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The Official Publication of the American Herbal Products Association
November 2012
www.ahpa.org
Volume 27, Number 11
In this issue of the AHPA Report
Inside AHPA
2
••AHPA Introduces Web-based Wiki Technology to Assist With Botanical Authentication Activities
••Nominations Now Being Accepted for 2013 AHPA Awards
••New Members
••Savings Opportunities for AHPA Members
••October AHPA Updates
••AHPA in the News
Legal & Regulatory 8
••Inspector General’s Claims Report: So What? by Anthony L. Young, Partner, Kleinfeld, Kaplan & Becker LLC,
and AHPA General Counsel
••A Review of Recent Regulatory Actions Against Homeopathic Drug Products by Michael McGuffin,
AHPA President
••August UK Echinacea Warning Based on Previous Monographs by Michael McGuffin
••FDA Sends a Warning by Marc Ullman
Botanical Science Update 16
••Meetings Attended by Steven Dentali, Ph.D., AHPA Chief Science Officer
••Literature Citations by Steven Dentali, Ph.D.
Calendar of Botanical Events
23
Inside AHPA
AHPA Introduces Web-based Wiki
Technology to Assist With Botanical
Authentication Activities
To further serve the herbal and botanical products industry, the
American Herbal Products Association (AHPA) has formally
launched the AHPA Botanical Authentication Wiki as a functional
open beta website.
The first known resource of its kind, the AHPA Botanical
Authentication Wiki, part of AHPA’s Botanical Authentication
Program, is a centralized source of reference information containing
examples and techniques that have been successfully applied to
authenticate selected botanical materials.
The AHPA Botanical Authentication Wiki, with more than 120
botanicals already online, includes botanical microscopy images,
high-performance thin-layer chromatography (HPTLC) techniques,
organoleptic properties, a discussion of potential adulterants, and also
forms an expandable platform that can easily introduce other methods
as it develops. It is hoped that the wiki will reduce the cost and time
associated with conducting botanical authentication activities.
The wiki will grow as users provide feedback and additional data on
key botanical ingredients. An expert advisory panel, professional
botanical analysts, and industry-user requests will add to these additional entries through a vetting process.
“The wiki is an evolving tool that can help make professionals more
efficient at authenticating herbal ingredient identity and respond to
changing industry conditions to provide timely and relevant information, unlike other, relatively static authentication reference
resources,” said Merle Zimmermann, Ph.D., AHPA information
analyst, who oversees the project. “As the site continues to grow, it
will become increasingly valuable as part of a well-rounded authentication toolkit.”
The AHPA Report, the official voice of the
American Herbal Products Association
(AHPA), is published monthly as a service
to AHPA members and friends of the
herbal products industry. The material
contained in this publication is for the
information of AHPA members. Although
the information is believed to be correct,
AHPA disclaims all responsibility for any
damage or liability that may result from
any reliance on the information contained
in this publication.
Articles may not be reproduced or reprinted
without written permission from AHPA.
Wiki registrations, free to AHPA members and for a limited time to
the industry at large, are available to anyone expressing an interest in
participating in the development of the site. Participation during
the beta stage of development will help ensure a high level of input
toward building a viable authentication resource.
In 1997, AHPA introduced its Botanical Authentication Program,
which now consists of:
¾¾ The
identification of known adulterants ¾¾ The
presentation of information on analytical methods to
help ensure botanical identity
¾¾ Training
for quality control personnel, including
hands-on seminars on microscopy and HPTLC
¾¾ The
AHPA Botanical Authentication Wiki
“Botanical authentication has always been a priority of AHPA,” said
Steven Dentali, Ph.D., AHPA’s chief science officer. “Providing the
means to clearly identify ingredients is just one of the ways AHPA
works to serve its members and the industry at large. The AHPA
Botanical Authentication Wiki is in continued active development
with a current high priority on the addition of practical HPTLC
identification methods.”
For more information and to register for open beta access to the
wiki, contact Merle Zimmermann, 301.588.1171 x106.
Nominations Now Being Accepted for
2013 AHPA Awards
Nominations are now being accepted for the American Herbal
Products Association’s (AHPA) 2013 AHPA Awards. The annual
awards, first presented in 2006, acknowledge individuals and organizations for making substantive, positive contributions to the
herbal products industry.
AHPA Staff
Michael McGuffin, President
Steven Dentali, Ph.D., Chief Science Officer
Devon Powell, Chief Operations Officer
Frank Lampe, Director of Communications & Editor, AHPA Report
Merle Zimmermann, Ph.D., Information Analyst
LaWanda Johnson, Communications Manager
Rosie Ysasi, Certification Program Coordinator
Anthony Young, General Counsel, Kleinfeld, Kaplan & Becker
Peter Evich, National Legislative Consultant, Van Scoyoc Associates
Kellie Greene Design, Layout & Production, AHPA Report
November 2012 • Page 2
Send inquiries, comments or
requests to:
American Herbal
Products Association
8630 Fenton Street, Suite 918
Silver Spring, MD 20910
Phone: 301.588.1171
Fax: 301.588.1174
Email: ahpa@ahpa.org
Website: www.ahpa.org
© Copyright 2012, American
Herbal Products Association
“AHPA recognizes that it requires a commitment to excellence
from those who are engaged in the production, research, and other
aspects of the trade in botanical and herbal products,” said AHPA
President Michael McGuffin. “The AHPA Awards symbolize the
industry’s appreciation of those efforts to make advancements in
the industry that AHPA serves.”
The AHPA Award categories are:
Herbal Hero: Individuals who make outstanding contributions to
AHPA committees or initiatives. Nominees must be employed by
AHPA member companies.
Herbal Industry Leader: Companies that set an example of outstanding business practices or organizations that work to move the
industry forward, exceeding the standards of normal business practices. Nominees must be members of AHPA.
Herbal Insight Award: Individuals or noncommercial organizations that have a significant impact on furthering knowledge and
understanding of botanicals and their uses. Nominees for the AHPA
Herbal Insight Award do not need to be associated with AHPA
member companies.
AHPA/Andy Templeton Photography
The AHPA Awards will be presented at the annual AHPA
member meeting and breakfast, scheduled in conjunction with
the Natural Products Expo West trade show in Anaheim, Calif.,
on March 7, 2013.
Steven Dentali (l.), AHPA’s chief science officer, presents the special
2012 AHPA Visionary Award to (from l. to r.), Feather Jones of
Sedona Tea Blends, Daniel Gagnon of Herbs, Etc., Tierney Salter of
Herbalist Inc., and Mitch Coven of Vitality Works, who accepted
the award for the late Michael Roland Shaw Moore.
The 2012 AHPA Awards recipients included Mitchell Coven, founder,
CEO, and president of Vitality Works, a privately held nutraceutical,
dietary supplement, and homeopathic manufacturing company in
Albuquerque, N.M., who received the Herbal Hero Award; Tom’s of
Maine, located in Kennebunk, Maine, which received the Herbal
Industry Leader Award; Roy Upton, executive director and editor of
the American Herbal Pharmacopoeia, who received the AHPA Herbal
Insight Award; and the late Michael Roland Shaw Moore, who
received a special AHPA Visionary Award for his approach to botanical medicines, the development of a contemporary approach to herbal
practice, and his broad impact on herbalists and the practice of
modern U.S. herbalism during the revival of American Herbalism in
the second half of the 20th century.
Guidelines for the nomination process include the following:
¾¾ Only
individuals employed by an AHPA member
company may nominate individuals or companies for
AHPA Awards.
¾¾ An
outside party must make nominations, preferably
with an objective perspective on how the candidate has
stood out in the community.
¾¾ Nominees
(companies and/or individuals) can be
nominated in only one category each year.
Nominations can be submitted using the online nomination form
and must be received in the AHPA office by Jan. 11, 2013.
