FWD 2 A Review of the New York Attorney General’s Recent Actions Against Herbal Dietary Supplements

HerbalEGram: Volume 12, Issue 3, March 2015

A Review of the New York Attorney General's Recent Actions against Herbal Dietary Supplements

NY Attorney General Forces Four Major US Retailers to Stop Selling Store-Brand Herbal Supplements, Subpoenas Testing Data, and Sends Letters to Additional Manufacturers

Natural Products Experts Issue Swift and Critical Response Focusing on AG’s Inappropriate Use of a Sole Testing DNA Method and Emphasizing Existing Analytical Methods and Regulatory Framework for Dietary Supplements

On February 2, four major US retailers were sent cease-and-desist letters demanding that they remove certain herbal dietary supplement products from their New York stores.1 The sender, however, was not a representative of one the federal agencies that oversees dietary supplements such as the US Food and Drug Administration (FDA) or the Federal Trade Commission (FTC); rather, the letters were issued by an unexpected party: New York State Attorney General Eric T. Schneiderman.

Store-brand herbal supplements from GNC, Target, Walgreens, and Walmart were deemed adulterated based solely on the results of a DNA barcoding analysis, which revealed the presence of unlisted ingredients — or a complete lack of the labeled herbs’ DNA — in 79% of the tested products.1 Instead of finding only ginkgo (Ginkgo biloba), St. John’s wort (Hypericum perforatum), ginseng (Panax spp.), garlic (Allium sativa), echinacea (Echinacea spp.), valerian (Valeriana officinalis), or saw palmetto (Serenoa repens) in the supplements, the attorney general-commissioned analyses found traces of potential allergens such as rice (Oryza sativa) and wheat (Triticum aestivum), and DNA from alleged adulterants, e.g., the onion (Allium spp.) or dracaena (Dracaena spp.) genera. In a large number of the tested products, according to Schneiderman’s office, there was no detectable DNA from any plant species whatsoever.1


Media Response to Ongoing Developments

Predictably, on February 3, many major American news outlets ran articles about Schneiderman’s findings and actions, and the media frenzy commenced. Over the following week, the New York Times featured four articles with familiar supplement-industry criticisms from staff writer Anahad O’Connor*,2-5 in addition to unfavorable editorials (“Herbal Supplements Without Herbs”6) and opinion pieces (“The Politics of Fraudulent Dietary Supplements”7). Herbal supplements were labeled “stupid pills” that likely contained more dust than active ingredients, sold in an allegedly unregulated market ripe with fraud and adulteration.

“The fact is virtually every product we tested includes ingredients not listed on the packaging, and close to 80 percent failed to show any evidence that they included even trace amounts of what was advertised,” noted a spokesperson for the New York Attorney General.8 “This is ultimately a matter of public health, and when public health is at stake the burden is on this largely unregulated industry to prove what’s in its products.”

Less than 24 hours after the New York Times broke the news online, the nonprofit American Botanical Council issued a press release stating that the New York Attorney General had misused the DNA barcode technology and that its results were “premature.”9 At the same time, natural products industry trade organizations10-12 issued press releases and email advisories alerting their members to the situation. A telling headline from a February 3 NutraIngredients-USA article,13 which included industry and natural health community leaders’ first reactions to the news, referred to Schneiderman’s actions as “uninformed,” “inappropriate,” and “premature.” As discussed later in this article, the industry’s and wider community’s initial response focused on the attorney general’s sole reliance on DNA barcoding, the method’s applicability to herbal extracts (See “Experts Question” section), and the existing regulatory framework for dietary supplements (See “Emphasizing Regulation” section).

Journalist Mary Esch described some of these primary concerns in a February 8 Associated Press article on DNA barcoding.14 “[I]ndustry groups and some independent experts say DNA testing alone is inadequate for analyzing botanical products that have gone through a lot of processing from leaf to tablet,” she wrote, later quoting American Botanical Council (ABC) Founder and Executive Director Mark Blumenthal, United Natural Product Alliance’s (UNPA) Loren Israelsen, Harvard’s Pieter Cohen, MD, and United States Pharmacopeia (USP) Director of Dietary Supplements Nandukumara Sarma, PhD — all of whom had raised significant scientific and technical concerns with the AG’s reliance on only one analytical method, which has been shown to be highly problematic and unreliable with the testing of botanical extracts.

