Update on federal cannabis exemption

Bleed­ing Heart­land

Update on efforts to obtain a federal cannabis exemption for Iowa

• Mon­day, Jun 21 2021
• carl

Carl Olsen is the founder of Iowans for Med­ical Mar­i­jua­na. – pro­mot­ed by Lau­ra Belin

In Feb­ru­ary 2019, I asked the Iowa Med­ical Cannabid­i­ol Board, which reg­u­lates our state’s med­ical cannabis pro­gram, if there was any­thing we could be doing about fed­er­al drug law, such as obtain­ing a fed­er­al exemp­tion (21 C.F.R. § 1307.03) like the one that cur­rent­ly exists for anoth­er fed­er­al Sched­ule I con­trolled sub­stance, pey­ote (21 C.F.R. § 1307.31).

In August 2019, at my request, the board rec­om­mend­ed that the Iowa Depart­ment of Pub­lic Health (IDPH) obtain a fed­er­al exemp­tion for cannabis.  How­ev­er, the depart­ment refused, say­ing none of the oth­er 46 states that have enact­ed med­ical cannabis laws have request­ed fed­er­al exemp­tions, and that Iowans were not being injured by the fed­er­al crim­i­nal­iza­tion of cannabis.

Keep in mind that patients had been tes­ti­fy­ing before the board about dis­crim­i­na­tion in schools and health care facil­i­ties because of the fed­er­al crim­i­nal­iza­tion of cannabis.  Iowa Attor­ney Gen­er­al Tom Miller signed a Sep­tem­ber 2019 bipar­ti­san let­ter from attor­neys gen­er­al say­ing the cur­rent fed­er­al pol­i­cy “pos­es a seri­ous threat to pub­lic safe­ty.”

Board under­stands need for fed­er­al exemp­tion

If you’ve ever won­dered about cit­i­zen boards over­see­ing state pro­grams, this is an exam­ple of a board that saw some­thing the depart­ment could not see.  Because the board is made up of cit­i­zen vol­un­teers, they under­stand the pro­gram bet­ter than the depart­ment that reg­u­lates it.  This par­tic­u­lar board is made up of sev­er­al doc­tors and a police offi­cer.  They under­stand fed­er­al reg­u­la­tion of con­trolled sub­stances bet­ter than most peo­ple.  I’m also a cit­i­zen vol­un­teer, and I was able to work with this board to pro­vide greater pro­tec­tion for patients than the depart­ment would have pro­vid­ed with­out us.  The board took the time to lis­ten care­ful­ly.

In Jan­u­ary 2020, the board rec­om­mend­ed the Iowa leg­is­la­ture obtain a fed­er­al exemp­tion for cannabis.  The leg­is­la­ture then instruct­ed the IDPH to obtain fed­er­al fund­ing guar­an­tees for schools and health care facil­i­ties.  The depart­ment deter­mined in Sep­tem­ber 2020 that the only way to obtain fed­er­al fund­ing guar­an­tees was to obtain a fed­er­al exemp­tion for cannabis.  Then the depart­ment dropped the ball and did noth­ing fur­ther.

Again, I want to express my deep­est appre­ci­a­tion to the Iowa leg­is­la­ture for cre­at­ing a board of med­ical and law enforce­ment pro­fes­sion­als to over­see our state cannabis pro­gram.  This board has proven its val­ue time and again.  Regard­less of what the depart­ment says about the oth­er 46 states’ fail­ure to address fed­er­al drug reg­u­la­tions, it’s not our busi­ness to inter­fere in their affairs.  But it is our busi­ness to pro­tect and improve the health of Iowans, and that’s exact­ly what we will do.

In Jan­u­ary 2021, the cannabid­i­ol board noti­fied the leg­is­la­ture that the depart­ment was stalling.  I don’t want to imply IDPH offi­cials were inten­tion­al­ly stalling.  For what­ev­er rea­son, the depart­ment could not see a clear path for­ward.  I’ll give the depart­ment the ben­e­fit of the doubt here.  It is clear­ly in everyone’s best inter­est to let the board con­tin­ue lead­ing on this mat­ter.

