­ol with­in this state.”

What the Med­ical Cannabid­i­ol Act of 2017 fails to men­tion is whether grow­ing mar­i­jua­na to man­u­fac­ture cannabis prod­ucts is con­sis­tent with exist­ing fed­er­al law.  Penal­ties for grow­ing cannabis are quite severe, with penal­ties rang­ing from 5 years in prison to a pos­si­ble life sen­tence and fines rang­ing from $250,000 to $50 mil­lion.[1]

While Iowa House Speak­er Lin­da Upmey­er has sug­gest­ed that fed­er­al pol­i­cy might con­tin­ue to over­look state med­ical mar­i­jua­na pro­grams under the Trump Admin­is­tra­tion, recent state­ments from the Unit­ed States Attor­ney Gen­er­al, Jeff Ses­sions, have indi­cat­ed oth­er­wise.[2]

Recent rul­ings from the Supreme Court of Col­orado high­light this incon­sis­ten­cy.  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.”)

 

Fed­er­al Law

Fed­er­al law does not pro­hib­it the med­ical use of mar­i­jua­na.  Fed­er­al law depends upon the clas­si­fi­ca­tion a con­trolled sub­stance is placed in.  Ini­tial place­ment of mar­i­jua­na was decid­ed by Con­gress in 1970, but cur­rent place­ment of mar­i­jua­na is an admin­is­tra­tive process under fed­er­al law.[3]

 

Ini­tial Clas­si­fi­ca­tion of Mar­i­jua­na by Con­gress

The Con­trolled Sub­stances Act of 1970, Pub­lic Law 91–513, cre­at­ed the Nation­al Com­mis­sion on Mar­i­hua­na and Drug Abuse to study 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, the most restric­tive cat­e­go­ry of drugs, pend­ing the Commission’s report.  See 21 U.S.C. § 812©, Sched­ule 1©(10) (1970).  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.

 

Fed­er­al Admin­is­tra­tive Process

Con­gress autho­rized the Attor­ney Gen­er­al to keep the clas­si­fi­ca­tions cur­rent.  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 is del­e­gat­ed by the Depart­ment of Jus­tice to per­form this func­tion, in con­junc­tion with the Food and Drug Admin­is­tra­tion which is del­e­gat­ed by the Depart­ment of Health and Human Ser­vices for this pur­pose.  See 21 U.S.C. § 811(b) (1970).

 

Fed­er­al­ism

The U.S. Con­sti­tu­tion, as well as the Iowa Con­sti­tu­tion, divides our gov­ern­ment into three branch­es.  The leg­isla­tive branch makes the laws.  The exec­u­tive branch enforces the laws.  The judi­cial branch resolves ques­tions about the con­sti­tu­tion­al­i­ty of a law and can over­rule a law in whole or in part.  The judi­cial branch can also enforce cor­rec­tive action if the exec­u­tive branch (an admin­is­tra­tive agency or the chief exec­u­tive) does not inter­pret the law cor­rect­ly.

Fed­er­al­ism is the oth­er fun­da­men­tal prin­ci­ple in our dual sys­tem of gov­ern­ment.  The states gave up some of their author­i­ty in order to form the fed­er­al union and the fed­er­al union must respect the indi­vid­ual sov­er­eign­ty of the states.  In every sit­u­a­tion, the ques­tion is how much state author­i­ty has been removed and how much has been retained.  When Con­gress makes a law, Con­gress may, or may not, explain clear­ly where the lines are drawn.

 

Con­tex­tu­al Analy­sis

The Med­ical Cannabid­i­ol Act of 2017 says mar­i­jua­na has med­ical use in the state of Iowa (for mak­ing an extract) and there is an out­dat­ed fed­er­al reg­u­la­tion that says mar­i­jua­na has no med­ical use in the states.  It might seem like a sim­ple ques­tion of who has the greater author­i­ty, a state or a fed­er­al admin­is­tra­tive agency.  But, Con­gress can autho­rize a fed­er­al admin­is­tra­tive agency to inter­fere with state law, so the analy­sis starts with the ques­tion of whether Con­gress autho­rized the Attor­ney Gen­er­al to inter­fere with state med­ical mar­i­jua­na laws.

To begin the analy­sis, fed­er­al courts have deter­mined that accept­ed med­ical use of a con­trolled sub­stance in the Unit­ed States can exist with­out fed­er­al inter­state mar­ket­ing approval.

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.

This may seem like a dumb ques­tion, but how do we know whether med­ical use of mar­i­jua­na has been accept­ed?  After the rul­ing in Grin­spoon, the fed­er­al courts and the admin­is­tra­tive agency began to address this ques­tion.

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.

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.

The answer as to who decides whether a sub­stance has accept­ed med­ical use was con­clu­sive­ly deter­mined by the fed­er­al courts in 2006.

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 “any phar­ma­ceu­ti­cal grade cannabi­noid found the plant Cannabis … that has a tetrahy­dro­cannabi­nol lev­el of no more than three per­cent …”  The Act specif­i­cal­ly autho­rizes cul­ti­va­tion and har­vest­ing of mar­i­jua­na plants for the pur­pose of man­u­fac­tur­ing med­ical cannabid­i­ol.  See H.F. 524, Sec­tion 9(1)(a), Iowa Code § 124E.5(1)(a) (2017).

Because states deter­mine “accept” med­ical use, mar­i­jua­na plants “specif­i­cal­ly autho­rized” for med­ical use are “accept­ed” for med­ical use with­in the mean­ing of the fed­er­al Con­trolled Sub­stances Act.

 

The Ele­phant in the Room

H.F. 524 fails to remove mar­i­jua­na from Iowa sched­ule 1, which says mar­i­jua­na has no accept­ed med­ical use in treat­ment in the Unit­ed States.  Iowa Code § 124.204(4)(m) (2017); Iowa Code § 124.203(1)(b) (2017).

This house­keep­ing mat­ter has been over­looked and it can have trag­ic con­se­quences.  The Iowa Sen­ate bill that passed by a vote of 45–5 on April 17, 2017, includ­ed the Iowa Board of Pharmacy’s rec­om­men­da­tion on Feb­ru­ary 17, 2010, that mar­i­jua­na should be removed from Iowa sched­ule 1.  This was care­less­ly stripped out of the House ver­sion.  The House ver­sion, H.F. 524, wasn’t pub­licly avail­able until 3:00 a.m. on the morn­ing after the day the leg­is­la­ture was sched­uled to adjourn for the year.  It was passed in the Iowa House at 5:30 a.m. and in the Iowa Sen­ate at 6:30 a.m.  This was not a care­ful­ly thought out, or care­ful­ly delib­er­at­ed, process.

 

Com­par­ing Clas­si­fi­ca­tions

A care­ful read­ing of both the state and fed­er­al drugs laws reveals that we don’t put plants with med­ical use in sched­ule 1.[4]

 

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 mar­i­jua­na extract (cannabid­i­ol), bring­ing the total to 46 out of 50 states that now depend on access to mar­i­jua­na for med­ical use or for mak­ing extracts for med­ical use.  In addi­tion, DC, Puer­to Rico, and Guam have accept­ed the med­ical use of mar­i­jua­na.

Con­tin­ued place­ment of mar­i­jua­na in sched­ule 1 is both pro­hib­i­tive and unlaw­ful.