On February 11, as the novelty of the issue was beginning to fade and articles on the topic had lost page-one status, the New York Attorney General sent a new round of letters to the same four retailers.15 This time, Schneiderman — a Harvard Law School-educated Democrat and the state’s highest-ranking law enforcement officer16 — issued subpoenas for any and all data supporting the “structure-function” claims of the retailers’ herbal products. Although the retailers had already complied with the AG’s first request and removed the affected supplements from New York stores — with Target and Walgreens going further and removing the supplements from stores nationwide15 — Schneiderman’s mission, it seems, was not yet finished.

Thus, it was perhaps less surprising when, on February 24, he sent letters to four additional supplement manufacturers (i.e., Nature’s 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. The companies were given a deadline of March 13 to comply,17 and members of the industry were left wondering what might come next. These four companies were not openly implicated in the AG’s initial actions against the four major retailers, but the actions against them created a sense of wrongdoing even though there was none cited in the AG’s letters.

Most recently, on March 9, the New York Times reported that attorneys general from Connecticut, Indiana, and Puerto Rico had pledged their support for New York Attorney General Eric Schneiderman’s ongoing investigation into herbal supplements.18 Although details are 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.19  “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 announced the publication a white paper20 commissioned by four trade associations representing the dietary supplements industry (i.e., the American Herbal Products Association [AHPA], the Consumer Healthcare Products Association [CHPA], the Council for Responsible Nutrition [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.”20 The 13-page document also includes a specific “critique of the DNA testing methods used in a recent investigation of botanical dietary supplements by the New York Attorney General’s Office.”


Investigation Prompted by 2013 Canadian DNA Barcoding Study

According to the New York attorney general’s February 3 press release,1 Schneiderman 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.21 The paper by lead author Steven Newmaster, PhD, an associate professor of biodiversity genomics at the University of Guelph22 — titled “DNA barcoding detects contamination and substitution in North American herbal products”21 — was one of the first cases of highly publicized negative results based on DNA barcoding of herbal products.

Numerous errors and methodological oversights in the paper by Newmaster et al. brought its results into question and led some organizations, such as the American Botanical Council, to call for its retraction from BMC Medicine.23 ABC, working in conjunction with experts in DNA barcoding and analysis from the University of Mississippi’s National Center for Natural Products Research (NCNPR) and AuthenTechnologies, published a comprehensive critique of the Newmaster paper in the November 2013 issue of HerbalEGram.23

“Ironically, readers of the [Newmaster] article can draw two opposing conclusions from this paper, neither of which is correct,” noted the authors of the HerbalEGram article in their conclusion.23 “First, herbal critics will look at the paper and see confirmation of their preconceived notions about the lack of competence of the herbal industry. On the other hand, herbal advocates will use the authors’ indifference to established practice, the extant peer-reviewed literature, and the current state-of-the-art herbal quality assurance processes to dismiss this paper and to pretend that quality issues do not exist.”23

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 community’s current dilemma with the New York attorney general’s DNA barcoding of major store-brand herbal supplements.

Schneiderman’s office, citing protocol for ongoing investigations, has refused to release additional details of the recent DNA barcoding results,24 which makes direct comparisons to the Newmaster et al. paper difficult. However, in both cases, DNA barcode technology was the only analytical method utilized to attempt to determine the identity of the herbal ingredients in the commercial herbal products tested. There were no additional tests performed in either study; i.e., other analytical methods were not employed to corroborate the results from the DNA testing. Prof. Newmaster subsequently acknowledged to Blumenthal that the use of additional analytical methods — particularly those described in officially recognized pharmacopeial monographs (e.g., those published by the United States Pharmacopeia) — would have been preferred as a means to corroborate the DNA results, but his research budget did not allow for such tests. Consequently, he published his negative findings based on his DNA barcode analysis without the ability to internally confirm his results.

Despite these issues, many major news outlets at the time used the results of Newmaster’s uncontrolled study to vilify herbal dietary supplements, but the natural product community’s experience navigating the media furor in some ways primed the community for a more deliberate response to negative DNA barcoding-based findings in the future.

