ABC Registered User Advisory
For Friends of the American Botanical CouncilGNC and NY AG Announce Agreement on DNA Testing of Herbal Supplements
New York Times story discusses arrangement where GNC will use DNA testing for all plant materials in dietary supplements
ABC's Blumenthal interviewed and quoted in article
(AUSTIN, Texas, March 25, 2015) The New York Times today published front-page article by reporter Anahad O’Connor that describes elements of an agreement between New York Attorney General (NY AG) Eric T. Schneiderman’s office and GNC of Pittsburgh, PA, related to the AG’s previous investigation into herbal dietary supplements sold by GNC. In the agreement GNC has agreed to employ DNA barcode testing in all of its crude botanical ingredients to be used in herbal dietary supplements within 18 months.1Mr. O’Connor initially broke the story with his article on February 3 describing the NY AG’s having sent cease-and-desist letters to GNC as well as Walgreens, Walmart, and Target for allegedly selling house brands of herbal dietary supplements that the NY AG had determined the listed ingredients were absent from about 80% of the products.2
This morning’s New York Times article quotes GNC CEO Michael G. Archbold as stating, “As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full compliance with all regulatory requirements.” Mr. Archbold was referring to an announcement that GNC had made earlier this month that its independent testing had confirmed the authenticity of the ingredients in the effected herbal supplements.3,4 This morning GNC issued a press release announcing the agreement although specific details were not given.5
The American Botanical Council’s Founder and Executive Director Mark Blumenthal was interviewed by Mr. O’Connor on Sunday. The one-hour interview covered many aspects of the background of this issue, including the capabilities, limitations, and problems associated with DNA barcoding in testing the authenticity of botanical extracts, the need for confirmatory testing by using other scientifically valid test methods, and much more.
Blumenthal emphasized to Mr. O’Connor that highly reputable experts in industry, academia, independent nonprofit research and standards-setting organizations, and government agencies have cast significant and serious doubt on the AG’s reliance on the DNA barcoding method used at Clarkson University as the sole test method utilized, particularly when such methods are unreliable for testing botanical extracts, of which about 76% of the tested products were labeled. Thus, said Blumenthal on several occasions in the interview, without any full disclosure and transparency on the part of the NY AG, serious scientists and others cannot rely on the unusual and non-credible test results upon which the NY AG based its legal actions.
A key point made by Blumenthal in the interview with Mr. O’Connor, but not mentioned in the article, is that there appeared to be a false presumption that GNC had agreed to what are most likely the AG’s stipulated terms because GNC had been seen as selling substandard herbal dietary supplements. In fact, in the agreement there is reportedly no admission of wrongdoing on behalf of GNC and, as Blumenthal pointed out, analytical experts and others have raised serious doubts about the conclusions that have been drawn on the faulty application of DNA barcode technology to GNC’s products, which were all botanical extracts.
Blumenthal told O’Connor that despite this growing view that the NY AG’s tests results were not valid, that independent testing of products similar to those that were tested by the AG would likely reveal problems with some of the products, as ABC is aware of adulteration problems associated with some of the herb categories, particularly ginkgo extract and St. John’s wort extract.
The article includes the following statements based on the interview:
Mark
Blumenthal, the executive director of the American Botanical Council, a
nonprofit organization that promotes the use of herbal products, said
he believed that the supplements included in the investigation most
likely suffered from some level of adulteration — an established problem
in the industry — but not to the extent suggested by the attorney
general. He criticized the attorney general’s testing procedures and
said his study data should be made public.
Mr. Blumenthal said he applauded GNC for reaching an agreement with New York and putting new procedures into effect, but he also worried that actions at the state level could create “a patchwork quilt of different quality standards and requirements” across the country.
“I’m concerned that this can potentially lead to various standards being set up in different states and that’s a legitimate issue for the industry and consumers,” he said.
In the interview, Blumenthal also noted the following points, among others, that were not mentioned in the Times article:Mr. Blumenthal said he applauded GNC for reaching an agreement with New York and putting new procedures into effect, but he also worried that actions at the state level could create “a patchwork quilt of different quality standards and requirements” across the country.
“I’m concerned that this can potentially lead to various standards being set up in different states and that’s a legitimate issue for the industry and consumers,” he said.
- NY AG appears to be attempting to establish new testing requirements beyond what is required by the US Food and Drug Administration’s (FDA) Good Manufacturing Practices (GMP) rule. This would be the responsibility of the FDA, not an individual state agency.
- It appears that the NY AG is doubling or perhaps tripling down on its intransigence with respect to its unscientific and untenable position on relying on only one DNA barcoding test upon which it has made its entire case and publicity campaign. By stipulating that GNC adopt and adhere specifically to DNA barcoding-based testing methods, the NY AG appears to be trying to validate his conclusions based solely on inadequate DNA testing of herbal dietary supplements without further verification of the results by standard chemically-based methods, which has been criticized in several recently published white papers, and also by inference by a letter from the FDA.
