Religious Exceptions to the CSA

The Drug Enforce­ment Admin­is­tra­tion (DEA) cre­at­ed a Guid­ance Doc­u­ment for the Reli­gious Free­dom Restora­tion Act (RFRA) in 2009 which is at the heart of a case argued before the Unit­ed States Court of Appeals for the Dis­trict of Colum­bia Cir­cuit on Novem­ber 14, 2025.  In re: Iowas­ka Church of Heal­ing, No. 25–1140.  The Guid­ance Doc­u­ment explains how to apply for a reli­gious excep­tion to the Con­trolled Sub­stances Act (CSA) of 1970 using the reg­u­la­to­ry author­i­ty in the CSA.

Pri­or to the deci­sion in Gon­za­les v. O Cen­tro Espíri­ta Benef­i­cente União do Veg­e­tal, 546 U.S. 418 (2006), the DEA had claimed it lacked the reg­u­la­to­ry author­i­ty in the CSA to make reli­gious excep­tions.  The Guid­ance Doc­u­ment does not include an apol­o­gy for that error, but it does final­ly set­tle the issue of whether the DEA has the author­i­ty to make reli­gious excep­tions.  It does, and it always did.

Con­gress enact­ed the RFRA in 1993 to ensure gov­ern­ment accom­mo­dates reli­gious beliefs when­ev­er it can, which is why the Guid­ance Doc­u­ment refers to the RFRA.  But, the Guid­ance Doc­u­ment does not cre­ate any new rights or reg­u­la­tions, it sim­ply for­bids the DEA from deny­ing it has always had the reg­u­la­to­ry author­i­ty to make reli­gious excep­tions.

The admin­is­tra­tive pro­ce­dures under the CSA include Judi­cial Review in the U.S. Court of Appeals, 21 U.S.C. § 877, but the RFRA pro­vides direct access for Judi­cial Relief in the U.S. Dis­trict Courts, 42 U.S.C. § 2000bb‑1©, with­out requir­ing, or in addi­tion to, peti­tion­ing the DEA for an excep­tion under the CSA reg­u­la­tions.  Con­gress want­ed the RFRA to be enforced and pro­vid­ed this extra pro­tec­tion to make sure of it.

The issue before the appel­late court in In re: Iowas­ka Church of Heal­ing is whether the RFRA cre­ates any greater pro­tec­tion under the CSA.  Specif­i­cal­ly in this case, whether the RFRA cre­ate any greater rights to a speedy response under the CSA reg­u­la­tions and the Admin­is­tra­tive Pro­ce­dures Act (APA).  Lis­ten­ing to the argu­ments in the case, it seems like the RFRA does not cre­ate any addi­tion­al right to speedy redress, but it does not dimin­ish the right to speedy redress under the APA.  If reliance on the RFRA is just a tech­ni­cal error and does not make any dif­fer­ence, the court may grant the relief request­ed with­out reliance on the RFRA.  A com­plaint under the APA is usu­al­ly filed in a U.S. Dis­trict Court, but it can be filed in the U.S. Court of Appeals when a case is pend­ing with the DEA because of 21 U.S.C. § 877.

Religious Exception by CSA Regulation

In 1970, the Attor­ney Gen­er­al, under the author­i­ty in 21 U.S.C. § 822(d), autho­rized an admin­is­tra­tive excep­tion for use of pey­ote in reli­gious cer­e­monies of the Native Amer­i­can Church.  Pey­ote is a Sched­ule 1 con­trolled sub­stance.  21 U.S.C. § 812©(Schedule 1)©(12)(Peyote).  The excep­tion was cre­at­ed as an admin­is­tra­tive reg­u­la­tion, 21 C.F.R. § 1307.31:

§ 1307.31  Native Amer­i­can Church.
The list­ing of pey­ote as a con­trolled sub­stance in Sched­ule I does not apply to the non­drug use of pey­ote in bona fide reli­gious cer­e­monies of the Native Amer­i­can Church, and mem­bers of the Native Amer­i­can Church so using pey­ote are exempt from reg­is­tra­tion.  Any per­son who man­u­fac­tures pey­ote for or dis­trib­utes pey­ote to the Native Amer­i­can Church, how­ev­er, is required to obtain reg­is­tra­tion annu­al­ly and to com­ply with all oth­er require­ments of law.