Although the natural products community’s reaction to the negative media coverage in February may seem familiar to some, the New York Attorney General’s actions are unprecedented, marking “the first time a state law enforcement agency has taken direct action against major supplement retailers for alleged fraud.”25

“The involvement of major retailers has the power to finally prompt the dietary supplement industry to take the needed steps to earn the lasting trust of consumers,” noted Frank L. Jaksch Jr., CEO of ChromaDex — a California-based natural products company specializing in phytochemical analysis — in an article for the San Jose Mercury News.26 “As the investigation invades headlines across the nation, rather than firing back, the industry should use this opportunity to improve.”26

Still, industry members have expressed concerns over long-term damage to the reputation of herbal supplements in the minds of legislators, health professionals, and the public. “However this shakes out,” wrote Elan Sudberg, CEO of Alkemist Labs, in a February 5 article for NewHope360,27 “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.”


Trade Organizations Launch Grassroots, Social Media, and Education Campaigns

In the days and weeks following the attorney general’s original cease-and-desist letters to the four major retailers, industry members distributed press releases and letters to the editors of major newspapers, scheduled industry-wide conference calls to discuss new developments, and created new educational resources and social networking campaigns to help address questions from the public and media outlets.

Israelsen, of UNPA, based in Salt Lake City, Utah, jump-started one such effort, emailing a plan of action to his UNPA colleagues less than 12 hours after the New York Times published the first articles on Schneiderman’s supplement investigation.

“Our first reaction was that the test results were so uncharacteristic of what we would expect and because they only used the DNA barcode testing, we felt it was important and urgent to secure samples of the same lot numbers of products in order to be able to test those lots with highly regarded, highly competent laboratories with deep expertise in these class of products,” Israelsen was quoted as saying in an article from Natural Products Insider.28

The response to Israelsen’s request was robust, and UNPA currently is in the process of testing the various herbal supplement lots, with results expected sometime in March.25 “We received over 20 boxes of samples, and we have established a highly secure chain of custody,” Israelsen told Holistic Primary Care.25 “We have two staffers inputting each sample received in preparation to send to independent labs to test for ID and conformance with the supplement facts panel. So far, we seem to be on track to have nearly 100% of all the affected lots.”

Israelsen later clarified that UNPA received 486 separate products purchased in retail stores of three of the companies that were sent the cease-and-desist letters. (After the news broke, Walgreens’ checkout system prevented clerks from selling the products in question, making their acquisition difficult, if not impossible.25)

Approximately one week later, CRN and the Natural Products Association (NPA) had launched a so-called “microsite”29 — created specifically to serve as consumer-friendly information hub — and a social media campaign,30 respectively. Shortly thereafter, AHPA created an online resource with six specific talking points to help industry members accurately communicate the main concerns with Schneiderman’s actions to media.31 CRN’s site consists of a simple home page with four options, allowing visitors to find selected expert opinions, an infographic on DNA barcoding, a list of CRN press releases on the topic, and a “Consumer Q&A.” NPA’s website is more action-oriented and features an overview of the situation and urges readers to email, call, or tweet their concerns directly to Schneiderman.

Less than two weeks after the social portal was launched, NPA noted in a press release32 that thousands of individual communications had been sent to the New York Attorney General through its social media campaign, with the number increasing daily. “This industry has a long and successful history of affecting change at the grassroots level when threats arise,” noted NPA CEO Daniel Fabricant, PhD in the release,32 “which is why it was so important for NPA to organize this campaign and give consumers, retailers, manufacturers and all interested parties the opportunity to stand up and speak out in response to Attorney General Schneiderman’s actions against dietary supplements.”


Experts Question Use of DNA Barcoding on Finished Herbal Products, Including Extracts

Despite the unexpected and escalating nature of the attorney general’s actions against herbal supplement retailers and manufacturers in February, the natural products community’s response could be considered prompt, critical, and largely uniform in message, primarily focusing on concerns with DNA barcoding of botanical extracts.

“DNA testing is a comparatively new technology,” noted Alkemist Labs’ Elan Sudberg.27 “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.”27

Schneiderman’s 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.33 Schulte’s assignment as investigator, however, was met immediately with criticism due to his lack of experience in botanical identity testing.9,25,33 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 and/or finished botanical dietary supplements.