Nominations will be reviewed by members of AHPA’s
Communications Committee, which represents a diverse group of
industry stakeholders. The committee recommends recipients for
each award category and presents these recommendations to AHPA’s
board of trustees for approval.
For more information on the 2013 AHPA Awards, contact Frank
Lampe, AHPA director of communications, 301.588.1171 x104.
New Members
Active Member
Flora, Inc. has been manufacturing and supplying quality herbal
remedies for distribution in Canada and the United States since
1987. Our roots stretch back to Germany in the early 1900s, where
Dr. Otto Greither, grandfather of the current owner, Thomas
Greither, dedicated his life to the discovery, production, and distribution of natural health care products. We have preserved his original dedication to perfect European herbal remedies that ensure
maximum purity, quality, and potency with a holistic approach to
health. Flora offers a wide array of premium health products prepared primarily with select botanicals, carefully nurtured and harvested from our own sustainable, organic farmlands. Our herbal
teas, tonics, and unrefined oils are thoughtfully formulated to ensure
optimum results. Flora’s award-winning supplements embrace the
wisdom of nature by incorporating the full-spectrum of inherent
natural plant constituents.
Associate Members
Founded in 2008, Genysis Nutritional Labs (GNL) is a full-service,
third-party contract laboratory that offers chemical and microbiological testing services using state-of-the-art equipment. In addition to
testing, GNL specializes in developing patentable formulations in the
field of sports nutrition and in the microbiological testing required to
ensure that your product is safe. We work with manufacturers of raw
materials, finished goods, and packaging to test for unique products.
GNL also provides analytical services to many of the leading sports
nutrition, direct selling, and food companies in the country. Our
mission is to professionally, effectively, and ethically perform testing
for our customers. We are dedicated to producing accurate and precise
results with exceptional customer support by meeting and exceeding
customer expectations in testing as well as products.
Waters Technologies Corp., a publicly traded corporation (NYSE:WAT)
headquartered in Milford, Mass., holds worldwide leading positions in
complementary analytical technologies: liquid chromatography, mass
spectrometry, rheometry, and microcalorimetry. These markets account
for approximately $5 billion of the estimated $20 to $25 billion worldwide analytical instrumentation market. Specifically, the company
designs, manufactures, sells, and services ultra-performance liquid chromatography, high-performance liquid chromatography, chromatography columns and chemistry products, mass spectrometry systems,
thermal analysis, and rheometry instruments. Waters Technologies
operates in two divisions: Waters Division and TA Instruments.
Savings Opportunities for AHPA Members
Within the pages of this edition of AHPA Report, we are pleased to
provide our members with several valuable money-saving opportunities. The following goods and services are offered at a discount
for—or are uniquely available to—AHPA members this month:
»» AHPA NDI Database and NDI Notifications Submissions
Package (page 24)
»» AHPA SupplySide West, $50 off registration (page 17)
»» American Herbal Pharmacopoeia, 10% off (page 12)
»» CPG Jobs, 15% off for employers (page 10)
»» Natural Business Journal, $150 off subscription (page 11)
»» TSYS Merchant Solutions (page 20)
October AHPA Updates
AHPA in the News
A recap of AHPA Updates issued to members during the month
of October:
A monthly review of media mentions related to the American
Herbal Products Association (AHPA) and/or AHPA staff.
¾¾ FDA
Delays Biennial Registration Renewal for Food
Facilities, October 1
¾¾ FTC
Issues The Green Guides for Environmental
Marketing Claims, October 2
¾¾ AHPA’s
McGuffin Presents at International
Pharmaceutical Federation Conference, October 8
¾¾ October
AHPA Report Articles Provides
Opposing Views on Proposition 37, October 10
¾¾ VIRGO
Offers $50 SSW Registration Discount to
AHPA Members; AHPA Meetings and 30th
Anniversary Member Reception Set for SSW,
October 17
¾¾ The
2012 Congressional Elections: What is at
Stake for the Supplement Industry?, Natural
Products Insider
¾¾ Congress
recognizes 100th anniversary of the
vitamin, NutraIngredients-usa.com
¾¾ AHPA
¾¾ AHPA
Hosts Supplement Seminar for Doctors,
Natural Products Insider
¾¾ AHPA
Adds Grapefruit Seed Extract to Known
Adulterants List, HerbalEGram
¾¾ AHPA
¾¾ Claims
¾¾ AHPA’s
¾¾ AHPA
Receives Patient Partnership Award from
Americans for Safe Access. October 17
Leads Seminar at FIP, Natural Products
Insider
on many supplements don’t comply with
law, report says, NutraIngredients-usa.com
wins Americans for Safe Access’ Patient
Partnership Award, Engredea News & Analysis
Dentali Discusses Career Trends in
Therapeutic Herbalism at Tai Sophia Institute,
October 17
¾¾ AHPA
¾¾ AHPA
Introduces Web-based Wiki Technology to
Assist With Botanical Authentication Activities,
October 25 ¾¾ AHPA
Responds to AP Article Sensationalizing
Ginseng Criminals, October 26
Report presents opposing Prop 37 articles,
Engredea News & Analysis
¾¾ AHPA
reschedules ‘Marketing Red Flags’ teleseminar, Engredea News & Analysis
¾¾ Prop
¾¾ AHPA’s
Marketing ‘Red Flags’ for Dietary
Supplements Teleseminar Focuses on Disease Claims
and Social Media Challenges, October 26
¾¾ AHPA
Provides Comments on Health Canada’s
Monograph on Traditional Chinese Medicine,
November 1
37 on GMO Labeling: Yay or Nay?
Nutritional Outlook
¾¾ Chokeberry
extracts are rich in antioxidant
anthocyanins, Engredea News & Analysis
¾¾ AHPA’s
Dentali Discusses Jobs in Herbal Industry,
¾¾ New
NIH Database Lacks Herbal Expertise,
¾¾ AHPA
Receives Americans for Safe Access Award,
¾¾ FSMA
registration process opens today,
NutraIngredients-usa.com
ve
Sathe !
te
Da
¾¾ Wikibotanica?
AHPA launches online tool to share
ID testing information, NutraIngredients-usa.com
¾¾ AHPA
The 2nd Annual
AHPA Botanical Congress
April 30, 2013 • New York
Presented in conjunction with
Virgo Publishing and SupplySide Marketplace
Launches Wiki Site for Authentication,
¾¾ Will
the ‘processed food’ definition in Prop 37
really kill off ‘natural’ claims on pack?
FoodNavigator-usa.com
www.ahpa.org
714-754-4372
WWW.ALKEMIST.COM
Legal & Regulatory
Inspector General’s Claims Report:
So What?
by Anthony L. Young, Partner, Kleinfeld, Kaplan & Becker LLC, and
AHPA General Counsel
The Department of Health and Human Services Office of the
Inspector General (OIG) from time to time issues reports and
studies on activities regulated by the department. You can find its
reports at the OIG’s website.
In October, the OIG issued two reports about dietary supplements: Dietary Supplements: Structure/Function Claims Fail to Meet
Federal Requirements and Dietary Supplements: Companies May be
Difficult to Locate in an Emergency.
Both reports arose out of an OIG investigation into whether
dietary supplement claims are substantiated. American Herbal
Products Association members and other companies received
inquiries from OIG last year and were asked to provide substantiation for claims made for a specific dietary supplement product.
The OIG does not issue press releases when it begins an inquiry,
and companies don’t make public the fact that they have received
an inquiry, so the investigation did not make the news. Claims Lack ‘Reliable Scientific Evidence’
Substantiation
This OIG investigation looked at products with claims to determine
whether the claims were substantiated, had been notified to the
Food and Drug Administration (FDA) in accordance with the
Dietary Supplement Health and Education Act (DSHEA), and bore
the DSHEA disclaimer. To ascertain whether claims were substantiated, OIG used FDA’s
Guidance for Industry: Substantiation for Dietary Supplement
Claims Made Under Section 403(r) (6) of the Federal Food, Drug,
and Cosmetic Act. If you have read this guidance, you understand
that it is a tough taskmaster. You should also remember that it is
guidance: It is nonbinding and bears a disclaimer on the first page.
