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  5. ALVA-AMCO Pharmacal Companies, LLC - 663727 - 08/09/2023
  1. Warning Letters

WARNING LETTER

ALVA-AMCO Pharmacal Companies, LLC MARCS-CMS 663727 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Micah S. Gerchenson
ALVA-AMCO Pharmacal Companies, LLC

7711 Merrimac Avenue
Niles, IL 60714-3423
United States

mgerchenson@kobayashi.com
customer_service@alva-amco.com
Issuing Office:
Office of Unapproved Drugs and Labeling Compliance

United States

WARNING LETTER

August 9, 2023

RE: 663727

Dear Micah S. Gerchenson:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.nauzenekids.com in May 2023. The FDA has observed that your firm offers “Nauzene Kids” for sale in the United States. Based on our review of your website and product label, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Please also reference warning letter 654226, issued on July 26, 2023, to Denison Pharmaceuticals, LLC, that summarized significant violations of current good manufacturing practice (CGMP) regulations for its finished pharmaceuticals.

Your “Nauzene Kids” product is particularly concerning from a public health perspective because of these CGMP violations and because it is directed for use in young children.

Unapproved New Drugs

Based on a review of the product label and your website www.nauzenekids.com, your “Nauzene Kids” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:

From the product label:
• “For Nausea & Upset Tummies”
• “Relief of Nauseas From:
    o ‘Car Sickness’
    o ‘Stomach Flu’
    o ‘Upset Tummies’”
• “Promptly relieves nausea and upset tummies – even from the ‘stomach flu’ and ‘car sickness’”
• “For the relief of upset stomach and nausea, including that due to ‘stomach flu,’ ‘car sickness’ or overindulgences in food or drink.”

From the website www.nauzenekids.com:
• “The Easy Fix for Upset Stomachs & Nausea”
    o “Trusted Relief for Upset Stomachs Caused by . . . Diet . . . Stomach Bug . . . Motion Sickness . . . Nervous Stomach”

“Your “Nauzene Kids” product is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that “Nauzene Kids” is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

CAPT Tina Smith
Acting Director
Office of Unapproved and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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