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MONQ, LLC was cited for marketing unapproved inhalation essential oil products (including "sleepy," "zen," "relieve," and "peace") as drugs in violation of sections 505(a) and 301(d) of the FD&C Act. The company made therapeutic claims about treating or curing opioid addiction and withdrawal symptoms despite lacking FDA approval, which posed a significant public health threat by potentially causing patients to forego established opioid addiction treatments. Additionally, the essential oil ingredients and impurities raised safety concerns including potential for laryngospasm, bronchospasm, and tissue toxicity in the airways.