 

Con­clu­sion

As the Supreme Court of Col­orado has shown, state law must explain how it com­plies with exist­ing fed­er­al law.  Fail­ure to address clas­si­fi­ca­tion of mar­i­jua­na in H.F. 524 leaves Iowa patients at risk of los­ing access to cannabid­i­ol, and puts grow­ers at risk of fed­er­al penal­ties up to life in prison and fines up to $50 mil­lion.  The leg­is­la­ture must address this mat­ter when it recon­venes in 2018.

 

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 Penal­ties

21 U.S.C. § 841(b)(1)(A)(vii) (2017)
1000 kilo­grams (2204.62 pounds / 1.10231 tons) or more of a mix­ture or sub­stance con­tain­ing a detectable amount of mar­i­hua­na, or 1,000 or more mar­i­hua­na plants regard­less of weight
$10/50 mil­lion — 10 years to life in prison

21 U.S.C. § 841(b)(1)(B)(vii) (2017)
100 kilo­grams (220.462 pounds / 0.110231 tons) or more of a mix­ture or sub­stance con­tain­ing a detectable amount of mar­i­hua­na, or 100 or more mar­i­hua­na plants regard­less of weight
$5/25 mil­lion — 5 to 40 years in prison

21 U.S.C. § 841(b)(1)© (2017)
50 to 99 kilo­grams or 50 to 99 plants
$1/5 mil­lion — up to 20 years in prison

21 U.S.C. § 841(b)(1)(D) (2017)
less than 50 kilo­grams of mar­i­hua­na, except in the case of 50 or more mar­i­hua­na plants regard­less of weight, 10 kilo­grams of hashish, or one kilo­gram of hashish oil,
$250,000/$1 mil­lion — up to 5 years in prison

 

[2] 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.”

 

[3] 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

 

[4] 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)© (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

 

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Medical Cannabis and the 2017 Iowa Legislative Session

This leg­isla­tive ses­sion began with four pro­pos­als for med­ical cannabis pro­grams, two in the Iowa Sen­ate, one by Democ­rats (S.F. 205) and one by Repub­li­cans (S.S.B. 1176 / S.F. 506), and two in the Iowa House, one by Democ­rats (H.F. 198 / H.F. 199) and one by Repub­li­cans (H.S.B. 132), and two pro­pos­als to extend the cur­rent Med­ical Cannabid­i­ol Act of 2014, one by Sen­ate Repub­li­cans (S.F. 470) and one by House Repub­li­cans (H.F. 520).  What we end­ed up with is a hybrid of bits and pieces from each of these six pro­pos­als (H.F. 524).

Cultivation, manufacture, and distribution

H.F. 524 extends the Med­ical Cannabid­i­ol Act of 2014, with the addi­tion of more med­ical con­di­tions and cul­ti­va­tion, man­u­fac­ture, and dis­tri­b­u­tion of cannabid­i­ol in Iowa.  The lim­it on THC remains the same, 3%.  Most peo­ple are say­ing this is not a big step for­ward, but cul­ti­va­tion, man­u­fac­ture, and dis­tri­b­u­tion in Iowa seem like huge steps for­ward to me.  Because there were pro­pos­als in both cham­bers, from both par­ties, ear­ly in the year to cul­ti­vate, man­u­fac­ture, and dis­trib­ute cannabis prod­ucts in Iowa, this was not a total sur­prise.  The dis­agree­ment was main­ly about how much THC there can be in the prod­ucts.  Both Sen­ate pro­pos­als would have elim­i­nat­ed the lim­its on THC, and the House was split (Repub­li­cans in favor of the 3% lim­it on THC and Democ­rats in favor of elim­i­nat­ing any lim­it on THC).  Because Repub­li­cans con­trol both cham­bers and the governor’s office, the 3% lim­it on THC pre­vailed.

This is a stun­ning result, con­sid­er­ing the Nation­al Acad­e­mies of Sci­ence report­ed ear­li­er this year that there is con­clu­sive evi­dence that high­er lev­els of THC are effec­tive in the treat­ment of chron­ic pain and mul­ti­ple scle­ro­sis (Chap­ter 4, Sec­tion 1), and no or insuf­fi­cient evi­dence to sup­port or refute the con­clu­sion that cannabis or cannabi­noids are an effec­tive treat­ment for epilep­sy (Chap­ter 4, Sec­tion 6).  The rea­son giv­en for the the low THC lim­it was that it pro­vides an effec­tive treat­ment for epilep­sy.

Introduced at 3:00 a.m.

Although I am opti­mistic, H.F. 524 is not well writ­ten.  H.F. 524 was nego­ti­at­ed in secret meet­ings in the wee hours of the morn­ing on Sat­ur­day, April 22, 2017, just before the leg­is­la­ture adjourned for the year.  I was not able to obtain a copy of the bill until 3:00 a.m. on Sat­ur­day morn­ing, April 22, 2017.  I left the capi­tol around 5:00 a.m. (after sit­ting in the bal­cony over­look­ing the House floor for 16 hours), because it was obvi­ous to me H.F. 524 wasn’t going to be amend­ed and H.F. 524 would either pass or fail as writ­ten.  I watched the debate from the House floor and the Sen­ate floor after I got home lat­er in the morn­ing.  The legislature’s plan was to adjourn the 2017 ses­sion that morn­ing, so I was fair­ly con­fi­dent the bill was going to pass as writ­ten.  The vote in the Iowa House was 83–11-6 at 6:00 a.m., H.J. 1135, and 33–7-10 at 6:30 a.m. in the Iowa Sen­ate, S.J. 1122.  Both cham­bers adjourned for the year at 7:15 a.m.

There is no explanation of federal law in the bill

In my opin­ion, there is a crit­i­cal ele­ment left out of both the ini­tial pro­pos­als and the final bill that passed.  There is not a sin­gle men­tion of fed­er­al law in the pro­pos­als or in the final bill, and yet most of the media cov­er­age dur­ing the ses­sion report­ed leg­is­la­tors express­ing con­cern about fed­er­al law.  That seems like a huge flaw to me.  If fed­er­al law is a con­cern, it should be addressed in the bill.  For exam­ple, a hemp bill was intro­duced, S.F. 329, that con­tains a sec­tion enti­tled “Com­pli­ance with Fed­er­al Law.”  S.F. 329 proves that leg­is­la­tors under­stand there is a fed­er­al law involved when­ev­er cannabis is being con­sid­ered.  Leav­ing that out of every pro­pos­al, and in the final bill, H.F. 524, is a crit­i­cal over­sight.

Iowa Pub­lic Radio, April 12, 2017, Advo­cates Plead for Med­ical Mar­i­jua­na; Sen­ate Com­mit­tee Approves Bill: “You’re still break­ing fed­er­al law.” -House Speak­er Lin­da Upmey­er.

KGLO AM 1300, March 27, 2017, Upmey­er says leg­is­la­tors work­ing on med­ical mar­i­jua­na issue: “She says they are already antic­i­pat­ing doing this bill with the pos­si­bil­i­ty of break­ing two fed­er­al laws.”

What do we know about federal law?

