AG Paxton, who is currently running for the U.S. Senate in Texas, announced his investigation based on concerns over heavy metals in protein powders on June 8 and quickly drew a reaction from the dietary supplements industry. In a letter to the AG’s office, Daniel Fabricant, PhD, president and CEO of the Natural Products Association, questioned the evidentiary foundation for the investigation, noting that “the importance of grounding regulatory action in sound science is illustrated by a cautionary precedent.”
That precedent is the 2015 investigation by then New York Attorney General (NYAG) Eric Schneiderman into herbal supplements, a probe that sent shockwaves through the industry and elevated DNA barcoding into the public consciousness.
History, however, has not judged the NYAG investigation kindly: The science it was built on ultimately collapsed, culminating in the 2024 retraction of the paper that sparked it all.
2013: Where it all began
Authored by Dr. Steven G. Newmaster et al. from the University of Guelph, a 2013 paper titled “DNA barcoding detects contamination and substitution in North American herbal products” detailed an analysis of 44 herbal supplements from 12 companies using DNA barcoding. The researchers reported that almost 60% of the products tested contained DNA barcodes from plant species not listed on the labels.
Analytical and botanical experts widely criticized the paper at the time of its publication—notably, the American Botanical Council (ABC) was quick to call for its retraction, and the American Herbal Products Association promptly submitted a letter to the journal’s editor to point out several inaccuracies.
Meanwhile, the study was picked up by Anahad O’Connor, a reporter for The New York Times, who authored an article with the headline “Herbal Supplements Are Often Not What They Seem“.
February 2015: Ignition and blast off
On February 3, 2015, the U.S. dietary supplements industry woke to a press release from the NY Attorney General’s office and another article in the New York Times announcing the launch of an investigation into herbal dietary supplements following DNA tests of products from GNC, Target, Walmart and Walgreens. Those analyses alleged that 79% of products did not contain the labeled substance or contained other non-listed ingredients. The retailers were ordered to stop selling a number of herbal supplements, including Ginkgo biloba, ginseng, valerian, garlic, echinacea, saw palmetto and St John’s wort.
Industry leaders and botanical experts were quick to point out that most of the products in question were purified extracts and therefore unlikely to contain much or any DNA in the first place.
The researcher commissioned by the NY Attorney General’s office to perform the DNA analysis specialized in reptilian and evolutionary biology. Industry stakeholders noted that he had not published any papers on DNA barcoding of botanicals or botanical extracts.
In response, GNC re-tested the product lots cited in the cease-and-desist letter and found all products to be pure and compliant prior to distribution, but Scheiderman could not be stopped: The investigation evolved quickly and took a twist barely 10 days later when the Attorney General issued subpoenas to the same four retailers, demanding evidence to support the structure-function claims on their labels.
Three weeks after issuing the first cease-and-desist letters to the four retailers, the Attorney General’s office expanded the investigation to four more major supplement manufacturers—NBTY, Pharmavite, Nature’s Way and Nutraceutical Corp—requesting detailed ingredient and quality control information on every herbal supplement they were selling in New York.
“As part of a broader investigation, NYAG is reviewing the sufficiency of the measures manufacturers and retailers are taking to independently assess the validity of their representations and advertising in connection with the sale of herbal supplements,” Schneiderman wrote in his letters to the companies.
March 2015: AG coalition forms, industry pushes back
Attorneys general from Connecticut, Indiana and Puerto Rico soon joined the fray, announcing that they had formed a coalition with Schneiderman, to “go further in investigating this industry and, as needed, in achieving reform.”
Trade associations representing the dietary supplement industry, namely the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA), mobilized and commissioned and published a white paper on the use of DNA barcoding for botanical supplements. That review concluded that DNA barcoding was a “...misuse of the technologies” that led to a “...misinterpretation of test results.”
NPA also authored a white paper titled “DNA Barcoding for Botanical Authentication”, which called for the NY Attorney General’s study data to be made public, “to apply scientific scrutiny to the findings, provide validation to the results or exonerate those companies undergoing current scrutiny.”
“Scientific scrutiny of the test results is the only way to fairly adjudicate the allegations made and to prevent further actions by states to remove products, produced in accordance with federally opted GMP standards, from retailer shelves,” the association noted.
GNC and the NY Attorney General’s office reached an agreement affirming that the company’s Herbal Plus products met FDA Good Manufacturing Practice (GMP) requirements, thereby validating their quality. As part of the agreement, the company committed to a testing regimen administered by the Attorney General’s office and agreed to provide clearer in-store consumer-facing messaging distinguishing herbal extracts from whole herb products.