In April, I filed a law­suit in Polk Coun­ty Dis­trict Court demand­ing Gov­er­nor Kim Reynolds obtain the fed­er­al fund­ing guar­an­tees required by the 2020 law.  In response, the IDPH sent let­ters to the Cen­ters for Medicare and Med­ic­aid, the Food and Drug Admin­is­tra­tion, the Depart­ment of Edu­ca­tion, and the Drug Enforce­ment Admin­is­tra­tion, request­ing fed­er­al fund­ing guar­an­tees.

When the cannabid­i­ol board met in May 2021, it wasn’t aware of the four let­ters sent by the depart­ment in April.  I pro­vid­ed board mem­bers with copies of the four let­ters and sug­gest­ed the board con­tact our fed­er­al leg­is­la­tors, Sen­a­tors Chuck Grass­ley and Joni Ernst, Rep­re­sen­ta­tives Ash­ley Hin­son, Mar­i­an­nette Miller-Meeks, Cindy Axne, and Randy Feen­stra, to assist us in obtain­ing fed­er­al fund­ing guar­an­tees.  A board mem­ber asked that my request be added to the agen­da for the next sched­uled meet­ing in August, and the depart­ment agreed to add it.

Iowa’s mem­bers of Con­gress not on board with need­ed leg­is­la­tion

Grass­ley and Ernst are among ten sen­a­tors co-spon­sor­ing S.253, the Cannabid­i­ol and Mar­i­hua­na Research Expan­sion Act.

In the U.S. House of Rep­re­sen­ta­tives, Miller-Meeks is one of two co-spon­sors of H.R.2932, the Vet­er­ans CARE Act.

I appre­ci­ate the fact they sup­port more research, but these bills pro­vide absolute­ly no pro­tec­tion for Iowa’s med­ical cannabis pro­gram.

Fed­er­al leg­is­la­tion exists that would pro­tect our state’s med­ical cannabis pro­gram, and our state’s mem­bers of Con­gress should be sup­port­ing it.  See H.R.3105 – Com­mon Sense Cannabis Reform for Vet­er­ans, Small Busi­ness­es, and Med­ical Pro­fes­sion­als Act, for exam­ple.

An esti­mat­ed 78 per­cent of Iowans sup­port expand­ing the med­ical use of cannabis in Iowa.  Sup­port for med­ical cannabis nation­al­ly is 91 per­cent, recent polling sug­gests.

Fed­er­al cannabis guide­lines

Not all state med­ical cannabis pro­grams are the same.  Exist­ing fed­er­al diver­sion avoid­ance can be pieced togeth­er from the fol­low­ing sources: (1) 21 U.S.C. § 814; (2) Gon­za­les v. Raich, 545 U.S. 1 (2005); (3) U.S. Depart­ment of Jus­tice Guid­ance, 2013; and (4) new DEA clas­si­fi­ca­tion for cannabis extract, 2016.  Iowa’s med­ical cannabis pro­gram sat­is­fies these guide­lines.

The fed­er­al pol­i­cy in 21 U.S.C. § 814(d)(1) is “that the par­tic­u­lar drug prod­uct is man­u­fac­tured and dis­trib­uted in a man­ner that pre­vents diver­sion”.  The spe­cif­ic fac­tors in 21 U.S.C. § 814(d)(2) are:

• (A) the pack­age sizes and man­ner of pack­ag­ing of the drug prod­uct;
• (B) the man­ner of dis­tri­b­u­tion and adver­tis­ing of the drug prod­uct;
• © evi­dence of diver­sion of the drug prod­uct;
• (D) any actions tak­en by the man­u­fac­tur­er to pre­vent diver­sion of the drug prod­uct; and
• (E) such oth­er fac­tors as are rel­e­vant to and con­sis­tent with the pub­lic health and safe­ty, includ­ing the fac­tors described in sub­sec­tion (b) as applied to the drug prod­uct.