First

We can read S.F. 329, which says it com­plies with 7 U.S.C. § 5940 (Pub. L. 113–79, title VII, § 7606, Feb. 7, 2014, 128 Stat. 912; Pub. L. 114–95, title IX, § 9215(f), Dec. 10, 2015, 129 Stat. 2166).

7 U.S.C. § 5940 says it pro­vides an excep­tion to 21 U.S.C §§ 801 et seq., The Con­trolled Sub­stances Act, title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242.

7 U.S.C. § 5940 defines hemp as cannabis with no more than .3% THC.

The Iowa Med­ical Cannabid­i­ol Act of 2014 defines cannabid­i­ol as cannabis with no more than 3% THC (ten times the amount of THC as defined in 7 U.S.C. § 5940).

Second

Con­gress has tem­porar­i­ly sus­pend­ed enforce­ment of 21 U.S.C. §§ 801 et seq. in the past two fed­er­al appro­pri­a­tions bills, and in the exten­sions for 2017 through May 5, 2017.  See, Con­gres­sion­al Research Ser­vice, R44782, “The Mar­i­jua­na Pol­i­cy Gap and the Path For­ward”, March 10, 2017, p. 15.

Pub. L. No. 113–235, § 538, 128 Stat. 2130, 2217 (2014) (“None of the funds made avail­able in this Act to the Depart­ment of Jus­tice may be used … to pre­vent such States from imple­ment­ing their own State laws that autho­rize the use, dis­tri­b­u­tion, pos­ses­sion, or cul­ti­va­tion of med­ical mar­i­jua­na”).

Pub. L. No. 114–113, § 542, 129 Stat. 2242, 2332–33 (2015) (“None of the funds made avail­able in this Act to the Depart­ment of Jus­tice may be used … to pre­vent any of them from imple­ment­ing their own laws that autho­rize the use, dis­tri­b­u­tion, pos­ses­sion, or cul­ti­va­tion of med­ical mar­i­jua­na”).

Pub.L. No. 114–254, § 101(1), 130 Stat. 1005, 1005-06 (2016) (extend­ing the date to April 28, 2017).

H.J.Res.99 — 115th Con­gress (2017–2018) (extend­ing the date to May 5, 2017).

See, Con­gres­sion­al Research Ser­vice, R44782, “The Mar­i­jua­na Pol­i­cy Gap and the Path For­ward”, March 10, 2017.

Update (May 1, 2017): Con­gress is set to re-autho­rize the sus­pend­ed enforce­ment until Sep­tem­ber of 2017.

Obvi­ous­ly, a tem­po­rary sus­pen­sion of enforce­ment is not a promise that enforce­ment will not be resumed.

Third

The U.S. Depart­ment of Jus­tice has cre­at­ed enforce­ment guide­lines that say enforce­ment of 21 U.S.C. §§ 801 et seq. will not like­ly be used against state med­ical mar­i­jua­na pro­grams.  Again, see, Con­gres­sion­al Research Ser­vice, R44782, “The Mar­i­jua­na Pol­i­cy Gap and the Path For­ward”, March 10, 2017. p. 12.

The Ogden Mem­o­ran­dum of Octo­ber 19, 2009 states that, “no State can autho­rize vio­la­tions of fed­er­al law.”

The Cole Mem­o­ran­dum of August 29, 2013 states that, “Nei­ther the guid­ance here­in nor any state or local law pro­vides a legal defense to a vio­la­tion of fed­er­al law, includ­ing any civ­il or crim­i­nal vio­la­tion of the CSA.”

Obvi­ous­ly, fed­er­al enforce­ment guide­lines do not pro­vide a legal defense for state med­ical mar­i­jua­na pro­grams, nor do they allow states to autho­rize vio­la­tions of fed­er­al law.

So, what federal law allows states to enact medical marijuana programs?

The fed­er­al Con­trolled Sub­stances Act (CSA), enact­ed in 1970, orig­i­nal­ly clas­si­fied cannabis as a sub­stance with no cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States.  The Attor­ney Gen­er­al was giv­en the duty of keep­ing the clas­si­fi­ca­tion (sched­ules) of con­trolled sub­stances updat­ed as cir­cum­stances changed.  21 U.S.C. § 811(a) (2017).  The Attor­ney Gen­er­al may “add sub­stances to,” “trans­fer sub­stances between,” or “remove sub­stances from” the sched­ules.  Since 1996, when Cal­i­for­nia became the first state in the Unit­ed States to accept the med­ical use of cannabis, a total of 45 states have accept­ed the med­ical use of cannabis or cannabis extracts.  By con­trast, noth­ing else in sched­ule 1 (the sched­ule cannabis was placed in by Con­gress in 1970) has been accept­ed by even a sin­gle state in the Unit­ed States.

Con­gress nev­er defined the term, “cur­rent­ly accept­ed med­ical use.”  Alliance for Cannabis Ther­a­peu­tics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (“nei­ther the statute nor its leg­isla­tive his­to­ry pre­cise­ly defines the term ‘cur­rent­ly accept­ed med­ical use’”).  Grin­spoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987) “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”).

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

The last time the Attor­ney Gen­er­al inter­pret­ed “cur­rent­ly accept­ed med­ical use” of cannabis was in 1991.  In 1991, there were no states in the Unit­ed States that had accept­ed the med­ical use of cannabis.  The 2009 and 2013 fed­er­al enforce­ment guide­lines appear to rely on this out­dat­ed inter­pre­ta­tion.  In fact, if you look at the state med­ical cannabis laws enact­ed since 1996, you’ll notice that none of them includes a state­ment of com­pli­ance with fed­er­al law.  Fail­ure to explain how the state med­ical cannabis law com­plies with exist­ing fed­er­al law deprives the Attor­ney Gen­er­al of the oppor­tu­ni­ty to update the clas­si­fi­ca­tion of cannabis. 

Conclusion

Fail­ure to explain com­pli­ance with fed­er­al law is a crit­i­cal flaw in H.F. 524.  The gov­er­nor should call the leg­is­la­tors back in a spe­cial ses­sion to address this error before sign­ing this leg­is­la­tion.

Any leg­is­la­tor, or the gov­er­nor, can request an opin­ion from the attor­ney gen­er­al, as set forth in Iowa Code § 13.2(3) (2017) and 61 Iowa Admin­is­tra­tive Code § 1.5 (2017).

Posted in Federal, States | 1 Comment

March 3 is the legislative funnel date

A vari­ety of med­ical cannabis bills have been filed in the Iowa leg­is­la­ture this year. One, HSB 132, has actu­al­ly passed in a Repub­li­can con­trolled sub­com­mit­tee. The end of this week, Fri­day, March 3, 2017, is the fun­nel date when bills have to be passed by a full com­mit­tee to remain eli­gi­ble for fur­ther debate. There are excep­tions to the fun­nel date and amend­ments can be filed to bills that are still viable after the fun­nel date, so don’t be com­plete­ly dis­traught if none of these bills pass­es out of com­mit­tee by Fri­day.

I’m going to describe sev­er­al of the bills by group­ing them by their sim­i­lar­i­ty.

