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here - American Herbal Products Association

The Official Publication of the American Herbal Products Association
July 2011
www.ahpa.org
Volume 30, Number 7
In this issue of the AHPA Report
Inside AHPA
2
• AHPA Relaunches Expanded NDI Database and Updated Notifications Submissions Package
• Microscopic ID of Popular Botanical Materials Seminar Set for October 1-2
• Donations for Botanical Safety Handbook Soar
• Findings from AHPA-ERB Foundation-funded Ginseng Report Presented at Forest Ecology Conference
• Dietary Supplement Caucus Hosts Tenth Capitol Hill Briefing
• McGuffin Highlights Value of AHPA’s Work at ODS Practicum
• AHPA’s Lampe Receives NPA Champion Award
• Savings Opportunities for AHPA Members
Special Topics 10
• The Food Safety Modernization Act: A Review of Implementation Meetings and Strategies
by Merle Zimmermann, Ph.D., AHPA Information Analyst
• California Plaintiffs Can More Easily Sue Companies over Misleading “Made in U.S.A.” Claims
by Linda Dougherty, Esq., Ullman, Shapiro & Ullman
Legal & Regulatory 14
• FDA Releases NDI Guidance; AHPA to Host NDI Seminar
• Latest Dietary Supplement Proposition 65 Settlement Proposed for $80,000; Complaints Continue to
Be Filed by Michael McGuffin, AHPA President
• Sens. Durbin and Blumenthal Introduce Dietary Supplement Legislation in the Senate
• Consent-Decree Conviction and Dividing Up Ill-Gotten Gains by Anthony L. Young, Esq., Partner,
Kleinfeld, Kaplan and Becker, LLP, and AHPA General Counsel
• Four Marijuana Bills Introduced in the House; DOJ Memo Creates Regulatory Concern for States
by Michael McGuffin
• Sens. Hatch and Harkin Express Support to FDA’s Hamburg for Upcoming NDI Guidelines
Botanical Science Update 21
• Meetings Attended
NCCAM Stakeholder Roundtable and Advisory Board Meetings by Steven Dentali, Ph.D.
• Request for Proposal: ODS Analytical Methods for Dietary Supplements
• Literature Citations by Steven Dentali, Ph.D.
FDA Collaborative Validation of Pesticide-Residue Analysis; FDA Finds Pesticides Must be
5-10 ppb to Consistently Measure; Using Genetics and Chemistry to Determine Natural
Product Origin; The Beginning of the End of ORAC Marketing?; Synergists in Goldenseal;
“Coffee Table” Book on Chocolate; Beyond Açaí: Four Under-Utilized Fruits of the Amazon
Region; Website Info for St. John’s Wort Rated as Poor; St. John’s Wort for Moderate
Depression: Better and Longer Lasting
Calendar of Botanical Events 25
Inside AHPA
AHPA Relaunches Expanded NDI
Database and Updated Notifications
Submissions Package In anticipation of the July 1 release of the Food and Drug
Administration’s (FDA) guidance on new dietary ingredients
(NDIs), the American Herbal Products Association (AHPA) has updated and relaunched two important resources for dietary supplement companies that include NDIs in their products.
The newly revised AHPA NDI Database and the AHPA Notifications
Submissions Package are available to AHPA members at a sizeable
discount.
Both products are designed to assist companies that intend to sell an
NDI or a dietary supplement that contains an NDI. The Federal
Food, Drug, and Cosmetic Act (FFDCA) as amended by the Dietary
Supplement Health and Education Act of 1994 defines a “new dietary ingredient” as one that was not marketed in the United States
prior to October 15, 1994.
In order to comply with this law, companies that intend to sell an
NDI or a dietary supplement that contains an NDI must first submit a notification to FDA that includes information that is the basis
for the company’s conclusion that the dietary supplement will “reasonably be expected to be safe.”
With these unique, newly updated NDI products, AHPA is able to
offer its members—and the supplement industry at large—the stepby-step tools they need to file successful NDI notifications.
“Both of these newly updated resources provide leading-edge, how-to
information and time- and money-saving materials to help AHPA
member companies successfully navigate the complexities of the NDI
submissions process,” said AHPA President Michael McGuffin. “With
the database and guidance updates we will provide to purchasers,
these products will continue to provide the best information on this
most important regulatory process long into the future.” 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.
The AHPA NDI Database—Relaunched and
Expanded
With more than 575 entries, the AHPA New Dietary Ingredient
(NDI) Database provides indispensable access to and understanding of notifications submitted to FDA for new NDIs that are used
in dietary supplements. It is the only up-to-date compilation of NDI
notifications available.
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.
As part of the subscription, AHPA members will be notified by
email when additions are made to the AHPA NDI Database.
Additionally, AHPA members will receive a $370 per year discount
when they subscribe.
For more information and to subscribe to The AHPA NDI Database,
click here.
The AHPA NDI Database is a
joint project of AHPA, which is
responsible for its content, and
NPIcenter, part of the New Hope
Supply Network, which provides
technical support to maintain the database.
The AHPA NDI Notifications Submissions
Package—Newly Revised and Updated
The AHPA NDI Notifications Submissions Package contains the
tools needed to successfully navigate FDA’s NDI notification
requirements:
A 40-page Guidance for New Dietary Ingredient Notifications for
Manufacturers and Distributors of New Dietary Ingredients
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
Rosie Ysasi, Certification Program Coordinator
Merle Zimmermann, Ph.D., Information Analyst
Anthony Young, General Counsel, Kleinfeld, Kaplan & Becker
Peter Evich, National Legislative Consultant, Van Scoyoc Associates
Kellie Greene Design, Layout & Production, AHPA Report
Monica Emerich, Ph.D., Copy Editor, AHPA Report
Bill Schoenbart, D.A.O.M., Proofreader, AHPA Report
July 2011 • 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: [email protected]
Website: www.ahpa.org
© Copyright 2011, American
Herbal Products Association
(updated June 2011) explains the NDI regulations, details
what information to include—and exclude—in a notification,
and provides three hands-on worksheets
The transcript and audio file of an AHPA-sponsored teleseminar
conducted by industry legal, nutrition, and regulatory experts
A tour and demonstration of the AHPA NDI Database
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 will receive a $300 discount when they purchase
this package.
For more information and to order the AHPA NDI Notifications
Submissions Package, click here.
Click here to view an article on the AHPA NDI products and an
interview with AHPA President Michael McGuffin at
NewHope360.com.
AHPA’s Michael McGuffin participates in successful
fundraiser for Sen. Tom Harkin
Michael McGuffin, AHPA president (r.), joins Sen. Tom Harkin,
D-Iowa, at a fundraiser for Harkin that was held at the Natural
Products Association Marketplace conference and trade show on
June 24 in Las Vegas. McGuffin was a host of the fundraiser.
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Microscopic ID of Popular Botanical
Materials Seminar Set for October 1-2
In order to assist manufacturers and suppliers in meeting the burdens of verifying the identity of botanical ingredients under the
Food and Drug Administration’s good manufacturing practice
(cGMP) and to protect them from potential liability, the American
Herbal Products Association (AHPA) is presenting a two-day educational training program, “Microscopic Identification of Popular
Botanical Materials.”
The hands-on program is scheduled for the weekend of October
1-2, 2011, at Rutgers University in New Brunswick, N.J. Elan
Sudberg, CEO of Alkemist Pharmaceuticals, will teach the course.
The federal cGMP regulation (21 CFR 111) requires that all dietary
ingredients be tested or examined to verify identity prior to use in a
finished product.
The material presented will familiarize participants with the various
plant parts at the macroscopic level to create an understanding of
the characteristic cellular features of each plant part using botanicalmicroscopy techniques developed over the last century by botanists
all over the world.
“It was probably one of the most useful ‘short courses’ I’ve ever taken,” says David R. Schroeder, who works in the quality control division for Standard Process, Inc., in Palmyra, Wis. “I’d done a lot of
reading on botanical microscopy, but none of it was really ‘clicking’
until I took this course.” Program Goals
The program’s overall goal is to have participants leave with the experience necessary to confidently conduct microscopic analysis on a variety of popular botanical ingredients. Additional program objectives:
Provide the beginning to intermediate microscopist the skills
and ability to confidently and competently analyze popular
botanical ingredients often used in commercial products
Provide hands-on experience: The majority of the program
(~75%) will be spent on the use of the microscope and the
analysis of botanical materials, including:
»» Example preparation and review
»» Identification of adulterated material, including common
fillers used to “cut” materials, such as flow agents & soluble
excipients
»» Connecting the dots: Comparing a Certificate of Analysis
(COA) and specifications to micro-analysis results;
General background on microscopy and usage of a microscope
Identification of appropriate reference resources:
»» Voucher specimens
»» Published references.
Information will be presented in morphological groups such as
barks, roots, leaves, seeds, etc., and their characteristic microscopic
components. The basic structure of the various tissue types will be
discussed and identified using actual examples from a vast database
of microscopic botanical images. Participants will spend a significant amount of time during the program conducting hands-on
training using a microscope. Equipment, chemicals, and supplies
will be discussed, if time permits and/or if requested.
Who Should Attend?
The “Microscopic Identification of Popular Botanical Materials”
seminar is geared toward laboratory personnel, QA/QC personnel,
dietary supplement companies looking for economical means to
comply with the cGMP requirements regarding establishing identity, or anyone with an interest in utilizing microscopy as a tool for
the identification of botanicals.
For Registration and More Information
To register and for more information, visit the seminar page on the
AHPA website, contact Devon Powell via email, or call 301.588.1171,
ext. 102.
Donations for Support of Botanical
Safety Handbook Soar
After a series of email outreaches and personal calls by members of the
Development Committee of the American Herbal Products Association
(AHPA) Education and Research Foundation on Botanicals (AHPAERB Foundation), donations to support the publication of the upcoming, revised edition of the Botanical Safety Handbook (BSH) saw a large
spike during the months of May and June.
