ALVA-AMCO Pharmacal Companies, LLC – FDA Warning Letter, Aug 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.
ID · ef211baa-41bb-44b1-9d21-418df979cf21
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.