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The Supplement Saga: A Review of the New York Attorney General’s Herbal Supplement Investigation

Editors note:This is a revised and updated version of an article that originally appeared in the March 2015 issue of HerbalEGram.


In early February 2015, New York Attorney General (NY AG) Eric T. Schneiderman initiated an unprecedented legal and public relations campaign against the American herb industry. Details about his first attack on herbal dietary supplements from major retailers GNC, Walgreens, Walmart, and Target emerged at midnight on February 3, when the New York Times reported that Schneiderman sent cease-and-desist letters to the retailers demanding that they remove certain store-brand botanical dietary supplement products from their New York stores.1 The move marked the first time a state law enforcement agency has taken direct action against major supplement retailers for alleged fraud.2

Schneiderman claimed that the supplements were adulterated based solely on the results of a DNA barcoding testing method, which reportedly found unlisted ingredients or a complete lack of the labeled herbs DNA in 79% of the tested products.1 The attorney general-sanctioned test method detected traces of DNA from alleged adulterants, including plants from the Allium (Amaryllidaceae) and Dracaena (Asparagaceae) genera, and potential allergens such as rice (Oryza sativa, Poaceae) and wheat (Triticum aestivum, Poaceae), instead of finding only echinacea (Echinacea spp., Asteraceae), garlic (Allium sativum), ginkgo (Ginkgo biloba, Ginkgoaceae), ginseng (Panax spp., Araliaceae), saw palmetto (Serenoa repens, Arecaceae), St. Johns wort (Hypericum perforatum, Hypericaceae), or valerian (Valeriana officinalis, Caprifoliaceae). In a large number of the tested products, according to Schneidermans office, there was no detectable plant DNA whatsoever.1

The herbal communitys response was swift and critical; trade associations, nonprofits, and others lambasted Schneidermans use of DNA barcoding,3-6 which many experts say is unsuitable for ingredient authentication in finished botanical products, particularly those containing extracts.7,8 The NY AGs herbal supplements investigation, however, was just beginning. Over the next few months, Schneidermans office targeted quality control measures and product manufacturers, formed a coalition of attorneys general in support of his cause, and successfully forced a major supplement company to incorporate DNA barcoding into its standard ingredient testing procedures.9-11 Schneiderman later asked Congress to launch an inquiry into what his office has called a largely unregulated industry.12

As Schneidermans investigation switched focus, so too did the herbal communitys arguments. Emphasizing issues with DNA barcoding, the robustness of current dietary supplement regulations, and numerous industry self-monitoring measures, members of the community referred to the NY AGs actions as an unfounded witch hunt,13 a political grandstand,14 and harassment based on science fiction.15 Although the communitys highly critical reaction may seem familiar to some, it quickly became clear that this situation was different. Not since DSHEA [the Dietary Supplement Health and Education Act of 1994] has there been a single event with the potential to affect how the botanical industry goes about its business, noted Loren Israelsen, president of the United Natural Products Alliance (UNPA), a trade group, in an article from Nutrition Business Journal.14

Schneidermans investigation was turning into the biggest challenge to the industrys credibility since the days of ephedra [Ephedra sinica, Ephedraceae],16-18 and the herbal community was concerned about the potential for significant, long-term damage to its reputation in the minds of legislators, health professionals, and the public.

Initial Reactions to Schneidermans Supplement Investigation

The media frenzy commenced shortly after Mr. Schneidermans announcement. Over the following week, the New York Times featured four articles with familiar supplement-industry criticisms from staff writer Anahad OConnor,19-22 in addition to unfavorable editorials (Herbal Supplements Without Herbs23) and opinion pieces (The Politics of Fraudulent Dietary Supplements24). Herbal supplements were labeled stupid pills that likely contained more dust than active ingredients.

This is ultimately a matter of public health, stated an NY AG spokesperson,25 and when public health is at stake the burden is on [the dietary supplements] industry to prove whats in its products.

The same day the New York Times broke the news, the nonprofit American Botanical Council (ABC) issued a press release stating that the NY AG had misused the DNA barcoding technology, particularly if the supplements contained botanical extracts later confirmed to be the case and that his results were premature.5 At the same time, natural products industry trade organizations3,4,6 issued press releases and email advisories alerting their members to the situation. A telling headline from a February 3 NutraIngredients-USA article,26 which included industry and natural health community leaders first reactions to the news, referred to Schneidermans actions as uninformed and inappropriate.

