No Mens Rea Required for DEA Registration Revocations Under 21 U.S.C. § 824; Due Process Satisfied by Opportunity for Hearing

Introduction

In Sualeh Kamal Ashraf v. United States Drug Enforcement Administration, the Eleventh Circuit affirmed a DEA final order revoking a physician’s certificate of registration (COR) to dispense controlled substances, denying his pending application, and denying any other pending registration applications. The decision is significant for three reasons. First, it clarifies that Ruan v. United States—a Supreme Court case imposing a “knowing or intentional” mens rea requirement in criminal prosecutions under 21 U.S.C. § 841—does not apply to administrative revocations under 21 U.S.C. § 824. Second, it underscores that procedural due process in DEA revocation proceedings is satisfied by notice and an opportunity for a hearing; a registrant who declines the hearing cannot later fault the process. Third, it reaffirms the DEA’s broad discretion to revoke a registration based on “public interest” factors, and to consider a registrant’s failure to accept responsibility.

The case arises from the DEA’s investigation of a Florida weight management clinic—“Doctor Drop It Like It’s Hot”—where Dr. Ashraf served as the supervising physician and held the clinic’s COR. After reports of missing controlled substances and an array of recordkeeping, dispensing, and security deficiencies, the DEA issued an Order to Show Cause proposing revocation and denial. Dr. Ashraf submitted a corrective action plan but did not request a hearing. On petition for review, he alleged procedural due process violations, disputed authorship of prescriptions cited by the DEA, and argued that Ruan required the DEA to prove he knowingly and intentionally acted without authorization. The Eleventh Circuit rejected each contention.

Summary of the Judgment

The Eleventh Circuit denied Dr. Ashraf’s petition for review and upheld the DEA’s revocation and denials. Applying deferential “arbitrary and capricious” review to the DEA’s decision, and “substantial evidence” review to the Administrator’s factual findings, the court concluded:

Procedural due process was not violated because Dr. Ashraf received adequate notice (via the Order to Show Cause) and a meaningful opportunity to be heard (a right to an administrative hearing and access to the record). Having declined to request a hearing, he cannot complain that the process was inadequate.
Substantial evidence supported the DEA Administrator’s conclusions that Dr. Ashraf’s conduct was inconsistent with the public interest, including improper prescribing without a physician–patient relationship, pervasive recordkeeping and inventory failures, lack of PDMP reporting, improper labeling, insecure storage, and failure to report theft to the DEA. Dr. Ashraf’s assertion that a clinic operator forged prescriptions did not rebut the Government’s prima facie showing—particularly in light of his admission that he left pre-signed prescription pads with the operator.
Ruan’s criminal mens rea holding under § 841 does not govern administrative revocations under § 824. Section 824 does not contain a knowledge or intent requirement, and “unintentional” or “innocent” misconduct can support revocation where the registrant’s continued registration would be inconsistent with the public interest.

The court also noted the DEA’s permissible reliance on public-interest factors (specifically factors (2) compliance with state/local law and (4) past experience) and Dr. Ashraf’s failure to accept responsibility as further justification for revocation and denial.

Analysis

Precedents Cited and Their Influence

Gonzales v. Raich, 545 U.S. 1 (2005): The court reiterated that the Controlled Substances Act (CSA) creates a “closed regulatory system,” underscoring the centrality of strict controls over manufacture, distribution, and dispensing. This contextual backdrop supports DEA oversight and enforcement actions, including registration revocations to protect the public interest.
Jones Total Health Care Pharmacy, LLC v. DEA, 881 F.3d 823 (11th Cir. 2018):
- Standard of review: Agency revocations are reviewed for abuse of discretion under the APA’s “arbitrary and capricious” standard. Factual findings are upheld if supported by substantial evidence.
- Burden-shifting: The government bears the initial burden to show continued registration is inconsistent with the public interest; once met, the burden shifts to the registrant to demonstrate trustworthiness.
- Due process/discovery: Due process is satisfied where the government’s theory and evidence are disclosed and the registrant can contest them; prejudice must be shown to establish any denial of process.
- Acceptance of responsibility: A registrant’s willingness (or refusal) to accept responsibility can be weighed in determining whether future compliance can be entrusted.
The Ashraf court leaned heavily on Jones for both procedural and substantive frameworks.
Mathews v. Eldridge, 424 U.S. 319 (1976); Grayden v. Rhodes, 345 F.3d 1225 (11th Cir. 2003); Schultz v. Alabama, 42 F.4th 1298 (11th Cir. 2022): These decisions supply the balancing test and core principles for procedural due process: adequate notice and a meaningful opportunity to be heard, assessed with sensitivity to context and the government’s interests. The court applied Mathews to conclude the DEA’s process was constitutionally sufficient.
Cotton v. Jackson, 216 F.3d 1328 (11th Cir. 2000): If a meaningful remedial procedure is made available and the plaintiff fails to use it, he cannot later claim a due process violation. This principle was decisive: Dr. Ashraf declined to request the administrative hearing that would have allowed him to challenge the facts and evidence (and to inspect the record under 21 C.F.R. § 1316.46).
McClelland v. Andrus, 606 F.2d 1278 (D.C. Cir. 1979): Cited via Jones for the principle that discovery is required if denial would prejudice due process. The court found no prejudice here because Dr. Ashraf had full notice and an opportunity to be heard.
Robert A. Leslie, M.D., 68 Fed. Reg. 15227 (DEA 2003); Morall v. DEA, 412 F.3d 165 (D.C. Cir. 2005); David H. Gillis, M.D., 58 Fed. Reg. 37507 (DEA 1993): These authorities confirm that the DEA considers the public interest factors in the disjunctive, need not make express findings on each factor, and may treat any one factor (or combination) as decisive. The Administrator permissibly focused on factors (2) and (4) based on the record.
Ruan v. United States, 597 U.S. 450 (2022): Ruan held that in a criminal prosecution under § 841, once the defendant meets a production burden under § 885, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted without authorization. The Eleventh Circuit held that Ruan’s criminal mens rea requirement is inapplicable to administrative revocations under § 824, which does not contain knowledge or intent language.
Romag Fasteners, Inc. v. Fossil, Inc., 590 U.S. 212 (2020); Fernandez v. Seaboard Marine LTD., 135 F.4th 939 (11th Cir. 2025): The court invoked the statutory-interpretation principle that courts may not add words to a statute, and must be especially cautious where Congress used the omitted terms elsewhere in the same statutory scheme. This supports refusing to graft Ruan’s mens rea into § 824. The court also marked CSA provisions distinguishing criminal and civil liability (e.g., § 842).
Bobby D. Reynolds, N.P., et al., 80 Fed. Reg. 28643 (DEA 2015); Paul J. Caragine, Jr., 63 Fed. Reg. 51592 (DEA 1998): DEA precedent states that “unintentional” or “innocent” misconduct does not preclude revocation or denial when the public-interest calculus weighs against continued registration. The court cited these in rejecting the argument that lack of intent bars revocation.

