LOS ANGELES, CA, October 09, 2026 /24-7PressRelease/ -- Citizens Commission on Human Rights International has submitted comments to the Food and Drug Administration opposing approval of psychedelic drugs for mental disorder or emotional distress. The comments respond to the FDA's request for input on "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs."

CCHR's submission said approval would add another class of psychotropic drugs with a high potential for adverse effects, including aggression, psychosis, and violence. Its submission recognizes that the agency may still proceed, and sets out minimum conditions on consent, administration, and accountability. Those conditions are not a concession that the products are acceptably safe.

Jan Eastgate, President of CCHR International, says, "Existing psychiatric drugs already carry serious risks and have not cured any mental disability. A new class of perception-altering drugs is now offered for problems that prior psychiatric drugs have caused. That is not a scientific answer to a 'mental health crisis.' It is a replay: bold promises before long-term safety is established and no evidence the drugs can cure. The pitches resemble those used when SSRI antidepressants were launched in 1988."

Classic psychedelics—LSD, psilocybin, DMT, and mescaline—are serotonergic agents promoted as an "alternative" to antidepressants. The National Institute on Drug Abuse warns that the effects of hallucinogens such as LSD "can be described as drug-induced psychosis—distortion or disorganization of a person's capacity to recognize reality, think rationally, or communicate with others."

Because psychedelics activate serotonin receptors, they can cause life-threatening serotonin syndrome if combined with other substances that raise serotonin, such as SSRI antidepressants. "Layering them onto people already prescribed multiple psychotropics, or already misusing substances, adds routes to psychosis, paranoia, and loss of control," Eastgate says.

CCHR notes that psychedelics are treated as contraindicated in pregnancy, in epilepsy and other seizure disorders, and in severe cardiovascular disease, including uncontrolled high blood pressure, heart failure, coronary artery disease, and a prior heart attack or stroke.

CCHR reports that psychedelics are contraindicated in pregnancy, epilepsy or other seizure disorders, and severe cardiovascular disease, including uncontrolled blood pressure, heart failure, coronary artery disease, or a prior heart attack or stroke.

The FDA's guidance on psychedelic trials says a standard placebo is problematic. Blinding means participants and researchers are not told who received the drug. These drugs' effects are obvious, so people can usually tell. A review of 48 trials found that, where this was checked, blinding failed: virtually everyone in the drug group, and about 93% in the placebo group, correctly identified which they had received.[1]

The FDA has issued Commissioner's National Priority Vouchers to three psychedelic programs, under criteria that include "innovative cures," aiming to cut application review from about 10 to 12 months to 1 to 2 months. CCHR says psychiatric drugs, including psychedelics, treat symptoms; they are not cures. The American Psychiatric Association states that psychiatric medications do not cure mental illness.

Informed consent is already weak in ordinary psychiatric prescribing. In a psychedelic session, it is effectively nullified. Medical literature, including APA publications, acknowledges that a person under the influence may be unable to give or withdraw consent once influenced by the drugs.

Psychedelics may raise the risk of acute psychosis, paranoia, hallucinations, and dissociative states that impair judgment. A 2025 review reported impaired judgment and mental function as a reason psychedelic use can produce abnormal behavior, including aggression.[2] Trials have recorded suicidal ideation, and session settings have produced allegations of sexual abuse.

Marketing wraps psychedelics in terms such as "plant medicine," "natural healing," and claims of "resetting" the brain or treating treatment-resistant conditions. Those are narratives, not established mechanisms. UK psychiatrist Joanna Moncrieff and colleagues have reported that no biological lesion has been scientifically validated as the cause of mental disorders.[3] Moncrieff warns that psychedelics do not produce the miracle cures people are led to expect.[4]

CCHR's position remains rejection. If any application is allowed to proceed, it says the following limits should be written into the label and any Risk Evaluation and Mitigation Strategy before the first commercial dose:

• No psychedelic to anyone under 18; during pregnancy or breastfeeding; or to an older adult with dementia, Alzheimer's disease, or any other condition that impairs understanding of consent. No dose under court order, in custody, or in any other setting where refusal is not free. Exclude anyone with a history of diagnosed psychosis, schizophrenia, or mania; past or active suicidal intent, a recent attempt or plan, self-injury, or a recent psychiatric hospitalization; and anyone with a history of violence, assault, homicidal ideation, or impulsive aggression.
• A class boxed warning and a Medication Guide covering psychiatric destabilization, impaired judgment, cardiovascular stress, and abuse.
• Two trained staff in the room. No take-home supply. No co-administration with interacting drugs (polypharmacy). Do not discharge a person while still impaired, or allow driving, use of machinery, or care of children.
• Mandate prescription-drug monitoring checks, unannounced inventory audits, and same-day reporting of missing doses to the Drug Enforcement Administration. Treat willful diversion or falsified records as chargeable under existing drug law, not only as a clinic fine.
• Report sexual contact or violence involving a client who was given the drug to the REMS administrator, the DEA, the medical licensing board, and law enforcement within 72 hours.
• Follow up at 24 hours and at 7, 30, and 90 days. No further dose after new suicidality, psychosis, or a cardiac event.

Approval without those limits, CCHR argues, would trade one set of psychiatric-drug harms for another.

CCHR International is a mental health industry watchdog, established in 1969 by the Church of Scientology and professor of psychiatry Thomas Szasz.

Sources:

[1] Jacob S Aday, et al., "Addressing blinding in classic psychedelic studies with innovative active placebos," Int J Neuropsychopharmacol, 4 Apr. 2025

[2] Norman Miller, "Psychedelics: Safety and Efficacy," Int J Environ Res Public Health, 21Jan. 2025

[3] "Medicating misery by doling out antidepressants is based on a myth: NHS psychiatrist Professor Joanna Moncrieff reveals the shameful truth about Big Pharma," The Daily Mail, 13 Jan. 2025

[4] Joanna Moncrieff, M.D., "Psychedelics: The New Psychiatric Craze," Mad in America, 2 Sept. 2021

Citizens Commission on Human Rights (CCHR) is an international mental health industry watchdog, established by the Church of Scientology, which had helped enact more than 190 worldwide reforms that protect the public from abuse.

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