NOW® Responds to FDA Warning Letter

NOW® Responds to FDA Warning Letter

BLOOMINGDALE, Ill.NOW® Foodsreceived a warning letter from the Food and Drug Administration (FDA) in Octoberrelating to the potential contamination of one lot of NOWs American Ginsengproduct with the pesticide quintozene. The agency originally discussed the issuewith NOW in mid-August, at which time NOW voluntarily recalled all lots of itsAmerican Ginseng products.

NOW noted it has augmented its in-house testing program toutilize more sensitive testing methods for quintozene, sourced a new supply ofAmerican Ginseng, and has amended its product specification sheets to strengthenits fungicide-free requirements. In addition, the company is requiring all lotsof ginseng to be tested per the FDA 303 Method II forPCNB and Degradants in Ginseng.

We are totally committed to the safety of our products forour customers, and equally committed to conformance to legal and regulatoryrequirements, said Michael Lelah, Ph.D., technical director for NOW(www.nowfoods.com). We are very serious about this and have already taken anumber of steps to go beyond addressing the product lot identified to includeall our ginseng products. Additionally, we have taken concrete corrective actionto prevent recurrence of this situation in the future. By these measures, wehave taken voluntary deliberate and significant corrective action to ensure thatthe ginseng products we sell conform to the most rigorous legal and regulatoryrequirements. All these actions were initiated prior to receiving FDAswarning letter, and indicate our concern and responsiveness to this issue.