GNC and NY AG Announce Agreement on
DNA Testing of Herbal SupplementsNew York Times story discusses
arrangement where GNC will use DNA testing for all plant materials in dietary
supplements
CLARIFICATION: A previous
version of this press release was issued by ABC a few hours ago. That version
inadvertently mischaracterized what ABC Founder and Executive Director Mark
Blumenthal told a New York Times reporter in
an interview yesterday. The Times and the ABC release incorrectly
state that Blumenthal said that adulteration of herbal ingredients in some
of the herbal supplements tested by the New York Attorney General
were “likely”; the term he used is “possibly,” as adulteration is
known to exist in some of the implicated herbs. Mr. Blumenthal has not yet seen
any results from independent lab testing of the implicated products and thus
cannot predict the likelihood of whether they may be adulterated. ABC laments
any confusion this may have caused.
(AUSTIN,
Texas, March 30, 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.1
Mr.
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 could possibly 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 [the term in the interview was "possibly"]
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:
- 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 it 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 identityprior 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 theextracts 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.
ABC has not
yet been able to obtain a copy of the final agreement. According to material
supplied to ABC by the New
York Times, some of the terms of the GNC agreement with the NY AG
are as follows:
- 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.”
Other
persons quoted in the article include Pieter Cohen, MD of Harvard, and David
Schardt of the Center for Science in the Public Interest.
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.