As a result of these efforts, a number of companies and individuals
have joined or made additional donations in support of the BSH:
At the $,5000 level:
Bodybuilding.com, The Hain Celestial Group, Herbalife
$4,000: Rainbow Light, Traditional Medicinals
$2,500: Herb Pharm
$2,000: Frontier Natural Products
$1,000: Alkemist Laboratories, Iovate Health Sciences,
Motherlove Herbal Company, Nuherbs, Paragon
Laboratories, Sabinsa
$500: American Botanical Council, BI Nutraceuticals,
Beehive Botanicals, Dicentra, EuroPharma, St. Francis
Herb Farm, Mountain Meadow Herbs, Pacific Botanicals,
Pharmline
$250: Earth Mama Angel Baby, Evergreen Herbs
$100: Dagmar Goldschmidt, Howard Miller
“Thanks to the generosity of these industry leaders, we’re closer than
ever to reaching our donor goal for the BSH,” noted Beth Lambert,
chair of the AHPA-ERB Foundation. “All of us working on this
important project thank these new donors, who join a growing list
of progressive companies and individuals that have made the support of the new BSH a priority.”
Supporters will be recognized as a named supporter of the revised
edition.
The new edition of the BSH will update this classic text with significantly expanded information on more than 500 herbs. It is the
product of a four-year collaboration of AHPA’s high-caliber research
and review team of experts in the fields of traditional herbalism,
conventional medicine, toxicology, botany, and other areas.
There is still time to make an annual pledge or one-time, tax-deductible contribution to support the distribution and continued development of this highly informative, clinically relevant publication.
The levels of support are listed below, along with the other donors
that have given generously to the BSH project.
Visionary ($10,000+): Herbs, Etc.
Benefactor ($5,000+): Aveda, Herb Pharm, Nature’s Way,
Traditional Medicinals
Champion ($2,500+): Amin Talati, CRC Insurance, Emerson
Ecologics, Frontier Natural Products, General Nutrition
Centers, Michael McGuffin, Pacific Nutritionals, Systemic
Formulas
Sponsor ($1,000+): Arise & Shine, Bent Creek Institute,
Herbalist & Alchemist, Mountain Rose Herbs, NOW Foods,
Jim Prochnow, Vitality Works
Advocate ($500+): Jon Beninger, Steven Dentali, Beth
Lambert, New Chapter
Supporter ($250+): Bighorn Botanicals, Mary Beth Watkins
Other Supporters: Cindy Angerhofer
See the AHPA-ERB Foundation website and click on “Make a
Donation” for the benefits associated with each level of support and
for more information, or contact Devon Powell, 301.588.1171, ext.
102, to contribute today.
The AHPA-ERB Foundation is a non-profit 501(c)(3) educational
foundation founded by AHPA for the purpose of promoting education and research on medicinal, therapeutic and health-promoting
herbs. Information on completed and current projects is available
online at www.AHPAFoundation.org. Findings from AHPA-ERB Foundationfunded Ginseng Report Presented at
Forest Ecology Conference Speaking on June 23, 2011, at the 8th North American Forest
Ecology Workshop, held in Roanoke, Va., James Chamberlain,
Ph.D., research forest products technologist at the National
Agroforestry Center of the U.S. Department of Agriculture Forest
Service, presented research about wild-crafted American ginseng
(Panax quinquefolius L.) from an unpublished report funded by the
American Herbal Products Association Foundation for Education
& Research on Botanicals (AHPA-ERB Foundation).
With support from the AHPA-ERB Foundation, Virginia Tech and
the Forest Service, Chamberlain’s presentation, “Relationships
Between Harvest of American Ginseng and Hardwood Timber
Production,” examined the relationship between the reported harvest of American ginseng and hardwood timber in the forests of the
eastern United States.
“American ginseng has been collected from eastern hardwood forests
and has added significantly to the economy of rural America for
hundreds of years,” Chamberlain said. “The harvest of ginseng and
timber are closely related; often loggers were digging ginseng, as
well. We found that on average, American ginseng provided close to
$25 million to the economies of the rural eastern United States every year from 2000 through 2007.” The study found no relationship between the harvest of ginseng and
the amount of public forest lands in counties from which it was collected. “We did find a strong relationship between forests with large
trees and ginseng harvest; as forests mature and produce larger trees,
ginseng harvest increased,” Chamberlain said. “This study demonstrates the importance of having good data on
medicinal forest products and providing transparency to these important forest natural resources. Through these and future efforts,
the industry, academia, and the government can work together to
help improve the sustainability of the plants that are critical to the
herbal medicine industry,” he added. some of the challenges and opportunities faced by forest ecologists
working in the southeastern United States—a region dominated
by short-rotation pine plantations.
The AHPA-ERB Foundation is a non-profit 501(c)(3) educational
foundation founded by AHPA for the purpose of promoting education and research on medicinal, therapeutic, and health-promoting
herbs. Information on completed and current projects is available
online at www.AHPAFoundation.org.
“The U.S. Fish and Wildlife Service has compiled data on ginseng
harvests for more than 25 years,” noted Michael McGuffin,
American Herbal Products Association (AHPA) president and an
AHPA-ERB Foundation board member. “The foundation believes
that it is essential to the understanding of the commerce of wildharvested plants to have specific data about that level of commerce,
in this case, American ginseng. This is especially important when we
recognize the importance of the wild-harvesting of medicinal plants
in rural areas with high unemployment.”
Dietary Supplement Caucus Hosts Tenth
Capitol Hill Briefing
An article co-authored by Chamberlain that includes some of the
findings from the AHPA-ERB Foundation report has been submitted to a peer-reviewed journal for publication.
The most recent Capitol Hill-based luncheon briefing, held on June
15, was filled to capacity with more than 125 people present, and
featured two speakers: former linebacker for the Chicago Bears and
National Football League Hall of Famer Dick Butkus; and sports
dietitian Dave Ellis, anti-doping chair and president of the Collegiate
and Professional Sports Dietitians Association.
The North American Forest Ecology Workshop allows forest ecologists from Canada, Mexico, and the United States to gather and
exchange current research and management approaches. The conference theme, “Forest Ecology in a Managed Landscape,” reflects
The Congressional Dietary Supplement Caucus (DSC), in cooperation with four supplement industry trade associations—the
American Herbal Products Association, the Council for Responsible
Nutrition, the Natural Products Association, and the United Natural
Products Alliance—reached a milestone in hosting its tenth DSC
Briefing on Capitol Hill since June 2008.
Ellis focused on the importance of proper nutrition for athletes and
how supplements can play a valuable role in meeting the increased
nutrient requirements due to depletions resulting from intense exercise and training. He advised athletes to focus on four key areas—including properly managing their food supply; being aware of which
dietary supplements are “permissible;” getting consistent periods of
rest; and making sure they get adequate amounts of quality foods.
Ellis said proper nutrition is a powerful tool that “can really help an
athlete outwork the competition.”
Butkus discussed his “I Play Clean” campaign, a national initiative
geared at educating high school athletes about the impact and
physical consequences of illegal anabolic steroid use. He also noted
the difference between illegal steroids and dietary supplements,
stating: “Dietary supplements are not steroids and steroids are not
dietary supplements. There is a legitimate role for supplements in
sports nutrition, with products like multivitamins, protein bars,
powders, to name a couple.” Butkus continued: “There is no place
[in sports] for products that are tainted with steroids or prescription drugs and are then illegally marketed as dietary supplements.”
He pointed to the need to educate parents, athletes, and team
leaders about nutrition and proper training as strategies to help
discourage young athletes from using anabolic steroids. More information, including a public service announcement, is available
on the “I Play Clean” website.
The dietary supplement industry trade associations are also concerned that athletes may be unable to distinguish between legitimate
dietary supplements and products that are illegally marketed as dietary supplements but in fact contain anabolic steroids or other
pharmaceutical ingredients; therefore, the industry joined forces
with the Food and Drug Administration last December to support
strengthened education and enforcement efforts in this area.
McGuffin Highlights Value of AHPA’s
Work at ODS Practicum
On June 8, 2011, American Herbal Products Association (AHPA)
President Michael McGuffin provided examples of AHPA’s activities
on behalf of the herbal products industry during the National
Institutes of Health (NIH) Office of Dietary Supplements’ (ODS)
2011 Mary Frances Picciano Dietary Supplement Research Practicum.
McGuffin’s presentation was part of the four-day practicum, held on
the main NIH campus in Bethesda, Md., June 6-9.
At the invitation of ODS, McGuffin joined teachers and doctoral or
post-doctoral students with an interest in dietary supplement use,
regulation, and policy in “A Conversation with the Industry.” In addition to the educational sessions, practicum participants met with
various stakeholders—Congressional representatives, the dietary
supplement industry, consumer advocacy groups, and media—who
study, advocate, regulate, or educate about dietary supplements.
McGuffin provided an overview of AHPA’s emphasis on representation, education, communication, and industry self-regulation. He
also highlighted some of AHPA’s specific work in protecting the
marketplace, including the association’s leadership in gaining passage of the Dietary Supplement and Nonprescription Drug
Consumer Protection Act, the law that instituted mandatory reporting of serious adverse events for both dietary supplements and nonprescription drugs. Additionally, he discussed AHPA’s current
process for revising its seminal work on herbal safety, the Botanical
Safety Handbook, and described the creation and maintenance of the
AHPA New Dietary Ingredient Database.
“The annual ODS Practicum provides an excellent forum for academics and others with an interest in supplement research and education to gain a better understanding of this product class,” said
McGuffin. “My goal was to communicate the value that a trade association can bring to the trade, but also to consumers and to
healthcare practitioners, by strengthening the dietary supplement
law and by addressing product safety and assisting in regulatory
compliance.”
McGuffin’s ODS Practicum presentation is available on the AHPA
website. More information on the annual practicum is available
here.
level possible and hopefully—in some small way—contribute to the
common good.”
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:
»» American Herbal Pharmacopoeia, 10% off for AHPA
members (page 19)
»» AHPA NDI Database and NDI Notifications Submissions
Package, members-only offers (page 24)
»» CPG Jobs, 15% off for employers (page 5)
»» TSYS Merchant Solutions, members-only offer (page 9)
»» The Tan Sheet, $360 off of new subscriptions (page 11)
To learn about AHPA’s revision of the Botanical Safety Handbook,
visit the AHPA Foundation for Education and Research on
Botanicals (AHPA-ERB Foundation) website.
