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Harm Reduction· Explainer

Ketamine's Boom Just Met Its Bill, and Nitrous Oxide Is Getting the Bill Too

Fourteen FDA warning letters, a Texas rulebook, a wave of nitrous bans, and a bladder injury nobody put on the brochure — the dissociative decade is being audited in public.

ByThe Rize NewsroomAugust 24, 20268 min readDissociatives

Ketamine spent six years getting a promotion — from the thing that emptied a corner of the dance floor at 3 a.m. to the thing your coworker mentions at lunch, between the standing desk and the sleep tracker. Telehealth clinics, mail-order lozenges, infusion suites with weighted blankets. Somewhere in there, a drug with fifty years of safety literature started getting handled like a supplement. This summer the bill came due.

Ketamine’s problem was never that it is both a medicine and a drug — it is that one supply chain served both with one set of safeguards built for the operating room.

The same sentence fits nitrous oxide, now being pulled off retail shelves state by state while staying in every dental office in America.

The letters, the rulebook, and the gap between them

On June 23, the FDA signed fourteen warning letters, posted publicly on July 7. Thirteen went to US-based online retailers, one to a seller in the Netherlands. The names read like a search results page: Ketamine Store, All Ketamine HCL, Buy Keta Online. The letters do not argue that ketamine is uniquely evil. They argue something narrower and more damning: these sites were shipping a prescription drug straight to consumers with no prescription, marketing it for treatment-resistant depression without approval for that use, and operating outside the risk-management program that governs the one approved ketamine derivative for depression. Fourteen letters in one day is not routine correspondence. It is a signal flare.

Texas is running the same play from the clinical side. The state Medical Board has proposed rules prohibiting home use of parenteral ketamine — parenteral meaning delivered by needle rather than swallowed, so IV, intramuscular, or under the skin. The proposal would also put a physician physically on site during treatment, cap how many patients one clinician can oversee at once, and make clinics register with the board. The Texas Tribune reported in April that operators warned of closures and stranded patients; the American Society of Anesthesiologists went the other way and told the board the safeguards were not strong enough. Oral, sublingual, and intranasal ketamine sit outside the proposed rules entirely.

Neither action tries to make ketamine illegal. Both answer a question the boom skipped: who is in the room, and what happens if something goes wrong? A drug that reliably makes people dissociate — detached from body, surroundings, sense of time — was being administered with nobody there to catch a blood pressure spike, a fall, a person who cannot say they are in trouble. That is not a moral failure. It is a staffing failure, and it took a national mail-order market for regulators to notice.

The bladder is the part nobody put on the brochure

If you use ketamine, or you love someone who does, this is the section that matters more than any rule the Texas Medical Board writes.

Heavy, frequent ketamine use damages the bladder. The clinical term is ketamine-induced cystitis — cystitis just means bladder inflammation — and what it describes is the protective lining of the bladder wall breaking down under repeated chemical insult. On the street it is called K bladder, and the people who have it do not describe it the way harm-reduction pamphlets describe most drug harms. A Liverpool addiction nurse told the BBC this month that young people in her care have talked about ending their lives because of it. Not because of withdrawal, not because of shame. Because the pain is constant, most pain medication does not touch it, and they cannot see an end to it.

Urology units in England and Wales report a steady stream of patients aged 16 to 24 with ketamine-associated bladder injury. Early on it looks like urgency, frequency, pain, blood in the urine. Late, it looks like a bladder that has scarred down to a fraction of its capacity, and a handful of patients under 25 have needed reconstructive surgery or full bladder removal.

Early on it looks like urgency, frequency, pain, blood in the urine.

Said plainly, without a lecture attached: this harm is dose- and frequency-dependent, and it is one of the few drug harms where cutting back early genuinely changes the outcome. Early damage can improve. Scarring does not. Almost nobody who develops it knew it was on the table, because ketamine spent a decade being reclassified as a wellness product, and wellness products do not come with urology referrals. If you have noticed you are urinating more often, or that it burns, or that you have started planning your day around bathrooms — that is not something to wait out. It is a urologist visit, worth having before it is an operation.