The First Amend­ment to the U.S. Con­sti­tu­tion allows reli­gious excep­tions but for­bids reli­gious pref­er­ences.

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

21 C.F.R. § 1307.31, cre­at­ed in 1970, is old­er than the DEA.  The DEA was cre­at­ed in 1973.  The DEA had to ask the Office of Legal Coun­sel to explain the pur­pose of the pey­ote excep­tion.  The Office of Legal Coun­sel told the DEA it has “a sec­u­lar pur­pose.”  Pey­ote Exemp­tion for Native Amer­i­can Church, 5 Op. Off. Legal Coun­sel 403, 415 (1981).

The author­i­ty for 21 C.F.R. § 1307.31 comes from 21 U.S.C. § 822(d) which says excep­tions must be “con­sis­tent with the pub­lic health and safe­ty” (a sec­u­lar pur­pose).  Indeed, any­one, includ­ing anoth­er reli­gious orga­ni­za­tion, can peti­tion “for the issuance, amend­ment, or repeal of any rule or reg­u­la­tion.”  21 C.F.R. § 1308.43.

In 2006 the Unit­ed States Supreme Court enjoined the enforce­ment of the CSA against anoth­er church pur­suant to the Reli­gious Free­dom Restora­tion Act (RFRA), 42 U.S.C. Chap­ter 21B.  In that case, the DEA told the court that only the Native Amer­i­can Church could have an excep­tion to the CSA because there is a “unique rela­tion­ship” between the Unit­ed States and Indi­an Tribes.  Gon­za­les v. O Cen­tro Espíri­ta Benef­i­cente União do Veg­e­tal, 546 U.S. 418, 433 (2006).

The Supreme Court reject­ed that argu­ment, cit­ing 21 U.S.C. § 822(d) as a sec­u­lar admin­is­tra­tive process and 21 C.F.R. § 1307.31 as a sec­u­lar excep­tion based on pub­lic health and safe­ty.  “Noth­ing about the unique polit­i­cal sta­tus of the Tribes makes their mem­bers immune from the health risks the Gov­ern­ment asserts accom­pa­ny any use of a Sched­ule I sub­stance, nor insu­lates the Sched­ule I sub­stance the Tribes use in reli­gious exer­cise from the alleged risk of diver­sion.”  O Cen­tro, 546 U.S. at 434.

The RFRA was enact­ed in 1993, 42 U.S.C. Chap­ter 21B, and autho­rizes Judi­cial relief.  The RFRA did not make any amend­ments to the CSA admin­is­tra­tive process.  42 U.S.C. § 2000bb‑1©, pro­vides:

©  Judi­cial relief
A per­son whose reli­gious exer­cise has been bur­dened in vio­la­tion of this sec­tion may assert that vio­la­tion as a claim or defense in a judi­cial pro­ceed­ing and obtain appro­pri­ate relief against a gov­ern­ment.  Stand­ing to assert a claim or defense under this sec­tion shall be gov­erned by the gen­er­al rules of stand­ing under arti­cle III of the Con­sti­tu­tion.

The Attor­ney Gen­er­al was giv­en the author­i­ty to make excep­tions to the CSA when the CSA was enact­ed.  The excep­tion the Attor­ney Gen­er­al made for the Native Amer­i­can Church, 21 C.F.R. § 1307.31, is autho­rized by 21 U.S.C. § 822(d) which says:

(d)  Waiv­er
The Attor­ney Gen­er­al may, by reg­u­la­tion, waive the require­ment for reg­is­tra­tion of cer­tain man­u­fac­tur­ers, dis­trib­u­tors, or dis­pensers if he finds it con­sis­tent with the pub­lic health and safe­ty.