Whole Plant Cannabis

SF 205 and HF 199 are very sim­i­lar. Both bills would allow whole plant cannabis to be grown and used for a vari­ety of med­ical con­di­tions in Iowa. These two bill have only Demo­c­rat cospon­sors and no Repub­li­can cospon­sors. Both bills look sim­i­lar to SF 484 from 2015 which passed by a nar­row par­ti­san vote in a Demo­c­rat con­trolled Iowa Sen­ate in 2015 and then died in a Repub­li­can con­trolled Iowa House in 2016. SF 205 has been assigned to a sub­com­mit­tee in the Repub­li­can con­trolled Iowa Sen­ate. HF 199 has not been assigned to a sub­com­mit­tee in the Repub­li­can con­trolled Iowa House. I’ve reg­is­tered in favor of both of these two bills, SF 205 and HF 199.

Cannabidiol Only

Iowa State Representative Clel Baudler

Iowa State Rep­re­sen­ta­tive Clel Baudler

I’m guess­ing that the rea­son HF 199 has not been assigned to a sub­com­mit­tee in the Repub­li­can con­trolled Iowa House is prob­a­bly because the Chair of the House Com­mit­tee on Pub­lic Safe­ty, Green­field Repub­li­can Rep­re­sen­ta­tive Clel Baudler, has filed his own med­ical cannabis bill, HSB 132. Chair­man Baudler’s bill actu­al­ly passed by a 3–0 vote in a sub­com­mit­tee on Feb­ru­ary 24, 2017, and Repub­li­cans are say­ing this is the bill that will even­tu­al­ly make it through the full com­mit­tee before the fun­nel date this Fri­day. How­ev­er, the chair of the com­mit­tee, Clel Baudler, now says he will not let the com­mit­tee vote on it, because there are only 4 Repub­li­cans will­ing to vote in favor of it. Rep. Baudler says he will not allow a vote on a bill that only a major­i­ty of Democ­rats will sup­port and the major­i­ty of his par­ty will not sup­port. I’ve reg­is­tered in favor of this bill, HSB 132.

Seriously?

Iowa State Senator Brad Zaun

Iowa State Sen­a­tor Brad Zaun

Final­ly, there are three bills that all have a very unusu­al sim­i­lar­i­ty. SF 282, filed by the chair of the Sen­ate Judi­cia­ry Com­mit­tee, Brad Zaun, and HSB 159, and HSB 164, filed by Rep. Baudler, all seem to be filed on behalf of a phar­ma­ceu­ti­cal com­pa­ny, GW Phar­ma­ceu­ti­cals (going by the name of Green­wich Bio­sciences, Inc.). All three of these bills have been assigned to sub­com­mit­tees, but it’s unclear if any of them will be approved by those sub­com­mit­tees. I have reg­is­tered against all three of these bills, SF 282, HSB 159, and HSB 164.

Complaint with the Iowa Board of Pharmacy

It just doesn’t seem appro­pri­ate to me for a phar­ma­ceu­ti­cal com­pa­ny to by lob­by­ing in Iowa for their prod­uct (with­out men­tion­ing the prod­uct by name in the bill) when the usu­al course of action with a phar­ma­ceu­ti­cal drug is to have a prod­uct approved by the FDA, clas­si­fied as a pre­scrip­tion drug by the DEA, and then approved by the state leg­is­la­ture after the fed­er­al approvals have been com­plet­ed. I’ve filed a com­plaint with the Iowa Board of Phar­ma­cy that will be con­sid­ered at their meet­ing on Wednes­day, March 8, 2017.

Congressman Young and Senator Whitver

Congressman David Young

Con­gress­man David Young

I met with Iowa Con­gress­man David Young and Iowa Sen­ate Pres­i­dent Jack Whitver on Fri­day, Feb­ru­ary 17, 2017, to, among oth­er things, let them know about my com­plaint with the phar­ma­cy board about SF 282. I received a nice post card from Con­gress­man Young fol­low­ing the meet­ing.

Postcard from Congressman Young

Post­card from Con­gress­man Young

Iowa State Senator Jack Whitver

Iowa State Sen­a­tor Jack Whitver



Summary

I’m not into con­spir­a­cy the­o­ries, but it does seem strange that the bill we were expect­ing, HSB 132, has sud­den­ly lost the sup­port of Chair­man Baudler, and now Chair­man Baudler is spon­sor­ing two crazy bills for a phar­ma­ceu­ti­cal com­pa­ny. A leg­is­la­tor on the sub­com­mit­tee that approved HSB 132 (Rep. Kristi Hager) told a moth­er of a child with epilep­sy (Erin Miller) that

Erin, I know this is a dif­fi­cult place to be. HSB 132 did not pass com­mit­tee so it won’t go any­where at this time.

How­ev­er HSB 164 was intro­duced which essen­tial­ly extends the cannabid­i­ol sun­set. Rep Klein, Kace­na, and myself have been assigned as the sub­com­mit­tee to this.

One of the rea­sons HSB 132 failed is in light of the cur­rent Fed­er­al Law stat­ing “while states can decrim­i­nal­ize mar­i­jua­na, fed­er­al law is clear that a state can­not issue licens­es or oth­er­wise sell mar­i­jua­na.” This bill called for licens­ing fees. Anoth­er con­cern was the use of Carv­er Col­lege of Med­i­cine and Col­lege of Phar­ma­cy for pro­vid­ing the sci­en­tif­ic tri­als with­out the allo­ca­tion of funds to do this. There were oth­er con­cerns around this in assur­ing a uni­form prod­uct, etc.

Thanks again for reach­ing out … Kristi

And then:

Erin, thank you. Your mom also wrote me and men­tioned the need your son has. I added a reminder note to look at an amend­ment to cov­er indi­vid­u­als receiv­ing cannabid­i­ol oil now who may not fall inside the Epid­i­olex guide­lines to allow them to con­tin­ue receiv­ing cur­rent ther­a­py. We’ll have our sub­com­mit­tee I’m guess­ing on Mon­day or Tues­day.

Green­wich Bio­sciences, Inc., is reg­is­tered in sup­port of HSB 159, but has not reg­is­tered any posi­tion on SF 282 or HSB 164. It still looks sus­pi­cious to me. It looks to me like SF 282 and HSB 164 are com­pro­mise posi­tions to HSB 159 intend­ed to keep the Iowa par­ents of chil­dren with epilep­sy in favor of the mod­i­fied ver­sions of the GW Phar­ma­ceu­ti­cal bill. That’s just my per­son­al opin­ion. I have been fol­low­ing this close­ly.

A sci­en­tist who works for GW Phar­ma­ceu­ti­cal helped me win my case with the Iowa Board of Phar­ma­cy in 2010, and that same sci­en­tist was involved in set­ting up clin­i­cal tri­als of the prod­uct here in Iowa with the Uni­ver­si­ty of Iowa med­ical school. Just to be clear, I have noth­ing against GW Phar­ma­ceu­ti­cal. I just don’t sup­port what GW Phar­ma­ceu­ti­cal is try­ing to do with these bills. Not every­one responds well to the GW Phar­ma­ceu­ti­cal prod­uct (which has no THC in it). Cur­rent Iowa law allows for cannabid­i­ol prod­ucts with up to 3% THC in them.


Clarification

I sup­port sec­tions 2 and 3, of SF 282 and HSB 164, which extend the cur­rent law. If you’re cov­ered now, you would still be cov­ered.

And, I am not opposed to resched­ul­ing Epid­i­olex, either.