AHPA’s Lampe Receives NPA Champion
Award
At a ceremony held during the 2011 Natural Products Association
MarketPlace conference and trade show in Las Vegas from June 2325, Frank Lampe, the director of communications for the American
Herbal Products Association, received the organization’s Champion
Award, which is given to industry members for making notable contributions to the natural products industry above and beyond commercial success.
Lampe was recognized for more than 22 years of service to healthyliving media, including his role as a pioneer in the “Lifestyles of
Health and Sustainability” (LOHAS) market, where he helped identify and quantify the marketplace and oversaw the first research on
the LOHAS consumer. In 2000, Natural Business Communications,
which he co-founded, launched the groundbreaking LOHAS
Journal. He also has served as editor of Natural Foods Merchandiser,
editorial director at New Hope Natural Media, and executive vice
president of InnoVision Health Media.
During his acceptance speech, Lampe noted that his first industry
trade show was the Natural Nutritional Foods Association show in
July of 1988, also in Las Vegas. “What gets me out of bed each
morning and what drives me is the focus, the dedication, the values,
the passion and the willingness to share of all the people I’ve met
and admired who make the world a better place,” he said. “It’s what
has pushed me every single day to do my own work at the highest
Special Topics
The Food Safety Modernization Act:
A Review of Implementation Meetings
and Strategies
by Merle Zimmermann, Ph.D., AHPA Information Analyst
The Food Safety Modernization Act (FSMA), passed by Congress in
December 2010 and signed by President Obama in January 2011,
has revolutionized the field of food safety. The biggest change to
food safety law since the passage of the Federal Food, Drug, and
Cosmetic Act in 1938, the FSMA empowers the Food and Drug
Administration (FDA) with extended powers in its mission of protecting the nation’s food supply and also enacts a paradigm shift in
the agency’s approach to food safety.
Instead of FDA having to primarily react to individual food hazard
events, FDA is now able to be proactive and prevent such events from
occurring at all. The new law tasks the agency and industry to apply
science-based hazard analysis and preemptive auditing to identify and
isolate questionable goods before they are released to the marketplace.
Among other provisions, the FSMA places additional responsibilities
on importers for the safety of their food products and provides FDA
with the power to detain said products when agency agents have “reason to believe” the products are adulterated or misbranded.
While the FSMA is focused primarily on food production and products, the law is of importance to dietary supplement manufacturers
and suppliers because elements of it apply to individual ingredients
and facilities both inside and outside the United States. Exemptions
exist to parts of the law applying to dietary supplement manufacturers, and these exemptions are equally applicable to both domestic
and foreign firms due to U.S. trade agreements. (See the AHPA
Updates of Dec. 20, 2010, and April 15, 2011, for further discussion
of this topic.)
FDA held several public meetings and hearings in March, April, and
June 2011 to present and discuss how FDA should implement certain
sections of the FSMA. In addition, FDA introduced a FSMA web
portal focused on the new law. New rules resulting from FSMA will
apply to all food sold in the United States, including imported food.
During all of the proceedings, FDA staff underscored the common
goal of food safety being shared by government regulation, industry,
and consumers, and how the development of the FSMA would be a
cooperative journey with government and industry working
together.
After the law’s passage, I attended the public FDA events, collecting
information and comments on the FSMA throughout the proceedings. Aside from overview speeches discussing the entire law, three
major topic groups were covered in five FDA meetings, hearings,
and media briefings over the last four months.
The FSMA and Importing Activities
The focus of the first two meetings was on the pending implementation of some of the elements of FSMA Title III, Improving the Safety
of Imported Food. More specifically, the March 29 meeting was titled, “FSMA and Imports: A New Paradigm for Importers,” and
focused on the changes directly affecting FDA and interested parties
such as growers, manufacturers, importers, and auditors. The March
30-31 meeting was called “Ensuring the Safety of Imported Foods
and Animal Feed: Comparability of Food Safety Systems and Import
Practices” and focused more on inter-government, bank, and multinational infrastructure development as opposed to individual
comments.
The first two meetings covered the same topics, however, and provided FDA ample opportunity to discuss the following sections of
the FSMA in detail:
Foreign Supplier Verification Program (Section 301)
Voluntary Qualified Importer Program (Section 302)
Building Capacity of Foreign Governments (Section 305)
Accreditation of 3rd-Party Auditors (Section 307)
During these meetings, FDA staff repeatedly stressed the risk-management nature of the new law, which requires FDA to efficiently
use its resources and to focus testing and regulation efforts on highrisk foods and food ingredients while continuing to monitor lowrisk products at a lower rate. Participation in the agency’s voluntary
supplier-verification and qualified-importer programs were suggested as ways that responsible companies could demonstrate their reduced levels of risk. FDA stated that participation in the programs
would not necessarily put shipments in an express lane though the
border, however.
The agency also recognized that U.S. trade obligations require both
domestic and foreign producers and importers to be treated on an
equal footing. It communicated its understanding of the potential
impact of new costs on small businesses and stated its intention to
minimize these while still meeting its food safety goals.
FDA promised that any new importer requirements would be clearly and widely publicized well in advance of compliance dates.
Representatives from FDA explained that the last section,
Accreditation of 3rd-Party Auditors (Section 307), will require accredited auditors to notify FDA of conditions that “could cause or
contribute to a serious risk to the public health” during both regulatory and consultative audits and welcomed further comments and
suggestions to clarify the exact scope of this section of the law.
In a recent media briefing on international drug and food issues
conducted by FDA, on June 20, 2011, these points were revisited.
FDA emphasized its commitment to international interagency cooperation and communication in implementing this part of the new
law and the importance of the third-party auditing program in vetting imports and facilities for compliance. FDA mentioned that, in
some cases, third-party auditing certification might be essential for
products to be straightforwardly imported across the border.
The agency is encouraging a position where the border crossing
would primarily serve as a checkpoint where prior data would be
reviewed and approved by the agency as opposed to its current,
more elaborate role.
The FSMA and Preventative Controls
On April 20, 2011, FDA continued its outreach program on the
FSMA law by holding a meeting entitled, “Focus on Preventative
Controls for Facilities.”
The focus of this meeting in the ongoing series was on preventative
controls used by facilities to identify and address hazards associated
with specific foods and food processes.
The FSMA sections of particular interest in this meeting included:
Inspections of Records (Section 101)
Hazard Analysis and Risk-based Preventative Controls
(Section 103)
Performance Standards (Section 104)
Fresh New Look!
Discussion primarily centered on Section 103, Hazard Analysis and
Risk-based Preventative Controls.
Hazard analysis was discussed in the framework of Hazard Analysis
and Critical Control Points (HACCP), a process where identifying
and controlling potential food-safety hazards becomes the focus of a
manufacturing safety system. This approach to product quality
originated during World War II and was utilized during the NASA
space flight program, where after-production testing to verify quality
of artillery shells and astronaut dietary meals was impractical. When
applied to food manufacturing, HACCP plans provide a systematic,
science-based method to ensure food safety. It also provides for a
new type of inspectional auditing, as a manufacturing plant’s
HACCP plan can be reviewed and validated independently of
physical inspection of the facility.
The U.S. Department of Agriculture has published a very clear, generic HACCP guide for processing plants preparing raw meat and
poultry products which, though it is focused on a different industry,
nevertheless provides good insight into applying the HACCP
philosophy.
During a breakout session discussing preventative controls, FDA
received a question from a webcast attendee regarding food categorization of high- and low-risk foods, and asking for further clarification. Jenny Scott, senior advisor to the director of the Office of Food
Safety at FDA’s Center for Food Safety and Applied Nutrition, an-
‘‘The Tan Sheet’’
NONPRESCRIPTION PHARMACEUTICALS AND NUTRITIONALS
Elsevier Business Intelligence is proud to partner with the American Herbal Products Association
to bring you special pricing for new subscriptions to “The Tan Sheet”.
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NONPRESCRIPT
ION PHARMACE
UTIC
dece mbe r 13, 2010
Dietary Supplements
People
“The Tan Sheet” does.
NBTY Appoints GE Vet
To Succeed
CEO Rudolph
“The Tan Sheet” is the best and only dedicated resource for understanding
the impact on YOUR company of these OTC issues and much more.
SPECIAL OFFER FOR AHPA MEMBERS
To start my subscription to “The Tan Sheet” (51 print issues plus free web access to
www.TheTanSheet.com) for the discounted rate of $1,435 – a savings of $360 off the
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McNeil Seeks Supr
eme
On OTC Labeling Pre- Court Opinion
emption
D S
an
FDA significantly overhau
ls a health claim
linking phytosterols
to a reduced risk
of
coronary heart disease,
expanding the
type of enriched conventi
onal foods and
forms of dietary
supplements that
can
make the claim . . .
.................
..8
New private NBTY
replaces long-tim
e
CEO Scott Rudolph
with Jeffrey Nagel,
a company outsider
and supplement
industry newcomer.
The Carlyle Group
brought Nagel in
to “support and
enhance the managem
ent team,” says
NBTY President and
Chief Financial Officer Harvey Kamil
.................
..5
On The Hill
House Adds Food Safety
To
Appropriations Bill To Resolve
Procedural Glitch
House Democrats
move to resolve a
constitutional glitch holding
up a food safety
reform bill by adding
the legislation to a
comprehensive appropri
ations bill. The
bill passes Dec. 8
by a 212-206 vote
with
food safety language
nearly identical to
the Senate’s more
limited version of
the
legislation . . . . . . .
.................
. 14
Table of Contents >
Table of Contents > 3
3
ALS AND NUTR
ITIONALS
Vol. 18, No. 50
top sto ries
FDA Expands Phytosterol
Heart
Health Claim In Propose
d Rule
PUbLISHed
WeeKLY
chiff
M
[email protected]
om
cNeil Consumer Healthc
are argues in a consum
Supreme Court’s 2009
er injury lawsuit that
the
decision in Wyeth v.
