FDA WARNING_LETTER - ALVA-AMCO Pharmacal Companies, LLC - August 15, 2023

The FDA reviewed www.nauzenekids.com in May 2023 and issued a Warning Letter to Micah S. Gerchenson regarding "Nauzene Kids." The product is deemed an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), violating sections 301(d) and 505(a).

"Nauzene Kids" is classified as a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims on its label and website indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or affecting body structure/function. Examples include "For Nausea & Upset Tummies," "Relief of Nauseas From: ‘Car Sickness’ ‘Stomach Flu’ ‘Upset Tummies’," and "The Easy Fix for Upset Stomachs & Nausea."

The product is not generally recognized as safe and effective (GRASE) for its stated uses, making it a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application exists for this product.