The DEA react­ed to the rul­ing in O Cen­tro by cre­at­ing the Guid­ance Doc­u­ment and began for­mal rule mak­ing to cre­ate a Reg­is­tra­tion for Reli­gious Orga­ni­za­tions, U.S. Gen­er­al Ser­vices Admin­is­tra­tion: RIN: 1117-AB66.  The Guid­ance Doc­u­ment says it is not legal­ly bind­ing:

The con­tents of this doc­u­ment do not have the force and effect of law and are not meant to bind the pub­lic in any way.  This doc­u­ment is intend­ed only to pro­vide clar­i­ty to the pub­lic regard­ing exist­ing require­ments under the law or Depart­ment poli­cies.

The for­mal rule mak­ing process is still in the ear­ly devel­op­ment stage.  The U.S. Gov­ern­ment Account­abil­i­ty Office recent­ly asked the DEA to clean up its mess.  GAO-24–106630, May 30, 2024.

There is a con­sis­tent pat­tern in the CSA.  Sup­pli­ers reg­is­ter, 21 U.S.C. § 822(a).  Users do not reg­is­ter, 21 U.S.C. § 822©.  The excep­tion for the Native Amer­i­can Church fol­lows that same pat­tern.  21 C.F.R. § 1307.31 (sup­pli­ers reg­is­ter and both the church and its mem­bers do not reg­is­ter).  The RFRA does not change this.  A court injunc­tion is not a DEA reg­is­tra­tion and does not change the CSA or the DEA reg­u­la­tions.

The Guid­ance Doc­u­ment says reli­gious orga­ni­za­tions may peti­tion for an exemp­tion, which has always been true, but that does not lead to the con­clu­sion that reli­gious orga­ni­za­tions must have a Cer­tifi­cate of Reg­is­tra­tion.

Sum­ma­ry:  The Drug Enforce­ment Admin­is­tra­tion sets forth guid­ance, in con­for­mance with Exec­u­tive Order 13891, which will inform reli­gious orga­ni­za­tions which use con­trolled sub­stances with­in the free exer­cise of their reli­gion, of the process in which they may peti­tion for an exemp­tion from the Con­trolled Sub­stances Act.

The Guid­ance Doc­u­ment says sup­pli­ers must apply sep­a­rate­ly under 21 C.F.R. § 1307.03 for exemp­tion from applic­a­ble reg­u­la­tions.

6.  Applic­a­bil­i­ty of DEA Reg­u­la­tions.  A peti­tion­er whose peti­tion for a reli­gious exemp­tion from the Con­trolled Sub­stances Act is grant­ed remains bound by all applic­a­ble laws and Con­trolled Sub­stances Act reg­u­la­tions gov­ern­ing reg­is­tra­tion, label­ing and pack­ag­ing, quo­tas, record­keep­ing and report­ing, secu­ri­ty and stor­age, and peri­od­ic inspec­tions, among oth­er things.  See 21 C.F.R. §§ 1300–1316.  A peti­tion­er who seeks exemp­tion from applic­a­ble CSA reg­u­la­tions (opposed to the CSA itself) may peti­tion under 21 C.F.R. § 1307.03.  Such peti­tion must sep­a­rate­ly address each reg­u­la­tion from which the peti­tion­er seeks exemp­tion and pro­vide a state­ment of the rea­sons for each exemp­tion sought.

The Guid­ance Doc­u­ment says reli­gious orga­ni­za­tions, not just sup­pli­ers, must have a Cer­tifi­cate of Reg­is­tra­tion, which is incon­sis­tent with the pey­ote excep­tion and uncon­sti­tu­tion­al.  The text high­light­ed in red and bold in the para­graph above hints at it but doesn’t explain it.  Where is the ref­er­ence to 21 C.F.R. § 1308.43?