Levine does not apply
prescription pharmac
to noneuticals because OTC
different regulatory
and Rx drugs are covered
labeling schemes.
by
In a writ of certiora
ri petition for a Supreme
Johnson & Johnson
Court hearing filed
subsidiary asks the
Nov. 30, the
court to weigh in on
up McNeil v. Valdes,
this issue by taking
in which McNeil appeals
a July 2009 ruling
Court of Appeal of
by the Third District
Florida.
Louis Bograd, an attorney
who works closely
rejects McNeil’s stance
with the trial lawyers’
on the Wyeth case,
association,
in which the Supreme
6-3 that FDA-approved
Court determined
labeling for prescrip
tion drugs does not
from seeking persona
preclude patients
l injury claims under
state tort laws (“High
Levine Ruling Returns
Court’s Wyeth v.
Pre-emption Status
Quo,” “The Tan Sheet”
March 9, 2009).
Bograd, of the Center
for Constitutional Litigatio
pre-emption issue
n, says the court’s
for drugs in Wyeth,
ruling on the
and the relative lack
rounding pre-emption
of controversy surfor OTCs, makes the
justices unlikely to
v. Valdes.
grant cert to McNeil
”Generally speaking
, absent a conflict
between
courts, the Supreme
the decisions of two
Court relatively rarely
appellate
takes a case,” added
litigation counsel at
Bograd, senior
Washington-based
CCL.
Bograd frequently
writes amicus briefs
on behalf of the America
Justice, which in 2008
n Association for
voiced objections to
FDA movement toward
empting liability claims
a policy of prelinked to OTCs (“Tort
Attorneys Concern
Pre-emption Describe
ed By State Claim
d In OTC Rule,” “The
Tan Sheet” Oct. 13,
2008).
Circumventing Wyeth v.
Levine
The family of Armand
o Valdes sued McNeil
in 1999 under Florida
after the then-16-year-old
state tort law
allegedly consumed
caffeine plus a Tylenol
taining pseudoephedrine
product con, then suffered heatstro
while playing roller
ke and cardiorespirator
hockey, leaving him
y arrest
permanently disabled
.
As far as Wyeth v.
Levine is concerned,
and
as the Valdes family
labeling mandated
argues, the drug
by FDA does not prevent
companies from adding
the combination of
PSE, caffeine and physical
warnings that
activity creates heart-re
But McNeil claims
lated
risks.
FDA’s OTC monogra
ph labeling requirem
difference between
ents create a material
OTCs and prescription
drugs, for which manufac
ster label warnings
through a “changes
turers can bolbeing effected” procedu
re.
To sign up for FREE
ONLINE ACCESS,
Story Continues > 4
go to: http://The
TanS
heet.ElsevierBI.
com
Offer available for new subscriptions
only. Offer expires 12/31/2011.
swered: “What is food categorization? … We were intentionally
vague in what we said here because we were hoping you would tell
us how you might categorize foods. One question: Is it high risk or
not?” This theme of public participation flows throughout FDA’s
approach to the FSMA, with the agency welcoming information on
how it should prioritize preparing best practices from existing companies and trade associations.
Codex Alimentarius standards were also mentioned as a possible
source of guidance for FDA, which the agency accepted gratefully.
The definition of a facility was also discussed, as well as the distinction between what determines a large and small facility. Due to international trade agreements, all such definitions would apply
equally to facilities stateside and overseas, and it was noted that exceptions related to “small” and “very small” businesses would need
to be written carefully to be fair and equitable to both domestic and
foreign producers. Although “small” businesses are limited to conducting operations within 275 miles from their headquarters or
within the same state, the “very small” business category had no
such restriction.
It was noted that some very large operations had 25 or fewer employees, due to efficiencies gained in automating their facilities.
FDA stated that it would consider the suggestions carefully to ensure that small businesses were not unfairly burdened.
FDA suggested working with industry representatives to conduct
safety and/or HACCP training for small businesses. The agency was
interested in leveraging preexisting organizations and programs to
distribute information.
Following further discussion, attendees requested that FDA issue
clear and direct guidance documents on the new laws to make it
easier for small businesses to educate themselves about compliance
with new and upcoming regulations. When asked about a particular
guidance, which did not yet exist, FDA staff stated that it would be
added to the list of documents to be produced.
FDA representatives agreed on the importance of clear documentation and requested that comments be submitted to the FSMA dockets requesting any guidances that are needed so that the agency
could prepare them and avoid future confusion.
FSMA’s Inspections and Compliance Provisions
On June 6, 2011, FDA engaged the community once more with a
public meeting titled, “FDA Food Safety Modernization Act: Focus
on Inspections and Compliance Provisions.”
At the meeting, FDA provided a forum for interested persons to address the guidance, regulation, and/or the implementation activities
related to the following topics:
Enforcement Authorities
Frequency and Targeting of Facility Inspections
Manner of Inspection in a Preventative Controls Environment
Enhancement of the Reportable Food Registry
Several key themes reappeared throughout the discussion.
During a discussion on how best to identify risk across the large
variety of different manufacturing approaches and facilities, it was
suggested by interested parties to conduct a joint FDA-industry
study on well-blinded data from across the entire production process. Collected data could include results from a variety of different
tests, biological and otherwise. The study might be a good way to
identify high- and low-risk conditions in practical situations, providing concrete safety data across a wide spectrum of manufacturing
methods.
FDA, however, expressed disinterest in participating, noting a potential conflict of interest that might arise if the agency handled
the blinded, raw testing data: as the participants would be anonymous, if FDA became aware of a potential food-safety issue from
the study data, the agency would be unable to fulfill its responsibilities to take regulatory action. Nevertheless, the agency agreed
that the information garnered from such a study would be invaluable in a science-based determination of food risk and reacted
positively to the idea that industry could conduct such studies
independently and report bottom-line results to the agency, which
could then use them to enhance its food safety activities under the
FSMA.
Further discussion of how FDA would allocate its inspection resources for the greatest benefit focused on the need for FDA to develop a matrix-based approach that would allow investigators to
consider the qualities of facilities and their operators along with the
products they were involved in producing. Third-party auditing was
suggested—along with food-risk assessment and HACCP-plan evaluation of manufacturing processes—as a means of deciding which
facilities most needed inspection.
Attendees recommended FDA require all manufacturing operations
to submit HACCP plans on request to avoid document management issues and an unfair burden to small operators who might not
have dedicated HACCP officers.
Discussion at the meeting also touched on the additional powers
given to FDA regarding product recalls and product holding. It was
generally agreed that the FSMA, aside from granting the agency additional enforcement options, required it to use these extended enforcement powers in a responsible and clear fashion.
Some of those present requested that FDA issue a guidance as soon
as possible clearly explaining its uses of its new enforcement responsibilities and how they would fit into the current system of warnings
and actions. It was also discussed that although FDA inspectors
would initiate some of these new enforcement activities, the responsibility for any actions clearly needed to remain with commissionerlevel agency personnel, as the law states.
Conclusion
The FSMA is clearly a game changer in the food safety field. The
new focus on risk-analysis activities from FDA and its willingness to
modify its point of view in response to comments from interested
parties makes participating in these proceedings of high importance
for industry.
The new law requires FDA to increase the frequency of inspections
to at least once every five years for low-risk facilities and products,
and once every three years for high-risk facilities and products.
The American Herbal Products Association (AHPA) already has
guidances available to assist with inspection proceedings and other
essential topics. These are available in the bookstore on the AHPA
website.
Further information on the three meetings held between FDA and
industry is available. FDA has posted agendas and webcasts of the
proceedings, available on-demand on the agency’s website:
Importing and Foreign Inspection Provisions of FSMA,
March 29, 2011
Preventative Controls in FSMA, April 20, 2011
Inspections and Compliance Provisions of FSMA,
June 6, 2011
FDA is continuing to accept general written comments on FSMA,
and AHPA’s Government Relations Committee is reviewing the
process in the interim and plans to provide commentary. Please contact Michael McGuffin if you would like to participate in AHPA’s
review or would like to contribute to the comments.
California Plaintiffs Can More Easily Sue
Companies over Misleading “Made in
U.S.A.” Claims
by Linda Dougherty, Esq.
Both federal law and California law prohibit the false or misleading
use of “Made in U.S.A.” claims on product labels. Such claims include any indication on the label that the product is domestically
made (such as “Made in U.S.A.,” “Made in America,” “U.S.A.,” an
American flag symbol, etc.). Under the Federal Trade Commission’s
(FTC) standard, such a claim is deemed misleading unless “all or
virtually all” of the costs associated with the product are domestic in
origin. Thus, under federal law, it is possible for a product to lawfully make a “Made in U.S.A.” claim even if the product contains
some minimal amount of foreign content.
However, products sold or offered for sale in California must also
comply with California’s standard, which is much more stringent
than the FTC’s standard. Under California law, a “Made in U.S.A.”
claim is deemed misleading whenever “the merchandise or any article, unit, or part thereof, has been entirely or substantially made,
manufactured, or produced outside of the United States.” In other
words, if any one component or ingredient of the product is imported, the product may not make a “Made in U.S.A.” claim under
California law, regardless of how minimal that one component or
ingredient is in relation to the overall product.
In addition to California’s stricter standard, California differs from
federal law in that the California law provides for a private right of
action. This means that a class-action consumer lawsuit may be
brought against a company that makes products sold in California if
the products bear a “Made in U.S.A.” claim that does not comply
with the California standard.
The Kwikset case is an example of such a lawsuit. (Kwikset Corp. v.
Super. Ct., No. S171845 [Cal. Jan. 27, 2011]). In Kwikset, a consumer in California bought a lockset sold by Kwikset Corporation
that was labeled “Made in the U.S.A.” Upon learning that the lockset contained pins made in Taiwan, the consumer brought a lawsuit
against Kwikset based on the California law prohibiting the use of
“Made in U.S.A.” claims on products that contain any part that is
made outside of the United States.
