The US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) are actively investigating online ketamine sellers due to the increasing availability of unapproved products and a surge in reported adverse events, including deaths. On July 7, 2026, the FDA's Center for Drug Evaluation and Research (CDER) issued 14 warning letters to e-commerce sites, most of which are US-based, for selling illicit and non-FDA-approved ketamine products for therapeutic purposes. These products are offered in various forms such as liquids, injectable vials, capsules, troches, suppositories, powders, and nasal sprays, often without requiring a prescription, posing significant risks to consumers due to potential contamination or inconsistent active ingredient levels.
This crackdown follows a growing trend of off-label ketamine use, fueled by an expansion of telehealth companies during the COVID-19 pandemic that prescribed ketamine therapy online, and a booming market for in-person ketamine clinics, which reached an estimated $3.4 billion in 2023 and is projected to grow 10% annually through 2030. The FDA highlighted specific dangers including psychiatric events, increased blood pressure, and respiratory depression, noting that Johnson & Johnson's Spravato (esketamine) is the only FDA-approved ketamine-based drug for treatment-resistant depression, while JHP Pharmaceuticals' Ketalar is approved only as a general anesthetic. The agency has strict monitoring requirements for Spravato users due to side effects like loss of consciousness or dissociation.
Increased public and regulatory scrutiny has been intensified by high-profile cases, such as the death of actor Matthew Perry in October 2023, which was linked to ketamine overdose. A North Hollywood drug dealer, Jasveen Sangha, also known as "Ketamine Queen," was sentenced to 15 years in federal prison in April 2026 for her role in distributing ketamine that led to Perry's death and at least one other. This case brought attention to the "Wild West" nature of ketamine treatment, where some clinics operate on a cash-only basis with little oversight, and generic ketamine is used off-label without the stringent requirements of FDA-approved alternatives. The FDA's recent actions signal a coordinated effort to regulate this burgeoning market and protect consumers from the inherent risks of unapproved and misbranded ketamine products.