7.  Activ­i­ty Pro­hib­it­ed Until Final Deter­mi­na­tion.  No peti­tion­er may engage in any activ­i­ty pro­hib­it­ed under the Con­trolled Sub­stances Act or its reg­u­la­tions unless the peti­tion has been grant­ed and the peti­tion­er has applied for and received a DEA Cer­tifi­cate of Reg­is­tra­tion.  A reg­is­tra­tion grant­ed to a peti­tion­er is sub­ject to sub­se­quent sus­pen­sion or revo­ca­tion, where appro­pri­ate, con­sis­tent with CSA reg­u­la­tions and RFRA.

The Guid­ance Doc­u­ment, says the deci­sion to grant or deny the peti­tion is a final deter­mi­na­tion sub­ject to judi­cial review in the Unit­ed States Court of Appeals.

8.  Final Deter­mi­na­tion.  After the filed peti­tion — along with all sub­mis­sions in response to any requests for addi­tion­al infor­ma­tion — has been ful­ly eval­u­at­ed, the Assis­tant Admin­is­tra­tor of the Diver­sion Con­trol Divi­sion shall pro­vide a writ­ten response that either grants or denies the peti­tion.  Except in the case of affirm­ing a pri­or denial or when the denial is self-explana­to­ry, the response shall be accom­pa­nied by a state­ment of rea­sons upon which the deci­sion is based.  This writ­ten response is a final deter­mi­na­tion under 21 U.S.C. § 877.

§ 877.  Judi­cial review
All final deter­mi­na­tions, find­ings, and con­clu­sions of the Attor­ney Gen­er­al under this sub­chap­ter shall be final and con­clu­sive deci­sions of the mat­ters involved, except that any per­son aggriev­ed by a final deci­sion of the Attor­ney Gen­er­al may obtain review of the deci­sion in the Unit­ed States Court of Appeals for the Dis­trict of Colum­bia or for the cir­cuit in which his prin­ci­pal place of busi­ness is locat­ed upon peti­tion filed with the court and deliv­ered to the Attor­ney Gen­er­al with­in thir­ty days after notice of the deci­sion.  Find­ings of fact by the Attor­ney Gen­er­al, if sup­port­ed by sub­stan­tial evi­dence, shall be con­clu­sive.

The Exec­u­tive Branch has got­ten itself into a pick­le here because the RFRA is not an admin­is­tra­tive process and Guid­ance Doc­u­ment says the CSA and its reg­u­la­tions haven’t changed since 1970.

A cod­i­fied reg­u­la­tion like the one in 21 C.F.R. § 1307.31, is a for­mal rule mak­ing process under 21 C.F.R. § 1308.43.

Regard­less of its intent, the Guid­ance Doc­u­ment is mis­guid­ed.  Omit­ting ref­er­ence to the rule mak­ing process used by the Native Amer­i­can Church under 21 C.F.R. § 1308.43 makes the Guid­ance Doc­u­ment mis­guid­ed.

Recent Federal Court Rulings

Recent fed­er­al court deci­sions have begun to add more clar­i­ty, explain­ing the reg­u­la­to­ry author­i­ty of the DEA under the CSA is entire­ly sep­a­rate from judi­cial author­i­ty under the RFRA.

In Okleveuha Native Amer­i­can Church v. Hold­er, 676 F.3d 829, 838 (9th Cir., 2012), the court said:

Like­wise, we are unper­suad­ed by the Government’s asser­tion that Plain­tiffs’ request for prospec­tive relief is unripe because Plain­tiffs did not request an excep­tion to the CSA from the DEA.  See 21 C.F.R. § 1307.03 (“Any per­son may apply for an excep­tion to the appli­ca­tion of any pro­vi­sion of this chap­ter by fil­ing a writ­ten request with the Office of Diver­sion Con­trol, Drug Enforce­ment Admin­is­tra­tion, stat­ing the rea­sons for such excep­tion.”).  The Gov­ern­ment argues that we should require Plain­tiffs to exhaust this admin­is­tra­tive rem­e­dy, because doing so would allow the DEA to apply its exper­tise to Plain­tiffs’ claim, pos­si­bly moot the case if the claim is grant­ed, and help build a record for judi­cial review.