What I am opposed to is men­tion­ing fed­er­al sched­ul­ing that has not hap­pened, and may nev­er hap­pen.

Show me proof that Epid­i­olex will ever be sched­uled.

The board has always rec­om­mend­ed the same changes to state sched­ul­ing as the fed­er­al gov­ern­ment makes, but only after the fed­er­al gov­ern­ment actu­al­ly makes the change (not before it).

So, we don’t need a law telling the board to do what it already does.

I see these bills would allow the board to make an emer­gency rule that would be effec­tive until the leg­is­la­ture approves it, but it’s still based on some­thing our state has no con­trol over (whether the fed­er­al gov­ern­ment approves Epid­i­olex, or not).

Anoth­er prob­lem I have is that the bill does not actu­al­ly say Epid­i­olex. Why not? What oth­er prod­ucts are there?

I’m only opposed to the part on fed­er­al sched­ul­ing. We can resched­ule Epid­i­olex right now. Show me a law that says we can’t.

We resched­uled nat­ur­al THC prod­ucts in 2008, and the fed­er­al gov­ern­ment still hasn’t approved any. What is that all about?

Iowa Code § 124.208(9)(b) (2017):

Any drug prod­uct in tablet or cap­sule form con­tain­ing nat­ur­al dron­abi­nol (derived from the cannabis plant) or syn­thet­ic dron­abi­nol (pro­duced from syn­thet­ic mate­ri­als) for which an abbre­vi­at­ed new drug appli­ca­tion (ANDA) has been approved by the Unit­ed States food and drug admin­is­tra­tion under sec­tion 505(j) of the fed­er­al Food, Drug, and Cos­met­ic Act and which ref­er­ences as its list­ed drug the drug prod­uct iden­ti­fied in para­graph “a”.

Fed­er­al sched­ul­ing only allows “syn­thet­ic” dron­abi­nol (THC). The fed­er­al gov­ern­ment pro­posed resched­ul­ing nat­ur­al dron­abi­nol in 2007.

Fed­er­al Reg­is­ter, Vol. 72, No. 184, Mon­day, Sep­tem­ber 24, 2007

This hap­pened again in 2010.

Fed­er­al Reg­is­ter, Vol. 75, No. 210, Mon­day, Novem­ber 1, 2010

But, nei­ther of these pro­posed fed­er­al rules were ever approved.

The list­ing for THC still says only “syn­thet­ic.”

21 C.F.R. § 1308.13(g) (2017):

Hal­lu­cino­genic sub­stances. (1) Dron­abi­nol (syn­thet­ic) in sesame oil and encap­su­lat­ed in a soft gelatin cap­sule in a U.S. Food and Drug Admin­is­tra­tion approved product—7369.
[Some oth­er names for dron­abi­nol: (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-diben­zo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahy­dro­cannabi­nol]

Obvi­ous­ly, we can resched­ule Epid­i­olex before the fed­er­al gov­ern­ment does. If that’s what we want to do, let’s do it. This non­sense about wait­ing for the fed­er­al gov­ern­ment is clear­ly a stall tac­tic.

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Is the DEA wrong about marijuana’s medical value?

The Question Presented

I’ve been asked to explain the U.S. Drug Enforce­ment Admin­is­tra­tion (DEA) deci­sion on July 19, 2016, not to accept the Mar­i­jua­na Resched­ul­ing Peti­tion filed by the states of Wash­ing­ton and Rhode Island on Novem­ber 30, 2011.  See Page 53688 of the Fed­er­al Reg­is­ter, Vol. 81, No. 156, Fri­day, August 12, 2016.

My Background

I have spe­cial exper­tise because I was one of the peti­tion­ers in the Mar­i­jua­na Resched­ul­ing Peti­tion filed by the Nation­al Orga­ni­za­tion for the Reform of Mar­i­jua­na Laws (NORML) in 1972 (I joined that case in 1985 and my name is on the cov­er of the Admin­is­tra­tive Law Judge’s Rul­ing on Sep­tem­ber 6, 1988), and final­ly resolved in the U.S. Court of Appeals in 1994 (I did not par­tic­i­pate in that appeal).  Alliance for Cannabis Ther­a­peu­tics v. DEA, 930 F.2d 936 (D.C. Cir. 1991); Alliance for Cannabis Ther­a­peu­tics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994).  I was also one of the orig­i­nal peti­tion­ers in the Mar­i­jua­na Resched­ul­ing Peti­tion filed by the Coali­tion for Cannabis Resched­ul­ing in 2002, and final­ly resolved in the U.S Court of Appeals in 2013 (I did par­tic­i­pate in that appeal, and I filed my own Peti­tion for Writ of Cer­tio­rari in the U.S. Supreme Court).  Amer­i­cans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2013).  The five part test that was devel­oped in the first peti­tion and applied in the sec­ond is the same test that was just recent­ly applied again by the DEA in the most recent peti­tion filed by the states of Wash­ing­ton and Rhode Island.

Dividing the Question

So, there are two ques­tions we need to ask.  First, the ques­tion most peo­ple are ask­ing, did the DEA apply the five part test cor­rect­ly?  The sec­ond ques­tion is one you won’t hear from any­one but me, and that is whether the five part test is even valid.  I’m not going to address the first ques­tion, because I don’t think its rel­e­vant whether DEA applied the five part test cor­rect­ly.  I’m going to divide the sec­ond ques­tion fur­ther and ask whether the five part test was ever valid at all, and then, if it was valid, I’m going to ask if the five part test is still valid today.

The Five-Part Test

On Page 938, Alliance for Cannabis Ther­a­peu­tics, 930 F.2d 936 (D.C. Cir. 1991), the court explains the dif­fer­ence between sched­ule 1 and sched­ule 2, “is whether a drug has ‘no cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States.’  This case turns on the appro­pri­ate def­i­n­i­tion and appli­ca­tion of that phrase.”

On Page 938, the court goes on to explain, “In a pri­or pro­ceed­ing, the Admin­is­tra­tor had employed an addi­tion­al eight fac­tor test to fur­ther elab­o­rate the char­ac­ter­is­tics of a drug that he thought had a ‘cur­rent­ly accept­ed med­ical use’:”

  1. Sci­en­tif­i­cal­ly deter­mined and accept­ed knowl­edge of its chem­istry;
  2. The tox­i­col­o­gy and phar­ma­col­o­gy of the sub­stance in ani­mals;
  3. Estab­lish­ment of its effec­tive­ness in humans through sci­en­tif­i­cal­ly designed clin­i­cal tri­als;
  4. Gen­er­al avail­abil­i­ty of the sub­stance and infor­ma­tion regard­ing the sub­stance and its use;
  5. Recog­ni­tion of its clin­i­cal use in gen­er­al­ly accept­ed phar­ma­copeia, med­ical ref­er­ences, jour­nals or text­books;
  6. Spe­cif­ic indi­ca­tions for the treat­ment of rec­og­nized dis­or­ders;
  7. Recog­ni­tion of the use of the sub­stance by orga­ni­za­tions or asso­ci­a­tions of physi­cians; and
  8. Recog­ni­tion and use of the sub­stance by a sub­stan­tial seg­ment of the med­ical prac­ti­tion­ers in the Unit­ed States.

