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Posted June 1, 2011

FDA Finds Pesticides in Ginseng Supplement

The U.S. FDA found pesticides in Root to Health, American Ginseng, Herbal Supplement (500 Veggie Capsules, 500 mg each) according to a May 13, 2011 Warning Letter from the FDA to the manufacturer of the product, Hsu's Ginseng Enterprises, Inc.

A sample of the product collected during an FDA inspection of the company's facility in Wausau, Wisconsin late in 2010 was found to contain pesticide chemical residue, namely Chlorpyrifos and Pentachlorobenzonitrile. There is a "no tolerance" policy in effect for these pesticides, i.e., they are not permitted at any level in foods or supplements. has, for several years, reported finding pesticides and other problems in ginseng supplements.

In addition to the presence of pesticides, the FDA notified the manufacturer that its inspection identified a number of deficiencies from Current Good Manufacturing Practice (cGMP) regulations for Dietary Supplements, including the following:

• Finished product release specifications for ginseng encapsulated products did not include that finished products meet identity, strength, purity, composition, or contamination limits.

• A review of the training records and procedure revealed that training records did not include such items as who was trained, training topics covered, who provided the training, course length, and if training objectives were successfully met.

• An attempt was made to review the firm’s copies of the batch records for both the American Ginseng 500 Veggie Capsules Herbal Supplement and the Bee Pollen & American Ginseng 100 Capsules Herbal Supplement; however, the documentation was not available.

The FDA Warning Letter is available using the link below.