We decline, how­ev­er, to read an exhaus­tion require­ment into RFRA where the statute con­tains no such con­di­tion, see 42 U.S.C. §§ 2000bb-2000b­b‑4, and the Supreme Court has not imposed one.  Indeed, the Supreme Court has reviewed a RFRA-based chal­lenge to the CSA with­out requir­ing that the plain­tiffs first seek a reli­gious use exemp­tion from the DEA.  Gon­za­les v. O Cen­tro Espíri­ta Benef­i­cente União do Veg­e­tal, 546 U.S. 418 (2006).  In so doing, it rec­og­nized that RFRA “plain­ly con­tem­plates that courts would rec­og­nize excep­tions [to the CSA] — that is how the law works.”  Id. at 434.

In Ari­zona Yage Assem­bly v. Gar­land, 595 F.Supp.3d 869, 880 (D. Ari­zona 2022), the court said:

Though there is a valid reg­u­la­tion, 21 C.F.R. § 1307.03, requir­ing per­sons seek­ing exemp­tions to file a writ­ten request with the DEA Office of Diver­sion Con­trol, the Ninth Cir­cuit held per­sons seek­ing a RFRA exemp­tion from the DEA are not required to exhaust the admin­is­tra­tive rem­e­dy under § 1307.03.[Footnote 7]  See Okle­vue­ha I, 676 F.3d at 838 (“We decline … to read an exhaus­tion require­ment into RFRA where the statute con­tains no such con­di­tion and the Supreme Court has not imposed one.”) (inter­nal cita­tion omit­ted).

[Foot­note 7] Judge Orrick of the North­ern Dis­trict of Cal­i­for­nia not­ed that even a new sub­stan­tive agency rule might not be able to impose a bind­ing admin­is­tra­tive exhaus­tion require­ment under Okle­vue­ha I. (Doc. 57 at 14) (“[I]t is pos­si­ble that regard­less of any new reg­u­la­tions [DEA may pro­mul­gate], the plain­tiffs will not have to seek an exemp­tion from the DEA pri­or to seek­ing judi­cial redress.”).

To raise a claim under the APA, Plain­tiffs are required to peti­tion for an exemp­tion or a new rule­mak­ing.  See 5 U.S.C. §§ 702, 704, 706; Mad­sen, 976 F.2d at 1220.  Then, if the DEA denied the peti­tion or refused to respond to it, Plain­tiffs could argue they were harmed because the DEA failed to com­ply with the APA.  See 5 U.S.C. § 706(1), (2) (set­ting forth the stan­dard of review of agency action).

Please notice the text in red and bold above is refer­ring to 21 C.F.R. § 1308.43.  And, in Ari­zona Yage Assem­bly v. Gar­land, 671 F.Supp.3d 1013, 1020 (D. Ari­zona, 2023), the court said:

The bulk of Defen­dants’ argu­ments stem from the fact that Plain­tiffs have not sought an exemp­tion from the applic­a­bil­i­ty of the CSA.  The DEA pro­mul­gat­ed the “Guid­ance” in 2009 in response to the Supreme Court’s rul­ing in Gon­za­les v. O Cen­tro Espíri­ta Benef­i­cente União do Veg­e­tal, 546 U.S. 418 (2006).  How­ev­er, in 2012 the Ninth Cir­cuit addressed a sim­i­lar argu­ment as Defen­dants make here, and the court refused “to read an exhaus­tion require­ment into RFRA where the statute con­tains no such con­di­tion.”  Okle­vue­ha I, 676 F.3d at 838 (stat­ing that “the Supreme Court has reviewed a RFRA-based chal­lenge to the CSA with­out requir­ing that the plain­tiffs first seek a reli­gious use exemp­tion from the DEA”) (cit­ing O Cen­tro, 546 U.S. 418).  Both the Supreme Court and the Ninth Cir­cuit have rec­og­nized that RFRA “plain­ly con­tem­plates that courts would rec­og­nize excep­tions [to the CSA]—that is how the law works.”  Id. (quot­ing O Cen­tro, 546 U.S. at 434).