AGSchneidermans actions against GNC, Walgreens, Walmart, and Target in early February are not the first example of DNA barcoding results being used against herbal supplements. According to the NY AGs February 3 press release,1 he first became interested in the contents, quality, and regulation of herbal dietary supplements after a study on DNA barcoding-based identification of dietary supplement ingredients appeared in the October 2013 issue of BMC Medicine. The paper by lead author Steven Newmaster, PhD, an associate professor of biodiversity genomics at the University of Guelph titled DNA Barcoding Detects Contamination and Substitution in North American Herbal Products28 was one of the first cases of highly publicized negative results based on DNA barcoding of commercial herbal products.

Numerous errors and methodological oversights in the paper by Newmaster et al. brought its results into question and led some organizations, including ABC, to call for its retraction from BMC Medicine.29 ABC, working in conjunction with experts in DNA barcoding and analysis from the University of Mississippis National Center for Natural Products Research (NCNPR) and AuthenTechnologies, published a comprehensive initial critique of the Newmaster et al. paper in the November 2013 issue of HerbalEGram.29

Despite describing an entirely different set of analyses, the authors of the 2013 HerbalEGram article could very well have been writing about the natural product communitys current dilemma with the NY AG. Schneidermans office, citing protocol for ongoing investigations, has refused to release additional details of the recent DNA barcoding results,30 which makes direct comparisons to the Newmaster et al. paper difficult. However, in both cases, DNA barcoding technology was the only analytical method utilized to attempt to determine the identity of the herbal ingredients in the commercial herbal products tested. Questions surrounding the test results have led some, like Council for Responsible Nutrition (CRN) President Steve Mister, to dig deeper into the available data.

[W]e may have overlooked a more fundamental flaw with the test method: the internal inconsistency of the test results that make the very method scientifically unreliable and invalid, wrote Mister in an April 14 article in Natural Products Insider.31 According to Schneidermans letter to GNC, just [t]wenty-two percent of the tests yielded DNA matching the product label. Thus, out of the 120 individual DNA tests performed on the GNC herbal products i.e., one bottle each of the six herbal products purchased from four different stores in New York 26 tests were positive for the DNA of the herb in question, including six positive tests for saw palmetto. Since each product was tested five times, one sample of saw palmetto must have returned both positive and negative results. Mister refers to this calculation as The Rule of Five.31

Can you imagine submitting a study for peer review where a test performed five times sometimes produces a positive response and sometimes not, but claiming that the tests are a definitive measure of the identity of the ingredients? asked Mister.31 [A] reasonable scientist would acknowledge the methodology is unreliable for the purpose it is being used.


n February 11, as the novelty of the NY AGs herbal supplements investigation was beginning to fade and articles on the topic had lost page-one status, the NY AG sent a new round of letters to the same four retailers.32 This time, Schneiderman a Harvard Law School-educated Democrat and the states highest-ranking law enforcement officer33 issued subpoenas for any and all data supporting the structure-function claims of the retailers herbal products a move that some say is a clear overstep of authority.2 Although the companies had already complied with the NY AGs first request and removed the affected supplements from New York stores with Target and Walgreens going further and removing the supplements from stores nationwide34 Schneidermans crusade was not yet finished.

Thus, it was perhaps less surprising when, on February 24, he sent letters to four additional supplement manufacturers (i.e., Natures Way of Lehi, Utah; NBTY of Ronkonkoma, New York; Nutraceutical Corp. of Park City, Utah; and Pharmavite of Mission Hills, California) requiring nine points of detailed information regarding their herbal supplement products.35 The companies were given a deadline of less than a month to comply, and members of the industry were left wondering what might come next. Although the manufacturers were not implicated in the NY AGs initial letters to the four major retailers, the actions against them created a false appearance of wrongdoing nonetheless.

In early March, the New York Times reported that attorneys general from Connecticut, Indiana, and Puerto Rico had pledged their support for NY AG Schneidermans ongoing investigation into herbal supplements.36 Although details were scarce, Schneiderman explained the general goals of the new coalition in a statement: The initiative seeks to enhance transparency and ensure that the herbal supplements industry is taking the steps necessary to validate their marketing claims, including [those related] to authenticity and purity, he said.10 By joining together, and building on the long track record of state attorneys general upholding the rights of consumers, we can go further in investigating this industry and, as needed, in achieving reform.

