Religious Exceptions to the CSA

The Drug Enforcement Administration (DEA) created a Religious Freedom Restoration Act (RFRA) Guidance Document at the heart of 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 created in 2009 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(c), 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).  Listing to the arguments in the case, it seemed 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 used 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(c)(Schedule 1)(c)(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, 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(c), provides:

(c)  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(c).  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.