Legal Reasoning

1) Procedural Due Process

The Order to Show Cause set out the legal bases, factual underpinnings, and specific regulatory and statutory violations alleged, and it notified Dr. Ashraf of his rights: to request a hearing before an administrative law judge and to submit a corrective action plan. It also implicitly carried the rights attached to a hearing, including access to the record (21 C.F.R. § 1316.46).

Applying Mathews, the court held the process constitutionally adequate: the private interest (a physician’s DEA registration), the risk of erroneous deprivation, and the governmental interest in regulating controlled substances were appropriately balanced by notice and an opportunity to be heard. Because Dr. Ashraf declined to request a hearing, Cotton foreclosed his due process claim; the availability of the hearing and record inspection defeated any assertion that he lacked notice or access to the evidence. The court analogized to Jones, where due process was satisfied because the registrant knew the government’s theory and evidence.

A concurrence by Judge Tjoflat sharpened the point: evidentiary challenges belong first in the DEA hearing. Skipping the hearing leaves the Administrator’s facts undisputed; appellate courts are not forums for do-overs.

2) Substantial Evidence and the Public-Interest Factors

The DEA may revoke if continued registration is “inconsistent with the public interest” (21 U.S.C. § 824(a)(4)), assessed under § 823(f)’s five factors. The Administrator may weigh factors as appropriate, need not make express findings on each, and can deem any one decisive. Here, the Administrator focused on:

Factor (2): Compliance with state and local law.
Factor (4): Past experience in the distribution of controlled substances.

The record—supported by DEA investigator evidence, a subpoena history, expert review, and site inspections—showed, among other things:

At least 35 prescriptions for controlled substances issued without evidence of a physician–patient relationship or medical justification (21 C.F.R. § 1306.04(a); Florida statutes cited in the Order).
Failure to keep required inventories and dispensing records (21 C.F.R. §§ 1304.11(b), 1304.22(c), 1304.03(b)), including inability to account for roughly 25,000 dosage units of phentermine.
Non-reporting to Florida’s PDMP (Fla. Stat. § 893.055(3)(a)).
Improper labeling of dispensed drugs (21 C.F.R. § 290.5).
Inadequate security and failure to report theft to the DEA (21 C.F.R. § 1301.76(a), (b)).
Admission to law enforcement that pre-signed prescription pads were left with the clinic operator.

Dr. Ashraf’s principal rebuttal was that the clinic operator forged his signature on prescriptions, but he produced no corroborating evidence, failed to provide patient files when requested or subpoenaed, and had already admitted leaving pre-signed pads. Under Jones’s burden-shifting framework, the Government easily made a prima facie case, and Dr. Ashraf did not carry his responsive burden to show he could be entrusted with a registration going forward.

The Administrator also permissibly weighed Dr. Ashraf’s lack of acceptance of responsibility as an aggravating factor, reasoning that refusal to acknowledge violations suggests a risk of recurrence and undermines future compliance and deterrence rationales.

3) Ruan’s Inapplicability to § 824 Revocations

Ruan interpreted § 841’s criminal prohibition and held that, after a defendant satisfies a production burden, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted without authorization. The court emphasized that Dr. Ashraf’s case involved a non-criminal, regulatory sanction under § 824. That section’s text contains no mens rea requirement and authorizes revocation upon a public-interest finding—distinct from criminal culpability.

