WASHINGTON -- Daniel Fabricant, executive director of the Natural Products Association (NPA) and former director of the Division of Dietary Supplement Programs at the U.S. Food & Drug Administration (FDA), has commented on New York Attorney General Eric T. Schneiderman's request to remove herbal supplements from the shelves of four major retailers--GNC, Target, Walmart and Walgreens--because they either could not be verified to contain the labeled substance or which were found to contain ingredients not listed on the labels.
The AG called for the retailers to immediately stop the sale of certain products, including echinacea, ginseng, St. John's wort and others.
"The full details and data the [N.Y. AG] found through the DNA tests have not been made available to the public," said Fabricant. "We do not know exactly what was tested, and no labels of products have been shared. The [NPA] has confirmed with one of the retailers, GNC, that every product tested was a botanical extract, in which DNA is unlikely to be intact, making that test not fit for [the] purpose; therefore, if the study is using the wrong tool, that hardly seems newsworthy or beneficial for consumers."
He said, "We do not have any insight into how reference materials were selected to compare the products in this study. We also do not know how products were obtained or sampled, nor do we know the chain of custody of said products. What's interesting is that in keeping with the federal regulations for dietary supplements, ingredient identity testing is a requirement, as are the use of reference materials to establish identity, so it's peculiar that a study to evaluate quality isn't consistent with parameters of what's required by the federal regulations for quality."
He continued, "Also, per these same regulations, manufacturers are given flexibility in testing decisions, and may or may not choose to use DNA barcoding, as it may or may not always be appropriate. Nevertheless, they have requirements on testing for identity that are required by law, and if those requirements aren't met, the government can and does take action, ensuring consumer protection is in place. Thus, it is unclear as to why the New York Attorney General is making this request."
Fabricant concluded, "We encourage the [N.Y. AG's] office to release the full study details promptly, and look forward to reviewing them thoroughly."
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