The OIG concluded that “Overall, substantiation documents for the
sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.” OIG also determined that
FDA could not easily determine whether manufacturers had submitted 30-day notifications for specific products and claims. In addition,
OIG found that 7 percent of the products reviewed did not have the
DSHEA disclaimer and 20 percent were making disease claims. On the claims-substantiation front, this report shows that when you
look at products squinty-eyed with a sharp pencil and make a cynical
analysis, you will find some with claims at risk.
Why is this of interest? The danger of reports like these is that they
are read by the lawyers who bring lawsuits against companies on
behalf of consumers who may have been misled by the unsubstantiated claims. Regulatory risks, specifically regarding FDA and the
Federal Trade Commission, can often be addressed by dropping
claims. Plaintiffs’ lawsuits usually do not stop until either the
company wins (with money passing to their lawyers for defense
costs) or when money passes from the company to the plaintiffs. The teaching here is the same as always: This OIG claims report is
about the industry within which you make your living. Just as a
teamster keeps his or her truck and rig in top condition, or a physician stays up to date on medical information, you need to read and
understand this report and evaluate how your company would have
fared had its labels been reviewed for claims, DSHEA disclaimer,
and substantiation. Companies should understand the recommendations made by the OIG, including that “FDA seek explicit statutory authority to review substantiation for structure/function claims
to determine whether they are truthful and not misleading.” This
should be a signal to every company in the industry to remain
informed and involved with its elected representatives through its
Stay Healthy
while Traveling
Did you know that according to the recent research,
Echinacea enhances immune and respiratory health
in long distance air travelers?*
Dr. Evelin Tiralongo and a team of researchers from Griffith University
(Australia) conducted a double-blind clinical trial investigating the effect
of Echinacea on immune and respiratory health of long distance air
travelers. MediHerb Echinacea Premium was used in this trial due to its
high alkylamide content, essential for the purpose of the research.
Adults flying economy class from Australia to America, Europe, or
Africa took Echinacea Premium tablets or a placebo for two weeks before
flying, during the trip, and for two weeks after returning to Australia.
The dose was one tablet twice daily, increasing to two tablets twice daily
while flying. Participants were allowed to increase the dose up to three
tablets twice daily if they experienced any respiratory or immune system
challenges. The higher dose could only be
continued up to eight consecutive days or twice
for four days during the whole travel period.
Echinacea Premium was found to significantly
support and protect immune and respiratory health
in air travelers who participated in the trial.*
This research (by Tiralongo E et al.) has been
published in the online journal Evidence-Based
Complementary and Alternative Medicine
(www.hindawi.com/journals/ecam/).
*These statements have not been evaluated by the Food
& Drug Administration. These products are not intended
to diagnose, treat, cure or prevent any disease.
www.standardprocess.com
www.mediherb.com
trade association should FDA seek such authority from Congress. claims, and lack compliance with current good manufacturing practice (cGMP) for drugs.
Registration Shortcomings
If marketers are considering this category, it must be approached
with a very careful attention to detail. OIG issued a second report that evolved from looking into whether
the companies distributing the products that they reviewed in the
claims investigation were registered under the Bioterrorism Act.
OIG found:
Twenty-eight percent of contacted companies had facilities
that failed to register with FDA as required. Of the companies with facilities that did register, 72 percent failed to
provide the complete and accurate information required in
the registry. Finally, 20 percent of dietary supplement labels
in our sample did not provide the required telephone
numbers or addresses.
The Bioterrorism Act requires facilities manufacturing, holding, or
distributing dietary supplements to be registered. The Dietary
Supplement and Nonprescription Drug Consumer Protection Act,
the law that requires reporting of serious adverse reactions to FDA,
requires a domestic address or phone number on the label of every
dietary supplement. FDA’s Compliance Policy Guidance (CPG) defines a homeopathic
drug in part as one that is “labeled as being homeopathic which is
listed in the Homeopathic Pharmacopeia of the United States (HPUS),
an addendum to it, or its supplements.” It also states that “Drug
products containing homeopathic ingredients in combination with
non-homeopathic active ingredients are not homeopathic drug
products” and that “Documentation must be provided to support
that those products or ingredients which are not recognized officially in the HPUS, an addendum to it, or its supplements are generally recognized as homeopathic products or ingredients.”
Late last year, FDA, working with the Federal Trade Commission,
acted to remove from the market products from seven companies
through the issuance of warning letters, asking them to remove
OTC human chorionic gonadotropin (HCG) drug products that
were labeled homeopathic for weight loss.
Most embarrassing to the industry in my view is that some companies do not seem to understand the need for the simple things such
as a DSHEA disclaimer, Bioterrorism Act registration, and domestic
address and phone number. FDA stated, “There is no substantial evidence HCG increases weight
loss beyond that resulting from the recommended caloric restriction. Consumers on a very low calorie diet are at increased risk for
side effects including gallstone formation, electrolyte imbalance,
and heart arrhythmias … There are no FDA-approved HCG drug
products for weight loss.” A Review of Recent Regulatory Actions
Against Homeopathic Drug Products
The letters warned the companies that they were violating federal
law by selling drugs that have not been FDA approved and that they
were making unsupported claims for the substances.
by Michael McGuffin, AHPA President
While the American Herbal Products Association has not seen any
recent indications that FDA is paying specific attention to homeopathics based solely on the basis of products being “formulations,”
in February, the agency issued a warning letter to Schwabe North
America concerning its Umcka products, based on active ingredients and claims. FDA stated:
Natural products marketers look at the homeopathic drug category
as a new sales opportunity because drug claims are lawful for such
products, they are not constrained by over-the-counter (OTC) drug
monograph limitations, and new drug applications are not (usually)
required. This article examines recent Food and Drug Administration
(FDA) actions, in which the agency has contended that products
variously are misbranded or adulterated, feature unsupported
We recognize that these products are identified as homeopathic drugs with active ingredients measured in homeo-
pathic strengths … the CPG identifies specific conditions
under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set
forth in the CPG, a homeopathic product must meet the
conditions set forth in the CPG. … The CPG additionally
states that ‘Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.’
In its warning letter to Schwabe, FDA concluded:
Although Aconitum napellus, Bryonia alba, Eucalyptus
globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, and Phosphorus are all recognized
homeopathic ingredients included in the HPUS,
Pelargonium sidoides is not included in the HPUS or any
of its addenda or supplements. Furthermore, to our knowledge, Pelargonium sidoides is not listed in any recognized
materia medica containing information on the preparation
of homeopathic medicines. Therefore, Pelargonium sidoides
is not a homeopathic ingredient and the Umcka products are
not considered homeopathic drug products under the CPG.
Accordingly, the policies set forth in the CPG for the
marketing of homeopathic drug products do not apply to the
Umcka products.
FDA’s action was not based on the fact that the product was a formulation, but that the formulation strayed from the confines of the HPUS.
One of those conditions is compliance with Section 503(b) of
the Act. Under the CPG, only homeopathic products intended
solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC.
Homeopathic products offered for conditions not amenable to
OTC use must be marketed as prescription products.
August UK Echinacea Warning Based on
Previous Monographs
by Michael McGuffin, AHPA President
AHPA inquiry found that no new data led to
agency’s label warning about allergic reactions in
children under the age of 12
The American Herbal Products Association (AHPA) has confirmed
that a press release issued on Aug. 20 by the U.K.’s Medicines and
Healthcare products Regulatory Agency (MHRA) urging consumers to not allow children under the age of 12 to use echinacea products due to concerns with a “low risk” of allergic reactions was based
on a review by MHRA of existing monographs.
