GNC, Walgreens, Target and Walmart sent cease and desist letters

‘Uninformed’, ‘inappropriate’ and ‘premature’: Industry experts round on NY AG’s action against major retailers over failed DNA tests for herbal supplements

By Stephen Daniells contact

- Last updated on GMT

NY AG takes on GNC, Walgreens, Walmart & Target on herbal supplements

Related tags: Ny ag, Identification, Dna

The New York Attorney General has sent letters to GNC, Target, Walmart, and Walgreens telling them to stop selling some herbal supplements after DNA tests found 79% didn’t contain the labeled substance or contained other non-listed ingredients. Analytical experts have slammed the choice of DNA barcoding as the method of choice for botanical extracts that may contain little to no cellular material.

Eric Schneiderman, NY’s Attorney General, commissioned Dr James Schulte II of Clarkson University in Potsdam, NY to perform the DNA barcoding of herbal supplements purchased from the four retailers in 13 regions across NY State. The data has not been made publicly available. (Barcodes are short genetic markers or signatures in DNA that identify which particular species it belongs to.)

“The DNA test results seem to confirm long-standing questions about the herbal supplement industry,” ​said Schneiderman in a press release. “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.” 

The labels

The AG’s investigation was prompted by a report in the New York Times​ in 2013 of a controversial paper by Prof Steven Newmaster and his group at the Guelph-based Biodiversity Institute of Ontario in the open access journal BMC Medicine. ​That paper was widely criticized by analytical and botanical experts and the American Botanical Council called for it to be retracted​.

Dr Schulte and the AG did not seem dissuaded by such limitations, however, and used the technique exclusively to analyze samples of Ginkgo Biloba, Ginseng, Valerian, garlic, Echinacea, saw palmetto, and St John’s wort

As reported by NutraIngredients-USA in 2013​, DNA barcoding offers a lot of potential for botanical testing, and is incredibly reliable, but only when performed on appropriate material.

Label data for the products tested are not available, but, according to the descriptions from the NY AG’s office and data available from the retailer websites, we estimate​ that 66% of the products tested were extracts, with a further 8% available as both whole herbs and extracts. That’s a potential 74% of products tested being extracts (see table below for more information. Caution​: These numbers are based on products listed on the websites of the four retailers and limited details provided by the AG in a press release. This data has not been confirmed).

Furthermore, the Natural Products Association has confirmed with GNC that every product tested was a botanical extract.

Herbal products tested NY AG
Table showing brand and products and type. Caution: This data has not been confirmed to match the actual tests performed by Dr Schulte. These are estimates from NutraIngredients-USA

But…

Danica Harbaugh Reynaud, PhD, a geneticist, botanical taxonomist, and CEO of AuthenTechnologies and expert in applying DNA analysis to botanicals, explained that botanical extracts are not appropriate for DNA barcoding. Dr Harbaugh Reynold also questioned the lab’s expertise in this area.  

“I’ve never even heard of this lab,” ​she told us. “They seem to be applying an inappropriate DNA method to finished products. The problem is that the media and the Attorney General will take DNA as the end-all even if it’s not applied properly.

“We have developed a method to analyze extracts but it’s very specific. General DNA barcoding does not work.”

“DNA testing is an emerging technology that has the potential to be useful in the future when it has been rigorously tested and validated – the usual course with new analytical methodologies,” ​said Michael McGuffin, president of the American Herbal Products Association. “But until DNA testing can stand on its own, any identification of an herb with this method must be confirmed with one or another of the long-established analytical tools that herbal experts use, such as chromatography, microscopy, or organolepsis.”

NutraIngredients-USA contacted Dr Schulte for comment on a number of issues, including his suitability to test botanicals and botanical extracts, but he passed the questions to the NY AG’s office. The NY AG’s office has not responded to requests for comment from this publication.

ABC

Mark Blumenthal, founder and executive director of the American Botanical Council, told us that his organization provided a comment to the New York Times​ explaining the limitations of DNA barcoding for testing the identity of botanical dietary supplements, and called the results from the one laboratory “preliminary and requiring further substantiation”​. [The NYT did not include ABC’s thoughtful comments in its coverage​]

“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," ​said Stefan Gafner, PhD, ABC’s Chief Science Officer. "Other processes, like extensive heat treatment, or submission of plant material to UV light also impact the quality and may lead to erroneous results using DNA methods.” 

