# FDA WARNING_LETTER - Cardio Renew Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/cardio-renew-inc/a51296cc-fb25-4f3c-a06e-8ec554d94333

> FDA WARNING_LETTER for Cardio Renew Inc on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cardio Renew Inc
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Gerald J. Berg](https://www.globalkeysolutions.net/people/gerald-j-berg/ebeb00b9-51c9-4bc4-b393-bfdb01862028)

Company: https://www.globalkeysolutions.net/companies/cardio-renew-inc/126498a7-0095-435d-84b8-e3afc327d140

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d