FDA WARNING_LETTER - Europharma Co., Inc. - February 28, 2013

The FDA reviewed EuroPharma Co., Inc.'s website, www.europharmausa.com, in February 2013 and determined that products Calm Kids, CholestCaps, CuraMed 375 mg, CuraMed 750 mg, Curamin, Mental Advantage, Tri-Iodine, and Viragen are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The therapeutic claims on the website, such as those for treating ADHD, allergies, heart disease, cancer, diabetes, pain, Alzheimer's, thyroid disorders, and infections, establish these products as drugs intended for the cure, mitigation, treatment, or prevention of disease.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval as required by section 505(a). Furthermore, since these conditions are not amenable to self-diagnosis and treatment, adequate directions for lay use cannot be provided, rendering the products misbranded under section 502(f)(1) of the Act.

The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act. EuroPharma Co., Inc. must take prompt action to correct these violations and prevent recurrence. Failure