The initial reaction from the industry was largely negative with some saying that the agreement served to validate the use of DNA barcoding. GNC CEO Mike Archbold subsequently published an open letter to the industry to address the criticism, stating: “Our assessment was quite simple. A protracted battle to establish what we already knew and what the NYAG has now confirmed—that our products are pure, safe and fully compliant with applicable regulatory requirements—would have been, at best, counterproductive.”
April 2015: Hits keep coming
Despite the settlement with GNC and the industry fightback, the hits kept coming. Schneiderman and 13 other attorneys general sent a letter to members of Congress requesting an investigation into the herbal supplements industry and asking them to consider expanding the FDA’s enforcement powers over it.
The FDA responded to the investigation during a session at the International Conference on the Science of Botanicals (ICSB) in Oxford, Mississippi, with Cara Welch, PhD, then acting director of the Division of Dietary Supplement Programs at FDA, stating that the agency was supportive of these actions if it led to a more compliant industry.
“We know there is a GMP problem out in the industry, so, in that respect we are very interested in every aspect of cleaning up the industry, whether it is from industry self-regulation, whether that is from the states themselves or whether that is from FDA,” she said at the conference.
Around the same time, the Organic and Natural Health Association made headlines by becoming the industry’s first trade association to meet with the NY Attorney General’s office and used the platform to call for the FDA’s current GMPs (code 21 CFR Part 111) to be expanded to raw material and ingredient manufacturers.
May 2015: DNA barcoding alone not definitive
NPA was the next to make an announcement following a meeting with the NY Attoney General’s office, issuing a joint statement from Schneiderman and the NPA’s Dr. Fabricant that marked the first acknowledgement that DNA barcoding results were not definitive.
“[N]o single test or technology alone can provide complete confidence to consumers, we support the application of DNA barcoding technology as part of a multi-faceted approach to assuring authenticity and identifying substitution,” the statement read.
By the end of May, Schneiderman and Indiana Attorney General Greg Zoeller had penned a letter to Dr. Stephen Ostroff, FDA’s acting commissioner, urging an “overhaul federal oversight of the dietary supplements industry.”
They also took the opportunity to urge the FDA to “swiftly act” on the citizen petition the Organic and Natural Health Association to extend the cGMPs (code 21 CFR Part 111) to raw material manufacturers.
September 2015: Devil’s claw draws spotlight
After a relatively quiet summer, the NY AG gaze shifted back to the herbal supplement sector, sending cease-and-desist letters to 13 companies marketing devil’s claw supplements, claiming the products fraudulently mixed one species of the botanical with a closely related species.
Herbal experts, however, quickly categorized the concerns as a non-issue, noting that using two species interchangeably had long been an officially accepted practice.
AHPA’s Herbs of Commerce, which has been accepted as authoritative by the FDA, lists Harpagophytum procumbens as the only species of “devil’s claw”, however veteran herbalists regard Harpagophytum zeyheri as substantially equivalent and comparable.
“Virtually all of the official herbal medicines made in the European Union are made from a mix of procumbens and zeyheri,” Roy Upton, executive director of the American Herbal Pharmacopoeia (AHP), said at the time.
2016: DNA barcoding debate continues
Just over a year after the investigation launched, GNC released a draft version of its botanical raw materials guidelines. These included specifications pertaining to cultivated botanicals, wild harvested materials and post-harvest processing.
GNC CEO Mike Archbold called the botanical raw material GMPs an “absolutely a great solution for the industry.”
“This ensures we have full traceability of our product from seed to shelf, so that we know what is actually gone on in the industry, where the product has come from,” he said. “We understand everything from the cultivar to the harvesting to the processing to the packaging to the shelf. So, when we say to the consumer that we know that’s in there is in there. We can guarantee the safety, purity, potency and quality of our products.”
Around the same time, the debate about whether DNA barcoding was fit for purpose roared back into focus, with two studies presented at ICSB 2016—one from scientists at the FDA and one from an Australian research consortium—concluding that DNA barcoding by itself was not an adequate method for analyzing botanical dietary supplements.
The NY Attorney General’s office was unmoved, with a spokesperson responding: “Testing using various chemical and genetic methods shows that, far too often, when consumers buy herbal supplements, they’re not getting what they paid for. We believe that DNA barcoding is a critical part of improving the industry’s approach to ensuring identity and avoiding contamination.