According to the Consortium for the Barcode of Life, an international initiative to catalog DNA sequences of the world’s plant and animal species,34DNA barcoding is a technique for characterizing species of organisms using a short DNA sequence from a standard and agreed-upon position in the genome. DNA barcode sequences are very short relative to the entire genome and they can be obtained reasonably quickly and cheaply.”34

To find a match, researchers compare DNA collected from the species being analyzed to one of the main barcode data repositories, e.g., the Barcode of Life Database (BOLD), the National Center for Biotechnology Information (NCBI) GenBank, or the Medicinal Materials DNA Barcode Database (MMDBD).34

The method is an extremely sensitive tool that can detect unimaginably small quantities of “contaminants,” which must be taken into account when interpreting results. CRN, the American Herbal Pharmacopoeia (AHP), UNPA, AHPA, and the Consumer Healthcare Products Association highlighted some of these concerns in a February 23 joint statement35 on the attorney general’s actions:

“Some manufacturers permissibly use such ingredients as rice bran as ‘flowing agents’ or other excipients in their products and label them appropriately. However, in the case of trace amounts of other botanical material, there are well-established legal thresholds that allow for trace amounts of some ingredients that are not considered harmful or required on labels,” the statement noted.35 “Separate allergen labeling regulations from the FDA identify the top eight allergens and require labeling statements to indicate the presence of such allergens unless a permissible threshold has been set. Dietary supplements are subject to these same allergen rules mandated for all foods and are tested for the presence of possible allergens.”29

According to the USP, herbal raw materials used in dietary supplements may contain no more than 2% of “foreign organic matter;36 such an allowance is based on the recognition that botanicals are agricultural products and are thus subject to minor contamination with other plants growing in agricultural settings.

Given its intricacies and relative infancy, DNA barcoding is not considered a universally appropriate method for identity testing of finished herbal products, especially extracts. In particular, the technology is not suitable for detecting plant DNA in dry, liquid, or powdered herbal extracts.29 Known more commonly as a vocal critic of the supplements industry, Dr. Pieter Cohen of Harvard Medical School has sided with the industry and other community experts on this particular issue.

“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 Observer.37 “The biological compounds extracted from the plant—the parts that supposedly have healing powers—would 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 an estimated 74% of the tested products were extracts even more troubling.13 GNC also has stated that all six of its herbal supplement products were extracts and are thus susceptible to inaccurate identification by DNA barcoding.13 From the beginning, GNC denied the accuracy and validity of the attorney general’s results and has complied with all of Schneiderman’s requests for information. Furthermore, the company commissioned an independent third-party laboratory to conduct four rounds of additional testing on its Herbal Plus supplements at various stages of processing, each time, according a GNC release, confirming their purity and compliance with federal standards.38

In addition to its limited utility for identifying materials in highly processed herbal dietary supplements, 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 Dr. Nandukumara Sarma in a USP blog post about the topic.39 “Thus, chemical analysis tests should be used to determine the strength of a supplement in a quantitative manner.”39

More often than not, botanical raw materials destined for finished dietary supplements will be exposed to multiple different types of analytical tests depending on where it is in the supply chain and its level of processing.12 As AHP’s Roy Upton explained in an extensive letter with attachments that he sent to Schneiderman: “Once the source plant is extracted and DNA is no longer present, other technologies are needed to determine the IDENTITY of the ingredient. Additional tests may be needed to determine the POTENCY of the finished product. Still different tests are needed to determine the PURITY of products in order to determine if ‘contaminations’ are in fact present.”12

As such, DNA barcoding is not currently referenced in any official USP monograph, nor is it used by the FDA for ingredient verification.39,40 However, according to a widely distributed statement from FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the Administration is using the technology for other 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 in the email.40 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.”40

In his correspondence to the attorney general, AHP’s Upton recommended using botanical analytical methods featured in “national and international guidelines for determining the identity, quality, and purity of these products and experienced labs that can conduct the tests.”12 His four-page letter with 54 pages of attachments includes a list of such respected guidelines and examples of “appropriate monographs for each of the botanicals tested.”12


Emphasizing Regulation through Existing Framework

Although detailed botanical monographs exist for each of the seven herbs involved in the New York Attorney General’s investigation, the adoption of such testing standards by dietary supplement manufacturers is voluntary per the 2007 dietary supplements final rule for current good manufacturing practices (cGMPs).41 The cGMPs require manufacturers to “perform identity testing on every dietary ingredient, every time it is used.” The manufacturer has the option to choose which particular type of identity test(s) to use for authentication of each dietary ingredient.40

“Even with the advent of GMPs, people outside the industry are often surprised to find that they don’t include specific standards for how you test specific products,” Tod Cooperman, CEO of ConsumerLabs.org, told NutraIngredients-USA.42 “Companies are supposed to choose reasonable, scientifically valid tests. But not 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.”