Mark Blumenthal called the NY AG’s actions “problematic”​. “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, but the AG should take every precaution to approach potential remedies appropriately and responsibly,” ​he told us.

“Conducting DNA tests with little or no apparent controls, 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 (cease-and-desist letters) is premature and unwarranted based on the evidence they have collected thus far. Additional testing in another DNA lab as well as by other appropriate and validated testing methods is required.”

The high failure rates are not seen by other analytical experts. Elan Sudberg, CEO of Alkemist Labs, told us that, for the industry as a whole, his lab does not see failure rates anywhere near the ones listed by the AG.

Questions

There is general frustration among industry stakeholders at the lack of transparency over the data. “There are so many details absent,”​ said Daniel Fabricant, PhD, CEO of the NPA. “There’s no peer-review. We don’t know the labels of the products. What were the reference materials used? We want to see the full study.”

We have questions of our own...

Please click HERE​to read our article: 10 questions we need answered regarding the NY AG’s botanical action

“The federal government and the FDA have never been shy, particularly in New York, about using the full force of the law,” ​said Dr Fabricant. “I was a federal regulator and I know that any actions become a matter of public record. There is none of that here from the AG. He’s fighting an uphill battle."

Steve Mister, CEO of the Council for Responsible Nutrition, said his organization was “stunned that the AG would use this type of testing and ignore that GMPs requires 100% identity testing.

“These are very reputable brands with mainstream products and a history of passing GMP inspections,” ​said Mister. “They have rigorous internal and third party inspections and the FDA is routinely in these facilities.”

Expect an aggressive response from the industry, he added. “We need to call out the attorney general to give us the test data and justify why they used DNA barcoding when it’s not a validated method for finished products. We need to put the AG under the same scrutiny as he has put the industry.”

UNPA: ‘The implications are not insignificant’

Loren Israelsen, president, United Natural Products Alliance, said that his organization is currently in consultation with a number of its 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”​.

“We will be actively evaluating the data, assuming that it becomes available, to determine the validity of the study and the AG’s actions. 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.”

CRN: ‘A self-serving publicity stunt’

CRN’s Mister described the NY AG’s actions as a “self-serving publicity stunt under the guise of protecting public health.

Retailer response

According to the New York Times​, Walgreens is removing the products from its shelves nationwide, while Walmart said it is contacting its supplement suppliers “and will take appropriate action.” GNC said it would work with the AG but stood by its products. Target hasn't commented. 

“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.”

Qualitative vs quantitative

The presence of potential ‘contaminants’, including include rice, beans, pine, citrus, asparagus, primrose, wheat, houseplant, and wild carrot is cited by the AG as posing “unacceptable risks to New York families—especially those with allergies to hidden ingredients”​.

However, a bigger question relates to the qualitative versus quantitative aspect of DNA barcoding – the technique is so accurate and sensitive that trace amounts of a foreign material will show up (qualitative) without providing any information about how much​ of that foreign material is present (quantitative).

“The DNA testing method does not provide information on the amounts of food contaminants found in the products,” ​said CRN’s Mister. “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.

“It could be that there is a bit of contamination that is not sufficient to trigger the labeling requirements for allergens, but is enough to show up in the DNA barcoding, but without seeing the data, we don’t know. This is a very one-sided conversation.”

The industry has also criticized how the Attorney General used his data. “Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial,”​ said Mister. “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.”

The case is being handled by Executive Deputy Attorney General Marty Mack and Assistant Attorney General Deanna Nelson with the assistance of NYAG’s thirteen regional offices.

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4 comments

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Test Methods

Posted by ricky,

i heard some contract manufacturers using TLC to test raw materials, very few uses HPTLC. HPTLC is said to be more accurate. i am not science major, anyone explain this? Not sure if these methods can be used to test finished products

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Odd science, but herbals need to be addressed

