Novid Group, Inc. – FDA Warning Letter, Dec 12, 2023

The FDA issued a Warning Letter to Dr. Kerner on December 7, 2023, regarding the distribution of novid NASAL SPRAY, an over-the-counter (OTC) combination antihistamine and nasal decongestant. The FDA reviewed the product's website on October 12, 2023.

The product is cited as an unapproved new drug, violating section 505(a) of the FD&C Act, and misbranded under section 502(ee). Prohibited introduction into interstate commerce is also cited under sections 301(d) and (a).

Novid NASAL SPRAY is deemed a "drug" due to its intended uses, including temporary relief of upper airway allergy/infection symptoms, runny nose, nasal congestion, sinus pressure, and claims of fighting viruses/bacteria, providing personal protection, and reducing inflammation.

The product is not generally recognized as safe and effective (GRASE) and lacks an FDA-approved application. It does not conform to OTC monograph M012 (Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products). Specifically, its active ingredients (sodium chloride and organic fulvic acids) are not permitted under M012, and its labeling includes unpermitted claims such as "fights and defends where viruses and bacteria attack" and "enhances the immune-enhancing activity."

The company must respond