53 Fed. Reg. 5,156 (1988).

On Page 939, Alliance for Cannabis Ther­a­peu­tics v. DEA, 930 F.2d 936 (D.C. Cir. 1991), explains why the DEA is cre­at­ing tests for deter­min­ing “cur­rent­ly accept­ed med­ical use.”  “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.” So, the DEA is try­ing to define a term used in the statute that Con­gress did not define.

What is impor­tant to note is that the eight-part test was the result of a pre­vi­ous test that was found invalid.  In Grin­spoon v. DEA, 828 F.2d 881, 891 (1st Cir. 1987), the court found that the Admin­is­tra­tor applied an incor­rect stan­dard in deter­min­ing the mean­ing of the phrase “cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States.”  53 Fed. Reg. 5,156 (1988).  The DEA has had a dif­fi­cult time cre­at­ing a valid inter­pre­ta­tion of the lan­guage used in the statute.

In Alliance for Cannabis Ther­a­peu­tics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994), the DEA’s “Final Order dis­cards the ear­li­er for­mu­la­tion and applies a new five-part test for deter­min­ing whether a drug is in ‘cur­rent­ly accept­ed med­ical use’:”

  1. The drug’s chem­istry must be known and repro­ducible;
  2. there must be ade­quate safe­ty stud­ies;
  3. there must be ade­quate and well-con­trolled stud­ies prov­ing effi­ca­cy;
  4. the drug must be accept­ed by qual­i­fied experts; and
  5. the sci­en­tif­ic evi­dence must be wide­ly avail­able.

57 Fed. Reg. 10,506 (1992).

So, the five-part test is the third time the DEA has tried to define a term that Con­gress did not define in the statute, “cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States.” We should be ask­ing our­selves if the DEA got it right on the third try.

Federalism

So, this brings us up to 1994 and the final rul­ing from the courts is that the five part test is a valid inter­pre­ta­tion of the lan­guage used in the statute. What hap­pens in 1996 is that Cal­i­for­nia becomes the first state to enact a law accept­ing the med­ical use of mar­i­jua­na. We now have a total of twen­ty-six (26) states that have accept­ed the med­ical use of mar­i­jua­na, and an addi­tion­al six­teen (16) states that have accept­ed the med­ical use of a mar­i­jua­na extract. Let’s do a lit­tle review here. In 1987, the DEA’s inter­pre­ta­tion of “cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States” was found to be invalid. In 1991, the DEA’s inter­pre­ta­tion of “cur­rent­ly accept­ed med­ical use” was found to be invalid. Notice how the words got trun­cat­ed to com­plete­ly ignore “in treat­ment in the Unit­ed States.” Then, in 1994, the DEA’s inter­pre­ta­tion of “cur­rent­ly accept­ed med­ical use” was found to be valid. So, why did the words “in treat­ment in the Unit­ed States” get left out? In 1994, there were no states that had accept­ed the med­ical use of mar­i­jua­na.

A cou­ple of graph­ics illus­trate the point.

States with Medical Marijuana laws (1994)

States with Medical Marijuana laws (2016)

Did the DEA apply the five-part test correctly?

Yes, under the five-part test, no plant could ever be approved for med­ical use by the DEA, which makes per­fect sense.  DEA has nev­er resched­uled a plant.  All the plants are in the same sched­ule Con­gress orig­i­nal­ly put them in.  Doc­tors are not writ­ing pre­scrip­tions for plants in sched­ule 2.  If opi­um plants and coca plants had to pass the DEA’s five-part test, they would fail the same way mar­i­jua­na does.  So, the test is being applied cor­rect­ly, the same way it would be applied to any oth­er plant.  Con­gress did not give the DEA any direc­tions on what to do if a plant is in the wrong sched­ule.  Because sched­ule 1 pre­vents their med­ical use, these plants will remain with­out med­ical use until Con­gress removes them from sched­ule 1.

Was the five-part test valid in 1994?

It’s hard to say whether a test for med­ical use of a plant in sched­ule 1 could ever be valid, because sched­ule 1 pre­vents them from being used for med­i­cine.  How­ev­er, the court did approve this test, so it was valid from that per­spec­tive.  The five-part test was not con­test­ed, so it was valid from that per­spec­tive.  In 1994, there were no states that had accept­ed the med­ical use of mar­i­jua­na, and there were no states that had accept­ed the med­ical use of mar­i­jua­na in 1970 when the law was writ­ten.  So, there wasn’t a bet­ter inter­pre­ta­tion of “cur­rent­ly accept­ed med­ical use” in 1994.  Appar­ent­ly, nobody want­ed to state the obvi­ous, a test for med­ical use of a plant in sched­ule 1 is an oxy­moron.  Accept­ed med­ical use in a state is a state deci­sion, but there were none in 1994 or in 1970.

Is the five-part test valid in August of 2016?

The prob­lem with the peti­tion filed by the states of Wash­ing­ton and Rhode Island is that it cedes state sov­er­eign­ty to a fed­er­al admin­is­tra­tive agency by accept­ing the DEA’s abil­i­ty to inter­pret the mean­ing of “accept­ed med­ical use in treat­ment in the Unit­ed States” with­out regard to state laws defin­ing mar­i­jua­na as med­i­cine  If the DEA is going to inter­pret the mean­ing of “accept­ed med­ical use in treat­ment in the Unit­ed States” with­out con­sid­er­ing state laws on the mat­ter then the five-part test is the only approved test for mak­ing that deter­mi­na­tion.  Both the states of Wash­ing­ton and Rhode Island clas­si­fy mar­i­jua­na as a sched­ule 1 sub­stance with no accept­ed med­ical use in treat­ment in the Unit­ed States in their own state drug laws, in clear vio­la­tion of the Full Faith and Cred­it Clause of the U.S. Con­sti­tu­tion.  Revised Code of Wash­ing­ton §§ 69.50.203(a)(2) and 69.50.204©(22) (2016); State of Rhode Island Gen­er­al Laws, §§ 21–28-2.03(2) and 21–28-2.08(d)(10) (2016).  The states of Wash­ing­ton and Rhode Island will not appeal from the DEA’s denial of their peti­tion, because they have no grounds on which to appeal (they have 30 days from the date of pub­li­ca­tion in the Fed­er­al Reg­is­ter to appeal), there­by prov­ing they knew they had no valid legal argu­ment when they filed their peti­tion.

So, the ques­tion is why the DEA is still being asked to inter­pret the mean­ing of “accept­ed med­ical use in treat­ment in the Unit­ed States” when we have forty-two states as of August of 2016 that have accept­ed it for med­ical use.  One expla­na­tion is that the states of Wash­ing­ton and Rhode Island have mar­i­jua­na clas­si­fied as hav­ing no accept­ed med­ical use in the Unit­ed States in their own state drug laws, despite the fact both states have defined mar­i­jua­na as med­i­cine in those same state drug laws.  How could a state act against its own inter­ests in this way?

Back to Federalism

Notice how the phrase “accept­ed med­ical use in treat­ment in the Unit­ed States” is inter­pret­ed by the court in 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.

And, notice in that case the phrase is not trun­cat­ed to only say “cur­rent­ly accept­ed med­ical use.”  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.

