Posted September 5, 2013

Seller of Herbal Supplements and "Tonics" Warned For Manufacturing Violations and Drug Claims

On May 24, 2013, the FDA issued a warning letter to Sundial Herbal Products following a facility inspection which found the company's products, including Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Sundial Ashanti Weight Loss Energy Lifter, Appetite Suppresser, African ManBack Tonic, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites supplements to be adulterated because they were packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish product specifications for the identity, purity, strength, and composition of finished batches of dietary supplements, failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement and failure to make and keep written procedures for the review and investigation of product complaints.

In addition, statements made about Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites product labels were found to be drug claims. Woman Back Tonic was promoted for the treatment of cysts and fibroids with statements such as, "Helps to break up abnormal growths, cysts & fibroids."

Koromantee was promoted for the treatment of ulcers and other digestive conditions with statements such as, "To release the stomach and intestines and waste gases such as worms and parasites and heal ulcers, hemorrhoids and rid the cancer of the stomach and intestines."

(See ConsumerLab.com's Encyclopedia of Natural Products article on Intestinal Parasites for more information about this condition.)

Wood and Root Tonic was promoted for the treatment of asthma and the flu, with statements such as, "clean... congestion of asthma and flu."

(See ConsumerLab.com's Reviews of Echinacea Supplements, Garlic Supplements, Vitamin C Supplements, and Zinc Supplements for tests of related products.)

The FDA found the names of Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites to constitute drug claims.

These products were also found to be misbranded because the labels did not provide certain information required by federal law. Labels for Arthritis, Asthma, Blood Pressure, Diabetics, Flu-Allergies HayFever, Heart, Hepatitis/Liver, Nerve Tonic, Worms & Parasites, Sundial Ashanti Weight Loss Energy Lifter and Appetite Suppresser, Woman Back Tonic, Koromantee, African ManBack Tonic, and Wood and Root Tonic failed to identify the products as dietary supplements, and did not provide a supplement facts panel.

To read the FDA's warning letter, use the link below.