Novid Group, Inc. Warning Letter Details

Summary

Novid Group, Inc. distributed novid NASAL SPRAY, an unapproved over-the-counter antihistamine and nasal decongestant drug product, in violation of federal law. The company's website made explicit drug claims about relieving allergy symptoms, nasal congestion, and sinus infections, establishing the product as a drug under the Federal Food, Drug, & Cosmetic Act without obtaining required FDA approval under section 505(a). The product was also misbranded under section 502(ee) of the FD&C Act for lacking proper regulatory authorization.