The day after the AG coalition was reported, a group of four expert scientists published a white paper on DNA barcoding commissioned by four trade associations representing the dietary supplements industry (i.e., the American Herbal Products Association [AHPA], the Consumer Healthcare Products Association [CHPA], CRN, and UNPA). The objective of the paper, according to the authors, is to provide an expert assessment of the capabilities and limitations of DNA barcoding for botanical dietary supplement authentication to inform assessments of the applicability and accuracy of DNA test results.7

On March 17, the Natural Products Association (NPA), another industry trade association, published a separate white paper on DNA barcoding methods for botanical authentication by its CEO, Daniel Fabricant, PhD, and senior vice president of scientific and regulatory affairs, Corey Hilmas, MD, PhD.8 Drs. Fabricant and Hilmas the former director of the US Food and Drug Administration (FDA) Division of Dietary Supplement Programs and the former chief of the FDA Dietary Supplement Regulation Implementation Branch, respectively address some of the specific analytical concerns raised by Schneidermans investigation, as ABC Chief Science Officer Stefan Gafner, PhD, describes in more detail on pages 59-61 of this issue.

Schneiderman and GNC Come to Terms to End Investigation

After two weeks of relative national media silence, the NY AGs investigation of herbal supplements once again made front-page headlines. On March 30, Schneidermans office issued a press release announcing that GNC had agreed to landmark reforms pertaining to its Herbal Plus® product line.11

According to the press release, the terms of the agreement with the NY AG require that GNC perform DNA barcoding on the active plant ingredients used in its products; implement testing for contamination with allergens, both before and after production; and post prominent signage advising consumers of the processed, chemical nature of extracts.11

As Schneidermans office noted, its agreement with GNC is the first in the nation to require testing standards for herbal supplements that exceed current FDA requirements.11

Provided GNC complies with the new standards, the NY AG agreed to stop the investigation into its Herbal Plus supplements and allow the full line of products back in New York stores. However, the specific product lots tested by Schneidermans office remain off store shelves, despite the subsequent testing performed by GNC and acknowledgment by the NY AG that the products were compliant with federal regulations.38 As Schneiderman admitted in his letter to GNC outlining the terms of the agreement, NYAG found no evidence in the course of its investigation that GNC deviated from the federal [FDA] Current Good Manufacturing Practices rules or standard industry practice in the production of the tested supplements.37

GNC explained their decision-making process in a letter to stakeholders.39 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.

In an email to HerbalGram, GNC CEO Mike Archbold noted that the terms of the agreement were in line with the companys history of exceeding current standards in order to ensure high-quality products. The initiatives we have agreed to in the context of this agreement are consistent with that effort, and with the direction in which the industry is moving, he wrote (email, April 30, 2015), and [it] will further expand and strengthen our testing deeper into our supply chain by leading industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and provide consumers with even greater confidence in our products.

Although the agreement applies only to GNC and its Herbal Plus products, both the NY AG and GNC have expressed a hope that other companies will follow suit an outcome Archbold describes as a win-win situation.38,39

As an industry leader, and as part of our commitment to continuous improvement, we will lead the efforts for higher standards, and if our actions lead to broader implementation of more robust practices across the industry, thats good for consumers, good for the industry, and good for GNC, wrote Archbold (email, April 30, 2015).

Supplements Community Responds to GNC Agreement

Members of the natural products community, however, did not describe GNCs deal with the NY AG in such positive terms. In press releases issued the same day as the announcement, industry organizations such as CRN and NPA called the decision a mistake and a 180 degree turn for Schneiderman, respectively.13,40 Others have expressed concerns about the potential repercussions of GNCs adoption of new ingredient testing standards, suggesting that the companys decision may have consequences for the herbal community at large.

The announcement further entrenches a state attorney generals office in a regulatory matter in which it has no expertise and substitutes face-saving requirements for meaningful advancement of the industry, said Steve Mister in a CRN press release after the agreement was publicized.40 Moreover, the agreement gives credence to the New York AGs misguided allegations based on its own DNA barcode testing that legitimate quality concerns existed about the products marketed by four retailers, when there were none.

More consequential, however, is the agreements potential to lead to a patchwork of separate quality standards and requirements for dietary supplements. In a press release, NPA voiced the concern that these actions could lead to each state instituting its own identity testing standards, preempting federal authorities already in place.13 Natural products organizations have repeatedly stressed that existing regulations when adequately enforced by the FDA are sufficient to ensure high-quality dietary supplement products, which therefore makes GNCs new standards redundant.