So, the DEA’s five-part test, just like approval for inter­state mar­ket­ing, does not take into account indi­vid­ual states.  The five-part test is for “every state,” just like the approval for inter­state mar­ket­ing, because it would require a find­ing of rec­og­nized med­ical use in every state.  This leaves absolute­ly no doubt, the five-part test is no longer valid.

This is not the first time state offi­cials in states such as Wash­ing­ton and Rhode Island have act­ed against the inter­ests of the peo­ple who elect­ed them.  In New York v. Unit­ed States, 505 U.S. 144, 181–182 (1992), the U.S. Supreme Court asked, “How can a fed­er­al statute be found an uncon­sti­tu­tion­al infringe­ment of state sov­er­eign­ty when state offi­cials con­sent­ed to the statute’s enact­ment?”  The con­text was dif­fer­ent in that case, but the idea is the same as it is here.  State offi­cials in the states of Wash­ing­ton and Rhode Island have con­sent­ed to the DEA inter­pret­ing a statute in a man­ner that infringes on their own state sov­er­eign­ty.

What the states of Wash­ing­ton and Rhode Island should have done is tell the DEA it has no busi­ness inter­pret­ing a term Con­gress has not defined (“med­ical use”) when the state has a law that defines the “med­ical use” of mar­i­jua­na.  See, Gon­za­les v. Ore­gon, 546 U.S. 243 (2006), for an exam­ple of how this works.  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.

DEA is the fed­er­al agency that acts for the U.S. Depart­ment of Jus­tice in mak­ing sched­ul­ing deci­sions.  In Gon­za­les v. Ore­gon, the Attor­ney Gen­er­al tried to tell the state of Ore­gon that the use of con­trolled sub­stances to assist in sui­cide was not a law­ful “med­ical use” of con­trolled sub­stances, but the court dis­agreed and said the state has the author­i­ty to decide what is “accept­ed for med­ical use” because Con­gress did not make those deci­sions in the fed­er­al statute.  The court said Con­gress could make deci­sion on “med­ical use,” but hasn’t.  Gon­za­les v. Ore­gon, 546 U.S. 243, 271–272 (2006):

Even though reg­u­la­tion of health and safe­ty is “pri­mar­i­ly, and his­tor­i­cal­ly, a mat­ter of local con­cern,” Hills­bor­ough Coun­ty v. Auto­mat­ed Med­ical Lab­o­ra­to­ries, Inc., 471 U.S. 707, 719, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985), there is no ques­tion that the Fed­er­al Gov­ern­ment can set uni­form nation­al stan­dards in these areas.  See Raich, supra, at 9, 125 S. Ct. 2195, 162 L. Ed. 2d 1. In con­nec­tion to the CSA, how­ev­er, we find only one area in which Con­gress set gen­er­al, uni­form stan­dards of med­ical prac­tice.  Title I of the Com­pre­hen­sive Drug Abuse Pre­ven­tion and Con­trol Act of 1970, of which the CSA was Title II, pro­vides that

[The Sec­re­tary], after con­sul­ta­tion with the Attor­ney Gen­er­al and with nation­al orga­ni­za­tions rep­re­sen­ta­tive of per­sons with knowl­edge and expe­ri­ence in the treat­ment of nar­cot­ic addicts, shall deter­mine the appro­pri­ate meth­ods of pro­fes­sion­al prac­tice in the med­ical treat­ment of the nar­cot­ic addic­tion of var­i­ous class­es of nar­cot­ic addicts, and shall report there­on from time to time to the Con­gress.”  § 4, 84 Stat. 1241, cod­i­fied at 42 U.S.C. § 290bb-2a.

This pro­vi­sion strength­ens the under­stand­ing of the CSA as a statute com­bat­ing recre­ation­al drug abuse, and also indi­cates that when Con­gress wants to reg­u­late med­ical prac­tice in the giv­en scheme, it does so by explic­it lan­guage in the statute.

It’s clear that Con­gress nev­er intend­ed to tell states what they can accept for med­ical use with­in their own bor­ders.  But, we have states telling the DEA it’s a fed­er­al deci­sion when it’s not.  The DEA sim­ply refus­es to budge until some­one gives them a valid legal argu­ment for remov­ing mar­i­jua­na from sched­ule 1.

There are three ways that could hap­pen: (1) an exec­u­tive order declar­ing mar­i­jua­na has accept­ed med­ical use in the Unit­ed States as a mat­ter of law would clar­i­fy that the DEA has no author­i­ty to keep mar­i­jua­na in sched­ule 1; (2) a rul­ing from a court declar­ing mar­i­jua­na has accept­ed med­ical use in the Unit­ed States as a mat­ter of law would clar­i­fy that the DEA has no author­i­ty to keep mar­i­jua­na in sched­ule 1; and, final­ly (3) a clar­i­fi­ca­tion from Con­gress explain­ing that state laws are accept­ed med­ical use in the Unit­ed States as a mat­ter of law would clar­i­fy that the DEA has no author­i­ty to keep mar­i­jua­na in sched­ule 1.  There are some bills pend­ing in Con­gress (S. 683 and H.R. 1538, for exam­ple) that would do this, but they are not as clean as sim­ply enforc­ing the exist­ing law (they would place mar­i­jua­na into anoth­er sched­ule, which an exec­u­tive or judi­cial rul­ing would not do, for the best exam­ple).

Con­gress has with­held fund­ing for enforce­ment of fed­er­al sched­ule 1 against med­ical use of mar­i­jua­na in states that have accept­ed it.  See Unit­ed States v. Marin Alliance, 3:98-cv-00086-CRB (N.D. Cal., 12/18/2015); and Unit­ed States v. Steve McIn­tosh, No. 15–10117 (9th Cir., 8/16/2016).  These cas­es demon­strate the dif­fi­cul­ty imposed on the fed­er­al courts, because the court has to deter­mine if the defen­dant was in com­pli­ance with a state med­ical mar­i­jua­na law, and then has to deter­mine if the mon­ey being appro­pri­at­ed for the pros­e­cu­tion of the case falls with­in the time peri­od that Con­gress has for­bid­den the appro­pri­a­tion of such funds for such pur­pos­es.  Wow!

International Law

Final­ly, the DEA rul­ing pub­lished in the Fed­er­al Reg­is­ter on August 12, 2016, relies on inter­na­tion­al treaty oblig­a­tions.  If a sched­ule is required by an inter­na­tion­al treaty, then the DEA is pre­clud­ed from apply­ing some or all of the sched­ul­ing cri­te­ria.  21 U.S.C. § 811(d)(1).  The courts have pre­vi­ous­ly deter­mined that inter­na­tion­al treaty oblig­a­tions pre­vent mar­i­jua­na from being sched­uled any low­er than sched­ule 2.  NORML v. DEA, 559 F.2d 735, 751 (D.C. Cir. 1977).  Because the abuse poten­tial for sched­ule 1 and sched­ule 2 is the same, the only rel­e­vant ques­tion then is whether mar­i­jua­na has “cur­rent­ly accept­ed med­ical use in treat­ment in the Unit­ed States.”  Abuse poten­tial is not rel­e­vant, because the inter­na­tion­al treaties pre­vent the DEA from con­sid­er­ing it.

Because the states of Wash­ing­ton and Rhode Island ced­ed the author­i­ty to define “med­ical use” to a fed­er­al admin­is­tra­tive agency, they also lim­it­ed the choic­es to sched­ule 1 or sched­ule 2, regard­less of whether mar­i­jua­na actu­al­ly belongs in either of those clas­si­fi­ca­tions.