The spe­cif­ic fac­tors in 21 U.S.C. § 814(b) are:

• (1) the scope, dura­tion, and sig­nif­i­cance of the diver­sion;
• (2) whether the drug or group of drugs is for­mu­lat­ed in such a way that it can­not be eas­i­ly used in the illic­it pro­duc­tion of a con­trolled sub­stance; and
• (3) whether the list­ed chem­i­cal can be read­i­ly recov­ered from the drug or group of drugs;

As states began to autho­rize med­ical use of cannabis, their ini­tial approach was to autho­rize per­son­al cul­ti­va­tion to avoid large scale oper­a­tions.  Licens­ing man­u­fac­tur­ers and dis­trib­u­tors did not occur until lat­er.  When the U.S. Supreme Court con­sid­ered whether per­son­al cul­ti­va­tion of mar­i­jua­na was out­side the scope of fed­er­al reg­u­la­tion, the court found:

“The par­al­lel con­cern mak­ing it appro­pri­ate to include mar­i­jua­na grown for home con­sump­tion in the CSA is the like­li­hood that the high demand in the inter­state mar­ket will draw such mar­i­jua­na into that mar­ket.”  Raich, 545 U.S. at 19.

As states began to license man­u­fac­tur­ers and dis­trib­u­tors, the ini­tial fed­er­al response was a stern warn­ing in 2011: “the busi­ness of cul­ti­vat­ing, sell­ing or dis­trib­ut­ing mar­i­jua­na, and those who know­ing­ly facil­i­tate such activ­i­ties, are in vio­la­tion of the Con­trolled Sub­stances Act, regard­less of state law.”

That warn­ing was replaced in 2013 with a green light sug­gest­ing such busi­ness­es could pro­ceed: “the exis­tence of a strong and effec­tive state reg­u­la­to­ry sys­tem, and an operation’s com­pli­ance with such a sys­tem, may allay the threat than an organization’s size pos­es to fed­er­al enforce­ment.”

Iowa’s med­ical cannabis pro­gram (Iowa Code Chap­ter 124E) address­es these con­cerns.  Unlike the sit­u­a­tion in the Raich case, Iowa does not autho­rize the per­son­al cul­ti­va­tion of cannabis.  Iowa autho­rizes “phar­ma­ceu­ti­cal grade cannabi­noids” in for­mu­la­tions “rec­om­mend­ed by the med­ical cannabid­i­ol board, approved by the board of med­i­cine, and adopt­ed by the depart­ment pur­suant to rule” (Iowa Code § 124E.2(10)).  DEA cre­at­ed a new drug clas­si­fi­ca­tion for “cannabis extracts” in 2016 (81 FR 90194, 12/14/2016).  There have not been any reports of diver­sion of these prod­ucts from legit­i­mate chan­nels.

Biden administration’s pol­i­cy would help

The Biden administration’s pol­i­cy on mar­i­jua­na is to fed­er­al­ly legal­ize med­ical use of cannabis and to leave deci­sions on oth­er uses of cannabis up to the states (empha­sis added):

Decrim­i­nal­ize the use of cannabis and auto­mat­i­cal­ly expunge all pri­or cannabis use con­vic­tions.  Biden believes no one should be in jail because of cannabis use.  As pres­i­dent, he will decrim­i­nal­ize cannabis use and auto­mat­i­cal­ly expunge pri­or con­vic­tions.  And, he will sup­port the legal­iza­tion of cannabis for med­ical pur­pos­es, leave deci­sions regard­ing legal­iza­tion for recre­ation­al use up to the states, and resched­ule cannabis as a sched­ule II drug so researchers can study its pos­i­tive and neg­a­tive impacts.

Bleed­ing Heart­land