CCHR Opposes FDA Approval of Psychedelic Drugs for Mental Health Treatment

The Citizens Commission on Human Rights International (CCHR) has formally opposed the approval of psychedelic drugs for mental health treatment in comments submitted to the U.S. Food and Drug Administration. The comments respond to the FDA's request for input on "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs." CCHR's submission argues that approval would introduce another class of psychotropic drugs with high potential for adverse effects, including aggression, psychosis, and violence.

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

Classic psychedelics such as 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 like LSD can be described as drug-induced psychosis, distorting or disorganizing 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. Eastgate said layering them onto people already prescribed multiple psychotropics, or already misusing substances, adds routes to psychosis, paranoia, and loss of control.

CCHR also reports that psychedelics are contraindicated in pregnancy, epilepsy or other seizure disorders, and severe cardiovascular disease, including uncontrolled high blood pressure, heart failure, coronary artery disease, or a prior heart attack or stroke. The FDA's guidance on psychedelic trials acknowledges that a standard placebo is problematic because the drugs' effects are obvious, so participants can usually tell which treatment they received. A review of 48 trials found that where blinding was checked, it failed: virtually everyone in the drug group and about 93% in the placebo group correctly identified their assignment.

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, and in a psychedelic session it is effectively nullified, as medical literature acknowledges that a person under the influence may be unable to give or withdraw consent.

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. 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, but CCHR says those are narratives, not established mechanisms.

CCHR's position remains rejection. If any application is allowed to proceed, it says strict limits should be written into the label and any Risk Evaluation and Mitigation Strategy before the first commercial dose. These include excluding anyone under 18, pregnant or breastfeeding women, older adults with dementia, and individuals with a history of psychosis, mania, suicidal intent, or violence. A class boxed warning and Medication Guide would be required, along with two trained staff in the room, no take-home supply, and no co-administration with interacting drugs. The group also calls for prescription-drug monitoring checks, unannounced inventory audits, same-day reporting of missing doses to the DEA, and mandatory reporting of sexual contact or violence within 72 hours. Follow-up at 24 hours and at 7, 30, and 90 days would be required, with no further dose after new suicidality, psychosis, or a cardiac event.

CCHR International is a mental health industry watchdog established in 1969 by the Church of Scientology and professor of psychiatry Thomas Szasz. The organization has helped enact more than 190 worldwide reforms that protect the public from abuse. For Texas businesses and healthcare providers, the FDA's decision on psychedelic approval could reshape mental health treatment options, insurance coverage, and liability standards. Employers and industry stakeholders should monitor these regulatory developments closely, as any approval with or without CCHR's recommended safeguards would carry significant implications for workplace safety, patient consent, and public health.