The Court will not depart from that clear prece­dent.  Accord­ing­ly, the Defen­dants’ alter­na­tive request that the Court stay the case to allow Plain­tiffs to apply for an exemp­tion is denied.

Iowaska Church of Healing (Oral Argument)

Oral argu­ment was held on Novem­ber 14, 2025.  The record­ing can be down­loaded here: 25–1140.mp3, or you can lis­ten to it here:

The first quote from Judge Hen­der­son around 7:52 to 8:56 nails it:

Let me ask you about 822(d), and unless I’m read­ing it incor­rect­ly, it says the Attor­ney Gen­er­al may, by reg­u­la­tion, waive the require­ment for reg­is­tra­tion, and so forth.  Now it doesn’t say any­thing about guid­ance, it says by reg­u­la­tion.  And if you had done what Native Amer­i­cans have done with pey­ote, which was by a rule, and they had sat on your peti­tion for a rule for six years, you’d be in a lot bet­ter posi­tion, at least in our abil­i­ty to say, make a deci­sion DEA.  Why?  Am I read­ing this wrong?  In oth­er words, when I read it I thought, well, I would think you’d say this was, maybe not ultra vires, but for the DEA to use the guid­ance pro­ce­dure rather than what the statute itself requires, which is by reg­u­la­tion.

Judge Kat­sas around 10:35 to 11:00:

Is the guid­ance, just fol­low­ing up on this dis­tinc­tion, is the guid­ance some free stand­ing process for RFRA exemp­tions?  Or is it an elab­o­ra­tion on the reg­u­la­to­ry scheme under 21 C.F.R. 1307?

Judge Kat­sas around 11:05 to 11:16:

I thought it was sep­a­rate, and yet we’re pri­mar­i­ly con­sid­er­ing this case under the guid­ance but your appli­ca­tion says you’re going under the reg­u­la­tions.  Not sure what, not sure if any­thing turns on it.  I’m just try­ing to fig­ure out what scheme we’re under.

Judge Kat­sas around 14:02:

I thought part of your duty to act argu­ment also involved RFRA, essen­tial­ly that RFRA itself?

Judge Gar­cia around 14:30

And, so I just want to make sure I under­stand your answers back to Judge Kat­sas’ first ques­tions, but your posi­tion is essen­tial­ly RFRA arguably impos­es an affir­ma­tive duty, we’re try­ing to do what DEA has asked us to do to secure an exemp­tion and so we’re try­ing to fol­low the guid­ance?  And you can see that the guid­ance process is a lit­tle bit unclear about how it con­nects back to the statu­to­ry author­i­ty, but you are essen­tial­ly seek­ing, ask­ing us to com­pel them to con­clude this guid­ance process.  Is that a fair char­ac­ter­i­za­tion?

Judge Gar­cia around 20:54

Can you just tell us what DEA’s view of this is, and if could try to sim­pli­fy, I’m inter­est­ed in what author­i­ty, when the DEA grants or denies this exemp­tion, what author­i­ty will it be act­ing under?

DEA around 21:12:

CSA

DEA around 21:55

A total exemp­tion would be 822(d)

Judge Kat­sas around 30:59

One last ques­tion on duty to act.  I had thought the strongest basis for DEA to act was the APA, and nobody cites it, but it has a pro­vi­sion which says an agency has to con­clude a mat­ter pre­sent­ed to it with­in a rea­son­able time.  Judge Hen­der­son has an Amer­i­can Rivers deci­sion that cre­ates a manda­to­ry duty to act for man­damus pupos­es.

DEA at around 19:36 men­tions three recent ayahuas­ca grants as rea­sons for the delay: (1) Church of Gaia in May of 2025; (2) Eagle and Con­dor in April 2024; and (3) San­to Daime in Decem­ber of 2024.