Dear Reader,
The
actions of the New York State Attorney General (NY AG) continue to have an
impact on the entire supplement industry and the herbal dietary supplements
industry in particular. As a reminder to readers, the NY AG conducted an
initial investigation into botanical dietary supplements based on DNA barcode
testing results that did not show the presence of DNA of the labelled species
in the majority of cases. This prompted his office to send cease-and-desist
letters to GNC, Target, Walgreens, and Walmart, demanding that they halt sales
of popular store-brand herbal dietary supplements. On March 27, 2015, an
agreement was signed between GNC and the NY AG allowing the same products
earlier described as “posing an unacceptable risk to New York families” back on
the shelves after the NY AG declared in the agreement that “results of this [GNC’s
in-house] testing likewise indicate that the tested supplements were
manufactured consistent with FDA cGMP requirement.”
The
agreement was picked up by the mainstream media, including a piece in the New York Times1 entitled “GNC to strengthen
supplement quality controls,” which also included a quote by ABC Founder and
Executive Director Mark Blumenthal. Both the agreement and subsequent New York Times article were topics of an ABC press release. The
investigation into dietary supplements will likely continue to make headlines,
as discussions between the NY AG and Target, Walgreens, and Walmart are ongoing
(as of May 28, 2015) and as dozens of individual and class-action lawsuits have
been filed against the four retailers. A more detailed look at the agreement
between GNC and the NY AG is provided in the “Regulatory Alerts” section of
this monitor, and a significantly detailed ca. 9500-word article by Tyler Smith was just published in the new issue of ABC’s peer-reviewed journal HerbalGram (#106).2
The
“Program News” section highlights the endorsement of the Botanical Adulterants
Program by numerous nonprofit research, analytical, and health professional
organizations. AOAC International, one of the most respected standard-setting
organizations worldwide, has endorsed the program. AOAC International has been
invested in the development of validated methods for herbal dietary supplements
for a number of years and has published, among others, official methods for detection
of aristolochic acid and ephedra (Ephedra sinica,
Ephedraceae) alkaloids, and for the identification of ginkgo (Ginkgo biloba, Ginkgoaceae) leaf extract, saw palmetto (Serenoa repens, Arecaceae) fruit, and goldenseal (Hydrastis canadensis, Ranunculaceae) root. The Program was
also recently endorsed by the Natural Health Products Research Society (NHPRS)
of Canada, the Hong Kong Baptist University’s (HKBU) School of Chinese Medicine,
and the Irish Register of Herbalists (IRH).
Authentication
of commercial ginkgo products is the focus of the “Science Update,” since there
were two papers published on the topic. One study reported on a DNA mini-barcode
approach to identify ginkgo in commercial dietary supplements; the other presented
a high-resolution gas chromatography-mass spectrometry (GC-MS) method to
determine the presence of ginkgolic acids. In both studies, the commercial
products were found to contain ginkgo, except in six samples (out of 37) of the
DNA mini-barcoding study, where no ginkgo DNA was found; the authors indicated
that this could be due to the extensive processing, which might have rendered the
products unsuitable for authentication by genetic methods.
Other
publications that are discussed in this section include the influence of
boiling time on DNA fragmentation and its impact on the ability to authenticate
Asian ginseng (Panax ginseng, Araliaceae) root;
a GC-flame ionization detector method using the enantiomeric ratio of two
monoterpenes after separation on a chiral column to authenticate Australian tea
tree (Melaleuca alternifolia, Myrtaceae) oil;
and a survey of commercial hong jing tian (Rhodiola crenulata, Crassulaceae) root and rhizome materials
sold in hospitals and drug stores in China.
This
monitor also features an “Industry Alert” implicating a raw material labeled as
cranberry (Vaccinium macrocarpon,
Ericaceae) extract that was shown to contain a different
proanthocyanidin-containing herbal extract, most likely peanut (Arachis hypogaea, Fabaceae) skin extract.
Reference
1. O’Connor A.
GNC to strengthen supplement quality controls. New
York Times. March 30, 2015:A1. http://well.blogs.nytimes.com//2015/03/30/gnc-to-strengthen-supplement-quality-controls/. Accessed
May 27, 2015.
2. Smith T. The Supplement Saga: A Review of the New York Attorney General’s Herbal Supplement Investigation. HerbalGram. 2015;106:44-55.
Stefan Gafner, PhD
Chief Science Officer
American Botanical Council
Technical Director,
ABC-AHP-NCNPR Botanical Adulterants Program