The 2007 final rule and cGMPs are just one facet of the regulations currently in place to help prevent adulterated products from entering the marketplace. Natural Products Insider noted other important examples of federal protections in a February 27 article:43 “The FDA enforces DSHEA, which regulates the manufacturing and distribution of dietary supplements, [and] cGMPs, which require manufacturers to perform identity testing on incoming materials and finished product testing to ensure identity, purity, strength, and composition,” the article noted.43 “The FDA has an arsenal of options available to ensure compliance: a 483, a Warning Letter, and even injunctive relief.”

When Schneiderman subpoenaed supporting evidence from GNC, Target, Walgreens, and Walmart for their products’ structure-function claims on February 13 — “a move that some say is a clear overstep of authority”25 the members of the industry and others in the natural products community were left perplexed once again.

“There are already federal laws and statutes in place to require dietary supplement firms to only make claims that are truthful and not misleading; obtain competent and reliable scientific evidence for claim substantiation; and file a 30-day structure/function notification for each claim that they make for dietary supplement products,” explained NPA’s Fabricant in an NPA press release.44 “The New York attorney general should be inquiring about this information with the Food and Drug Administration, as the agency should already have this information at hand.”44

The author of a recent Natural Products Insider article expressed similar concerns, but with stronger hints of frustration and skepticism. “Why is Schneiderman using resources and taxpayer dollars to investigate something squarely within the expertise and jurisdiction of the Food and Drug Administration (FDA)?” the author asked.43 “Political gain and publicity? Likely.”


Self-Reflection & Future Responses

New York Attorney General Eric Schneiderman’s selection of major US retailers’ store-brand herbal supplements (of seven relatively well-known herbs) seems to suggest that he was going after the widest possible audience. Still, consumers and industry experts alike sometimes wonder how such lower-cost house brands and generic brands can match the purity and quality of other well-known nationally branded supplements.

There are still many unknowns in the attorney general’s unexpected and aggressive investigation into herbal supplements that began in early February. Faced with a lack of essential details regarding Schneiderman’s testing procedures, motivation, or goals, many in the dietary supplement industry have started asking questions regarding the commitment of some companies to high quality ingredients and products.

As Frank Jaksch explained to the San Jose Mercury News,26 “The bottom line is that this investigation ultimately raised serious questions about the quality of dietary supplements. In order to regain consumer trust and provide top quality products as promised, the industry must use an attack such as the attorney general’s as a catalyst for change,” he wrote.26 “The debate should lie in how. What should that change be?”

At least one proposal seems to have consistent support from natural products-related organizations, including nonprofits, industry trade groups, analytical labs, and others:27,45 the need for increased transparency in all areas of the supply chain. Ideally, increased transparency would help the industry take a more proactive approach to inevitable negative press.

“If anything, this latest and in some ways most damaging round of negative media coverage based upon what my colleagues and I believe will ultimately be shown to be flawed science underscores the need for testing transparency,” Sudberg wrote.27 “Companies can no longer afford to just say their products are tested; they are going to have to start revealing where they are tested, by what methods and why.”21

While advocating for these higher standards, representatives in the industry and other relevant herb-focused organizations should remember to keep their message simple. In the case of the recent New York attorney general investigation, it may be safe to presume that the minutia of barcoding analyses — despite the validity of the point — will be lost on the average consumer.

“I just don’t think that’s the kind of storyline that will resonate with our consumers,” noted Steve Mister, CRN president and CEO, in a recent Nutritional Outlook article.46 “For the most part, consumers don’t want to have to determine between DNA analysis and chemical analysis. They want to trust the brands that they buy.”46


*New York Times staff writer Anahad O’Connor has covered major herbal supplement-related news developments in the past, including the highly problematic 2013 Newmaster et al. study16 alleging widespread adulteration.


—Tyler Smith


References

1. A.G. Schneiderman Asks Major Retailers To Halt Sales Of Certain Herbal Supplements As DNA Tests Fail To Detect Plant Materials Listed On Majority Of Products Tested [press release]. Albany, NY: New York State Attorney General’s Office; February 2, 2015. Available at: www.ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests. Accessed February 24, 2015.

