Bloomingale, IL, November 16, 2004 – On August 13, 2004, NOW Foods received test results from FDA indicating the presence of quintozene and other fungicides & derivatives in one lot of NOW’s American Ginseng product. NOW immediately put all American Ginseng product at its facility on hold, and confirmed FDA’s results through the company’s own testing. In addition NOW extended testing to all ginseng products beyond the one lot identified by FDA.
As soon as test results verified the presence of quintozene, NOW voluntarily initiated the recall of all lots of American Ginseng products. This recall not only includes the single lot that FDA identified, but all other available lots and products. NOW provided updates to FDA on the progress on the recall in letters dated August 16, August 17, August 19, August 24, August 25, September 3, and October 12, 2004.
NOW Foods has augmented its already extensive in-house testing program following this recent correspondence with FDA, which indicated that the Agency is utilizing more sensitive testing methods than in the past. This is part of NOW’s ongoing dedication to its state of the art quality assurance program.
NOW Foods has now sourced a new supply of American Ginseng that is fungicide-free, and as well has amended the company’s Product Specification Sheet to strengthen the fungicide-free requirements. In addition, the company now requires that each lot of ginseng be tested for fungicides per the FDA 303 Method II for PCNB and Degradants in Ginseng, a much more sensitive test than the industry generally uses.
NOW Foods is one of many ginseng manufacturers who have recently received warning letters as a result of an FDA enforcement action. and who may also have initiated recalls. The recall is classified as a Class II Recall - where the probability of serious medical consequences is remote. NOW Foods has not received any complaints about this product, before or since the recall. This should assure retailers that their customers are not at any health risk.
“ We are totally committed to the safety of our products for our customers, and equally committed to conformance to legal and regulatory requirements. We are very serious about this and have already taken a number of steps to go beyond addressing the product lot identified to include all our ginseng products. Additionally, we have taken concrete corrective action to prevent recurrence of this situation in the future,” stated Michael Lelah, PhD NOW's Technical Director.
“By these measures, we have taken voluntary deliberate and significant corrective action to ensure that the ginseng products we sell conform to the most rigorous legal and regulatory requirements,” Lelah continued. “All these actions were initiated prior to receiving FDA’s Warning Letter, and indicate our concern and responsiveness to this issue.”
NOW Foods received a Warning Letter from FDA dated October 21, 2004 as follow up to their August letter on test results. NOW has responded to FDA with a letter detailing the steps the company has already taken, which include a more extensive product recall than FDA had asked for, and increasing NOW’s already impressive testing program to match the FDA’s more sensitive testing procedures.
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