The second time this exact collision has happened

Ketamine exists because PCP failed. PCP was developed as a surgical anesthetic in the 1950s and pulled from human medical use in the 1960s, when its dissociative and psychiatric aftereffects proved too severe for patients to tolerate; it remains in veterinary medicine to this day. Ketamine was the shorter-acting, gentler successor, and the FDA approved it as an anesthetic in 1970. It worked. It still works, and it sits on the WHO essential medicines list.

Then it drifted. Special K showed up in the 1990s rave scene, and ketamine spent two decades in a gray zone: indispensable in trauma bays, faintly disreputable everywhere else. The rehabilitation came in 2019, when the FDA approved esketamine for treatment-resistant depression — a genuine breakthrough for people who had failed every other option. What followed was not a careful clinical rollout but a market. Telehealth clinics multiplied through the pandemic and after it, faster than the safety infrastructure other controlled substances took decades to accumulate.

So this is the second time ketamine’s dissociative properties have collided with a medical establishment eager to use them. PCP’s collision ended with the drug abandoned for humans entirely. This one is being handled differently, and the difference is the whole story: regulators are building guardrails around the medicine instead of throwing it out. Clinicians are arriving at the same place. At the American Society of Clinical Psychopharmacology meeting this summer, a panel led by Dr. Benjamin Brody of Weill Cornell laid out what the evidence supports: at low doses with appropriate spacing, ketamine appears neurotrophic — brain-nourishing, encouraging new connections to grow. At higher doses, too close together, poorly monitored, the concern flips to neurotoxicity, meaning damage to nerve cells themselves. Where that line sits is still an open question. The panel’s answer was not retreat but standardization: vital signs, in-person observation, attention to cumulative exposure over months rather than one session’s effect.

Nitrous oxide is the same argument, running faster

While ketamine gets audited, its cousin is getting banned. New York’s Senate passed Nima’s Law in June, 59 to 2, banning retail sale of nitrous oxide to the public, with civil penalties for businesses that keep selling. Medical, dental, industrial, and propellant uses are preserved. The bill is named for Nima Pazooki of Jericho, Nassau County, who died after prolonged nitrous exposure — he was in recovery and attending meetings, the symptoms that killed him went undiagnosed, and his parents learned about the nitrous only afterward. Sponsor Sen. Christopher Ryan’s framing was blunt: existing law had not prevented recreational use, and the consequences were devastating.

Congress is weighing a federal version. H.R. 7945, the Nitrous Oxide Safety Act of 2026, from Rep. Kevin Mullin, got a House Energy and Commerce subcommittee hearing on July 22, reported in early August by the Academy of General Dentistry. It would direct the Consumer Product Safety Commission — the federal agency that pulls dangerous consumer goods, cribs to space heaters, off the market — to designate recreational nitrous oxide a banned hazardous product. Medical, dental, industrial, and research uses are carved out, which is why dentists are watching rather than panicking.

Medical, dental, industrial, and research uses are carved out, which is why dentists are watching rather than panicking.

Driving all of it is a mortality curve. A widely cited 2025 JAMA Network Open study by Rachel Hoopsick and Andrew Yockey found US nitrous oxide deaths climbed from 23 in 2010 to 156 in 2023 — a roughly 578% increase, 1,240 deaths across the period, about three-quarters in the final seven years. That curve tracks flavored, branded, gallon-sized canisters arriving in smoke shops and gas stations, sold in a legal space that existed because nitrous was always the harmless one. Whipped cream. The dentist’s mask. A gas so mundane nobody asked what a non-dental dose does. Both drugs got here the same way: a medical use built trust, the trust became permission, the permission outran the safeguards.

Ketamine will survive this. It is too useful in too many hands — anesthesiologists, emergency physicians, psychiatrists treating people who have failed six antidepressants — to go the way PCP went. What is ending is the stretch when it was easier to get ketamine mailed to your apartment than to get an appointment with someone who could tell you whether you should. That was never a golden age. It was a gap between a promise and the infrastructure to keep it, and people walked into that gap because it was the only door standing open.

Filed Under

harm-reductionpolicybiologyKetamineNitrous OxideFDA

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