- It is not clear at this time as to which herbal dietary supplements products of GNC’s, if any, may be out of compliance with label claims regarding their identity, which would give the AG sufficient leverage to force GNC to agree to the terms of the reported agreement. Thus, it is not clear to ABC why GNC has agreed to the stated terms.
- He stressed that, of the four companies to which cease-and-desist letters were sent by the NY AG in February, GNC is the only company to ABC’s knowledge that purchases its own raw materials and extracts and processes them into dietary supplements in its own facilities. Therefore, GNC is not dependent on third-party contract manufacturers and has significantly more control over its purchasing and manufacturing processes than the other companies, allowing GNC to negotiate terms with the NY AG to which it believes it can adhere and comply.
- GNC’s agreement to utilize DNA testing on botanical raw materials to determine their identity prior to their being extracted suggests that the NY AG now appears to have realized that DNA testing is not suitable or fit for purpose for the extracts themselves, even though the NY AG’s office has not publicly acknowledged such a now well-known fact.
- GNC does not produce its own botanical extracts. The requirement that GNC stipulate that its extract suppliers utilize DNA test methods on botanical raw materials to authenticate their identity can help ensure that the extractor is using correct botanical materials for extraction. However, Blumenthal noted that it is quite possible that some high-quality extractors in the international market may already use DNA barcoding with other analytical methods. But, he emphasized, it does not mean that if this were to become a standard industry practice, as the NY AG appears to be promoting, that 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. DNA testing will not be able to detect such changes in the chemical composition; only appropriate chemical testing methods, as is currently used in many parts of the botanical industry, can do this. In addition, DNA barcode testing can be easily fooled by adding a few sprinkles of authentic plant material to an otherwise unacceptable material and, therefore, cannot guarantee by itself the quality of an ingredient or supplement.
- GNC agrees to routinely test for various potential contaminants (which is a normally required provision of the current GMP rule), specifically those that may cause allergic reactions;
- GNC agrees to the stipulation that “all herbal ingredients used in its products are manufactured in facilities that are certified as good manufacturing compliant by a third-party accreditation body, such as ISO, USP, or NSF”;
- “Within 18 months, GNC will begin utilizing DNA barcoding to confirm the authenticity of all plants used as sources for its herbal supplements products prior to processing. GNC will contribute any new barcodes, and the scientific methods used to identify them, to a publicly accessible database within 24 months”;
- “GNC will prominently display signs in stores across the country and on its website that explain the difference between whole herbs and extracts”;
- “GNC will provide semiannual reports to the Attorney General’s Office, detailing all plant species sourced after authentication using DNA barcoding; the name and address of all facilities in which DNA barcode authentication was performed; a list of materials rejected as a consequence of the results of the barcoding and the results of the randomized testing for common allergens.”
The new GNC agreement was also the subject of this morning’s “Marketplace” segment on National Public Radio’s Morning Edition, and, presumably, other media has been and will be reporting and misreporting on this development for at least the next few days, or longer.
A comprehensive article on this issue since the NY AG’s February 3 announcement was published in ABC’s monthly e-newsletter HerbalEGram in March, available here.6
References
1. O’Connor A. GNC to Strengthen Supplement Quality Controls. New York Times. March 30, 2015. Available at: http://well.blogs.nytimes.com/2015/03/30/gnc-to-strengthen-supplement-quality-controls/?&hp&action=click&pgtype=Homepage&module=first-column-region®ion=top-news&WT.nav=top-news. Accessed March 30, 2015.
2. O’Connor A. 4 Retailers Told to Stop Selling Supplements: Tests Find Fillers, Not Medicinal Herbs [print version]; New York Attorney General Targets Supplements at Major Retailers [online version]. New York Times, Feb 3, 2015. Available at: http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=0. Accessed March 30, 2015.
3. GNC Holdings. GNC Refutes New York State Attorney General’s Claims in Full and Robust Response. Business Wire. February 9, 2015. Available at: www.businesswire.com/news/home/20150209006388/en/GNC-Refutes-York-State-Attorney-General’s-Claims#.VRk2GULQBJ1. Accessed March 30, 2015.
4. Armental M. GNC Says Outside Testing of Nutritional Supplements Found No Improper Labeling. Wall Street Journal. March 10, 2015. Available at: www.wsj.com/articles/gnc-says-outside-testing-of-nutritional-supplements-found-no-improper-labeling-1426033941. Accessed March 30, 2015.
5. GNC Holdings. GNC Reaches Agreement with New York Attorney General. Business Wire. Available at: http://www.businesswire.com/news/home/20150330005372/en/GNC-Reaches-Agreement-York-Attorney-General#.VRkzuELQBJ0. Accessed March 30, 2015.
6. Smith T. A Review of the New York Attorney General's Recent Actions against Herbal Dietary Supplements. HerbalEGram. March 2015;12:3. Available at: http://cms.herbalgram.org/heg/volume12/03March/NYAG_HerbalSupplement_InvestigationReview.html. Accessed March 30, 2015.
