Cardio Renew received a Warning Letter from the FDA in October 2010 indicating that the promotional content on the Cardio Renew websites and on their product labels was not in compliance with the FDA’s requirements. Cardio Renew’s EDTA Cardio System Cleanse has not been approved as a marketable drug by the FDA, so any reference to specific health benefits or to the system as a cure or medical treatment is prohibited by federal guidelines. After receipt of the warning letter, Cardio Renew took immediate action to modify their website content and labeling to ensure compliance.
Cardio Renew provides products that are geared towards heart health and wellness. Using reputable systems and products, the company has developed an EDTA Cardio System Cleanse that is unique and provides a system approach to improving cardio health. However, the products have not been evaluated by the Food and Drug Administration and therefore may not be intended for the treatment, prevention or cure of any condition or disease.
The Food and Drug Administration does not allow for the discussion, expansion, or marketing of any health benefits related to a product that has not been identified as a “Drug” as identified under section 201(g)(1)(B)
In order to comply with the FDA’s requests for correcting the issues on the Cardio Renew website as identified in the warning letter, the company performed a complete evaluation of their website content, product labels, and other promotional materials. All content was evaluated for compliance and modified where needed. On August 29, 2011, the FDA issued a Close Out Letter to Cardio Renew that recognized that proper corrective action had been taken to address the violations that were identified in the Fall of 2010.
Cardio Renew has indicated that they now have a system in place to make sure that there is an ongoing effort to monitor all promotional materials, website content and labeling for FDA compliance. Subsequent inspection by the FDA will ensure that continued efforts are made to maintain communication of only approved information regarding the products offered by Cardio Renew.