FDA WARNING_LETTER - Sundial Herbal Products - November 15, 2012

On October 4-November 15, 2012, the FDA inspected Sundial Herbal Products in Bronx, NY, an herbal supplement manufacturer. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products, including Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites, were deemed "unapproved new drugs" due to therapeutic claims on their labeling, such as "Helps to break up abnormal growths, cysts & fibroids" and "clean…congestion of asthma and flu." These products are not generally recognized as safe and effective and lack FDA approval. Additionally, Koromantee, Wood and Root Tonic, Asthma, Diabetics, and Hepatitis/Liver products are misbranded because they address conditions not amenable to self-diagnosis, thus lacking adequate directions for lay use.

Even if not unapproved drugs, all listed products, plus Blood Pressure, African Manback Tonic, Heart, Nerve Tonic, and Sundial Ashanti Weight Loss Energy Lifter and Appetite Suppresser, are adulterated dietary supplements due to Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies include: * Failure to verify identity of dietary ingredients prior to use (21 CFR 111.75(a)(1)(i)). *