The New York Attorney Generals investigation and todays agreement with GNC provide clear evidence that current federal regulation of dietary supplement manufacturing is effective, said AHPA President Michael McGuffin on March 30, emphasizing that the investigation found GNCs products to be fully compliant with current Good Manufacturing Practices (cGMPs), which include identity testing.41 DNA testing will add no additional assurance of the correct identification of any herbal ingredient that has already been verified by one or more of the other long-established analytical tools now used by responsible herbal manufacturers. Regulations, requirements and best practices for botanical identification and supplement manufacturing should be based on valid science coupled with qualified expertise and experience.

Although the adoption of specific testing methods by dietary supplement manufacturers is voluntary per the 2007 dietary supplements final rule for cGMPs,42 the regulation requires manufacturers to perform identity testing on every dietary ingredient, every time it is used. The manufacturer has the flexibility to choose which particular type of identity test(s) to use for authentication of each dietary ingredient.43

Companies are supposed to choose reasonable, scientifically valid tests, noted Tod Cooperman, CEO of, in an article from NutraIngredients-USA.44 [N]ot defining these things leave[s] it open for an herbal company, or even the New York AG, to decide for itself in each case what is a reasonable test.

Perhaps what is most concerning, some members of the herbal community have suggested, is that the agreement exalts DNA barcoding a nascent and evolving analytical method over other well-established, scientifically sound analytical methods such as chemical fingerprinting for botanical ingredient testing.

As John Bradley, editor-in-chief of Nutrition Business Journal, explained in an April 2 article, consumers may view the agreement as a vindication for Schneiderman and a legitimization of DNA barcoding as an airtight testing standard. That could have damaging implications for the industry and consumers, because it suggests that things have been fixed now. They havent.45

Reverberations of the agreement are already being felt in the analytical community. In fact, its already begun to cause problems, said Alkemist Labs Elan Sudberg, writing for New Hope 360.46 Suddenly we are receiving requests to perform DNA analysis for our customers. Some are asking if every single reference sample in our herbarium of over 10,000 specimens has been DNA barcoded. Overnight, DNA barcode testing has [the appearance of becoming] the gold standard.

Its the CSI effect I was worried about, where the uninformed quickly flock to the shiniest and newest technique on the block, wrote Sudberg in an email to HerbalGram (May 8, 2015), referring to the popular American television show in which forensic DNA testing frequently helps solves crimes. Yet the average consumer may not realize that, while DNA barcoding has its place in this industry, it cannot assess plant parts (which is legally mandated by the FDAs cGMPs) or quality it can only identify the species. DNA barcoding is not a gold standard; rather, it is just another tool in the orthogonal approach to quality.

GNC Agreement Reignites DNA Barcoding Conversation

Despite the industry backlash against GNCs agreement, the company did not intend to disrupt the landscape of supplement ingredient testing in the United States. As with any compromise, the terms of the agreement were designed to be mutually beneficial and to help resolve an issue. However, from the start, GNC along with many, perhaps most, natural products organizations did not believe there was a problem with the products.

Where NYAG and GNC disagree, Schneiderman wrote in his letter to GNC that outlined the new procedure,37 is on the sufficiency of federal rules and testing requirements and their relationship to state consumer protections laws. The FDA does not mandate the use of DNA-based technologies, like barcoding, to authenticate herbal supplements. Instead, the FDA allows companies to support their claims through other methodologies, including chemical analysis methods, like those employed by GNC, he continued. Given the existence of chemically-similar natural or synthetic substitutes, NYAG is concerned that standard chemical approaches provide inadequate assurance of the authenticity of herbal supplements.

If the inadequacy of standard testing procedures is the problem, then DNA barcoding, Schneiderman suggests, is the solution. Thus, one obvious question remains: does the addition of DNA-based analytical methods guarantee the authenticity of herbal dietary supplements? The answer seems to be a resounding no.

Importantly, DNA barcoding is not currently referenced in any official United States Pharmacopeia (USP) monograph, nor is it used or endorsed by the FDA for botanical ingredient verification.47,48 According to a widely distributed statement from FDAs Center for Food Safety and Applied Nutrition (CFSAN), the Administration is, however, exploring the technology for such purposes. The FDA does not currently use DNA sequencing for dietary supplement ingredient verification, but is actively working toward developing validated methods for plant identification, for use by both industry and the agency, CFSAN stated.48,49 In addition, they noted that the FDA is working on building a library of DNA sequences for plants, but this project is not complete. The agency currently uses chemical markers or fingerprints when it performs ingredient verification.

