FDA WARNING_LETTER - Artery Health Institute LLC

The FDA reviewed The Artery Health Institute, LLC's website, www.arteryhealthinstitute.com, in June 2010 and determined that their "Advanced Formula EDTA Oral Chelation" product is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The website's claims, including "UNCLOG arteries," "reverse atherosclerosis," "lower cholesterol levels and blood pressure," and "prevent heart attacks and strokes," establish the product's intent for disease cure, mitigation, treatment, or prevention, violating the Act.

The product is considered a "new drug" under section 201(P) of the Act because it is not generally recognized as safe and effective for its promoted uses. New drugs require prior FDA approval under section 505(a) of the Act, which this product lacks. Furthermore, the product is misbranded under section 502(f)(1) of the Act because it is offered for conditions not amenable to self-diagnosis and treatment by laypersons, meaning adequate directions for safe use cannot be provided. Introducing a misbranded drug into interstate commerce violates section 301(a) of the Act.

The FDA requires prompt corrective action within fifteen working days, including written notification of steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory actions such as