FDA WARNING_LETTER - MONQ, LLC - June 30, 2022

The FDA and FTC issued a Warning Letter to Eric Fishman regarding products sold on monq.com, including "sleepy," "zen," and "ocean" essential oil products. The agencies reviewed the website in May and June 2022.

The letter states that the essential oil products are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d), because they are marketed with claims to treat or cure opioid addiction and withdrawal symptoms. Examples of claims cited include "Aromatherapy for Recovery from Addiction," "Best Essential Oils to Help With Opiate Withdrawal Symptoms" (listing lavender, ylang ylang, eucalyptus, cinnamon, ginger, peppermint, bergamot, lemon, and rosemary oils), and claims about affecting serotonin, endorphin, and noradrenaline release.

The FDA emphasizes that these products are not recognized as safe and effective for their intended uses and lack FDA approval. The agency also raises safety concerns regarding oral inhalation products, including potential for laryngospasm, bronchospasm, tissue toxicity, or systemic effects.

The FTC concurrently demands that the company cease making unsubstantiated claims about treating, preventing, or curing human disease, including addiction. The FTC states that competent and reliable scientific evidence, such as well-controlled human clinical studies, is required to substantiate