Though MHRA’s announcement identified the issue as “not a serious
safety issue,” it also advised parents and caregivers not to use oral herbal
products containing echinacea for children under 12 years of age following the precautionary advice from the Herbal Medicinal Products
In another warning letter, issued in July against Grato Inc., FDA
found that some of the company’s homeopathic products contained
ingredients that did not meet the CPG’s definition of a homeopathic drug. FDA stated, “We recognize that ‘Vital Male Sexual
Energy,’ ‘Vital HGH Skin Hair Nails,’ ‘Vital HGH Immune
Booster,’ ‘Vital HGH,’ and ‘AR Arthritis’ are labeled as homeopathic
drugs with active ingredients measured in homeopathic strengths.”
Since the products’ ingredients were not included in the HPUS or
any of the addenda or supplements, FDA concluded that “these
ingredients are not considered homeopathic drug ingredients” and
“… are not considered homeopathic drug products under the CPG.”
Another July warning letter by FDA against A. Nelson & Co. cited
current good manufacturing process issues and misbranding violations, citing claims that in FDA’s view made the company’s homeopathic products prescription drugs. According to FDA, “They are
intended to treat diseases that require diagnosis and treatment by a
physician or are intended to provide treatment for symptoms usually
caused by an underlying disease process that requires diagnosis and
treatment by a physician.”
In its warning letter to A. Nelson, FDA concluded:
…the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall
under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG.
Committee, as set out in the European Medicine Agency’s Community
Monographs for Echinacea species. Each of these monographs states
that the perceived benefits of the use of echinacea in children under 12
are outweighed by the potential risks in this age group, and that there
is a low risk of allergic reactions, but these could be severe.
AHPA has now been informed by MHRA that the Aug. 20
announcement was based on a review of monographs that were
issued in 2008 for E. purpurea fresh herb, in 2009 for E. pallida root,
in 2010 for E. purpurea root, and in March 2012 for E. angustifolia
root. Each of these already restricts use of echinacea for children
under 12, and MHRA has stated that there was no new information
that precipitated the Aug. 20 announcement.
It thus appears that the only significant new detail in MHRA’s recent
announcement is that the agency has now associated an age restriction of 12 years with potential allergenicity.
Although the potential for an allergic response to the flowers and
flowering parts of echinacea have long been recognized, echinacea
products are generally known to be well tolerated.
FDA Sends a Warning
United Nutrition Labs Inc. of Reedsville, Pa. While the letter contained only four observations related to the company’s current good
manufacturing practice (cGMP) for dietary supplements and a
general comment suggesting additional company action, it delivered
two very significant warnings that any company manufacturing
dietary supplements would do well to heed.
The United warning letter was based on the agency’s determination
that United failed to adequately respond to the FDA 483 (Report of
Inspectional Observations) issued to the company following a fourday inspection by two agency investigators. A review of the warning
letter indicates that the company failed to provide FDA with adequate documentation of the various corrective actions it represented
would be undertaken to correct deficiencies in its GMPs. Specifically,
the agency cited United’s failure to:
¾¾ Establish
specifications for the identity, purity, strength,
and composition of each batch of dietary supplements it
produced,
¾¾ Conduct
at least one appropriate test or examination to
verify the identity of each dietary ingredient used in a
dietary supplement,
¾¾ Include
by Marc Ullman
On July 24, the Food and Drug Administration (FDA) issued a relatively brief (just a little more than two pages) warning letter to
in each Master Manufacturing Record procedures
for adequate sampling of material or a cross reference to
Standard Operating Procedures governing sampling
procedures, and
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¾¾ Calibrate
instruments used to test dietary supplements or
components of dietary supplements in accordance with
the manufacturer’s instructions or on a regularly documented basis.
With each of these observations, FDA noted that while the company
had acknowledged the need for corrective action and described its
plans to rectify each, no documentation demonstrating that the corrections had taken place was provided. In other words, United
received its warning letter because it neglected to respond to its 483
by providing FDA with copies of revised Standard Operating
Procedures, Master Manufacturing Records, and completed documentation showing recalibration of equipment. Experienced counsel
and consultants, who confront issues of FDA compliance, could
easily have readily explained to the company that even if it completed every one the corrective actions it described to FDA, the
failure to include a piece of paper showing what had been done
would result in a warning letter. This is one of the many reasons I
advise my clients that as far as FDA is concerned, “If it isn’t in
writing, it didn’t happen.”
In addition to this unfortunately typical subject matter (the supplement industry’s apparent inability to comply with many of the fundamental aspects of the GMPs is a subject for another day), the
United warning letter included two passages that should give every
dietary supplement manufacturer pause.
After reciting the four specific violations, the warning letter went on
to comment that “Under 21 CFR 111.12(c), each person engaged
in the manufacturing, packaging, labeling, or holding or in performing any quality control operations, must have the education,
training, or experience to perform the person’s assigned functions.
However, we note that your firm’s Quality Control Director is not
qualified to perform her assigned functions in that she does not have
the experience, knowledge, and level of training necessary to perform
the functions of this position.”
per hour per investigator plus expenses. This includes travel time,
meals, hotel rooms, and transportation costs. Fees for reinspections outside of the United States will result in charges of $289 per
hour. It is not hard to imagine these fees rapidly mounting into the
tens of thousands of dollars for a multiday inspection involving
more than one investigator.
Every dietary supplement manufacturer that produces products
labeled as dietary supplements should take note of the threat of reinspection fees and the agency’s focus on the qualifications for quality
managers. Neither of these items had previously appeared in any
warning letter directed to a dietary supplement manufacturer and
suggests that FDA is prepared to turn its attention to its powers in
these areas. Companies that attempt to navigate inspections and
respond to FDA 483s without the assistance of qualified counsel
and consultants place themselves in a position where they are particularly at risk of being targeted by FDA for this type of message—
something any prudent company would seem to want to avoid.
Marc Ullman is a partner in Ullman, Shapiro & Ullman LLP, which
serves as general counsel to the International Aloe Science Council. The
firm’s practice concentrates on legal and regulatory issues affecting the
aloe, dietary supplement, and natural products industry.
This article appeared in the August 2012 issue of Inside Aloe Online.
Reprinted by permission of the International Aloe Science Council. All
rights reserved.
Complimentary Seminar: November 20, 2012, 8:00 am, Toronto
It appears that this is the first time FDA has cited this provision of
the dietary supplement GMP regulations in any warning letter, and
companies would be well advised to ensure that they are maintaining complete documentation of their employees’ training and experience, especially for their quality control/quality assurance directors.
Failure to attend to this kind of housekeeping matter could result in
a determination by FDA that a facility is completely out of compliance with the GMP regulations.
False Labelling and Advertising Claims
in the Food, Beverage and Natural
Health Products Industries:
A Cross-Border View
In closing the warning letter, FDA noted that the Food Safety
Modernization Act of 2011 “authorizes FDA to assess and collect
fees to cover FDA’s costs for certain activities, including reinspection related costs … Reinspection-related costs means all expenses,
including administrative expenses, incurred in connection with
FDA’s arranging, conducting, and evaluating the results of the
reinspection and assessing and collecting the reinspection fees.”
(Yes, FDA can charge you for the cost of charging you). For
domestic reinspections, FDA has set the reinspection fee at $209
• Labelling and Marketing Natural Health Products in
Canada
Topics include:
• Marketing and Selling Food, Beverages and Dietary
Supplements in the U.S.
• Canadian Class Actions Relating to False Claims: What
Lies Ahead?
To register and for more information:
http://www.fasken.com/en/labellingand-advertising-claims-11-20-2012/
VANCOUVER CALGARY TORONTO OTTAWA MONTRÉAL QUÉBEC CITY LONDON PARIS JOHANNESBURG
Join Us!
