FDA WARNING_LETTER - Cardio Renew Inc

The FDA issued a Warning Letter to Cardio Renew, Inc. after reviewing their websites (www.cardiorenew.com, www.cardiorenew.org, www.cardio-renew.com, www.cardiorestore.com, and www.oralchelationblog.com). The FDA determined that "Cardio Renew" and "Cardio Restore" products 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) [21 U.S.C. § 321(g)(1)(B)].

The therapeutic claims on the websites, including testimonials and video content, establish the products' intent for use in the cure, mitigation, treatment, or prevention of various diseases such as Alzheimer's, Angina, Arteriosclerosis, Cardiovascular Disease, Diabetes, Erectile Dysfunction, Heart Failure, High Blood Pressure, and Strokes. These claims violate the Act.

The products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their promoted uses. Marketing new drugs without prior FDA approval, as required by section 505(a) of the Act [21 U.S.C. § 355(a)], is illegal.