EPH Technologies was hit with an FDA warning letter for marketing unapproved drugs, including a product it claimed would relieve opioid withdrawal symptoms.
In its investigation of the Aztec, New Mexico company, the FDA determined that the firm was selling Detoxoplex, an unapproved new drug to treat opioid addiction and withdrawal, on its website. The firm advertises the product as “an all-natural proprietary blend” of amino acids, enzymes, minerals, peptides and proteins.
Detoxoplex — which the website claimed would relieve and reduce “symptoms typically associated with withdrawal from opioid use” — was called out as misbranded because patients cannot self-diagnose or treat opioid withdrawal symptoms, the agency said.
“This unproven treatment could cause patients to forgo or delay FDA-approved treatments for opioid addiction and withdrawal,” the agency said, noting that its safety and efficacy had not been proven.