The AHPA 30th Anniversary Member Reception
at SupplySide West
¾¾
Meet the AHPA board of trustees
¾¾
Celebrate AHPA’s 30th anniversary
¾¾
Enjoy great food and libations
¾¾
Engage in some great networking!
Tuesday, Nov. 6, 6:30 – 8 p.m.
Galileo 904
The Venetian & Sands Expo
Las Vegas, Nevada
The AHPA 30th Anniversary Member Reception is sponsored by the following companies
representing the AHPA board of trustees:
A special thank you to
our full-year sponsors:
AHPA’s 30th anniversary is proudly sponsored by:
Botanical Science Update
by Steven Dentali, Ph.D., AHPA Chief Science Officer
Requirements (SMPRs). In concert with this activity, the National
Institute of Standards and Technology is developing a standard reference material suite of St. John’s wort ground aerial tops, extracts,
and finished tablets.
MEETINGS ATTENDED
AOAC Annual Meeting and Exposition
I attended AOAC’s 126th Annual Meeting and Exposition that took
place in Las Vegas from Sept. 30 to Oct. 3. In addition to presiding
over the Editorial Board meeting where issues relevant to AOAC
publications were discussed, I cochaired a session with Amitabh
Chandra of Amway on new analytical trends and techniques for
evaluating botanicals.
The speakers included Sidney Sudberg of Alkemist Pharmaceuticals
and Kim Colson from Bruker BioSpin, who spoke on determining
botanical quality via high-performance thin layer chromatography
(HPTLC) and nuclear magnetic resonance (NMR), respectively.
HPTLC continues to prove its practical value in botanical authentication, and it is now being demonstrated that NMR is another effective
tool for fingerprinting and quantification of botanical constituents.
Mark Roman of Tampa Bay Analytics Research shared a practical
perspective of how to efficiently run a third-party natural products
testing program. Following his presentation, Gabriel Giancaspro of
the U.S. Pharmacopeia discussed how following the deletion of
original pharmacopeia botanical monographs, new analytical technologies now allow the readmittance of monographs with updated
methods of analysis. Ian Acworth of Thermo Fisher Scientific closed
the session with a discussion of a metabolomic approach in the analysis of wines, teas, and fruit juice adulteration from one of his many
poster presentations.
AOAC St. John’s Wort Working Group Session
Regarding new methods of analysis applied to botanical materials,
AOAC held a meeting on Sept. 30 to again begin the process of validating methods of analysis for the determination of hypericins,
hyperforins, and flavonoids in St. John’s wort (Hypericum perforatum) herb (traditionally the flowering tops/aerial parts), powdered
extracts, tablets, hard-shell capsules, and liquid alcohol extracts. The
previous effort to validate a single method of analysis for these three
classes of compounds failed.
After some discussion, it was recognized that the goal is the validation of a method that can detect and quantify certain analytes in
specific matrices, not to authentic materials. In other words, the
method is an analytical one, not an identity one. Funded by the
National Institutes of Health (NIH) Office of Dietary Supplements,
this work will proceed by developing the voluntary consensus standards that identify the minimum performance requirements for the
St. John’s wort methods, so called Standard Method Performance
Careers in Integrative Health at Tai Sophia
Institute
I was a speaker on a panel of herbal experts at the Tai Sophia Institute
in Laurel, Md., on Oct. 11 as part of a “Careers in Integrative
Health” symposium, which brought together a diverse group of
industry professionals who shared their career experiences and
trends in their fields with Tai Sophia students.
The two-hour panel discussion also included presentations by Helen
Oketch of the U.S. Pharmacopeia, Nancy Booth of Spherix Inc., Susan
Leopold of United Plant Savers, Steven Casper of the Food and Drug
Administration, and William Obermeyer of ConsumerLab.com.
National Advisory Council for Complementary
and Alternative Medicine
I attended the 47th meeting of the National Advisory Council for
Complementary and Alternative Medicine held on Oct. 12 at the
NIH campus in Bethesda, Md. The meeting included discussions of
the Complementary and Alternative Medicine for Urological
Symptoms (CAMUS) study, and an update on herb-drug interaction
initiatives.
LITERATURE CITATIONS
DNA Barcodes Differentiate Asian and American
Ginseng
� Wallace
LJ, Boilard SMAL, Eagle SHC, Spall JL, Shokralla
S, Hajibabaei M. DNA barcodes for everyday life: Routine
authentication of Natural Health Products. Food Res Int.
2012 Nov;49(1):446-452.
This study reported on the DNA barcode analysis of 95 Canadian
natural health products, focusing on shark and ginseng products.
This research presented practical applications of this emerging technology applied to natural product authentication. Ginsengcontaining products made up 41 of 70 medicinal plant products
with the remainder including Echinacea, St. John’s Wort, green tea,
milk thistle, feverfew, dandelion, and chamomile.
The researchers reported that all ginseng products labeled “American
ginseng (Panax quinquefolius)” were the correct species, but that 50
percent of the products labeled “Korean ginseng (Panax ginseng)”
were American ginseng (P. quinquefolius). Curiously, of the other
botanicals, a product labeled Echinacea purpurea yielded a sequence
closely matching species from the walnut family. The only other
discord between label claim and DNA analysis was for a product
labeled “black cohosh (Actaea racemosa)” found to contain a DNA
sequence from Acetea asiatica.
Nematicides from Botanicals Reviewed
� Ntalli
NG, Caboni P. Botanical nematicides: A review. J
Agric Food Chem. 2012 Oct 10;60(40):9929−9940.
This article provides a comprehensive review of botanical compounds,
organized by chemical class, that are toxic to nematodes. Responding
to the “need for discovering less toxic and environmentally acceptable
substitutes for commercial nematicides,” the report is organized into
sections on naturally occurring aldehydes and ketones; alkaloids; glycosides; glucosinolates and isothiocyanates; limonoids, quassinoids,
and saponins; organic acids; phenolics, flavonoids, and quinones;
piperamides; polyacetylenes and polythienyls; and terpenes. The
authors conclude that these constituents “can play a major role in
finding leading compounds for chemical synthesis.”
American Ginseng Sample Contained No
Pesticide Residue
Multiresidue pesticide analysis of dried botanical dietary
supplements using an automated dispersive SPE cleanup for
QuEChERS and high-performance liquid chromatographytandem mass spectrometry. J Agric Food Chem. 2012 Oct
10;60(40):9991−9999.
This is another report of the use of the “Quick, Easy, Cheap,
Effective, Rugged, and Safe” (QuEChERS) sample cleanup method
followed by liquid chromatography–mass spectrometry/mass spectrometry analysis of 236 pesticides in Asian (Panax ginseng) and
American (Panax quinquefolius) ginseng roots, ginkgo (Ginkgo
biloba) leaves, and saw palmetto (Serenoa repens) berries.
Spike recovery, matrix effects, and instrument limits of detection
studies were performed. A total of 13 pesticides were found in four
ginseng matrices with an average of five pesticides in each. The
exception was one American ginseng sample that was found to not
contain any of the 236 pesticides. The pesticides in ginseng found
by researchers represented different pesticide classes, suggesting
varied and widespread pesticide use in ginseng production.
Pygeum Phytochemical Population Differences
Probably Genetic
� Kadu
CA, Parich A, Schueler S, Konrad H, Muluvi GM,
Eyog-Matig O, Muchugi A, Williams VL, Ramamonjisoa
L, Kapinga C, Foahom B, Katsvanga C, Hafashimana D,
� Chen
Y, Al-Taher F, Juskelis R, Wong JW, Zhang K,
Hayward DG, Zweigenbaum J, Stevens J, Cappozzo J.
AHPA SupplySide West Meeting Schedule
Nov. 6 – 7 • Venetian & Sands Expo • Las Vegas
Tuesday, Nov. 6
Show Floor Hours
Wednesday, Nov. 7:
9 a.m. – 5:30 p.m.
