FDA Issues Warning to LimpiaArteria

BRONX, N.Y.FDA issued a warning letter to LimpiaArteria, based in Bronx, N.Y., after determining claims made on the companys website for its LimpiaArteria product position it as a unapproved new drug, not a dietary supplement. The product is described as a supplement containing oral liquid EDTA (ethylene diamine tetra-aceitc acid), with the ability to dissolve levels of minerals and heavy metals in the body to fight cardiovascular disease. Therapeutic claims on the site include the ability to reduce, prevent or improve" conditions including diabetes, high cholesterol, impaired vision and arthritis. Further, FDA cited concerns with personal testimonials concerning use of the product to reduce blood pressure, heart attack symptoms and arthritis.

FDA noted the product has not been recognized as safe and effective for the disease conditions, making it a new drug; it also does not bear adequate directions for use and is offered for conditions that are not amenable to self-diagnosis, making it misbranded. The agency noted failure to address any violations of federal law could result in enforcement action including, but not limited to, seizure and injunction.