American Lifestyle – FDA Warning Letter

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