FDA WARNING_LETTER - Dr Jen Hartley/Healing Artistry, LLC - November 05, 2019

The FDA issued a Warning Letter to Dr. Jen Hartley on October 29, 2019, following a review of her website, www.drjenhartley.com, in 2019. The FDA determined that products sold on the website, including “Colloidal Silver,” “Chronic Pain Tincture,” “Heart Health Tincture,” “Insulin Balance Tincture,” and “Intestinal Restore Tea,” are unapproved new drugs.

The products are deemed drugs under section 201(g)(1) of the FD&C Act because their website claims indicate they are intended for use in diagnosing, curing, mitigating, treating, or preventing diseases in humans or animals. Examples of violative claims include "Lowers Cholesterol & Blood Pressure, Prevents Stroke & Heart Disease" for "Heart Health Tincture," "Diabetes, Hypoglycemia" for "Insulin Balance Tincture," and "Reduces Systemic Inflammation & Pain" for "Chronic Pain Tincture." "Intestinal Restore Tea" was marketed for "gastric distress, Chrone’s, IBS or Leaky Gut."

"Colloidal Silver" was cited for claims such as "Nature’s Antibiotic, Antiviral, AntiCancer" and "Kills All Infections," intended for both humans and animals. These products are considered "new drugs" under section 201(p) of the FD&C Act