2. O’Connor A. New York Attorney General Targets Supplements at Major Retailers. New York Times. February 3, 2015. Available at: http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/. Accessed February 24, 2015.

3. O’Connor A. What’s in Those Supplements? New York Times. February 3, 2015. Available at: http://well.blogs.nytimes.com/2015/02/03/sidebar-whats-in-those-supplements/. Accessed February 20, 2015.

4. O’Connor A. Chains Pull Dietary Aids Off Shelves After Inquiry. New York Times. February 12, 2015. Available at: http://well.blogs.nytimes.com/2015/02/12/chains-pull-dietary-aids-off-shelves-after-inquiry/. Accessed February 24, 2015.

5. O’Connor A. Knowing What’s in Your Supplements. New York Times. February 12, 2015. Available at: http://well.blogs.nytimes.com/2015/02/12/107141/. Accessed February 17, 2015.

6. New York Times Editorial Board. Herbal Supplements Without the Herbs. New York Times. February 7, 2015. Available at: www.nytimes.com/2015/02/07/opinion/herbal-supplements-without-herbs.html. Accessed March 2, 2015.

7. Egan T. Stupid Pills: The Politics of Fraudulent Dietary Supplements. New York Times. February 6, 2015. Available at: www.nytimes.com/2015/02/06/opinion/the-politics-of-fraudulent-dietary-supplements.html. Accessed March 3, 2015.

8. O’Keefe M. Supplement experts: AG Eric Schneiderman is blinded by bad science. New York Daily News. February 4, 2015. Available at: www.nydailynews.com/blogs/iteam/supplement-insiders-schneiderman-blinded-flawed-data-blog-entry-1.2103537. Accessed March 3, 2015.

9. ABC Says New York Attorney General Misused DNA Testing for Herbal Supplements, Should Also Have Used Other Test Methods as Controls [press release]. Austin, TX: American Botanical Council; February 3, 2015. Available at: http://cms.herbalgram.org/press/2015/ABCSaysNYAttyMisusedDNA.html. Accessed March 6, 2015.

10. New York Attorney General’s allegations based on inadequate testing of herbal supplements [press release]. Silver Spring, MD: American Herbal Products Association; February 3, 2015. Available at: www.ahpa.org/Default.aspx?tabid=505. Accessed March 3, 2015.

11. CRN Criticizes New York State Attorney General ‘Sting’ on Herbal Dietary Supplements As Uninformed, Reckless and Inexcusable [press release]. Washington, DC: Council for Responsible Nutrition; February 3, 2015. Available at: www.crnusa.org/CRNPR15-CRNCriticizesNYAGHerbal020315.html. Accessed March 3, 2015.

12. Upton R. American Herbal Pharmacopoeia Responds to New York Attorney General with Extensive Analytical Data on testing for Botanical Adulteration [press release]. Scotts Valley, CA: American Herbal Pharmacopeia; February 6, 2015. Available at: www.herbal-ahp.org/documents/newsroom/NY%20AG%20Response%202.pdf. Accessed March 6, 2015.

13. Daniells S. ‘Uninformed’, ‘inappropriate’ and ‘premature’: Industry experts round on NY AG’s action against major retailers over failed DNA tests for herbal supplements. NutraIngredients-USA website. Available at: www.nutraingredients-usa.com/Research/NY-AG-takes-on-GNC-Walgreens-Walmart-Target-on-herbal-supplements. Accessed March 9, 2015.

14. Esch M. Supplements industry derides NY attorney general’s DNA tests. Associated Press. February 10, 2015. Seattle Post-Intelligencer website. Available at: www.seattlepi.com/news/medical/article/Supplements-industry-derides-NY-attorney-6069689.php. Accessed March 9, 2015.

15. Edwards L. Herbal horrors: Tennessee and Alabama won’t say if they’re pulling herbal supplements. Chattanooga Free Press. February 19, 2015. Available at: www.timesfreepress.com/news/life/entertainment/story/2015/feb/19/herbal-horrors/288816/. Accessed March 9, 2015.

16. About the Attorney General. New York State Attorney General website. Available at: www.ag.ny.gov/about-attorney-general. Accessed March 10, 2015.

17. Daniells S. NBTY, Pharmavite, Nature’s Way and Nutraceutical Corp. pulled into NY AG’s probe. NutraIngredients-USA website. Available at: www.nutraingredients-usa.com/Trends/NY-Attorney-General-actions/NBTY-Pharmavite-Nature-s-Way-and-Nutraceutical-Corp.-pulled-into-NY-AG-s-probe. Accessed March 3, 2015.

