Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your website for your essential oil product ingredients, including lavender, ylang ylang, eucalyptus, cinnamon, ginger, peppermint, bergamot, lemon, and rosemary, establish that your essential oil products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2You market various inhalation essential oil products for the treatment or cure of opioid addiction and withdrawal symptoms.
Passage 3However, these products have not been determined by FDA to be safe and effective for these (or any other) uses.
Passage 4Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal.
Passage 5Furthermore, the use of your essential oil products raises safety concerns for the agency because the ingredients and/or impurities in oral inhalation products may trigger laryngospasm or bronchospasm, may be toxic to the tissues in the upper or lower airways, or may be absorbed and exert undesirable systemic effects or organ toxicity.
Passage 6Your essential oil products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Passage 7Your essential oil products are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 8There are no FDA-approved applications in effect for any of the above mentioned products.