The US Food and Drug Administration’s (FDA’s) drug review agency has initiated a crackdown on e-commerce sites selling illicit ketamine products to consumers as classic psychedelic therapies edge closer to the market through standard channels.
On 7 July 2026, the US regulator’s Center for Drug Evaluation and Research (CDER) sent out 14 different warning letters to online sites selling non-FDA-approved ketamine for therapeutic purposes – all but one of which are based in the US, with the other located in the Netherlands.
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One of the sites reprimanded by the FDA in this regulatory sweep was LyfeUnit, which claims to sell injectable “pharmaceutical grade ketamine” suitable for treatment-resistant depression (TRD). Currently, Johnson & Johnson’s Spravato (esketamine) is the only ketamine-based drug that has secured the FDA go-ahead in TRD, while JHP Pharmaceuticals’ Ketalar (ketamine) is approved only as a general anaesthetic.
In a letter to LyfeUnit, the FDA noted that increasing consumer interest in the use of ketamine products, paired with the easy online availability of unapproved and misbranded products “put US consumers at risk of serious adverse events” – a factor which is particularly pertinent for injectable ketamine products like LyfeUnit’s offerings, the FDA says, as unregulated and potentially contaminated samples can lead to septicaemia or sepsis.
Within another letter addressed to Legit Ketamine Suppliers, the US regulator also highlighted the inherent risk that unapproved or misbranded drugs can have on consumers due to their potential to contain varying levels of “active ingredients, or even different ingredients altogether.”
Other companies that received letters were All Ketamine HCL, Buy Keta Online, Ketaminetroches, Keta Med Lab, Ket Plug, Ketacyn Pharmaceuticals, Extra Medication, Pure Arylcyclohexylamine Store, Ketdaxandrugs, Ketamine Troche Store, Med Shop and Ketamine Store.
Illicit ketamine sellers crop up as Spravato sees strong commercial success in the TRD space, with the therapy achieving blockbuster status in 2024. According to GlobalData’s Pharmaceutical Intelligence Center, Spravato’s commercial success is slated for further strong growth, with the therapy expected to near the $5bn sales mark in 2032.
The psychedelic renaissance in mental health
As the understanding of how both classical psychedelics and psychedelic-adjacent therapies like Spravato can influence care in mental health conditions like depression, many in the neuropsychiatry field are excited about the drug class’s potential in treatment.
One of the believers is Dr Hans Eriksson, CMO of HMNC Brain Health, who previously told Pharmaceutical Technology’s sister publication, Clinical Trials Arena that psychedelic medicines could offer treatment durability that traditional therapeutics can’t.
With Spravato already on the market and Compass Pathways’ psilocybin-based TRD therapy, COMP360, currently under FDA review, the psychedelic revolution could soon be well underway. This could be especially true in the US, as President Donald Trump recently signed an executive order focused on accelerating the route of psychedelics to the market.
However, with psychedelic therapies creating a buzz both within the industry and amongst the public, there remains a need to secure accessibility for patients as to prevent them from turning to the illicit drug trade, as seen with some patients on obesity drugs in Britain.
In a previous conversation with Pharmaceutical Technology, experts noted that systemic change must be made for the effective implementation of psychedelic therapies, as regulation introduces complexity.
