Dear Reader,
On
February 2, 2015, cease-and-desist letters, calling for an immediate
termination of sales of a number of herbal dietary supplement products
in the state of New York, were sent by New York Attorney General (AG)
Eric T. Schneiderman to four of the largest retailers in the United
States: GNC, Walgreens, Walmart, and Target. The action has attracted a
lot of media attention and has led to a flurry of comments in the social
media, e.g., by confused consumers, worried physicians, and industry
critics. The cease-and-desist letters were based on an initiative by the
AG to verify the composition of various herbal dietary supplements (a
majority of which apparently contain herbal extracts) using DNA
barcoding, which ultimately failed to find DNA from the botanical
ingredient on the label in 79% of the cases. Details on the experimental
conditions have not been released to date, but experts in the analysis
of botanical ingredients point out that DNA barcoding is not an
officially accepted technology for the authentication of botanical
extracts, and is likely to provide erroneous results since many of the
processes used in the manufacturing of such extracts will denature,
reduce, or altogether eliminate the original DNA. The capabilities and
limitations of DNA barcoding of botanical dietary supplements were
reviewed in a white paper by four highly respected experts in the
analysis of botanicals and herbal dietary supplements.
The capabilities and limitations of DNA barcoding of botanical dietary
supplements were reviewed in a white paper by four highly respected
experts in the analysis of botanicals and herbal dietary supplements.
The paper was underwritten by four industry trade associations. A
separate white paper by two former high-ranking FDA officials — now
working at another trade association — was published a week later.The
authors of both papers concluded that the NY AG's results were invalid based on inadequate and inappropriate testing.
In addition to the cease-and-desist letters, the Attorney General’s
office has issued subpoenas to the retailers to provide support for the
structure-function claims made on the product labels. According to a
press release by the office from March 10, the NY AG was joined by AGs
from Connecticut, Indiana and Puerto Rico to form a coalition in an
effort to “ensure that herbal supplement manufacturers and retailers
comply with the law.” A summary of the actions
by AG Schneiderman written up by HerbalGram Associate Editor Tyler
Smith, and the response by members of the Botanical Adulterants Program, such as the press releases by ABC and AHP, are given in the “Botanical Adulterants Program Recent News” and “Regulatory Alerts” sections of this Monitor.
The ABC-AHP-NCNPR Botanical Adulterants Program has started 2015 by
publishing the first in a series of Laboratory Guidance Documents (LGD), a
comprehensive review of methods to authenticate and detect adulteration of skullcap (Scutellaria lateriflora, Lamiaceae). The
LGDs are intended to complement the existing reports on adulteration already
published by the Program. At the same time, the Program has released a short overview on the scope and contents of LGDs, written to put the series in context
of its goal to raise the awareness of quality issues related to the
adulteration of botanicals.
The endorsement by a number of important professional organizations – the
Academy of Integrative Health & Medicine, the American Herbalists Guild and
the National Institute of Medical Herbalists
– as well as several trade associations – the British Herbal Medicine
Association and Natural Products New Zealand – has added additional support to
the Program on a global level. Such recognition is further evidence that
adulteration of botanical materials is considered a matter of global importance
and that the initiatives launched by the BAP are considered to be beneficial
for the herbal trade and to provide tangible results.
The “Botanical Adulterants Monitor” for the first time features two
cases of adulteration reported by members of the dietary supplement manufacturing
industry. The two cases have been summarized in short paragraphs in a new
section entitled “Industry Alerts”. In both cases, the presence of adulteration
has been supported by robust analytical data. We hope that the timely
announcement of cases of adulteration of raw materials supplied to the industry
can help to prevent the spread of adulterated materials into finished consumer
products.
The scientific section has been dedicated in part to the detection of
adulteration of proanthocyanidin-containing materials. The news on adulteration
of grape (Vitis vinifera, Vitaceae) seed extracts
with peanut (Arachis hypogaea, Fabaceae) skin
extracts in particular has been troubling, not only because it is an illegal
and unethical activity, but also because it may put the safety of consumers at
risk due to the relatively high prevalence of allergies to peanuts and
peanut-derived materials in the general population. It is a welcome development
that responsible third-party analytical laboratories associated with the
Program, i.e., the scientists at Alkemists Laboratories and NSF International,
have developed methods to detect the admixture of peanut skin extract to grape
seed extracts.
Another topic in the science section is the adulteration of botanicals
used in the Ayurveda, Siddha,
and Unani Medicine systems in India. While the paper by Kumar
presents a literature review on adulteration of mainly endangered species from
the Northern part of India, the publication by Seethapathy et al. has a much narrower focus and presents
results of the analysis of 60 commercial herbal laxative products sampled in
three provinces in Southern India, giving evidence of adulteration in 20% of
the analyzed samples, mainly due to substitutions of one Senna
spp. (Fabaceae) with another.
Other papers reviewed include a critical look at pharmacopeial methods
to authenticate bilberry (Vaccinium myrtillus,
Ericaceae) fruit extracts, and a paper documenting the challenges in the
morphological authentication of Moldavian dragonhead (Dracocephalum moldavica, Lamiaceae).
Stefan Gafner, PhD
Chief Science Officer, ABCTechnical Director, ABC-AHP-NCNPR Botanical Adulterants Program