In order to have standing to bring such a lawsuit in California, a
plaintiff must show that he or she “lost money or property” as a result of the label misrepresentation. In Kwikset, the plaintiff argued
that he satisfied this standing requirement insofar as he “lost” the
money he paid for the product because he would not have bought it
if he had known it contained foreign parts. The defendant company
countered that a plaintiff has not “lost” any money so long as the
product was not overpriced or defective. Arguing that the lockset,
despite any label misrepresentation, was equal in value to the
amount the plaintiff had paid for it, the defendant company alleged
that the plaintiff had received the benefit of his bargain and therefore lacked standing to bring suit.
On January 27, 2011, the Supreme Court of California settled
this question in the Kwikset case, ruling that a plaintiff has satisfied the “lost money or property” standing requirement so long
as he or she would not have purchased the product absent the
label misrepresentation. In other words, if a plaintiff in California
alleges that he or she was induced to buy a product based on a
“Made in U.S.A.” claim that is false or misleading under
California’s strict standard, that plaintiff has standing to sue.
This decision drastically relaxes the standing requirement, thereby making it easier for plaintiffs in California to sue companies
over label misrepresentations.
While every company must be aware of the FTC standard, companies selling products labeled “Made in U.S.A.” in California are well
advised to take steps to ensure that their products satisfy California’s
stricter requirements for making such claims.
Linda Dougherty, Esq., is an associate of the law firm of Ullman,
Shapiro & Ullman, LLP.
This article originally appeared in the February 2011 issue of Inside
Aloe, the official publication of the International Aloe Science Council.
Legal & Regulatory
FDA Releases NDI Guidance; AHPA to
Host NDI Seminar
The U.S. Food and Drug Administration (FDA) on July 1 posted its
long-awaited guidance for new dietary ingredients (NDIs). The
guidance, called “Draft Guidance for Industry: Dietary Supplements:
New Dietary Ingredient Notifications and Related Issues,” can be
accessed by clicking on the above title. A preliminary review of the guidance indicates that it is a combination of reinterpretation of certain elements of the existing law and
specific suggestions to assist companies in providing the information
needed to avoid having FDA identify concerns or objections to an
NDI notification. American Herbal Products Association (AHPA)
staff and counsel will be reviewing this guidance in greater detail
over the next several days.
“Even though the guidance is not binding, we should all be concerned about any attempt by FDA to use this forum to change the
rules and practices that have been accepted and in place for 17
years,” commented Michael McGuffin, AHPA president. “At the
same time, it appears that the agency has learned from the process of
reviewing submitted notifications, and has described, for the first
time, at least some of its expectations for the content of NDI
notifications.”
The AHPA Government Relations Committee will be preparing
comments to submit to FDA on the draft guidance, as needed.
Please contact Michael McGuffin if you would like to be involved in
this review process.
McGuffin was interviewed for an article on the NDI guidance that
was posted on the NewHope360.com website on July 1. You can
access that article here.
Additionally, AHPA will host an educational seminar, “FDA’s New
NDI Guidance: What You Need to Know.” This teleseminar will
be scheduled within the next several weeks to ensure that adequate
time is allowed to receive AHPA member input on FDA’s new
guidance. It will include a review of FDA’s new teachings and will
provide a step-by-step approach for successful submission of an
NDI notification.
Support Safety by Supporting the Botanical Safety Handbook Revision
AHPA’s Botanical Safety Handbook is a reference book that provides safety information
on more than 600 species in trade as ingredients in dietary supplements. An essential
reference for healthcare providers, consumers, retailers and manufacturers of herbal
products, its safety classifications are frequently cited in other publications.
Time for an update
• Significant herbal research has been published since the BSH was published in 1997
• A number of new ingredients are now on the market.
The revision will be based upon comprehensive literature reviews for each herb, historical uses and traditional
knowledge, and case reports of adverse reactions and herb-drug interactions, herb-drug interaction studies,
metabolism studies, toxicology studies and clinical trials.
The BSH revision is to be completed over a three-year period, and seed money for the project has been pledged
by the Office of Dietary Supplements at the National Institutes of Health, the University of Massachusetts, and
individual and corporate contributions to the AHPA-ERB Foundation.
Pledge your tax-deductible contribution today!
Contact Michael McGuffin at [email protected].
Latest Dietary Supplement Proposition 65
Settlement Proposed for $80,000;
Complaints Continue to Be Filed
by Michael McGuffin, AHPA President
Starting in April 2010 and as of June 14, 2011, a private plaintiff, San
Diego, Calif.-based Environmental Research Center (ERC), has
issued 223 (1) Proposition 65 notices—including almost 100 in 2011
alone—against 136 separate companies. Each of these notices alleges
exposure to lead (and in one case to arsenic) by one or more dietary
supplements or other natural products. Under California’s Proposition
65, “The Safe Drinking Water and Toxic Enforcement Act of 1986,”
a product that exposes a consumer to more than 0.5 mcg per day of
lead is generally required (1) to bear a “clear and reasonable” warning
that the product contains lead and that lead is “known to the State of
California to cause birth defects or other reproductive harm.”
Only nine of the companies who have received notices from ERC
have subsequently been named in complaints, which is the next step
in the legal process through which a notice is resolved. One such
complaint was filed in September 2010 against 1338299 Ontario,
doing business as Integrity Marketing, in the matter of its product,
Internal Flush®. Five retail chains were identified in separate notices
as resellers of this product (2), which ERC alleged to “cause exposures to lead and lead compounds.”
A proposed, stipulated-consent judgment, signed by both ERC
and Integrity Marketing on April 18, 2011, has now been filed in
the California Superior Court in Marin County. The judgment
would result in total settlement costs of $80,000, presumably to be
borne by Integrity Marketing rather than by the retailer defendants, each of whom is released from all claims under the terms of
the proposed judgment.
American Herbal Products Association (AHPA) members have been
informed on numerous occasions over the past year of the activities
of ERC in targeting supplement products. The activities of this
plaintiff were first reported last summer to call attention to ERC’s
first 52 notices, all of which had been issued in the prior four months
(1). Subsequent articles noted this plaintiff’s continued attention to
the supplement class (3, 4) and recorded a developing focus by ERC
Proposition 65: The Options
Companies that sell dietary supplements
and other natural products, such as protein
powders and green foods, need to be aware
of their options in dealing with Proposition
65, especially as the law affects the presence
of lead in these products. These include:
Stay Out: Restrict your sales to exclude
all California commerce, including
Internet sales and sales made by
3rd-party distributors
Stay Small: Limit the number of your
employees to not more than nine
Analyze for Lead Speciation:
Confirm that any lead present at over
0.5 mcg/day at the highest-labeled
daily dose is “naturally occurring” and
so is present “solely as a result of
natural geologic processes.”
Consultations with numerous AHPA members indicate that the three points above are
not realistic options for most companies.
The California marketplace is essential to
most natural product sales; only the smallest firms can comply with the small company exemption; the burden of proving that
lead is naturally occurring rests squarely on
marketers and is a costly process, especially
for companies with numerous ingredients.
That leaves the following options:
Analyze and Limit: Do not be the
second one to know how much lead is
in your product! AHPA has reached
agreements with analytical labs that
provide significant discounts to AHPA
members, and they will let you know if
your products contain more than 0.5
mcg/day of lead. Contact Steven
Dentali for more information.
Warn: Provide the required clear and
reasonable warning on any product lot
with greater than 0.5 mcg/day of lead.
Several companies have now taken this
approach, and it may come to be that
this labeling will become more
common, so that most products in
some classes will all provide the same
information to consumers. Contact
Michael McGuffin if you want to
discuss this option further.
Wait to Get Sued: The average
settlement to date in the natural
products category is just over
$150,000, which does not include legal
expenses. Wouldn’t you rather make a
donation to the AHPA-ERB
Foundation instead? The only feasible
ways to avoid this last option, in the
face of the ongoing attention to the
supplement product class, are either to
analyze your products and keep them
below 0.5 mcg/day of lead, or consider
the use of product-warning labels.
Are there other options? Many in the industry have suggested that new ideas need
to be explored. It is generally agreed
though that the likelihood of having the
Proposition 65 law overturned is very low;
the state legislature can only amend it by a
two-thirds majority and only “to further
its purposes,” and there is little evidence to
suggest that the citizenry would vote to
overturn the “Safe Drinking Water and
Toxic Enforcement Act” (Proposition 65’s
formal name). The idea of federal preemption has been examined for many years
with no success.
If you have any new ideas on this issue, please
contact Michael McGuffin to discuss them.
But in the meantime, the first five of the
above options must be considered by all marketers doing business in California—as the
last one is the default option and will be selected not by you, but by a private plaintiff.
on green foods and products in the sports supplement category (5).
In addition, AHPA and its Proposition 65 counsel, Trent Norris, from
the firm Arnold & Porter, have prepared a document that is essential
to understanding the impact of this law for supplement companies.
Any AHPA member can obtain the document, Background on
California Proposition 65: Issues related to heavy metals and herbal products, by downloading it. A more complete review of the issue is available in the form of AHPA’s educational symposium, Living with
Proposition 65: Preventative Measures & Defending Against a 60-Day
Notice, which can be purchased at the AHPA Bookstore.
Sens. Durbin and Blumenthal
Introduce Dietary Supplement
Legislation in the Senate
Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., on
June 30 introduced legislation that, according to a press release posted on Durbin’s website, “would ensure that consumers have the information they need to distinguish between products that are safe
and others that contain potentially dangerous ingredients which
haven’t been approved by the Food and Drug Administration (FDA).
1. McGuffin M. August 2010. 52 New Proposition 65 complaints filed against supplements companies; Settlements now
exceed $4 million. AHPA Report 25(8):10-11.
“The Dietary Supplement Labeling Act would improve the information available to consumers, and to curb the prevalence of drinks
and foods that are masquerading as dietary supplements as a means
of avoiding reviews and regulation by the FDA,” according to
Durbin in the release.
2. New Albertsons; CVS Pharmacy; The Kroger Company;
Rite-Aid Corporation; and Wal-Mart Stores.
According an earlier press release posted on Durbin’s site on June 27,
the bill would:
References
3. McGuffin M. September 2010. Proposition 65 redux. AHPA
Report 25(9):13.