Standards-setting bodies such as the USP are also considering adopting DNA-based testing methods, but, as they have stated, more work is needed.50 With the appropriate validation, USP may incorporate DNA tests into specific product quality standards, but even then it is envisioned not as stand-alone procedure, but as a complement [a different approach to measure the same outcome otherwise known as an orthogonal method] to existing chromatographic, spectroscopic, and botanical morphological (microscopic/macroscopic) analytical procedures.

DNA testing is a comparatively new technology, explained Sudberg.51 It has the potential to become an important tool in identity testing, particularly when used knowledgably. However, like any test method, in the hands of a technician who does not have a working knowledge of the materials he is dealing with, the results have the potential to be inaccurate.51

For Schneidermans original tests, his office commissioned Clarkson University professor James A. Schulte II, PhD an expert in reptilian biology to test the selected herbal dietary supplements. The DNA barcode analyses were conducted at Beckman Coulter Genomics, a DNA sequencing lab based in Massachusetts.52 Schultes assignment as investigator, however, was met immediately with criticism due to his apparent lack of experience in botanical identity testing.2,5,52 To date, no scientific papers can be found that are authored or co-authored by Prof. Schulte on the subject of genetic testing of plant material or finished botanical dietary supplements.53

However, even if there were a plethora of experts trained in DNA barcoding of botanical ingredients, the analysts would still be lacking an essential tool a complete database of DNA barcodes for herbal ingredients sold in dietary supplements.

Most of the species under investigation by the NY AG cannot be accurately identified without a proprietary database of reference standards, as several of the species under investigationincluding St. Johns wort and Echinaceado not have publically available reference sequences from the genes necessary to identify them, explained the authors of the Reynaud et al. white paper7 in a Nutritional Outlook article from April 2.54 The story detailed Danica Harbaugh Reynauds, PhD, mostly favorable opinion of DNA barcoding. Dr. Reynaud is the CEO of AuthenTechnologies LLC, a contract laboratory that specializes in DNA-based analyses of natural products.55

Reynaud says she is skeptical of how thorough or effective this database could really be in order to achieve complete DNA sequencing data for most commercially used herb species, the article noted.54 She says it would take years and millions of dollars to construct onesomething thats likely well beyond the scope of what GNC has agreed to do.

In other words, as American Herbal Pharmacopoeia (AHP) President Roy Upton told Nutrition Business Journal the same day, The AG cant realistically hold someone to a standard that does not exist.14

Given its intricacies and relative infancy, DNA barcoding is not considered a universally appropriate method for identity testing of finished herbal products, especially without corroboration with at least one other widely recognized scientifically valid method. In particular, the technology is not ideal for detecting plant DNA in dry, liquid, or powdered herbal extracts, as such processes can denature, degrade and destroy DNA.50 Pieter Cohen, MD of Harvard Medical School known as a vocal critic of the supplements industry has acknowledged this point as well.

DNA barcoding looks for a specific fragment of DNA, but the ingredients in herbal supplements are often highly processed crushed, dissolved, filtered and dried so that they may no longer contain the particular fragment of DNA that researchers are searching for, making the supplement appear to be mislabeled, Dr. Cohen was quoted as saying in the New York Observer.56,57 The biological compounds extracted from the plantthe parts that supposedly have healing powerswould be in the supplement without the DNA sought in the tests.

Understanding the shortcomings of DNA barcoding for botanical extracts makes the fact that up to 74% of the products tested by Schneidermans office were extracts even more troubling.13,26 GNC also has stated that all six of its herbal supplement products were extracts and are thus susceptible to inaccurate identification by DNA barcoding.26

However, it seems that this point was not entirely lost on the NY AGs office. The terms of the NY AGs agreement with GNC specify that DNA barcoding will be performed on ingredients prior to extraction. In a subsequent press release, Schneidermans office even adopted new phrasing when referring to the extracts in the dietary supplements his office commissioned to Dr. Schulte for testing. Some products were so thoroughly processed that the genetic material of the original natural plant source was unrecognizable, the release stated.12,37 The fact that such processing is the intentional, established way to produce botanical extracts was not mentioned.

In addition to its limited utility for identifying materials in finished extracts, DNA barcoding has another significant shortcoming. While DNA barcoding is a valid and useful technology, it is qualitative in nature (i.e., it can confirm whether DNA is present or not, but it does not indicate in what quantity the plant material is present), explained USP Director of Dietary Supplements Nandakumara Sarma, PhD, in a USP blog post about the topic.47 Thus, chemical analysis tests should be used to determine the strength of a supplement in a quantitative manner.