Thursday, Nov. 8:
9 a.m. – 5:00 p.m.
View SW Schedule
AHPA members save
$50 on registration:
Use promo code AHPA$50
Room Number
9:00 – 11:45 a.m.
Galileo 1004
Finance & Governance Committee Annual
Planning Meeting
12:00 noon – 12:30 p.m.
Board of Trustees Luncheon
Galileo 1004 12:30 – 6:00 p.m.
Galileo 1004 Board of Trustees Meeting
6:30 – 8:00 p.m.
Galileo 904
AHPA 30th Anniversary Member Reception
Wednesday, Nov. 7
Room Number
9:00 – 11:00 a.m.
Galileo 1004 Government Relations Committee Meeting
11:15 a.m. – 1:45 p.m.
Galileo 1004 Joint Meeting of Botanical Raw Materials, Standards
and Analytical Committees
2:00 – 3:30 p.m.
Galileo 1004 Joint Meeting of the Education and
Small Business Committees
3:45 – 5:15 p.m.
Communications Committee Meeting
Galileo 1004 Friday, Nov. 9
8:30 a.m. – 4:30 p.m.
2012 Aloe Summit: Inside Aloe: Turning Science into Sales
(requires separate registration)
Obama C, Vinceti B, Schumacher R, Geburek T. Bioactive
constituents in Prunus africana: Geographical variation
throughout Africa and associations with environmental and
genetic parameters. Phytochemistry. 2012 Nov;83:70-78.
Twenty populations of pygeum (Prunus africana), also known as
African cherry trees, were collected from throughout its range and
the bark analyzed in order to determine the chemical diversity of
phytosterols, pentacyclic triterpenoids, and ferulic acid esters within
and between populations. The bark of this tree is a traditional medicine used in the treatment of benign prostate hyperplasia.
intense sunlight (its native habitat) to maca raised in an experimental
field and greenhouse in the Czech Republic.
Contained in the underground storage organ known as a hypocotyl,
macamides are the presumed active constituents that increase physical energy, support the immune system, and act as an aphrodisiac
believed to enhance fertility in humans and domestic animals. The
European field-grown plants had smaller hypocotyls than the
Peruvian ones, with greenhouse plants producing ones smaller still.
The researchers found a pronounced variation in chemical-constituent
makeup between populations that they attributed to probable
differences in genetic makeup. They did not find significant differences
in chemical results to correlate with environmental differences. The
authors suggest that their data on geographical chemical diversity is
helpful for conservation strategies for this important medicinal plant.
The macamide content followed a similar pattern with European field
plants, containing at least six times lower amounts than were found in
plants from the Peruvian highlands. No macamides at all were found
in the greenhouse plants. Josef Brinckmann of Traditional Medicinals,
who provided the article, stated that it “provides additional evidence
of the importance of geographical origin for quality and efficacy,
which, I think, may be generalizable to other cases of introducing a
species for cultivation in a significantly different ecosystem.”
It Matters Where You Make Your Maca
Heart of a Lion and Safe for Mom
� Melnikovova
I, Havlik J, Fernandez E, Cusimamani LM.
Macamides and fatty acids content in comparison maca
plant cultivation under greenhouse and field conditions.
Boletín Latinoamericano y del Caribe de Plantas Medicinales
y Aromáticas. 2012 Sep;11(5):420-427.
This study, available for free download, compared the chemical constituents of Peruvian maca (Lepidium meyenii) grown at high altitude,
in poor and rocky soil, and in freezing conditions with high wind and
� Wojtyniak
K, Szymański M, Matławska I. Leonurus cardiaca
L. (Motherwort): A Review of its Phytochemistry and
Pharmacology Phytother Res. 2012 Oct 8. doi: 10.1002/
ptr.4850. [Epub ahead of print]
This review covers the phytochemistry and pharmacology of a wellappreciated plant among herbalists that has so far been overlooked
by the mass market. A lovely plant whose literal Latin name is lion
heart, motherwort (Leonurus cardiac) is mild acting and has been
traditionally used for nervous heart conditions and digestive disorders. Mild positive effects on the heart can be attributed to the herb
with support for this activity provided by pharmacological and clinical trials. Like hyssop and lemon balm, this is a good herb to grow
and to get to know better.
Curcumin Stability and Bioactivity Altered by
OTC Drugs
A special thank you to
our full-year sponsors:
� Choi
HA, Kim MR, Park KA, Hong J. Interaction of
over-the-counter drugs with curcumin: Influence on
stability and bioactivities in intestinal cells. J Agric Food
Chem. 2012 Oct 16. [Epub ahead of print]
This report looked at the interaction of the over-the-counter drugs
ibuprofen, acetylsalicylic acid, and acetaminophen on the stability
and other properties of curcumin, a major polyphenolic compound
found in turmeric (Curcuma longa) roots. Curcumin stability was
enhanced in the presence of the drugs under physiological conditions. Curcumin bioactivities were also altered.
Cabbage Family Sprouts Vary in Phytochemical
Content and Composition
� Baenas
N, Moreno DA, Garcia-Viguera C. Selecting
sprouts of Brassicaceae for optimum phytochemical
composition. J Agric Food Chem. 2012 Oct 12. [Epub
ahead of print]
Cabbage family (Brassicaceae) vegetables or cruciferous foods that
include broccoli, kale, cress, turnips, mustard, etc., are associated
with health-promoting effects partly due to their glucosinolate and
phenolic constituents. This study evaluated the phytochemical
content of sprouts of several of these plants, because sprouts are recognized as being phytochemically rich relative to mature plants.
Harvested at eight or 12 days of production, these plants might be
more appropriately considered microgreens, according to a report in
last month’s AHPA Report. In general, the studied sprouts were
found to be rich in glucosinolates and antioxidants, with red cabbage
and radish producing higher biomass, while white mustard, turnips,
and kohlrabi tested higher for glucosinolates with less biomass
production.
Standardization of Valerian to Total Valerenic
Acids May Be Misleading
� Felgentreff
F, Becker A, Meier B, Brattström A. Valerian
extract characterized by high valerenic acid and low acetoxy
valerenic acid contents demonstrates anxiolytic activity.
Phytomedicine. 2012 Oct 15;19(13):1216-1222.
The sedative action of valerian (Valeriana officinalis) root and
rhizome is believed to be associated with effects on gamma aminobutyric acid (GABA) type A receptors through the action of
valerenic acid (VA) and its hydroxyl and acetoxy derivatives. In
vitro results suggest that acetoxyvalerenic acid (AVA) may inhibit
the activity of VA. The present study employed two extracts with
the same total amount of valerenic acids but different ratios of VA
to AVA in tests designed to demonstrate anxiolytic efficacy and
antidepressive action in mice. Diazepam and imipramine were
used as positive controls.
analysis of eight cultivars of betel (Piper betle) leaves, differences were
found in the abundance of characteristic betel phenols, which could
be separated into cultivar clusters after principal component analysis.
Thanks are expressed to Paul O. Danis, Ph.D., of Eastwoods
Consulting for drawing AHPA’s attention to this study.
Aloe Vera Constituent Content Changes with
Leaf Size
� Lee
S, Do SG, Kim SY, Kim J, Jin Y, Lee C. Mass spectrometry-based metabolite profiling and antioxidant activity
of Aloe vera (Aloe barbadensis Miller) in different growth
stages. J Agric Food Chem. 2012 Oct 11. [Epub ahead of
print]
This study reported the application of the latest and greatest in chromatographic and mass spectrometric detector technologies combined with data processing techniques to investigate changes in the
phytochemistry of Aloe vera leaf and its antioxidant activity relative
to leaf size.
