The New York Attorney General’s office has sent cease-and-desist letters to four major retailers, GNC, Target, Walmart and Walgreens, for allegedly selling store brand herbal supplement products that either could not be verified to contain the labeled substance, or were found to contain ingredients not listed on the labels.

The letters, sent Monday, call for the retailers to stop the sale of certain popular products, including Echinacea, ginseng, St. John’s Wort and others. Attorney General Eric Schneiderman requested the companies provide detailed information relating to the production, processing and testing of herbal supplements sold at their stores, as well as set forth a thorough explanation of quality control measures in place.

The Attorney General’s Office claimed that DNA testing, performed as part of an ongoing investigation, showed that, overall, just 21% of the test results from store brand herbal supplements verified DNA from the plants listed on the products’ labels—with 79% coming up empty for DNA related to the labeled content or verifying contamination with other plant material. The retailer with the poorest showing for DNA matching products listed on the label was Walmart. Only 4% of the Walmart products tested showed DNA from the plants listed on the products’ labels, allegedly.

In a statement, Attorney General Schneiderman said, “This investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements. The DNA test results seem to confirm long-standing questions about the herbal supplement industry. Mislabeling, contamination, and false advertising are illegal. They also pose unacceptable risks to New York families—especially those with allergies to hidden ingredients. At the end of the day, American corporations must step up to the plate and ensure that their customers are getting what they pay for, especially when it involves promises of good health.”

Industry Fires Back
Industry trade associations questioned the testing protocol and defended their constituents’ products. The data found through the DNA tests have not been made available to the public, noted Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), and former director of the Division of Dietary Supplement Programs at FDA, who encouraged the New York Attorney General’s office to release the full study details promptly.

“We do not know exactly what was tested, and no labels of products have been shared,” said Dr. Fabricant. “The Natural Products Association 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 purpose. Therefore, if the study is using the wrong tool, that hardly seems newsworthy or beneficial for consumers.”

“In addition,” he continued, “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.”

Ingredient identity testing is a requirement under federal regulations, 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,” Dr. Fabricant said. “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.”

The Council for Responsible Nutrition (CRN) criticized the AG’s actions, calling them a self-serving publicity stunt under the guise of protecting public health.

“Supposed concerns about the products in question are based on a novel testing method that has been roundly criticized by botanical scientists who question whether DNA barcoding technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products,” said Steve Mister, president & CEO of CRN. “Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.”

According to the AG, while overall 21% of the product tests confirmed DNA barcodes from the plant species listed on the labels, 35% of the product tests identified DNA barcodes from plant species not listed on the labels, representing “contaminants and fillers.” A large number of the tests did not reveal any DNA from a botanical substance of any kind. Some of the contaminants/fillers identified include rice, beans, pine, citrus, asparagus, primrose, wheat, houseplant, wild carrot and others. In many cases, unlisted contaminants were the only plant material found in the product samples, according to the AG.

Mr. Mister noted that the DNA testing method does not provide information on the amounts of food contaminants found in the products. “This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients like gluten, and trace amounts of DNA from rice, beans, pine, citrus, etc. are not considered harmful or required on labels. Announcing the detection of minute amounts of these substances unnecessarily alarms consumers without informing them whether the detection of DNA from these substances poses any allergic risk.”

An expert in DNA barcoding technology, Dr. James A. Schulte II of Clarkson University in Potsdam, NY, was hired by the Attorney General’s office to perform the testing. DNA barcodes are short genetic markers in an organism’s DNA and are used to identify it as belonging to a particular species.

The DNA tests were performed on 3-4 samples of each of the six herbal supplements purchased from New York stores. Each sample was tested with five distinct sequence runs, meaning each sample was tested five times. Three hundred and ninety tests involving 78 samples were performed overall, the AG said.

“Instead of giving companies a reasonable opportunity to respond to these concerns,” Mr. Mister said, “the AG unfortunately chose to label them guilty without a fair trial. Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards.”

Dietary supplement companies are required by law to adhere to Good Manufacturing Practices (GMPs) which include identity testing for all botanical materials used, he added. “Different identification test methods, from simple titration to chromatography and mass spectrometry, are appropriate for different stages of the processing—from the whole plant to the extract, to the finished product. Companies identify all incoming materials and keep records of these test results, and those test results could have been shared if companies had been approached in a reasonable manner with a reasonable timeframe. The FDA, which enforces these identity requirements through routine inspections, does not require DNA barcode testing; nor should it, given that this novel approach has not been validated for finished products.”

NPA encouraged the New York Attorney General’s office to release the full study details. “Consumers should know that supplements are a safe part of a balanced approach to a healthy lifestyle that includes good diet and exercise,” said Dr. Fabricant, “and they should consult with their doctor or healthcare professional before making any changes to their healthcare regimen.”