18. O’Connor A. Safety of Herbal Supplements Pulls Prosecutors Together. New York Times. March 9, 2015. Available at: http://well.blogs.nytimes.com/2015/03/09/safety-of-herbal-supplements-pulls-prosecutors-together/?ref=health&_r=0. Accessed March 11, 2015.

19. Daniells S. AGs from Connecticut, Indiana, and Puerto Rico join NY AG as probe expands. NutraIngredients-USA website. Available at: www.nutraingredients-usa.com/Regulation/AGs-from-Connecticut-Indiana-and-Puerto-Rico-join-NY-AG-as-probe-expands. Accessed March 11, 2015.

20. Reynaud DT, Mishler BD, Neal-Kababick J, Brown PN. The Capabilities and Limitations of DNA Barcoding of Botanical Dietary Supplements [white paper]. Richmond, CA: AuthenTechnologies; March 2015. Available at: https://gallery.mailchimp.com/2d47ec72fa1542de734a46f71/files/Reynaud_DNA_Barcoding_White_Paper.pdf. Accessed March 12, 2015.

21. Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution. BMC Medicine. 2013;11:222. Available at: www.biomedcentral.com/1741-7015/11/222. Accessed March 9, 2015.

22. Dr. Steven Newmaster. University of Guelph Department of Integrative Biology website. Available at: www.uoguelph.ca/ib/people/faculty/newmast.shtml. Accessed March 11, 2015.

23. Gafner S, Blumenthal B, Reynaud DH, Foster S, Techen N. ABC Review and Critique of the Research Article “DNA Barcoding Detects Contamination and Substitution In North American Herbal Products” by Newmaster et al. HerbalEGram. November 2013;10:11. Available at: http://cms.herbalgram.org/heg/volume10/11November/DNAbarcodingReviewandCritique.html. Accessed March 9, 2015.

24. Daniells S. NY Office of the Attorney General: ‘We will not be publishing the data for peer review. This is part of an ongoing investigation’. NutraIngredients-USA website. Available at: www.nutraingredients-usa.com/Regulation/NY-Office-of-the-Attorney-General-We-will-not-be-publishing-the-data-for-peer-review.-This-is-part-of-an-ongoing-investigation. Accessed March 3, 2015.

25. Goldman E. NY Attorney General Assails Herbal Medicine. Holistic Primary Care. February 26, 2015. Available at: www.holisticprimarycare.net/latest-articles/12-herbal-medicine/1679-ny-attorney-general-assails-herbal-medicine.html. Accessed March 9, 2015.

26. Jaksch FL. Frank L. Jaksch, Jr.: Regaining Trust in the Dietary Supplements Industry. San Jose Mercury News. February 19, 2015. Available at: www.mercurynews.com/opinion/ci_27558592/frank-l-jaksch-jr-regaining-trust-supplements. Accessed March 9, 2015.

27. Sudberg E. Next steps for the supplement industry? More transparency around testing. NewHope360 website. Available at: http://newhope360.com/idea-xchange/next-steps-supplement-industry-more-transparency-around-testing. Accessed March 3, 2015.

28. Long J. Supplement Industry to Test Botanical Products at Heart of NY AG Probe. Natural Products Insider. February 7, 2015. Available at: www.naturalproductsinsider.com/Blogs/Supplement-Law/2015/02/Supplement-Industry-to-Test-Botanical-Products-at.aspx. Accessed February 20, 2015.

29. CRN Responds to NY Attorney General Actions Against Herbal Supplements. Council for Responsible Nutrition USA website. Available at: www.crnusa.org/NYAG/. Accessed March 3, 2015.

30. Protect Consumer Access to Supplements: Tell New York Attorney General to Release DNA Study Data. Natural Products Association website. Available at: http://cqrcengage.com/nnfa/app/write-a-letter?0&engagementId=77689. Accessed February 24, 2015.

31. Correcting the Record: Addressing the New York Attorney General. American Herbal Products Association website. Available at: www.ahpa.org/Default.aspx?tabid=507. Accessed March 12, 2015.