However, even when applied to raw herbal materials, DNA barcoding is not enough to satisfy cGMP rules, which require the plant part of each ingredient to be verified and labeled on products.46 Its important to note here that dietary supplements containing botanical ingredients must list the part of the plant used in the final product, Dr. Fabricant explained in a press release from NPA.13 DNA barcoding will not provide useful information as to whether roots, stems, leaves or flowers are used in the supply of the raw material.

Still, many experts and organizations including the most vocal critics of AG Schneidermans actions and members of the natural products community agree that DNA barcoding may eventually become a useful and appropriate analytical tool.

DNA testing poses some unique benefits, USP noted recently.50 Its sensitivity and specificity helps in accurate identification of the botanical species as well as adulterants and contaminants especially in material where the macro-botanical characteristics are no longer present, such as powdered or ground material. However, this same sensitivity can lead to false results and that calls for careful interpretation of the data.

Dr. Reynaud, whose lab currently offers DNA barcoding for certain herbal extracts, has mostly positive things to say about GNCs new testing requirements. I think its a great idea, she told Nutritional Outlook.54 Weve been pushing for that for all of our clients for years. Typically chemical tests are limited in that they are looking for either target molecules or target species and arent as equipped for identifying unexpected adulterants or differentiating between closely related species.

However, as ABCs Blumenthal explained in an ABC press release about GNCs agreement,58 the DNA barcoding of raw plant materials is not enough to guarantee the authenticity of finished herbal products. Since the technology is unable to determine quantities, DNA barcoding conceivably would confirm the presence of the labeled herb even if only a pinch of the genuine substance were added to the tested material. A potentially unscrupulous extractor could still subsequently manipulate the extract in such a way as to create a false sense of value, i.e., adulterate it with other extracts and/or additional unlabeled chemical compounds, natural or synthetic, from other sources, Blumenthal explained.58 DNA testing will not be able to detect such changes in the chemical composition.

Together, the shortcomings of DNA barcoding of botanicals bring into question the utility of the NY AGs landmark reforms for ingredient testing. As Steve Mister concluded in CRNs press release on the subject,40 DNA barcode testing remains a flawed method for across-the-board testing for analyzing the quality of botanical ingredients and finished products.


AG Coalition Asks Congress to Investigate Supplements Industry

Just three days after Schneiderman announced his agreement with GNC, the NY AG issued yet another press release regarding herbal supplements.12 By this time, Schneidermans coalition of state attorneys general had grown to 14 members from just four individuals in mid-March. With the backing of 13 of his colleagues (some experts have questioned whether the NY AG may have been unable to attract more AGs to his group), the NY AG asked Congress to open an investigation into the herbal supplements industry and to consider a more robust oversight role for the FDA.

The letter began with an explanation of some of the concerns reaffirmed by Schneidermans investigation: Many of the products tested were [allegedly] contaminated with allergens, plant species left off the label, or other potentially dangerous substances, or so thoroughly processed that the genetic material of the original natural plant source was unrecognizable or not present at all.12,59

In the letter addressed to chairmen and ranking members of Congressional subcommittees on health and consumer protection, the coalition asked Congress to address issues outlined in five bullet points (see Table 3).

After mentioning a number of examples from journal articles and media reports of adulterated supplements including those found to contain high levels of heavy metals or prescription drugs, as well as supplements labeled as containing black cohosh (Actaea racemosa, Ranunculaceae) that have been associated with cases of liver damage Schneiderman took to criticizing the current regulatory framework.

In FY 2013, FDA inspectors cited two out of every three supplement manufacturers for allegedly violating cGMPs. More than one in five of those citationscalled Form 483sobserved that the manufacturer failed to verify that a finished supplements batch met product specifications as to identity, purity, strength, or composition, he noted in the letter to Congress.59 A similar proportion was cited for failing to employ an appropriate test or examination to verify the identity of a dietary ingredient before incorporating it in the final product.

Speaking to Capital New York, an online news site owned by, a few days later, Schneiderman added that the Administration was able to inspect less than three percent of the manufacturers of herbal supplements according to the most recent data available.60 In the same article, however, he acknowledged that the FDA is understaffed and lacking in resources.