“We’re heartened by the responsible voices in the supplements industry who agree—and are beginning to incorporate DNA barcoding as part of their testing protocols.”
Soon after, an expert review by scientists from the National Center for Natural Products Research (NCNPR) at the University of Mississippi, the American Botanical Council, and the University of British Columbia added more nuance to the discussion.
“The manufacturing process of herbal products that involves extensive heat treatment, irradiation, distillation, filtration, UV light exposure and/or supercritical fluid extraction leads to either complete removal of DNA or degradation of DNA into smaller fragments,” it concluded. “Hence, DNA barcoding is not feasible for processed herbal products such as extracts and tinctures in which the DNA is not present at all or highly degraded.”
Even as concerns about the technology’s limitations became clear, the NY Attorney General’s office continued to make DNA barcoding a key condition of settlement. Following earlier agreements with GNC and Nature’s Way, Schneiderman’s office announced that NBTY would adopt DNA barcoding to authenticate its herbal ingredients.
2021-2022: The whistleblower emerges
Many thought the story was over, especially when Schneiderman resigned in 2018 following allegations that he had physically abused at least four women during romantic relationships.
But then Ken Thompson, a former graduate student-turned whistleblower who had co-authored a 2014 paper published in Biodiversity and Conservation with Dr. Steven Newmaster at the University of Guelph came forward, raising doubts about the availability, sources and reproducibility of the data used.
His efforts to shine a light on his concerns were the subject of two articles published in Science in 2021, and the paper, which employed DNA barcoding, was subsequently retracted by the journal in October 2021.
“Post-publication review of the article confirmed concerns with the data availability, and the validity of the data included in the article could not be confirmed,” the retraction notice stated.
This inevitably led to more scrutiny of Dr. Newmaster’s other works, with a storm erupting around the 2013 BMC Medicine paper that had sparked NY Attorney General’s investigation.
An explosive article published in Science detailed allegations of fraud, plagiarism and missing data. According to the article, eight researchers from the University of Guelph, the University of Toronto, the University of British Columbia, and Stanford University submitted a 43-page letter to the University of Guelph calling for the retraction of the 2013 paper, citing significant flaws in the study and two others by Newmaster and his colleagues. In February 2022, The editorial team at BMC Medicine announced that it had launched an investigation.
An internal investigation by the University of Guelph subsequently cleared Dr. Newmaster of misconduct despite “many shortcomings” with his work and “a pattern of poor judgement.” The BMC Medicine editorial team bowed to the findings of the university investigation, announcing in September 2022 that the paper would be allowed stand unchanged.
2024: ‘Flawed science and political egos’
The growing number of whistleblowers, however, would not be silenced. As detailed in an article by investigative journalist Charles Piller in Science, Thompson and seven other accusers appealed to the Secretariat on Responsible Conduct of Research (SRCR), the Canadian federal agency responsible for scientific misconduct, which eventually found Guelph’s initial investigation to be inadequate and ordered the university to launch a new investigation.
The new investigative panel subsequently reported evidence of data fabrication and called for the retraction of the 2013 paper, which was formally announced by the journal’s editor on July 4, 2024. Notably, Dr. Newmaster and three other authors disagreed with the decision, while a fifth author stopped short of endorsing the retraction.
The news was bittersweet for many in the industry. Stefan Gafner, PhD, chief science officer at ABC, called the retraction a “sad day for science”.
“All of us rely on sound data to learn, innovate, assess problems and make decisions,” he said at the time. “If we look at the glass half full, this retraction may motivate us to be more critical when evaluating published papers. If we look at the glass half empty, we may see the eroding trust of the public in scientific data.”
“The publication of the 2013 Newmaster paper using DNA barcoding to identify dietary supplement ingredients had especially far-reaching consequences as it led to the flawed investigation and subsequent regulatory actions by then NY AG Eric Schneiderman.”
The last word should be left for Mike Archbold, who had led GNC from 2014 until he stepped down in the summer of 2016 after two challenging years for the retailer.
“They launched this investigation into GNC and into others, [and] they ignored the scientists who were challenging the testing methods,” he said. “When presented with mountains of data supporting the products that were in question, the Attorney General’s Office remained unrelenting, and at the same time, simultaneously refusing to produce their own results.
“So, it is great to see that the science that started this, ultimately has been withdrawn,” he added. “My big takeaway is flawed science and political egos make for some strange bedfellows.”
