# FDA WARNING_LETTER - American Lifestyle - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/american-lifestyle/2a77b86f-bfab-4991-b038-020b8061c168

> FDA WARNING_LETTER for American Lifestyle on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: American Lifestyle
- Product Type: Drugs
- Office Name: New York District Office
- Summary: On May 2015, the FDA obtained product samples and reviewed the websites of American Lifestyle, identifying violations of the Federal Food, Drug and Cosmetic Act (FD&C Act) related to the marketing and sale of several products.

**Violations and Deficiencies:**

*   **Unapproved New Drugs with Undeclared Pharmaceutical Ingredients:** "Vicerex" and "Sudibil-Xr" were found to contain undeclared propoxyphenyl thioaildenafil and tadalafil, respectively, both PDE-5 inhibitors. These are active pharmaceutical ingredients in FDA-approved ED drugs (Viagra and Cialis). As such, these products are unapproved new drugs and misbranded. They are considered prescription drugs due to potential harmful effects and are not safe for use without practitioner supervision. Their labeling lacks adequate directions for use and is false/misleading by not disclosing the PDE-5 inhibitors, posing serious health risks, especially when interacting with nitrates.
*   **Unapproved New Drugs Marketed with Therapeutic Claims:** "AloeElite," "Biotin," "Echinacea," "Glucose M2," "Kalawalla," "Liver MaXX," "OxyFlush," and "Resvert" are marketed with therapeutic claims (e.g., treating Ulcerative Colitis, diabetes, cold/flu, psoriasis, liver diseases, preventing cancer) that classify them as unapproved new drugs. These products are not generally recognized as safe and effective for their claimed uses

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/american-lifestyle/a59021b7-8e37-4c1c-8a5f-77a0432a6563

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d