Direct the Food and Drug Administration (FDA) to establish a
definition for “conventional foods.”
4. Denhard J. October 2010. Steady rise on Prop 65 cases. AHPA
Report 25(10):12.
Require supplement labels to disclose known risks of ingredients and to display a mandatory warning if the product
contains a dietary ingredient that may cause potentially serious
adverse events.
5. McGuffin M. February 2011. Sports supplements, green foods
targeted by Proposition 65 in 2010; Attention continuing in
2011. AHPA Report 26(2):12.
Require manufacturers to register dietary supplement products
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with FDA, and provide a description of each dietary supplement, a list of ingredients, and a copy of the label.
Require supplement labels to include a batch number.
Durbin’s June 27 press release makes it clear that he is most focused
on products in food or beverage forms and specifically mentions
several liquid brands, including Rockstar Energy Drink, 5-Hour
Energy, and Drank. The latter contains melatonin and, according to
the press release, the company rebranded the product as a dietary
supplement when FDA issued a warning letter last year, which identified melatonin as an unapproved food additive. According to
Durbin, “FDA has not yet taken action, because without a clear
definition for ‘conventional food and beverage’ it is difficult to address this kind of conflict.”
“In reviewing this press release, it appears that this bill would largely
propose legislative solutions where what is needed is regulatory enforcement,” commented Michael McGuffin, president of the
American Herbal Products Association (AHPA). “Supplements may
not be represented as conventional foods and must be labeled to
include all information—including safety information—that is material in light of the consequences that may result from their use.
And while no one will argue with the wisdom of using product lot
numbers, it is already the standard industry practice to do so.”
The most controversial part of the Dietary Supplement Labeling Act
may well be its requirement for product registration, a change that
Presents:
Durbin has sought in the past.
“AHPA is in communication with Senator Durbin’s office, and I will
be reviewing the actual legislation as soon as it is available,” added
McGuffin. “As always, AHPA’s primary focus will be on identifying
and opposing any legislation that in any way reduces consumer access to safe dietary supplements.”
Consent-Decree Conviction and Dividing
Up Ill-Gotten Gains
by Anthony L. Young, Esq., Partner, Kleinfeld, Kaplan and Becker,
LLP, and AHPA General Counsel
Signing a consent decree is serious business. Once a consent decree, a judicial decree that sanctions a voluntary
agreement between parties in a dispute, has been signed and is in
force, it must be complied with. When a company is found to be out
of compliance or evading it, the consequences can be substantial.
Quality Formulation Laboratories, American Sports Nutrition, and
the companies’ owner and managers were each found guilty of criminal contempt in violating a consent decree regarding the operation
of their dietary supplement manufacturing businesses. The consent
decree required that the defendants shut down their manufacturing
operations and not reopen their current facilities or any other ones
without first correcting these violations and getting the Food and
Drug Administration’s (FDA) approval to reopen.
The criminal contempt charges alleged that managers Ahmad
Desoky and Omar Desoky, with knowledge of the court’s order, assisted their father, company owner Mohamed S. Desoky, in violating the order, and thus were criminally liable for the violations, even
though they were not named as defendants in the original civil case.
What did they do? They set up their businesses in a separate location
in another state, almost immediately after signing the consent decree. They moved their employees and their equipment to the new
location. And they operated their former New Jersey facility in violation, as well. They were convicted on the criminal contempt charges in a jury trial
and at press time await sentencing. Really, are the cGMPs for dietary
supplements that difficult to meet?
Where Does All That Forfeiture Money Go? It’s increasingly true that crime doesn’t pay. In successfully prosecuted criminal cases, the “fruits” of any crime are seized, whether those
fruits are in bank accounts or in material assets such as big houses,
cars, or boats. For example, the Federal Trade Commission takes
seized fruits and sets up a system to try to return illegally gotten
funds back to consumers who were misled.
In the CortiSlim weight-loss dietary supplement case against
Window Rock Enterprises Inc. and Infinity Advertising Inc., Los
Angeles-based companies that sold the product, FTC took two of
the guilty parties’ homes, a boat, a car, and the title to one of the
defendant’s relative’s home (while allowing the relative to live in it
while they remained alive). In the Genescience Pharmaceuticals case, where a Chinese drug
company and its CEO were found guilty for illegally marketing human growth hormone in the United States, $4.5 million was divided
up among law enforcement offices in Rhode Island, and the defendants were required to donate $3 million to the Rhode Island
Foundation to support sports anti-doping efforts. The company had previously forfeited an additional $2.7 million in
the case.
“I am pleased that this ground-breaking federal prosecution, which
was a success on so many levels, has resulted in the distribution of
such significant, forfeited amounts to state and local law enforcement agencies in Rhode Island. The defendants paid directly for
their misconduct through the forfeiture of these assets,” noted U.S.
Attorney Peter F. Neronha.
Successful law enforcement is a growing vehicle for financing prosecutors and police forces. In California, county district attorneys’
offices use the money they receive from consumer-protection-case
awards or settlements to fund their offices. And in many states,
weights and measures enforcers do the same. In states along the
Florida–New York corridor, law enforcement is funded by the value
of seized drugs, cash, and cigarettes.
Four Marijuana Bills Introduced in the
House; DOJ Memo Creates Regulatory
Concern for States
by Michael McGuffin, AHPA President
Three bills were introduced in the U.S. House of Representatives on
May 25 that would, in the (unlikely?) event of passage, change the
way that medical marijuana is regulated in the United States.
The three bills are:
H.R. 1983: The States’ Medical Marijuana Patient Protection
Act, introduced by Rep. Barney Frank, D-Mass.
H.R. 1984: The Small Business Banking Improvement Act of
2011, introduced by Rep. Jared Polis, D-Colo.
H.R. 1985: The Small Business Tax Equity Act of 2011,
introduced by Rep. Pete Stark, D-Calif.
Each of these bills was co-sponsored by all three of these congressmen, and Rep. Ron Paul, R-Texas, joined as a co-sponsor of H.R.
1984 and H.R. 1985, as did Rep. Dana Rohrabacher, R-Calif., on
National and International
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H.R. 1983 and H.R. 1985. On May 11, Paul introduced legislation
that would legalize cultivation and processing of industrial hemp.
A short summary of these three newly introduced bills can be found
at Rep. Stark’s website in the form of a press release.
The two business-focused bills each address issues faced by companies that are engaged in medical marijuana businesses in states that
have legalized this practice. One such issue is that current law establishes reporting requirements by banks for certain banking activities
identified as “suspicious transactions” [31 U.S.C. §5318 (g)]. A suspicious transaction is defined in regulation as one that is “relevant to
a possible violation of law or regulation” [31 CFR §103.18 (a)]. The
implication of this has been that companies engaged in businesses
that are legal under state law but not under federal law are not able
to maintain bank accounts with federally chartered banks and have
encountered significant difficulties in obtaining bank loans. The
somewhat ironically numbered H.R. 1984 would address this by
exempting from these “Big Brother” reporting requirements transactions by a “legitimate business … engaged in activities that are
currently legal under State law.”
H.R. 1985 would amend Section 280E of the Current IRS Code.
This section of the IRS Code dictates that no deductions or credits
are allowed on tax returns related to any business that “consists of
trafficking in controlled substances … which is prohibited by
Federal law or the law of any State in which such trade or business
is conducted.” This bill would create a specific exemption for “sales
of marihuana … intended for patients for medical purposes pursuant to the law of a State.” Thus, companies that sell medical marijuana where this is allowed under state law would be able to comply
with the same rules as all other law-abiding federal taxpayers come
April 15 of each year.
The most broad-reaching of these bills is Rep. Frank’s H.R. 1983.
Upon passage, his bill would have the immediate effect of removing
from the federal law, that is, the Controlled Substances Act (CSA),
any prohibitions or restrictions against use, prescribing, or providing medical marijuana in states where such practices are legal. This
legislation would also initiate a process whereby the Drug
Enforcement Administration (DEA) would be required, within one
year, to issue a proposed rule in which that agency would recommend that marijuana be reclassified “as other than ‘Schedule I’ or
‘Schedule II’ substances.”
It is illegal to possess non-prescribed drugs classified in any schedule,
though some penalties are reduced for drugs in lesser schedules, so
the passage of this law would not have the effect of legalizing marijuana nationally. But it is only Schedule I—where marijuana is now
classified—that defines the drugs listed therein as having “no currently accepted medical use in treatment in the United States.”
On June 20, Reps. Polis and Frank sent a letter to Attorney General
Eric Holder, in which they expressed their view that “it is important” that the attorney general “restates the Ogden memo,” a com-
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munication dated Oct. 19, 2009, from then U.S. Deputy Attorney
General David Ogden, in which the Department Of Justice (DOJ)
expressed its intention to refrain from making “prosecutional priorities” of the use and supplying of medical marijuana in states that
have legalized such use and supply.
The following day, the Ranking (Democratic) Member of the House
Judiciary Committee, John Conyers, D-Mich., authored a letter to
Holder to “ask about the status” of the Odgen letter and to request
information “about the status of federal prosecutions in states that
have medical marijuana laws.” In his letter, Conyers also stated that
he understands that the attorney general intends to soon offer “clarifying guidance on this issue, and offers his hope that Holder “will
continue to honor the spirit” of the Ogden memo.
However, on June 29, in a memo authored by current Deputy
Attorney General James M. Cole, the DOJ instructed the head of
the DEA and officials in the U.S. Attorneys Office to treat medical
marijuana dispensaries as top priorities for prosecutors and drug
investigators.
The new DOJ memo would appear to negate the spirit of the
Ogden memo and created confusion and concern among medical
marijuana growers and sellers in those states that have made it legal for sale.
“Persons who are in the business of cultivating, selling or distributing marijuana, and those who knowingly facilitate such activities,
are in violation of the Controlled Substances Act, regardless of state
law,” the memo reads. “Consistent with resource constraints and the
discretion you may exercise in your district, such persons are subject
to federal enforcement action, including potential prosecution.
State laws or local ordinances are not a defense to civil or criminal
enforcement of federal law with respect to such conduct, including
enforcement of the CSA.”