The researchers reported finding the relative content of sugars
increasing gradually with increases in leaf size. Changes in the concentrations of chromones, and anthraquinones, anthrones were not
as straightforward, as some rose, some fell, and others rose and fell
with increasing leaf size.
New at the AHPA Online Bookstore
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give you and your company a competitive edge and the
ability to stay ahead of the curve on important business,
scientific, and regulatory issues.
Anxiolytic activity was better demonstrated in the high-VA- and
low-AVA-content extract (12-to-1 ratio) than in the lower-VA and
higher-AVA one (2-to-3 ratio). The apparent ability of AVA to at
least partially inhibit the antianxiety effect induced by VA led the
authors to conclude that standardization of valerian extracts to total
valerenic acids may be misleading and could also explain why many
previous trials have not had more positive outcomes.
Click on any item below to learn more and for ordering
information or visit the AHPA Online Bookstore.
DART Mass Spectrometry Technology Applied to
Betel Leaf Analysis
>Seminar: cGMP Compliance TeleSeminar: Variances
� Bajpai
V, Sharma D, Kumar B, Madhusudanan KP.
Profiling of Piper betle Linn. cultivars by direct analysis in
real time mass spectrometric technique. Biomed
Chromatogr. 2010 Dec;24(12):1283-1266.
> Seminar: FDA cGMP Inspections & Emerging
Compliance Issues for Dietary Supplements
>Publication: The AHPA Interim Guidance for New
Dietary Ingredient Notification for Manufacturers and
Distributors
>Publication: Shelf Life Dating of Botanical Supplement
Ingredients and Products
> Relaunched and Expanded: The AHPA NDI Database
Every so often, new technologies arrive that offer significant advantages over existing ones. Direct analysis in real time (DART) MS is
one such technology because it allows the MS analysis of plant products without requiring sample preparation. Employed here in the
Topical Aloe Leaf Preparation Effective in Healing
Infected Leg Ulcers
� Banu
A, Sathyanarayana B, Chattannavar G. Efficacy of
fresh Aloe vera gel against multi-drug resistant bacteria in
infected leg ulcers. Australas Med J. 2012;5(6):305-309.
This article, available for free download, describes the beneficial
effect of aloe vera (Aloe vera) inner leaf juice (the crushed, filtered,
and sterilized inner leaf gel) used topically to treat leg ulcers. Thirty
patients with nonhealing, infected leg ulcers from various causes
were matched to controls being treated with topical antibiotics and
not responding to therapy. Bacteria were cultured from both groups,
most of which were found to be multidrug resistant.
The growth of bacterial cultures in the controls persisted into the
11th day of the study when all but two of the aloe vera–treated
patients produced no viable bacteria. Concurrent clinical improvements in wound healing were observed in the aloe vera–treated
group. This cheap, low-cost, generally available therapy that can be
self-administered appears to be effective without side effects and
without leading to drug resistance.
Aloe Vera Mouthwash May Be Useful in Treating
Radiation Burns
� Ahmadi
A. Potential prevention: Aloe vera mouthwash may
reduce radiation-induced oral mucositis in head and neck
cancer patients. Chin J Integr Med. 2012
Aug;18(8):635-640.
The wound-healing properties of topically applied aloe vera were
employed in this study that used an aloe vera mouthwash to prevent
and treat damage to the oral mucosa that often arises from the radiation used against head and neck cancers. A reduction in oral candidiasis may also be seen with this treatment.
Asian Ginseng Shows Promise for Diabetes
Treatment
� Shergis
JL, Zhang AL, Zhou W, Xue CC. Panax ginseng in
randomised controlled trials: A systematic review. Phytother
Res. 2012 Sep 12. doi: 10.1002/ptr.4832. [Epub ahead of
print]
Asian ginseng (Panax ginseng), one of the most commonly used and
researched herbs, has little support for its treatment of specific
disease conditions. This is more likely a reflection of its action in
promoting overall health as an adaptogen, if you will, than its use in
treating specific diseases. The researchers conducted a systematic literature review in order to summarize the current evidence from
published Asian ginseng clinical studies.
A review of four English databases yielded 475 studies, 65 of which
were included in the systematic review. Healthy people were the
subjects in 39 studies, and the rest included people with various
disease conditions. The researchers reported that no serious adverse
events were reported in any study, and that P. ginseng has promising
therapeutic effects on immune response, particularly cell-mediated
immunity, and glucose metabolism. The most promising outcomes
were associated with the treatment of chronic respiratory diseases
and type 2 diabetes.
Ginger Offers Little Protection Against Heavy
Metal Exposure
� Nwokocha
CR, Owu DU, Nwokocha MI, Ufearo CS,
Iwuala MO. Comparative study on the hepatoprotection to
heavy metals of Zingiber officinale. Phcog Res 2012 Oct
17;4:208-213.
This research studied the effects of a 7 percent ginger (Zingiber officinale) rhizome diet in rats that consumed heavy metals (cadmium,
lead, and mercury) in their drinking water. In addition to the control
with no ginger supplementation, one group began consuming
ginger at the same time as the heavy metals, another group one week
later, and the third group one week before starting the heavy metal
ingestion. Heavy metal accumulation was measured in the animals’
livers at the end of six weeks.
Although reductions in body weight from heavy metal exposure
were not significantly altered by ginger administration, some protection against heavy metal accumulations in the liver that varied
with the metal and methodology of exposures was noted. Some
protection against heavy metal accumulation was found for
cadmium, less for mercury, and none for lead, although the ginger
pretreatment group showed less accumulated lead at week two, but
no protection by week six.
Cissus Extracts Show Promise in Bone Healing
� Stohs
SJ, Ray SD. A review and evaluation of the efficacy
and safety of Cissus quadrangularis extracts. Phytother Res.
2012 Sep 13. doi: 10.1002/ptr.4846. [Epub ahead of print]
This review of winged treebine Cissus quadrangularis, a traditional
medicine native to India and Africa, evaluated the literature beginning with published reports on the herb powder and extracts in
accelerating the healing of bone fractures and those that demonstrated anti-osteoporotic activity though not via any human clinical
trials. Antioxidant and anti-inflammatory activities were also
covered as were the more recent studies conducted by Oben at al.
with extracts of this plant in weight management and in metabolic
syndrome formulations.
Other investigators have not yet confirmed effects seen in human
studies, and specific active constituents or mechanisms of action
have not been identified. Extracts are said to be standardized to
ketosteroid content, though the assays reportedly used are nonspecific. However, an HPLC method for phytosterols determination
has been published. Reports of anabolic steroid content appear to be
unsupported, and no human clinical studies supporting increases in
lean muscle mass have been reported. No significant safety concerns
were noted in human, animal, and cell culture systems.
Bodybuilder Supplement Possible Cause of
Hepatitis
� Timcheh-Hariri
A, Balali-Mood M, Aryan E, Sadeghi M,
Riahi-Zanjani B. Toxic hepatitis in a group of 20 male
body-builders taking dietary supplements. Food Chem
Toxicol. 2012 Oct;50(10):3826-3832.
These researchers reported on 20 cases of male bodybuilders who
developed hepatitis following chronic ingestion of three products: a
creatine supplement, an “optimizer of testosterone production” supplement, and an amino acid– and creatine-based supplement, for
one year.
A quantitative causality assessment based on the Council for
International Organization of Medical Sciences scale for hepatocellular damage was used to evaluate all three supplements, with the
grade of causality for probable hepatocellular injury caused by these
supplements determined to be ‘‘possible.’’ The researchers concluded
“that there should be some concerns about possible supplementinduced liver injury in all bodybuilders” and that they should be
warned of possible adverse effects, including hepatitis.
Echinacea Extract Offered Benefit Against Colds
� Jawad
M, Schoop R, Suter A, Klein P, Eccles R. Safety and
efficacy profile of Echinacea purpurea to prevent common
cold episodes: A randomized, double-blind, placebo-controlled trial. Evid Based Complement Alternat Med.
