Dear Reader,Continuing his investigations into the quality of herbal supplements, the
New York Attorney General’s (NY AG’s) office issued 13 cease-and-desist letters
to companies marketing devil’s claw dietary supplements in the state of New
York. The basis of the letters are results provided by experts from the New
York Botanical Garden using a DNA mini-barcode approach to show that the herbal
dietary supplements contained Harpagophytum zeyheri
(Pedaliaceae) or a mixture of H. procumbens
and H. zeyheri. While it is permissible in
many jurisdictions (particularly Europe) to use the two species
interchangeably, the NY AG based some of his regulatory action on the first
edition of American Herbal Products Association’s Herbs of
Commerce (1992), which, according to industry self-regulation, lists
only H. procumbens as the plant species that
should be sold as devil’s claw in the Unites States. This investigation is
covered below in the Regulatory Alerts section of this issue of the “Botanical
Adulterants Monitor,” along with a short summary of the latest developments in
the aftermath of the investigations by the NY AG into the identity of the
ingredients contained in popular botanical dietary supplements sold at GNC,
Target, Walgreens, and Walmart. In addition, the section reports on an
investigation into the quality of ginkgo (Ginkgo biloba,
Ginkgoaceae) extracts by the China Food and Drug Administration.
In August, the Botanical Adulterants Program (BAP) released the
Laboratory Guidance Document (LGD) on bilberry extract. This document, which is available
free of charge through the ABC website, sums up the conclusions of a
review of 39 methods for the analysis of bilberry (Vaccinium
myrtillus, Ericaceae) fruit extracts, which were evaluated with
respect to their suitability to authenticate bilberry and to detect
adulteration. I am grateful to the 16 reviewers who have taken the time to read
the document and provided the expert feedback to help improve it. The next document
in the LGD series, which will be on black cohosh (Actaea
racemosa, Ranunculaceae) root and rhizome, is in the final editing
stages.
In the past few months, we received two alerts regarding high-performance
thin-layer chromatography (HPTLC) documentation on the adulteration of
passionflower (Passiflora incarnata,
Passifloraceae) herb with a flavonol-glycoside-rich material. The occurrence of
passionflower herb adulteration was reported independently by laboratory
personnel from two European botanical supplement industry companies, one of
which is currently investigating the extent of this problem. To our knowledge,
there have not been any reports on passionflower adulteration from within the
United States, but we welcome additional information from anyone who has
encountered this type of apparent fraud.
The review on newly published science pertaining to topics of
adulteration includes two documents on analytical methods to detect active
pharmaceutical ingredients (APIs) that are mixed with botanical materials. The proposed
new chapter on “Adulteration of Dietary
Supplements with Drugs and Drug Analogs” by the United States Pharmacopeial
Convention was published in the Pharmacopeial Forum
in June.1 It provides tools for detection of APIs in unapproved
drug products mislabeled (masquerading) as dietary supplements. The occurrence of products wherein prescription drugs
are mislabeled as herbal products is not new, dating as far back as the late
1970s, when a Chinese arthritis formula – known as “black pearls” – which was labeled
to contain only herbs but was determined by laboratory testing to contain
undisclosed levels of various anti-inflammatory, sedative, or diuretic APIs, was
sold in the United States.2 The second publication with regard to
APIs describes high-performance liquid chromatography-mass spectrometry
(HPLC-MS) methods for the detection of admixture of synthetic yohimbine
hydrochloride to products labeled to contain extracts of yohimbe (Pausinystalia johimbe, Rubiaceae) bark.
Additional topics in the Science Update section focus on chemical and DNA-based
methods for the authentication of cordyceps (Ophiocordyceps sinensis, syn. Cordyceps
sinensis, Ophiocordycipitaceae) fruiting bodies,
horsetail (Equisetum arvense, Equisetaceae) herb, and buchu
(Agathosma betulina, A. crenulata, and A. serratifolia, Rutaceae) leaf. The section ends with summaries of two
posters presented at the annual meeting of the American Society of
Pharmacognosy (ASP), which was held in Copper Mountain, Colorado in July. One
poster detailed the complexity of accurate authentication of licorice (Glycyrrhiza glabra, Fabaceae) and Chinese licorice (G. uralensis, G. inflata) root
raw materials due to similarity in appearance of the plants, overlapping
habitat, and the occurrence of hybridization, which results in mislabeled
commercial materials and materials being composed of mixtures of species. The
second poster presented a nuclear magnetic resonance (NMR)-based method to
detect adulteration of maca (Lepidium meyenii,
Brassicaceae) roots.
References
1.
Bzhelyansky
A. Expert Panel Update: <2251> Adulteration
of dietary supplements with drugs and drug analogs. Pharmacopeial Forum. 2015;41(3).
2.
Blumenthal M, McCaleb R. Black pearls lose luster:
Prescription drugs masquerade as Chinese herbal arthritis formula. HerbalGram. 1990;(22):4-5, 38-39.
Stefan Gafner, PhD
Chief Science Officer
American Botanical Council