Meanwhile, on June 23, Reps. Frank and Paul introduced a new
bill that would go much further than the three introduced in May.
The “Ending Federal Marijuana Prohibition Act of 2011” (H.R.
2306) would completely remove marijuana from the CSA, except
that it would still be unlawful to ship marijuana into any state for
a use that is illegal within that state. In other words, this bill would
transfer from the federal government and to the states full authority to control the legal status of Cannabis spp. within each state.
The legislation introduced by Frank and Paul is the first that seeks to
decriminalize marijuana since the Marijuana Tax Act was enacted in
1937. Joining Frank and Paul as co-sponsors were Reps. Steve
Cohen, D-Tenn., Conyers, Polis, and Barbara Lee, D-Calif.
The American Herbal Product Association’s Cannabis Committee
will be following these bills closely. If you have any interest in these
bills, please contact Michael McGuffin.
Sens. Hatch and Harkin Express Support
to FDA for NDI Guidelines In a letter dated June 21, 2011, Sens. Orrin Hatch, R-Utah, and
Tom Harkin, D-Iowa, expressed their support for the publication of
the new dietary ingredients (NDI) guidance to Food and Drug
Administration (FDA) Commissioner Margaret Hamburg, M.D.
Their letter also clarified their expectation that the guidance will be
consistent with the legislative compromise enshrined in the Dietary
Supplement Health and Education Act of 1994 (DSHEA).
The full letter can be accessed here. Hatch and Harkin pointed out that section 113(b) of the FDA Food
Safety Modernization Act states that FDA shall publish guidance
that clarifies when a dietary supplement ingredient is a new dietary
ingredient; when a manufacturer or distributor of a dietary ingredient should provide FDA with information described in section
413(a)(2) of the Federal Food, Drug, and Cosmetic Act; the evidence needed to document the safety of new dietary ingredients;
and the appropriate methods for establishing the identity of a new
dietary ingredient.
Their letter reiterated that the NDI guidance is to “effectuate the
regulatory balance that Congress struck in writing DSHEA” and
that it should “refrain from erecting barriers that will inhibit or
needlessly delay consumer access to safe products that were in fact
marketed in the U.S. prior to October 15, 1994.”
“The intent of the law was to ... minimize regulatory burdens that
might inhibit consumer access to lawfully manufactured and labeled
dietary supplements,” Hatch and Harkin added.
The senators also encouraged Hamburg to conduct outreach to educate manufacturers and consumers about the new NDI guidance
and FDA’s regulatory expectations in this area. “We appreciate this proactive appeal by Senators Hatch and Harkin to
Dr. Hamburg to ensure that the upcoming NDI guidance is in full
alignment with the provisions of DSHEA,” said Michael McGuffin,
American Herbal Products Association (AHPA) president.
McGuffin also noted that prior to the release of the NDI guidance
from FDA, AHPA completed revisions to two of its popular NDIrelated resources: the AHPA NDI Database, which provides access to
and understanding of the notifications submitted to FDA for NDIs
that are used in dietary supplements, and The Guidance for New
Dietary Ingredient Notifications for Manufacturers and Distributors of
New Dietary Ingredients, a 40-page, practical guidance document to
help companies file successful NDI notifications, prepared by the
AHPA Government Relations Committee. This publication is part of
the AHPA NDI Notifications Submissions Package, which is available
at the bookstore on the AHPA website (see related story, pg. 2).
Botanical Science Update
by Steven Dentali, PhD
MEETINGS ATTENDED
NCCAM Stakeholder Roundtable and Advisory
Board Meetings The National Center for Complementary and Alternative Medicine
(NCCAM) held a Stakeholder Roundtable on Tuesday, April 26, on
the National Institutes of Health (NIH) campus in Bethesda, Md. I
attended as one of about 40 participants that included representatives from the American Health Association, the American
Pharmacists Association, the American Association of Naturopathic
Physicians, the American Nurses Association, AARP, the Arthritis
Foundation, the American Medical Association, and many more.
After Josephine Briggs, M.D., NCCAM’s director, provided insight
into NCCAM’s legislative mandate, she covered the major goals of
NCCAM’s strategic plan, remarking that more than 5,000 public
comments had been received during the process of creating it. She
also focused on the importance of integration of complementary
and alternative medicine (CAM) practices and announced the
launch of the agency’s new web portal resources for healthcare providers. The remainder of the meeting was an open dialogue with the
attendee organizations.
The clear message I heard from NCCAM at this meeting was its
desire to continue to strengthen partnerships, including those with
industry. NCCAM is often seen just as a funder of research, and this
meeting highlighted the agency’s interest in industry and those with
both a practitioner and patient focus. The range of discussion during this productive exchange included curriculum development for
medical students, building the evidence for CAM modalities, and
the importance of the patient-practitioner dialogue.
I also attended the open session of the 42nd meeting of the National
Advisory Council for Complementary and Alternative Medicine,
held in Bethesda, Md., on June 3, 2011. Brian Berman, M.D., the
founder and director of the University of Maryland Center for
Integrative Medicine, was welcomed as a new member of the council. The topics covered at the meeting included outcomes and effectiveness research at NCCAM, cost minimization and analyses and
the state of Washington’s approach to CAM funding, CAM at the
Department of Veterans Affairs, and approval of a concept for a
systematic review of CAM. While not natural product oriented, this
meeting did show the progress made by NCCAM in tackling the
challenge of evaluating how CAM is actually used.
REQUEST FOR PROPOSAL
The Office of Dietary Supplements at the National Institutes of
Health has issued a request for proposals for “Analytical Methods
Development, Optimization, and Validation: Dietary Supplement
Constituents,” which is posted at FedBizOpps. Complete information can be found here and at other links on that page.
The statement of objectives in Attachment 1 (page 37 of 47) of the
application document that can be found here provides background
information and program objectives. Applicants should be in a position to conduct, support, and/or provide oversight for method development and optimization through collaborative study of
analytical methods.
This opportunity is similar to work previously carried out by the
Association of Analytical Communities (AOAC) collaborative study
directors. You may apply as an individual laboratory or you may
consider a collaborative application.
The proposal response date is July 28, 2011.
What’s In a Name?
Member Price: $79.99
Herbs of Commerce, 2nd Edition
Non-Members: $99.00
by Michael McGuffin, John Kartesz, Albert Leung and Arthur Tucker
This revised edition, published in 2000, lists 2,048 separate species, including 25 fungi and 23
seaweeds, by their Standardized Common Names and Latin binomials, and includes Indian Ayurvedic
names for more than 300 plants and Chinese (pinyin) names for 500 herbs. Also, 639 botanical
synonyms are included; older botanical names no longer accepted can be cross-referenced.
AHPA published the first edition in 1992 to reduce confusion by establishing “standardized” common
names. It was recognized and codified when FDA adopted the original edition in 1997: the common
names may be used instead of Latin binomials to identify herbal ingredients in dietary supplements.
June
May
July 2011
2011 •• Page
Page 21
21
Order online at ahpa.org
or call 301-588-1171
LITERATURE CITATIONS
FDA Collaborative Validation of Pesticide-Residue
Analysis
�Sack
C, Smoker M, Chamkasem N, Thompson R,
Satterfield G, Masse C, Mercer G, Neuhaus B, Cassias I,
Chang E, Lin Y, Macmahon S, Wong J, Zhang K, Smith
RE. Collaborative validation of the QuEChERS procedure
for the determination of pesticides in food by LC-MS/MS.
J Agric Food Chem. 2011 June 22;59(12):6383–6411.
Seven FDA laboratories collaborated to validate the QuEChERS
(Quick, Easy, Cheap, Effective, Rugged and Safe) extraction procedure combined with HPLC-MS/MS analysis to detect, identify, and
confirm the identity of 173 pesticides in carrot, spinach, and orange
matrices in less than 20 minutes. Most of the compounds (161 of
173) could be detected at less than 10 ng/g (10 ppb) concentration
levels. The procedure was shown to be specific, accurate, reproducible, sensitive, and linear as an effective screening tool for the determination of pesticide residues in these materials.
FDA Finds Pesticides Must be 5-10 ppb to Consistently Measure
�Zhang
K, Wong JW, Yang P, Tech K, Dibenedetto AL, Lee
NS, Hayward DG, Makovi CM, Krynitsky AJ, Banerjee K,
Jao L, Dasgupta S, Smoker MS, Simonds R, Schreiber A.
Multiresidue pesticide analysis of agricultural commodities
using acetonitrile salt-out extraction, dispersive solid-phase
sample clean-up, and high-performance liquid chromatography-tandem mass spectrometry. J Agric Food Chem. 2011
Jun 14. doi: 10.1021/jf2010723 [Epub ahead of print]
This larger study evaluated matrix effects for 209 pesticides in apple,
avocado, beet, bell pepper, blueberry, broccoli, cabbage, carrot,
corn, cucumber, eggplant, grape, green bean, onion, orange, peach,
potato, spinach, strawberry, tomato, ground hazelnuts, honey,
milled wheat flour, and raisins again using QuEChERS extraction
and HPLC-MS/MS analysis. The researchers concluded that analytes must have concentrations of at least 5-10 ppb to obtain consistent results using their methodology. They demonstrated fitness for
screening and surveillance applications of the methods with pesticide concentrations ranging from 2.5 to >1000 ppb in a variety of
agricultural samples.
Using Genetics and Chemistry to Determine
Natural Product Origin
�Wen
H, Lee MY, Song Y, Moon S, Park S. Combined
genomic-metabolomic approach for the differentiation of
geographical origins of natural products: Deer antlers as an
example. J Agric Food Chem. 2011 June
22;59(12):6339–6345.
Although deer antlers were the example used in this study of determining the geographical origin of a natural product, the lesson
may also apply to herbs. This is particularly true where more than
one species may be involved. If different species are limited to different growing regions, then DNA analysis may provide genomic
data sufficient to pinpoint where each item was grown. However,
when the same species are grown in different countries and regions, as can happen with botanicals, then an additional analysis
of the plant’s metabolites, a metabolomic study, can provide the
key to their origin.
