Firm Petitions for Adding Chromium to OTC Acne Monograph

Metabolic Therapy Inc. has filed a petition asking FDA to amend the Over-the Counter Acne Drug Products monograph for active ingredients to indicate that chromium is safe and effective for acne treatment. The petition says that when glucose levels and insulin levels rise, the liver responds to the higher insulin levels by converting the higher glucose levels into higher levels of systemic triglycerides in the blood. It says insulin may promote acne by its peripheral effect on cellular carbohydrate metabolism.

Epidemiological studies also suggest that traditional diets with a low glycemic load are protective against acne, and one open label trial showed that 400 mcg of chromium improves acne, the petition contends. “Further, there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims that chromium reduces insulin resistance and aids carbohydrate metabolism,” it adds.