Loren Israelsen, president of the United Natural Products Alliance (UNPA), said the trade group is “currently in consultation with a number of our Science & Technology Services members and appropriate partner organizations because there has been an ongoing interest in and concerns regarding the viability of DNA testing for botanicals.”

“It is now clear that a majority of the products tested using DNA analysis are plant extracts, which do not inherently contain intact DNA from the plant material," said Mr. Israelsen. "This fact alone suggests that the majority of testing done is invalid. Working with our member companies, we will continue with our own internal testing of these products to determine whether we can confirm the results released by the New York attorney general’s office.”

The validity of the data is a central question, he added. “We are actively evaluating currently available data and will continue to make available our test results. Additionally, we will continue to research and review this situation as the implications for responsible industry as well as the public’s perception of it and its products are not insignificant.”

ABC’s POV
The American Botanical Council (ABC) was contacted by New York Times writer Anahad O’Connor on Monday afternoon requesting a comment on the Attorney General’s (then-embargoed) press release.
Chief Science Officer of ABC and Technical Director of the ABC-AHP-NCNPR Botanical Adulterants Program Stefan Gafner, PhD, and ABC Founder and Executive Director Mark Blumenthal sent the following statement to Mr. O’Connor, which was not included in the Times’ articles that appeared online and on the front page of the New York Times this morning (above the fold):

“The AG’s study is not based on adequate science and its actions are thus premature. The use of DNA barcoding technology for testing of the identity of botanical dietary supplements is a useful but limited technology. DNA testing seldom is able to properly identify chemically complex herbal extracts as little or no DNA is extracted in many commercial extraction processes. Basing its actions on the basis of only one testing technology from only one laboratory, the NY AG results are preliminary and require further substantiation. Additional testing using microscopic analysis and validated chemical methods should be conducted to confirm the initial results upon which the AG is acting.”

ABC also added the following statement based on recently published DNA studies on commercial ginkgo extracts conducted at the New York Botanical Garden and the highly respected University of Mississippi’s National Center for Natural Product Research:
“The AG’s test results do not comport with other recently published research on herbal dietary supplements. Two recent tests from reputable laboratories on commercial ginkgo extracts have found ginkgo in all or almost all of the samples tested.”


The Washington Post also posted a story this morning, and other media outlets are expected to follow suit.


According to Mr. Blumenthal, “From a scientific perspective, it appears that the NY AG is way out in front of the available scientific evidence to support and substantiate his position. We cannot know this for certain until we know more about the testing protocols, but in general, as we told the New York Times, DNA barcode testing often cannot determine the identity of a botanical material if it’s been extracted, or if the material has been submitted to a prolonged heat treatment,” he continued, “so, if any of the products tested were extracts—e.g., ginkgo, and possibly the St. John’s wort products—then it’s understandable why they got a negative finding. This also may be true for other products tested, i.e., if they were extracts.”


“Further,” said Dr. Gafner, “it seems as if there wasn’t any verification of the results. As we noted in the statement to the New York Times, microscopy and validated chemical test methods, like those found in official pharmacopeias for these seven herbs, should have been conducted to confirm the DNA findings. The best way to determine the identity of botanical materials and ingredients in finished supplements is to use a range of appropriate methods whenever possible.”


“The action by the New York Attorney General is highly problematic,” added Mr. Blumenthal. “We here at ABC are sympathetic with the AG’s obvious concern about the reported problems associated with adulteration of herbal ingredients in dietary supplements. After all, ABC is the international leader in educating the industry, researchers, and health professionals about the problems associated with adulterated botanical ingredients through our leadership of the ABC-AHP-NCNPR Botanical Adulterants Program. However, everything we are doing in our Program is based on scientific research, including evaluation of appropriate testing methods, and full peer review. We respectfully must question whether an appropriate level of scientific rigor has been applied in this case.”



“The New York AG should take every precaution to approach potential ways to deal with this problem by using appropriate protocols, including an extensive review by competent scientists who are familiar with the analysis of botanical dietary supplements,” added Dr. Gafner. “Conducting DNA tests with little or no apparent verification by other test methods, and without employing a second or even a third analytical laboratory to confirm the findings of the first lab results, and then proceeding to engage in regulatory activity is premature based on the evidence they have collected and disclosed thus far. Additional testing in another qualified DNA lab as well as by other appropriate and validated testing methods is required.”



Dr. Gafner emphasized that although some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication. Other processes, such as extensive heat treatment or submission of plant material to UV light also impact the quality and may lead to erroneous results using DNA methods.



“If, when the dust settles on this issue and all appropriate analytical methods and protocols are used to test these products, and they still confirm the NY AG’s initial tests, only then should the New York AG (and the Food and Drug Administration) pursue appropriate legal and regulatory enforcement options,” said Mr. Blumenthal. “However,” he continued, “that can happen only when all appropriate tests are run by people who are expert in the testing of plant materials. Based on what we can determine, that hasn’t occurred here.