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

Source: https://www.keypedia.com/records/warning_letter/alva-amco-pharmacal-companies-llc/ef211baa-41bb-44b1-9d21-418df979cf21

> FDA WARNING_LETTER for ALVA-AMCO Pharmacal Companies, LLC on August 15, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ALVA-AMCO Pharmacal Companies, LLC
- Inspection Date: 2023-08-15
- Product Type: Drugs
- Office Name: Office of Unapproved Drugs & Labeling Compliance
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/alva-amco-pharmacal-companies-llc/8e5b7658-0e97-4eb0-a797-32fb2dec8264

Office: https://www.keypedia.com/offices/office-of-unapproved-drugs-labeling-compliance/227bf244-f9f7-4163-8e58-76f95b5e2641