2012;2012:841315. Epub 2012 Sep 16.
This article, available for free download, reports on the safety and
efficacy of a commercial Echinacea purpurea extract (Echinaforce,
produced by A. Vogel Bioforce AG, Switzerland) in a randomized,
double-blind, parallel, placebo-controlled clinical trial conducted
with 755 subjects. This is reportedly the largest clinical trial to date
in a long-term (four month) prevention and treatment with
Echinacea for the common cold. Participants consumed approximately 3 ml of product daily, upping the dosage to about 5 ml per
day during the acute stages of colds.
No significant differences were found between active and placebo
groups with regard to adverse events. Significant differences were
found in the number of cold episodes and episode days and in the
number of recurring infections, with the advantage going to those
subjects in the Echinaforce group. Nasal secretions were analyzed for
the presence of viruses to substantiate the existence of cold infections.
The researchers concluded that the product had a very good safety
profile and was very well tolerated. They also stated that “prolonged
treatment with Echinaforce was associated with significant therapeutic benefits” and that the results from this trial “suggested that
prolonged treatment with Echinaforce was associated with significant therapeutic benefits.”
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• Premises Liability
• World Wide Coverage
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RT Specialty of Illinois, LLC is the exclusive
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• United Natural Products Alliance (UNPA)
RT Specialty is also represented as an
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The Right Solution for Life Science Risk –
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Dick Griffin at Grifcon Enterprises
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at (916) 434-8874 or
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• Clinical Trials
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Calendar of Botanical Events
�
BIT’s 1st Annual World Congress of SQ Foods-2012
�
Integrative Healthcare Symposium
February 27 – March 2, 2013 • New York, N.Y.
November 1 – 3 • Shenzhen, China
�
International Conference on Advances in Plant Sciences
November 14 – 18 • Chiang Mai, Thailand
�
False Labeling and Advertising Claims in the Food, Beverage
and Natural Health Products Industries: A Cross-Border View
November 20 • Toronto, Canada
�
First International Symposium on Medicinal Plants and
Natural Products
December 3 – 6 • Quito, Ecuador
�
Natural Products Expo West
March 7 – 10, 2013 • Anaheim, Calif.
�
8th International Conference on Herbal Medicine
April 12 – 14, 2013 • Melbourne, Australia
�
12th Annual Oxford International Conference on the Science
of Botanicals
April 15 – 18, 2013 • Oxford, Miss.
�
Psychedelic Science 2013
April 19 – 21, 2013 • Oakland, Calif.
�
Fertility & Antioxidants Therapy 2012
�
Rocky Mountain Dietary Supplement Forum
December 6 – 7 • Paris, France
September 12 – 13, 2013 • Boulder, Colo.
�
Natural Supplements: An Evidence-Based Update
January 30 – February 2, 2013 • San Diego, Calif.
Are new dietary ingredients
part of your growth strategy?
Then you need to know about New Dietary Ingredients (NDIs) and two newly
updated resources from the American Herbal Products Association:
The AHPA New Dietary Ingredients Database
The AHPA NDI Notifications Submissions Package
With more than 575 entries, the AHPA NDI Database provides
indispensable access to and understanding of notifications submitted
to the Food and Drug Administration (FDA) for new NDIs that are used
in dietary supplements. It is the only up-to-date compilation of NDI
notifications available.
The AHPA NDI Notifications Submissions Package contains the tools
you need to successfully navigate FDA’s NDI notification requirements:
This subscriber-based database also provides a concise “outcome
statement” for each NDI file that quickly summarizes how FDA has
responded to every notification, and the problems—if any—that the
agency identified for each.
Subscribers will be notified by email when
additions are made to the AHPA NDI
Database.
For more information and to subscribe to
The AHPA NDI Database, click here.
¾
A 40-page Guidance for New Dietary Ingredient Notifications for
Manufacturers and Distributors of New Dietary Ingredients
(updated June 2011) explains the NDI regulations, details what
information to include—and exclude—in a notification, and
provides three hands-on worksheets
¾
The transcript and audio file of an AHPA-sponsored teleseminar
conducted by industry legal, nutrition and regulatory experts
¾
A tour and demonstration of the AHPA NDI Database
¾
A Food and Drug Law Journal article by Michael McGuffin, AHPA
President, and Anthony Young, AHPA General Counsel, titled,
“Premarket Notifications of New Dietary Ingredients: A Ten-Year
Review”
Purchasers will automatically receive an update of the Guidance for
New Dietary Ingredient Notifications for Manufacturers and Distributors
of New Dietary Ingredients shortly after the release of FDA’s guidance
document on NDIs.
AHPA members receive a $370 discount per year
For more information and to order the AHPA NDI Notifications
Submissions Package, click here.
AHPA members receive a $300 discount
301-588-1171 • 301-588-1174 fax
ahpa@ahpa.org • www.ahpa.org
8630 Fenton Street, Suite 918, Silver Spring, MD 20910
A spe ci al th an k you to ou r
5 + Year Members
A.M. Todd Botanical Therapeutics
Whole Foods Market
CANTOX Health Sciences International
Blue Poppy Enterprises
Acadian Seaplants, Ltd.
Chemical Solutions Ltd.
Coltsfoot, Inc.
Amin Talati Law
Draco Natural Products
DMD Pharmaceuticals
Beehive Botanicals, Inc.
Drucker Labs
Emerson Ecologics
Greenberg Traurig
Duncan's Botanical Products, Inc.
Gemini Pharmaceuticals, Inc.
New Chapter, Inc.
Foodscience Corporation
Heritage Store, Inc.
Oregon's Wild Harvest
Gradient Corporation
MB North America
Organic India USA
Himalaya Herbal Healthcare
Metagenics, Inc.
PhytoLab GmbH & Co. KG
Life Line Foods, LLC
Mountain Rose Herbs
RainTree Nutrition, Inc.
Market America
Natura Health Products, Inc.
Solgar Vitamin & Herb
Martin Bauer, Inc.
Novel Ingredient Services, LLC
Strategic Sourcing, Inc.
MOLEAC
Nutrition Now, Inc.
Synergy Production Laboratories
Neways International
High Quality Organics
Animal Essentials, Inc.
Origana Nutraceuticals, Inc.
Paradise Herbs & Essentials, Inc.
Aveda Corporation
Poms & Associates
Paragon Laboratories
Ayurvedic Institute
Purapharm International (HK) Ltd.
Ridge Runner Trading Company, Inc.
Bioforce USA
United Nutrition LLC
Trace Minerals Research
Energique, Inc.
Botanics Trading, LLC
Verdure Sciences (Geni Herbs)
Herbal Extracts Plus, Inc.
Concordia Partners LLC
Benedictine Healing Products
Herbal Teas International
Earthrise Nutritionals
BI Nutraceuticals
Herbco International, Inc.
Guayaki S.R.P., Inc.
Bionorica AG
Irwin Naturals
Herbalife International, Inc.
CAMAG Scientific, Inc.
Medical Horizons, Inc.
Komal Herbals, Inc.
Evergreen Herbs & Medical Supplies
Natural Health Products Directorate
Kroeger Herb Products
Far East Summit, LLC
Ohio River Ginseng & Herb
Lang Naturals, Inc.
General Nutrition (GNC)
Oriental Herb Company
Pure Encapsulations
Hansen Beverage Company
QuantaFoods, LLC
St. Francis Herb Farm, Inc.
Memory Secret, Inc.
Sabinsa Corporation
Swanson Health Products
Neos Therapeutics (PharmaFab)
Wilson Fur & Ginseng
Tango Advanced Nutrition
Northland Ginseng Farms, Inc.
Auburn Laboratories, Inc.
Tazo Tea Company
Tishcon Corporation
Vitamin Shoppe Industries, Inc.
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