Save to favorites
This feature is restricted to active members.
Join now to save favorites and get all member benefits, including over 1,300 reviews.
Join NowAlready a member? Sign in here.
Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted September 5, 2013
Seller of Herbal Supplements and "Tonics" Warned For Manufacturing Violations and Drug Claims
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."
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.
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