Threatened with a Congressional inquiry of the industry they represent, herbal supplement trade associations responded, immediately dismissing the proposed investigation as unnecessary and a waste of taxpayer money.

As the former head of the FDAs Division of Dietary Supplement Programs, I have seen first-hand how the agency may take swift and forceful action when dietary supplement companies violate federal regulations, noted NPAs Fabricant in a press release.15 The FDA is properly equipped to identify and go after firms that pose a threat to public health. Attorney General Schneidermans claims that the FDA doesnt have ample authority in this area show a complete misunderstanding of the regulatory structure in place to protect consumers and remove products from the market.

GMPs are just one facet of the regulations currently in place to help prevent adulterated products from entering the marketplace. The FDA has an arsenal of options available to ensure compliance: a 483, a Warning Letter, and even injunctive relief, Natural Products Insider noted in an article from late February.61

CRNs Mister, in a press release, noted that the concerns raised about alleged widespread safety issues are not true, based on [the] governments post-market surveillance system which demonstrates relatively few safety issues for these products.62 He added that CRN supports additional FDA resources to promote stronger and swifter enforcement of these existing regulations.

Extending cGMPs to the Botanical Supply Chain

On April 15, the recently formed Organic & Natural Health Association (Organic & Natural), a trade group, met with the NY AGs office to discuss the herbal supplements investigation.63 Karen Howard, CEO and executive director of Organic & Natural, called the meeting encouraging, and the organization presented a regulatory proposal for raw herbal ingredients in a press release the following day.63

Ensuring supply chain integrity must start at the earliest possible point, said Todd Harrison, president of Organic & Natural and an attorney at Venable LLP.63 It would make sense to apply the FDAs current cGMPs (code 21 CFR Part 111) to raw material manufacturers. Not only does it provide flexibility but would also be welcomed by branded ingredient manufactures that are already following cGMPs but are forced to compete with lower quality ingredient manufactures that have minimal, if any, cGMPs.

21 CFR Part 111 the cGMP statute describes the federal requirements for dietary supplement manufacturing, packaging, labeling, and holding processes. Currently, the regulation does not apply to manufacturers of raw ingredients, extracts, or related materials destined for dietary supplements.43 Organic & Natural hopes to extend the reach of Part 111 to these manufacturers and says it is in the process of submitting an FDA citizens petition to that end.

Based on their conversations with the NY AGs office, Howard and Harrison came away from the meeting with added perspective on the industrys response to the investigation. In an article from Natural Products Insider, Harrison said that the NY AGs staff made it clear they were surprised everybody believes this is about testing rather than the quality of the supply chain.64

Members of the natural products community have voiced concerns about the potential drawbacks of focusing primarily on DNA barcoding in the weeks before Organic & Natural and other trade associations, such as NPA and CRN,65 met with the NY AGs staff. The scientific and technical minutiae of the DNA testing argument despite the arguments scientific validity is likely lost on the average consumer, and, apparently, the NY AG as well.

[The NY AGs office] didnt seem to be terribly concerned about the fact that the [DNA barcoding] tests are inconsistent because they got what they wanted, Mister told Natural Products Insider,65 which was a lot of media attention for the Attorney General out of this investigation.

Herbal Community Shifts Focus

When it started to become apparent that the herbal communitys DNA barcoding message was not going to shut down Schneidermans investigation overnight or erase three months of negative media coverage from consumers minds the natural products industry and herbal community were left to decide what to do next. Many believed that a uniform message was essential, but it was unclear as to what that message would be and for whom it would be intended.

The bottom line is that this investigation ultimately raised serious questions about the quality of dietary supplements, explained Frank Jaksch, Jr. in a guest article for San Jose Mercury News.66 In order to regain consumer trust and provide top quality products as promised, the industry must use an attack such as the Attorney Generals as a catalyst for change. The debate should lie in how. What should that change be?

Two notions have received somewhat broad support from members of the herbal supplements community: the need for increased transparency in the supply chain and more robust education efforts for the public and policymakers alike.67,68

Both sides want to ensure consumers are provided the highest quality products possible, and the only way to do that in our opinion is to ensure the integrity of your supply chain, said Harrison.64 We think focusing on testing methodology is missing the point. It is only a tool. It is not the be-all end-all.

