Regulating the Regulators: NY AG Relies Only on DNA Testing for Commercial Herbal Supplements – Significant Problems with the Misuse of an Analytical Method
by Mark Blumenthal
HerbalGram. 2015; American Botanical Council
As
many are now aware, on February 3, New York State Attorney General Eric T.
Schneiderman announced that he had commissioned lab testing of a total of seven
herbal dietary supplements sold by four major national retail chains. The test
results indicated that most of the supplements were deficient in regards to
identity and purity. Extensive mainstream media coverage followed the
lamentable lead of the New York Times, which introduced the story with a
front-page, above-the-fold article by reporter Anahad O’Connor. Mr. O’Connor contacted the American
Botanical Council (ABC) for input, but our comment was not included. We issued
a press release questioning if any of the tested products were extracts
in pill form, which subsequent information has suggested that possibly about
75% were. Experts have noted that using DNA testing alone to identify an
extract in a single-herb commercial product has limited application as most
plant extracts do not
contain the DNA of the source plant material; also, heat
and other processing conditions can degrade any DNA that may migrate into an
extract. Many medicinal plant and analytical experts believe that the NY AG
relied too heavily on results determined solely by the DNA testing method, and
that other appropriate analytical methods also should have been used. Validated
methods published in official pharmacopeias include microscopy to identify
plant cell structures and various chemical tests to detect the presence or
absence of key chemical marker compounds that are characteristic of the herbs
and their extracts. As we pointed out to the Associated Press and in other
media interviews, Mr. Schneiderman, the highest law enforcement official in New
York, should be committed to the highest levels of due diligence — procedurally
and scientifically. Unfortunately, this appears questionable.
ABC
is not attempting to defend the tested products or the companies; instead, we,
and many others, question the appropriateness of the analytical method and
scientific protocol used in this case, on which legal and regulatory
enforcement actions have been based. One of many problems is that consumers
have a misunderstanding of the relevance of DNA in herbal extracts due to some
popular media such as television crime dramas, and will presume that the NY AG’s methods and data are accurate and
sufficient.
The
American Herbal Pharmacopoeia (AHP) sent a 58-page document to the NY AG that
presented pharmacopeial standards and test methods for all of the seven
contested herbs, and the United States Pharmacopeia has issued statements
emphasizing the need for multiple analytical methods to confirm the identity of
botanical supplements.
ABC
is the managing partner, with AHP and the University of Mississippi’s National Center for Natural
Products Research (NCNPR; a Food and Drug Administration-funded Center of
Excellence for Botanical Dietary Supplement Research), in the ABC-AHP-NCNPR
Botanical Adulterants Program, an international educational program designed to
educate industry members and related stakeholders about the prevalence of
adulteration of botanical dietary ingredients and supplements. We recognize
that there is a quality problem in the global herbal industry. However, the
actions of the NY AG — which we have called premature — do
not meet the criteria for the basis of strong evidence for rational law
enforcement and only further muddy the water regarding the perception of the
quality of herbal products. Consumers deserve both reliable herbal products and
responsible and accountable actions from their elected officials. The
misuse of analytical methods and lack of scientific discipline do not benefit
the public’s
welfare.
In this issue, our
friend and ABC Advisory Board member Giovanni Appendino and his colleagues in
Italy have reviewed the Mediterranean plant Helichrysum italicum, a
traditionally used herb and source of an essential oil with a wide range of
applications.
As
part of our ongoing series of herb profiles, veteran ABC staffer Gayle Engels
and ABC Advisory Board member Josef Brinckmann of Traditional Medicinals
provide a concise review of andrographis, one of my most trusted herbs during
cold-and-flu season.
Finally,
old friend and herbal tea expert Brian Keating and HerbalGram Editor Ash
Lindstrom and colleagues have written this publication’s first-ever Tea Market Report. The
2014 Tea Market Report joins our long series of Herb Market Reports, which are
often our most-cited articles.
