Nyxxodine™ contains no nicotine, is not a tobacco derivative, and is not a component of or part of a tobacco product. As such, it does not fall under the regulatory purview of the FDA’s Center for Tobacco Products.
Nyxxodine™ does not meet the definition of nicotine provided by the Family Smoking Prevention and Tobacco Control Act, is not a salt or complex of nicotine, and is not itself derived from tobacco or nicotine; accordingly, Nyxxodine™ is not subject to FDA tobacco requirements.
Nyxxodine™ is not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Nyxxodine™ is intended only for experienced adult users of vapes and pouch-based products.