But, the inter­na­tion­al treaties them­selves pro­vide the answer.  Only one of the treaties is specif­i­cal­ly men­tioned, the Sin­gle Con­ven­tion on Nar­cot­ic Drugs, 1961 (As amend­ed by the 1972 Pro­to­col), but all of the treaties use the same lan­guage in their enforce­ment sec­tions:

Arti­cle 36(2) “Sub­ject to the con­sti­tu­tion­al lim­i­ta­tions of a Par­ty, its legal sys­tem and domes­tic law, …”

The treaty does not apply if there is a domes­tic law that allows the activ­i­ty.  A domes­tic law would be intrastate and sole­ly with­in the bor­ders of a state.  State med­ical mar­i­jua­na laws are exempt from the inter­na­tion­al treaties.

The states of Wash­ing­ton and Rhode Island have not only ced­ed their state sov­er­eign­ty to a fed­er­al admin­is­tra­tive agency, but they have also ced­ed their state sov­er­eign­ty to an inter­na­tion­al admin­is­tra­tive agency, the Unit­ed Nations Com­mis­sion on Nar­cot­ic Drugs.  This is treach­ery of the high­est mag­ni­tude.

Posted in Federal | 8 Comments

Attention on medical marijuana shifts to Congress

Atten­tion has shift­ed from state leg­is­la­tion to Con­gress and can­di­dates run­ning for fed­er­al office. While rumors have been spread­ing around that the DEA is going to resched­ule mar­i­jua­na in July of 2016, on July 6, Con­gress­man David Young became the first fed­er­al elect­ed offi­cial from Iowa to co-spon­sor H.R. 1538: the CARERS Act of 2015.

david_young

Con­gress­man David Young

Although the CARERS Act is over­ly com­plex, it would remove mar­i­jua­na from fed­er­al sched­ule 1 and rec­og­nizes that mar­i­jua­na does have med­ical use. I have asked Con­gress­man Young to file an amend­ment to the CARERS Act that would sim­ply remove mar­i­jua­na from fed­er­al sched­ule 1 and require the fed­er­al admin­is­tra­tive agen­cies to work with the states to come up with rea­son­able reg­u­la­tions.

On July 4, I wrote Sen­a­tor Chuck Grass­ley ask­ing him why his pre­dic­tion that the DEA would reclas­si­fy cannabid­i­ol in the first half of 2016 had not mate­ri­al­ized. On July 5, I got a call from David Ble­ich in Sen­a­tor Grassley’s DC office. What I learned is that the DEA is telling Sen­a­tor Grass­ley that they will rule on the mar­i­jua­na resched­ul­ing peti­tion filed in Novem­ber of 2011 by the states of Wash­ing­ton and Rhode Island with­in the next cou­ple of weeks.

Mr. Ble­ich referred to a series of let­ters from Sen­a­tor Eliz­a­beth War­ren request­ing updates on the sta­tus of pend­ing FDA reviews on cannabis and cannabid­i­ol. Let­ter of July 9, 2015; Let­ter of Octo­ber 15, 2015; Let­ter of Decem­ber 21, 2015; Let­ter of April 4, 2016; Let­ter of June 23, 2016.

Recent edi­to­ri­als from John Hudak and Grace Wal­lack at the Brook­ings Insti­tu­tion on May 27, 2016, and from Jacob Sul­lum at Rea­son Mag­a­zine on July 4, 2016, explain why they think resched­ul­ing of mar­i­jua­na by the DEA is very unlike­ly.

Mr. Ble­ich also men­tioned a new bill being intro­duced in the Sen­ate Judi­cia­ry Com­mit­tee that seems to have strong bipar­ti­san sup­port, S. 3077: the MEDS Act.  When I wrote to Con­gress­man David Young to thank him for cospon­sor­ing the CARERS Act, I also sug­gest­ed that he cospon­sor the com­pan­ion bill in the U.S. House of Rep­re­sen­ta­tives, H.R. 5549: the Med­ical Mar­i­jua­na Research Act of 2016. Again, H.R. 5549 is over­ly com­plex and could sim­ply be amend­ed to remove mar­i­jua­na from fed­er­al sched­ule 1 and instruct the fed­er­al agen­cies to work with the states to come up with rea­son­able reg­u­la­tions.

What these two bills scream out is that there is some­thing wrong with the way cannabis is clas­si­fied under fed­er­al law. Con­gress seems to be try­ing to bend over back­ward to avoid address­ing the issue. S. 3077 and H.R. 5549 would cre­ate a slew of excep­tions to sched­ule 1 for mar­i­jua­na. For exam­ple, it would allow a doc­tor who has a license to pre­scribe drugs in sched­ule 5 to con­duct research with mar­i­jua­na with­out hav­ing a sched­ule 1 license. I’m ask­ing my rep­re­sen­ta­tives in Con­gress to sup­port these bills, even though they are extra­or­di­nar­i­ly com­plex, because some­thing is bet­ter than noth­ing. But, I have also asked them to file amend­ments to sim­pli­fy these bills.

Final­ly, Mr. Ble­ich said he did not expect the FDA review of cannabid­i­ol to be com­plet­ed before the end of the year. The FDA is still doing safe­ty stud­ies and it will take them an addi­tion­al 6 months to ana­lyze the 8 fac­tors in 21 U.S.C. § 811©. Mr. Ble­ich agrees there is no prece­dent for resched­ul­ing a mol­e­cule and this is the first time the FDA has con­sid­ered resched­ul­ing a mol­e­cule that is not con­tained in a drug prod­uct being sub­mit­ted for com­mer­cial mar­ket­ing approval. Mr. Ble­ich said this FDA review was in response to a request from Sen­a­tor Grass­ley and Sen­a­tor Fein­stein and was con­sid­ered to be a peti­tion for resched­ul­ing of CBD. Mr. Ble­ich said clin­i­cal tri­als with Epid­i­olex are going well and that phar­ma­ceu­ti­cal grade CBD may be avaible from GW Phar­ma­ceu­ti­cals in the next year or two. And, final­ly, Mr. Ble­ich said a com­pa­ny in the south­west­ern Unit­ed States is work­ing on man­u­fac­tur­ing syn­thet­ic CBD.

Spe­cial thanks to Paul Armen­tano, Deputy Direc­tor at NORML for send­ing me infor­ma­tion on the com­pa­ny mak­ing the syn­thet­ic CBD:

FYI: For those inter­est­ed, the com­pa­ny is Insys Ther­a­puet­ics and they received FDA orphan drug sta­tus for syn­thet­ic CBD two years ago:
http://finance.yahoo.com/news/insys-therapeutics-cannabidiol-gets-orphan-193003258.html

They also have a syn­thet­ic alter­na­tive THC drug (aka Syn­dros) that recent­ly gained FDA approval: http://www.marketwatch.com/story/insyss-stock-soars-after-cannabis-based-oral-drug-gets-fda-approval-2016–07-05?siteid=yhoof2 join­ing a hand­ful of oth­er syn­thet­ic THC ana­logues in the mar­ket.

This is not an OTT stock but a larg­er US-based biotech.

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