But ABCs Mark Blumenthal believes that focusing on both issues is warranted. As the managing organization of the ABC-AHP-NCNPR Botanical Adulterants Program, ABC has been educating and promoting the proposition for over four years that industry members and others must become more aware of the level of adulteration of raw materials and extracts in the botanical supply chain, he said.27 However, as science-based organizations, ABC and its Program partners cannot accept the misuse of DNA barcoding as the sole method to test botanical dietary supplements for their identity and authenticity, particularly when they are made with extracts. Although we consider DNA testing to be another valuable tool in the analytical toolbox, it has its limitations, as others have artfully demonstrated.

Establishing a legal or regulatory agenda, and a public media campaign, based on unreliable and probably inaccurate results from inadequate testing is not scientific and ultimately is not in the public interest, continued Blumenthal. Inasmuch as we want to see improvements where needed in detecting adulterated botanical materials, this should be conducted in a scientifically valid and technically defensible manner.

The trade associations meetings with the NY AG in mid-April signaled that the natural products communitys message was evolving. The focus was moving beyond the science of supplements to politics, seeking to influence state officials who have the clout to not only take enforcement actions against an industry currently under assault but severely damage its credibility.69

Although spreading the word about existing supplement regulations and the benefits of natural products may not shift the balance in favor of the herbal community overnight, organizations such as NPA, CRN, and others believe that they are conversations worth having. Over the past month, CRN has met with a number of state AGs around the country, Mister said in press release,62 and we are gratified that the concerns go away once were given the opportunity to fully explain the issue.

Fighting Back and Looking Forward

It has been more than three months since AG Schneiderman began his herbal supplement investigation. In that time, his office issued five press releases on the topic, and industry and community groups have responded with many more of their own. Although the natural products community is well acquainted with negative media coverage surrounding allegedly adulterated supplements, there seems to be a general consensus that these events are industry changing.

In my experience over 41 years in the herbal community, this is the biggest issue that has been on the table, Blumenthal told Nutritional Outlook.70 In the same article, Mister shared a similar concern: This is a paradigm-changing moment in terms of the way consumers [feel] about the industry, he said.

For almost three months, NY AG Schneiderman was unrelenting in his actions against members of the herbal supplements community. Each time Schneiderman switched his focus from herbal supplement quality and structure-function claims to the misleading nature of extracts and the federal regulatory framework the industry fought back. In the end, the natural products community and AG Schneiderman may share a common goal the assurance of safe, high-quality, and authentic botanical supplements for consumers. The difference lies in the best way to achieve that goal.

Every time something happens, the industry wants to fight or rebut, Jaksch noted in a recent Natural Products Insider article.65 Maybe it is time to consider a different tactic, as whatever is being done now does not seem to be working. I am not saying that I support the NY AGs actions, but perhaps it might [be] better to join him, and try and figure out a way to compromise.

Already, there have been hints of compromise. Schneiderman agreed to stop its investigation into GNCs products in exchange for the companys adopting a new albeit controversial DNA-based testing standard for raw ingredients. In April, multiple trade associations met separately with the NY AGs office to discuss the investigation, which led to frank conversations and at least one quality control proposal. Additionally, industry groups and others have made it clear that they support increased resources for the FDA to enhance its ability to enforce existing regulations.

More recently, the NY AGs office issued a joint statement with NPA in perhaps what is the clearest sign of compromise yet.71 In a May 11 press release about the development, the NY AGs office acknowledged its shared goals with NPA to provide authentic, pure, and fully compliant herbal supplements for consumers; Schneiderman also acknowledged one of the industrys main criticisms about using DNA barcoding as the sole test method to authenticate botanical ingredients.

While no 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, Fabricant and Schneiderman noted in the joint statement.71 This includes testing herbal/botanical ingredients prior to extraction in circumstances where [a] DNA Barcode is available for the relevant species. We view this dialogue as a positive step in resolving our differences and we are hopeful that we can work in collaboration to enhance confidence and safe access for consumers.

In the meantime, the herbal community has adopted a mantra of transparency, integrity, and education a message that is more likely to resonate with consumers than debating the intricacies of botanical genetic analyses. There are still many unknowns in the NY AGs unexpected and aggressive investigation into herbal supplements, but one thing is clear the natural products community has been dealt a serious blow.

However this shakes out, wrote Sudberg in an article for NewHope36051 just two days after Schneidermans original announcement, and even if the results of this well-publicized testing are ultimately discredited, the damage is done in the minds of consumers, and quite possibly in the minds of Congress.


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2.        Goldman E. NY Attorney General assails herbal medicine. Holistic Primary Care. February 26, 2015;16(1). Available at: Accessed May 12, 2015.

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