FDA WARNING_LETTER - Limpia Arteria - February 28, 2011

The FDA issued a Warning Letter to Lawrence Merlino regarding the product LimpiaArteria, promoted on www.limpiarteri.com. The FDA reviewed the website in February 2011 and determined that LimpiaArteria is promoted for conditions that cause it to be an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug because therapeutic claims on the website, including "Reduce, Prevent or Improve...Diabetes, Fibromyositis, Arthritis Symptoms, High Blood Pressure, High Cholesterol," and "Improve Heart Function," establish its intent for disease treatment or prevention. Personal testimonials also make disease claims, such as improving heart attack symptoms, arthritis, and normalizing blood pressure.

LimpiaArteria is considered a "new drug" because it is not generally recognized as safe and effective for its claimed uses and lacks prior FDA approval. Furthermore, it is misbranded because its labeling fails to bear adequate directions for use, as the conditions it addresses are not amenable to self-diagnosis and treatment by laypersons.

The introduction of this misbranded drug into interstate commerce violates the Act. The letter 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 enforcement actions like seizure and injunction.