32. NPA Grassroots Campaign in the Thousands [press release]. Washington, DC: Natural Products Association; February 18, 2015. Available at: www.npainfo.org/NPA/NewsRoom/News_Releases_2015/NPA_Grassroots_Campaign_in_the_Thousands.aspx. Accessed February 20, 2015.

33. Twilly N. How Not to Test Dietary Supplements. The New Yorker. February 10, 2015. Available at: www.newyorker.com/tech/elements/dna-barcoding-new-york-dietary-supplement. Accessed March 9, 2015.

34. Techen N, Parveen I, Pan Z, Khan IA. DNA barcoding of medicinal plant material for identification. Curr Opin Biotechnol. 2014;25:103-110. Available at: www.sciencedirect.com/science/article/pii/S0958166913006721. Accessed March 11, 2015.

35. New York Attorney General Questions Certain Herbal Dietary Supplements – But Scientists, Experts Say the AG Used the Wrong Test [press release]. Washington, DC: Consumer Healthcare Products Agency; February 27, 2015. Available at: www.chpa.org/DSJointIndustryWhitePaper.aspx. Accessed March 3, 2015.

36. Specifications for Dietary Supplement Raw Material and/or Finished Product. USP Dietary Supplement Verification Program: Manual for Participants. Rockville, MD: United States Pharmacopeial Convention; March 2009:24. Available at: www.usp.org/sites/default/files/usp_pdf/EN/dsvp_manual_2013-10.pdf. Accessed March 11, 2015.

37. Steir J. Schneiderman’s Supplement Scam. The Observer. February 26, 2015. Available at: http://observer.com/2015/02/schneidermans-supplement-scam/. Accessed March 9, 2015.

38. Daniells S. GNC: Independent, third party tests ‘conclusively’ confirm Herbal Plus products meet all requirements. NutraIngredients-USA website. Available at: http://www.nutraingredients-usa.com/Regulation/GNC-Independent-third-party-tests-conclusively-confirm-Herbal-Plus-products-meet-all-requirements/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=11-Mar-2015&c=9QWA60P9Pf5Ku5Gb69tqcQ%3D%3D. Accessed March 11, 2015.

39. Sarma N. DNA Testing of Herbal Supplements - Does it Work or Doesn’t It? United States Pharmacopoeia: Quality Matters blog. Available at: http://qualitymatters.usp.org/dna-testing-herbal-supplements-does-it-work-or-doesnt-it. Accessed February 24, 2015.

40. Spicer M. FDA Does Not Use Testing Behind New York Enforcement On Major Retailers’ Herbals. The Tan Sheet. February 4, 2015.

41. FDA Issues Dietary Supplements Final Rule [press release]. Silver Spring, MD: US Food and Drug Administration; June 22, 2007. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108938.htm. Accessed March 3, 2015.

42. Schultz H. Cooperman: AG used wrong test, but that doesn’t mean there isn’t a quality problem in supplement industry. NutraIngredients-USA website. Available at: www.nutraingredients-usa.com/Regulation/Cooperman-AG-used-wrong-test-but-that-doesn-t-mean-there-isn-t-a-quality-problem-in-supplement-industry. Accessed March 9, 2015.

43. Stump E. Looking for Logic in New York: What’s Going On? (Part 1 of 2). Natural Products Insider. February 26, 2015. Available at: www.naturalproductsinsider.com/blogs/supplement-perspectives/2015/02/looking-for-logic-in-new-york-part-1.aspx. Accessed February 20, 2015.

44. NPA CEO Responds after New York Attorney General Subpoenas Retailers for Evidence to Support Label Claims [press release]. Washington, DC: Natural Products Association; February 24, 2015. Available at: www.npainfo.org/NPA/NewsRoom/News_Releases_2015/NPA_CEO_Response_after_NY_AG_Subpoenas_Retailers.aspx. Accessed February 20, 2015.

45. Shultz H. Experts panel offering ready access could fend off future public relations debacles like AG affair, observers say. NutraIngredients-USA website. Available at: www.nutraingredients-usa.com/Regulation/Experts-panel-offering-ready-access-could-fend-off-future-public-relations-debacles-like-AG-affair-observers-say. Accessed March 3, 2015.

46. Grebow J. Editor: New York Attorney General Case Requires Strong Response, Supplement Leaders Say. Nutritional Outlook. February 23, 2015. Available at: www.nutritionaloutlook.com/150223/NYAG. Accessed February 20, 2015.