Posted by Zach,

Herbal supplements, and many other botanicals and phytochemical agents, despite the methods used to extract them, are still marketed based on PURPORTED effects or physiological roles, hence the debate over whether or not to evaluate these substances in the context of the DRI, or recommended intake; in other words, little is known about the physiological properties of these substances, how the affect health, IF they affect health and, most importantly, how much is enough, or not enough, or too much...The outcome, usually optimized health, is also incredibly hard to measure as it is subjective and, with these compounds, it's hard to determine mechanisms of actions and potential interactions with other nutrients. Despite the "lore" of these alternative choices, they are still not backed by proper nutritional studies, which compromises our knowledge of them and their potential effect on health. However, because they are herbals, and this may be conjecture, they are often touted as "harmless" and thought to be appropriate alternatives or adjuvants to traditional nutrients or medical treatment. We have failed ourselves and nutritional studies by believing we can take a traditional (and highly romanticized) cultural herbal therapy, pack it into a gelatin capsule, wash it back with a cup of water, and be better. Without proper understanding of the kinetics, mechanisms, and physiological interactions, and ultimately the development of intake guidelines that reflect dietary standards, we shouldn't really be taking herbal supplements very seriously. Honestly, after working at a few large supplement chains, observing vile marketing strategies and manufacturer practices, and approaching a PhD in Nutritional Biology, I think we should stick to what we know to be true rather than seek out some false hope in the form of a funny tree name. Don't get me wrong, I used to believe the hype, then again I was selling them, and I was fueled by Google when customers had questions, rather than my current understanding of clinical and functional research. Even with multi vitamins, I can see how we haven't moved too far away from the days of elixirs and potions and cure-alls.

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The problem with identity testing

Posted by James Neal-Kababick,

I am a forensic scientist, government recognized phytochemistry expert & FDA trained botanical microscopist with over two decades of expertise in dietary supplement testing. I have already learned that the samples tested from one location were extracts. Most extracts don’t contain DNA as it is destroyed/removed in the process. Heat treatment used to reduce bioburden can denature DNA. I have investigated samples failed by DNA testing that were fine. Where DNA is denatured, the only DNA detected is the trace amount found just about everywhere. This is amplified and can give the false impression that a product is fake & filthy. The 2013 DNA study referenced in this article was so bad experts requested it be retracted. I have taken a lot of heat for exposing fraud in the industry and was on Dr. Oz speaking about tainted supplements with drugs and will not hesitate to point out real issues. However, this situation reeks of bad study design and a failure to apply the correct analytical techniques to at least some of the products tested. DNA testing of dietary supplements is not like DNA testing in criminology. It is still evolving with serious issues that are being addressed by NIH, USP and experts in the field.

DNA nutra article
This article points out many of the issues I am seeing more and more in the industry. Using DNA to test extracts for identity is completely inappropriate. Even in cases where the botanical is in raw form, we have seen more than one case of the denatured DNA from heat treatment of the botanical masking its presence with only the trace contamination being amplified. Testing by microscopy and chemical analysis has shown in some of these cases that the DNA findings were not representative of the sample and this greatly concerns me. I strongly support properly performed DNA testing as part of a holistic identity testing program. When combined with expert microscopy and chemical profiling using HPTLC or other chemical test methods, it helps provide a big picture of the sample under test. Being an FDA trained botanical microscopist and government recognized expert in phytochemistry with over two decades of experience in authenticating botanicals using classical methods, I see the improper application of DNA as a serious issue for our industry. Barcoding does not work in many cases and what is fine for a fresh plant or herbarium specimen may be unsuitable for commercially processed botanical material. GeneBank is full of erroneous data and DNA experts that I respect and recommend to my clients have commented that barcoding and the use of GeneBank can result in erroneous data. DNA is not the silver bullet for identity testing anymore than any other single technique is. The reason we have so many ways to test botanicals is because we need them. There is no one size fits all approach despite the desire of industry to have one. Unfortunately, I am seeing more and more poor quality microscopy, HPTLC and DNA identity testing show up as clients seek a second opinion. I have even obtained so called “botanical reference materials” that were the wrong species. Techniques like these require years of experience to master. You just can’t put a technician in front of a microscope, sequencer, FTIR or a TLC development chamber, and expect them to produce data on par with experts that have been doing this work for decades. And if you are using technicians to gather the data, you need to have an experts eyes on that data and I mean for every sample every time on every day! There is a reason I strongly encourage my clients to use orthogonal testing approaches. What one test does not reveal, another can and that is the difference between cGMP compliant identity testing and testing that is not fit for purpose. As an industry, we need to do more to educate consumers and mainstream media on the issues because they are only getting one side of the story and it is often not even true. I sent my comments in to the NYT and Washington Post and I hope others will too.

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