FDA WARNING_LETTER - Cellular Rx Inc - April 30, 2011

On April 2011, the FDA reviewed the website www.cellpro7.com and determined that the product Cell Pro 7 is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on the website, including "Arthritis, joint and muscle pain relief," "Migraine... and Allergy headache relief," and "Asthma, COPD, bronchial infection relief," establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease. The website also features testimonials claiming relief from arthritis, depression, allergies, severe burns, cluster headaches, and a reduction in PSA levels. Additionally, the Facebook account http://www.facebook.com/pages/Cell-Pro7/351345481336 contains testimonials making disease claims, such as controlling osteoarthritis, diabetes, and blood pressure.

The FDA states that Cell Pro 7 is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs require prior FDA approval under section 505(a) [21 U.S