NOW Foods makes ginseng changes after FDA letter
industry and its consumers that it has responded to the FDA's
warning letters about its American ginseng product, reports
Philippa Nuttall.
In the statement, the Bloomingdale, Illinois based supplement manufacturer said it had tested all its ginseng products for the presence of quintozene, before recalling all lots of American ginseng and changed its testing method and ginseng supplier.
On 13 August, NOW had received test results from the FDA indicating the presence of quintozene and other fungicides and derivatives in one lot of the company's American ginseng product. NOW states that it reacted by immediately putting all American ginseng product at its facility on hold. It then confirmed the FDA's results through the company's own testing and extended the testing to all ginseng products.
NOW added that as soon as the test results verified the presence of quintozene, it recalled all lots of American Ginseng products and has since provided the FDA with regular updates on the progress of the recall.
In addition to these steps, NOW notes that it has since augmented its in-house testing program and now sources American ginseng that is fungicide-free.
"We have amended the company's product specification sheet to strengthen the fungicide-free requirements and now require 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," said the company, pointing out that it is not alone in receiving a warning letter from the FDA about ginseng.
"We are committed to the safety of our products and to conformance to legal and regulatory requirements. We 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," said Michael Lelah, NOW's technical director.
He added : "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 the FDA dated 21 October 2004 as a follow up to their August letter on test results.
Ever since the ephedra affair last year, the FDA has said it intends to improve the way dietary supplements are regulated to protect consumers against unsafe products and prevent manufacturers making false or misleading claims.
This approach led last week to the announcement of three major regulatory initiatives by the FDA to further DSHEA ten years after the legislation was first implemented.
The three initiatives, including a regulatory strategy, an open public meeting - held on Monday - and a draft guidance document for the industry, will refine the direction the agency is taking to regulate dietary supplements, according to FDA acting commissioner Lester Crawford.
"We now have a clear roadmap to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling," said Crawford.
The regulatory strategy, said the FDA, will lead to greater collaboration between it and other bodies - such as the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative Medicine, the National Toxicology Program in the Department of Health and Human Services and the University of Mississippi's National Center for Natural Products Research - in the making of decisions concerning supplements.
The body also announced that it will put into place an improved process to monitor safety concerns about dietary ingredients and supplements. This process will begin with what the FDA is calling a "signal detection", or, in other words, the identification of a concern.
When the quality or quantity of these signals indicates that there may be a public health problem - for example a rush of reports in the media about the potential dangers of a certain supplement - the FDA may then seek input from an independent third party review before reacting.
The body noted that any action it takes will be based on the scientific evidence available. The National Nutritional Foods Association (NNFA), however, voiced concerns about the "signal detection" approach to safety issues. David Seckman, the CEO of the NNFA, noted that the government agency should be aware that adverse event reports (AERs) are notoriously unreliable and must come through a system that has been redesigned to screen out inappropriate reports.
The supplement industry, though, is generally in agreement that companies producing unsafe products or indulging in false advertising need to be brought to task to secure the future of the industry.
Kiran Krishnan from Amano Enzyme USA - that manufacturers the enzyme Nattokinase - recently told NutraIngredientsUSA.com he was concerned that other natto products on the market were not up to standard and could ruin the reputation of the supplement, particularly in the post-ephedra climate where the FDA is acting much quicker to remove products if there is any doubt about their safety and efficacy.