Using a sufficient number of samples from Canadian, Korean, and
New Zealand locations, these researchers were able to determine the
origin of deer antler samples by first separating them into species by
their DNA and then further by their chemistry based on NMR
spectral data. The authors state their belief that this method is “generally applicable to many herbal medicinal products for which various species are grown internationally.”
The Beginning of the End of ORAC Marketing?
�Finley
JW, Kong AN, Hintze KJ, Jeffery EH, Ji LL, Lei XG.
Antioxidants in foods: State of the science important to the
food industry. J Agric Food Chem. 2011 Jun 10. doi:
10.1021/jf2013875 [Epub ahead of print]
This paper supports the one by Hollman et al., reported on last
month, that was not able to conclude that measures of antioxidant
activity correlate with direct health benefits and which calls into
question the concept that health benefits are derived from antioxidant-rich materials through direct action of high oxygen radical absorbance capacity (ORAC) values acting to directly quench reactive
oxygen species (ROS) in the body. Recent findings indicate that
antioxidant function may also affect gene expression that produces
antioxidant enzymes. Several other mechanisms by which antioxidant function may be regulated are also explored in this review, including recent evidence suggesting that low levels of ROS may be
needed to stimulate an antioxidant response from the body, and it
may be detrimental to remove too many of them.
The authors point out that ORAC tests used to promote polyphenol-rich products measure only direct-acting ROS quenching and
because they reach only low levels in plasma after ingestion “may
play a very minor role in antioxidant balance.” It is clear that the
understanding of the “health roles of antioxidants is changing and
nutritional messages used to market antioxidant-containing foods
often are not supported by contemporary evidence,” they add. The
authors also point out that recent findings have “implications for the
fortification of foods with antioxidants, as well as for the consumption of many dietary supplements” and the corollary “that supplemental doses of some antioxidants may block beneficial actions of
other physiological processes, and at high doses some antioxidants
may be toxic.”
Synergists in Goldenseal
�Junio
HA, Sy-Cordero AA, Ettefagh KA, Burns JT, Micko
KT, Graf TN, Richter SJ, Cannon RE, Oberlies NH, Cech
NB. Synergy-directed fractionation of botanical medicines:
A case study with goldenseal (Hydrastis canadensis). J Nat
Prod. 2011 Jun 10. doi: 10.1021/np200336g [Epub ahead
of print]
The antibacterial activity of the yellow alkaloid that makes goldenseal
root golden (berberine), against Staphylococcus aureus is inhibited by a
multidrug-resistance efflux pump of the bacteria that actively excretes
berberine from its cells. By employing synergy-directed fractionation,
these researchers were able to isolate and identify three flavonoids that
inhibit the efflux pump of S. aureus, thereby increasing the antibacterial activity of goldenseal’s berberine.
The researchers also made traditional-type tinctures and verified the
presence of higher amounts of berberine in the root extract compared
to leaf, with the reverse situation occurring in leaf extracts (less alkaloid, more flavonoid). This suggests that a combined leaf and root
extract may have better antimicrobial activity than either one alone.
“Coffee Table” Book on Chocolate
�Cooper
R. Book Review of Chocolate: History, Culture and
Heritage. J Nat Prod. 2011 Jun 22. doi: 10.1021/
np200515k [Epub ahead of print]
This book review makes the almost 1,000-page subject an attractive
choice if you want a cultural and historical reference text about
chocolate that contains 56 chapters written by 114 authors!
Beyond Açaí: Four Under-Utilized Fruits of the
Amazon Region
�Gordon
A, Jungfer E, da Silva BA, Maia JG, Marx F.
Phenolic constituents and antioxidant capacity of four
under-utilized fruits from the Amazon region. J Agric Food
Chem. 2011 Jun 11. doi: 10.1021/jf201039r [Just accepted
manuscript]
This study characterized the phenolic constituents and measured the
total oxidant-scavenging capacity of four underutilized fruits from
the Amazon region of Brazil, namely araçá (Psidium guineense), jambolão (Syzygium cumini), muruci (Byrsonima crassifolia), and cutite
(Pouteria macrophylla).
Website Info for St. John’s Wort Rated as Poor
�Thakor V,
Leach MJ, Gillham D, Esterman A. The quality
of information on websites selling St. John’s wort.
Complement Ther Med. 2011 Jun;19(3):155-160.
The authors of this Australian study recognized that the substantial
body of quality information supporting the use of St. John’s wort
(SJW) for the treatment of depression is on par with standard anti-
depressants while causing fewer side effects. They also reiterated the
well-known effects of SJW in increasing the metabolism of certain
drugs including warfarin, oral contraceptives, and many others.
Their review evaluated the quality of 54 websites evenly split between online pharmacies, online health food stores, and herbal medicine manufacturers offering SJW for sale. It was not clear if their
Google search was preferential for Australian websites, but all the
websites studied were found to be of poor quality, with the information on manufacturers’ websites considered the worst.
The lowest scores were received in response to questions regarding 1.)
is it clear what sources of information were used to compile the information? 2.) does the webpage provide details of additional sources of
support and information? 3.) does the website describe what would
happen if no treatment is used? 4.) does the website describe how the
treatment choices affect overall quality of life? and 5.) is it clear from
the website that there may be more than one possible treatment
choice? The best-performing-website attributes were in response to
the questions 1.) is it clear when the information used or detailed on
the e-commerce website was produced? 2.) does the webpage describe
the indications of SJW? 3.) are drug interactions mentioned? 4.) does
the website provide support for shared decision-making? and 5.) is the
information related to SJW most visible and easy to access?
St. John’s Wort for Moderate Depression: Better
and Longer Lasting
�Gastpar
M, Singer A, Zeller K. Comparative efficacy and
safety of a once-daily dosage of hypericum extract STW3VI and citalopram in patients with moderate depression: a
double-blind, randomised, multicentre, placebo-controlled
study. Pharmacopsychiatry. 2006 Mar;39(2):66-75.
�Singer
A, Schmidt M, Hauke W, Stade K. Duration of
response after treatment of mild to moderate depression
with Hypericum extract STW 3-VI, citalopram and
placebo: A reanalysis of data from a controlled clinical trial.
Phytomedicine. 2011 Jun 15;18(8-9):739-742.
The primary objective of this trial that tested a St. John’s wort extract
(STW3-VI), active control drug, and placebo, was to see if STW3VI was safe, better than placebo, and not inferior to the active drug
(citalopram) in treating moderate depression. This three-arm, double-blinded, randomized, multicenter clinical study involving 388
patients did just that, with STW3-VI and the active drug demonstrating equal efficacy, with both performing significantly better
than placebo. Significantly more adverse advents were found with
the active drug compared to placebo.
The recent follow-up report of this study, a reanalysis of the data
from 154 patients that responded to the active drug or STW3-VI in
the original trial, showed that 30 patients relapsed, with most from
the active drug arm and eight each from the placebo and STW3-VI
arms. The duration of the response to each treatment arm was longest for STW3-VI and shortest for placebo.
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.
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
The transcript and audio file of an AHPA-sponsored teleseminar
conducted by industry legal, nutrition and regulatory experts
A tour and demonstration of the AHPA NDI Database
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”
For more information and to subscribe to
The AHPA NDI Database, click here.
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
[email protected] • www.ahpa.org
8630 Fenton Street, Suite 918, Silver Spring, MD 20910
Calendar of
Botanical Events
�
Putting Herbal Medicines into
Practice, A seminar from the College
of Medicine’s Science Council
July 6 • The Royal Botanic Gardens
Kew, Richmond, Surrey, UK.
�
I International Symposium on
Medicinal, Aromatic and Nutraceutical
Plants from Mountainous Areas
July 6 - 9 • Saas-Fee, Switzerland
�
International Symposium for
High-Performance Thin-Layer
Chromatography
July 6 - 8 • Basel, Switzerland
�
Botany 2011: Healing the Planet
July 9 - 13 • St. Louis, Mo.
�
27th International Symposium on the
Chemistry of Natural Products
July 10 - 15 • Brisbane, Australia
�
American Council for Medicinally
Active Plants Conference
July 17 - 20 • Alabama A&M
University, Normal, Ala.
�
Annual Meeting of the American
Society of Pharmacognosy
July 30 - August 3 • San Diego, Calif.
�
American Association of Naturopathic
Physicians Convention
August 17 - 20 • Phoenix, Ariz.
�
Society for Medicinal Plant and
Natural Product Research
September 4 - 9 • Antalya, Turkey
�
International Symposium of
Essential Oils
September 11 - 14 • Antalya, Turkey
�
Natural Products Expo East
September 21 - 24 • Baltimore, Md.
�
Phytochemicals in Nutrition and Health
September 27 - 30 • Bari, Italy �
2011 AIA International Aromatherapy
Conference & Wellness Expo
September 29 - October 3 •
Minneapolis, Minn. �
AOAC Europe International Work-
shop, Quality Control of Botanicals,
TCM, Herbal Food Supplements and
Herbal Medicinal Products
October 10-12 • University Erlangen,
Nuremberg, Germany
�
3rd International Conference of
Bioinformatics, Natural Products and
Traditional Medicine
October 14 - 16 • Xi’an, China
�
5th International Conference on
Polyphenols and Health
October 17 - 20 • Barcelona, Spain
�
22nd Annual American Herbalists
Guild National Symposium
October 21-23 • St. Petersburg, Fla.
�
Medicinal and Aromatic Plants in
Generating New Values in the 21st
Century (Program flyer)
November 9-12 • Sarajevo, Bosnia
and Herzegovina
�
International Symposium on Medicinal
and Aromatic Plants
November 15 - 18 • Chiang Mai,
Thailand
�
International Symposium on Medicinal
and Aromatic Plants; History of
Mayan Ethnopharmacology
November 20 - 23 • Antigua,
Guatemala
�
International Food Supplements
Conference
December 8-9 • Berlin, Germany
�
Phytochemical Society of North
America, 50th Anniversary Meeting
December 10 - 15 • The Island of
Hawai`i, Hawaii

here - American Herbal Products Association

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