Statutory interpretation principles (Romag Fasteners and similar guidance) caution against adding words to a statute, especially when Congress used the omitted terms elsewhere in the CSA (for example, § 842’s “knowing” requirement for criminal liability, contrasted with its civil liability counterpart). Consistent with DEA precedent (Reynolds; Caragine), the court confirmed that even “unintentional” or “innocent” misconduct can warrant revocation when the public-interest calculus disfavors continued registration. Nothing in Ruan suggests otherwise, and no authority supports importing Ruan’s criminal mens rea into § 824 administrative proceedings.

Impact

1) Immediate Implications for Registrants

Invoking Ruan will not forestall or raise the government’s burden in administrative revocations under § 824. The DEA need not prove knowing or intentional misconduct to revoke.
Hearings matter. A registrant who declines the administrative hearing and the chance to inspect the record will face steep uphill review and cannot credibly allege due process violations.
Acceptance of responsibility is material. Blaming staff or contractors—particularly where pre-signed pads or lax controls are admitted—will cut against reinstatement or continued registration.
Compliance mechanics are critical: maintain and produce required inventories; keep dispensing records; report to PDMPs; use proper labels; secure controlled substances; and report losses or theft to DEA promptly.

2) Enforcement and Litigation Strategy

DEA can continue to rely on § 823(f) factors (especially factors (2) and (4)) and need not make findings on every factor. Deterrence and trustworthiness remain central.
From a litigation posture, registrants should treat the Order to Show Cause as the start of an evidentiary process and promptly request a hearing if factual disputes exist. Corrective action plans are not substitutes for disputing facts and do not stay revocation timelines by themselves.

3) Broader Doctrinal Effects

This published Eleventh Circuit decision supplies binding circuit precedent that Ruan does not govern § 824 revocations and that the public-interest standard is independent of criminal mens rea.
The decision fortifies the waiver principle in administrative law: failing to invoke available procedures forecloses later due process and evidentiary objections.
Expect continued focus on documentation of physician–patient relationships and legitimate medical purpose for controlled substances, especially in weight-loss and pain-management contexts.

Complex Concepts Simplified

CSA “closed system”: A comprehensive framework requiring every step of controlled-substance handling to occur under authorization, with rigorous tracking and security to prevent diversion.
Certificate of Registration (COR): A DEA authorization permitting entities or practitioners to handle controlled substances. Without it, dispensing is unlawful.
Public-Interest Factors (21 U.S.C. § 823(f)): Five considerations the DEA uses when deciding to grant, deny, or revoke a registration, including compliance with law and past experience. The DEA may weigh them flexibly.
Arbitrary and Capricious Review: A deferential standard under the Administrative Procedure Act. Courts uphold agency decisions if rational and supported by the record; they do not re-weigh evidence.
Substantial Evidence: Less than a preponderance; enough relevant evidence that a reasonable person could agree with the agency’s factual findings, even if the evidence could support a contrary conclusion.
Ruan’s Mens Rea Rule: In criminal prosecutions under § 841, the government must prove a defendant knowingly or intentionally acted without authorization. This rule does not apply to administrative revocations under § 824.
PDMP: A state Prescription Drug Monitoring Program tracking controlled-substance dispensing to prevent misuse. Failure to report to PDMPs can violate state law and factor into DEA actions.
Corrective Action Plan: A registrant’s proposed remedies in response to an Order to Show Cause. It is not a substitute for a hearing and does not function as a factual rebuttal unless accompanied by a proper request to present evidence.
“Acceptance of Responsibility”: A factor the DEA may consider in assessing future compliance. Acknowledging past violations can support trustworthiness; denial or deflection can weigh against continued registration.

Conclusion

Sualeh Ashraf v. DEA clarifies a pivotal boundary in controlled-substance regulation: administrative revocations under § 824 are not governed by Ruan’s criminal mens rea standard. The DEA need not prove intent; it need only show that continued registration would be inconsistent with the public interest, supported by substantial evidence. The decision reaffirms that procedural due process in this context is satisfied by clear notice and a meaningful opportunity for a hearing—an opportunity that must be exercised to preserve factual challenges.

For practitioners and registrants, the case is both a caution and a roadmap. Compliance failures—recordkeeping, inventory controls, PDMP reporting, labeling, storage, and reporting of theft—can cumulatively justify revocation regardless of intent. Delegation to staff does not shift responsibility, and the use of pre-signed prescription pads is particularly perilous. Strategically, registrants must promptly request hearings to contest factual findings and should be prepared to produce records that substantiate the legitimacy of prescribing practices. Substantively, the case strengthens the DEA’s hand in maintaining the CSA’s closed system, while providing courts with a clear doctrinal line between criminal prosecutions and administrative sanctions.

The key takeaways: Ruan does not apply to § 824; due process is satisfied by notice and a hearing opportunity; and the DEA may revoke based on public-interest factors, including a registrant’s failure to accept responsibility. The Eleventh Circuit’s published opinion will likely guide future revocation challenges and compliance strategies across the controlled-substances landscape.