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FREE
ACCESS TO THE AHPA REPORT (For Non-Members) (scroll down
to the bottom after following this link)
The
AHPA New Dietary Ingredients (NDI) Database
NEW!
AHPA
REFERENCE BOOKS and RESOURCE MATERIALS
EDUCATIONAL
SEMINARS and MATERIALS
SYMPOSIUM
PROCEEDINGS
GENERAL
REFERENCE
| Reference
Books and Resource Materials Published by AHPA |
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Herbs
of Commerce, 2nd Edition
by Michael McGuffin, John Kartesz, Albert
Leung and Arthur Tucker
The standard by which all plant
common and scientific names will be determined on all products containing
herbs, this edition lists Latin binomials, Standardized Common Names,
Ayurvedic, Chinese (pinyin), and other common names for 2,048 species,
including 25 fungi and 23 seaweeds. A must-have for anyone who writes
about or manufactures herbal products.
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Botanical
Safety Handbook
by Michael McGuffin, Christopher Hobbs, Roy Upon and Alicia
Goldberg
Provides safety data on more
than 550 herbs as guidelines for product labels, including contraindications,
side effects, and special warnings. An
essential reference for healthcare providers, consumers, retailers and
manufacturers of herbal products, its safety classifications are frequently
cited in other publications. The BSH lists specific information on the
safe use of herbs, including labeling recommendations, dose limits, and
possible adulteration. Each herb is classed as can
be safely consumed when used appropriately, herbs with the following restrictions,
for external use only, or not to be used during pregnancy.
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-
Retail
Labeling of Dietary Supplements Containing Soft or Powdered Botanical
Extracts
- Manufacture and
Sale of Bulk Botanical Extracts
- Use of Marker Compounds
in Manufacturing and Labeling Botanically Derived Dietary Supplements
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Standardization
of Botanical Products (also sold separately, below)
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Manual
for Alcohol Tax Drawbacks for Manufacturers of Nonbeverage Products
Sold as Liquid Herbal Supplements (also sold separately, below)
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Manual
for Alcohol Tax Drawbacks for Manufacturers of Nonbeverage Products Sold
as Liquid Herbal Supplements
by the Liquid Extracts Committee of the American Herbal
Products Association
The
Manual for Alcohol Tax Drawbacks serves as guidance to assist manufacturers
to understand and conform to the Federal Regulations that govern the drawback
of prepaid excise tax on alcohol used in the products of nonbeverage products.
This document is particularly relevant to manufacturers that purchase
alcohol manufactured in the U.S. and that produce herbal extracts and
tinctures that are sold in liquid form as dietary supplements. Used to
train ATF Staff.
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Standardization
of Botanical Products
The
White Paper on Standardization of Botanical Products describes the
many factors that contribute to the proper standardization of a botanical
product. The scope of the document covers a variety of preparations, from
crude botanicals to extracts to solid oral dosages. This document is intended
to foster a heightened awareness of the complexities associated with standardization
and to facilitate informed discussions between raw material suppliers,
product manufacturers, practitioners, clinicians, regulators and consumers.
|
Good Documentation
Practices Manual
The manual focuses on documentation systems in the
context of manufacturing, packing, or holding dietary supplements, although
the principles and many of the procedures and forms overlap with documentation
practices used in drug companies and ISO registered companies, and are also
relevant to food and food ingredient facilities.
The information contained
within the manual should assist your company with:
- Providing appropriate documentation to control and reflect company operations.
- Facilitate document creation, approval, issuance, retrieval, and revision.
- Preventing record falsification and minimize errors.
- Facilitate records filing, retention, purging, and destruction efforts.
Related seminars (can be purchased separately):
AHPA
Primer on Products Liability Insurance for the Dietary Supplement Industry
Like all other consumer-goods industries, manufacturers
and distributors of dietary supplements purchase products liability insurance
in order to protect their businesses and assets against claims associated
with their products. AHPA created this document to provide some basic understanding
of products liability insurance and the processes involved in purchasing this
insurance by dietary supplement companies. This primer is organized in a question
and answer format and addresses numerous issues that are commonly encountered
in obtaining products liability insurance.
Click HERE
to download the AHPA Insurance Primer.
AHPA
Guidance: How to Conduct an FDA Inspection
Revised
after a comprehensive review by Michael McGuffin, Tony Young, and Staci Eisner
that includes updates based on recent regulations (as of Oct. 2009), this
guidance is what every supplement manufacturer needs and should have in order
to understand their obligations and responsibilities during an FDA inspection.
Written in Q&A format in four sections, the 51-page guidance presents
an overview of FDA's authority, suggestions on steps a firm should take prior
to an inspection, guidane on what to expect during an inspection, and discusses
observational findings once an inspection has taken place. Also includes an
SOP template for conducting inspections and the relevant text of applicable
laws and regulations.
Background
on California Proposition 65: Issues related to heavy metals and herbal products
Written
by Michael McGuffin, AHPA
President, and Trent Norris (Arnold & Porter LLP), AHPA’s
Counsel for California Proposition 65, “Background
on California Proposition 65: Issues related to heavy metals and herbal products”
replaces
a document of the same name dated November 2004.The backgrounder provides
invaluable information on the regulatory and liability implications of Proposition
65 on heavy metals that may be present in herbal products sold in the State
of California.
Heavy
Metals: Analysis and Limits in Herbal Dietary Supplements: White Paper
This document is focused on the heavy metals lead (Pb), mercury
(Hg), cadmium (Cd) and arsenic (As). It presents proposed interim limits for
these four elements with accompanying explanations as to how these limits
were determined. It also discusses relevant regulations about the presence
of these chemicals in products sold in the United States, and daily limits
that have been set for these by regulatory agencies, both within the United
States and elsewhere. In addition, it reviews available analytical methods
for measuring heavy metals, and provides guidance on how to determine which
analytical methods are most suitable for dietary supplements and on how to
choose a contract lab that can properly conduct heavy metal testing.
Latin
Custom Dictionary from AHPA's Herbs of Commerce, 2nd
ed.
An
easy-to-install custom dictionary (.dic file) that, once placed
on your computer, will help to ensure that your labels, scientific
papers, and other technical documents contain the correct spelling
of Latin family, genus and species names. Based on AHPA's Herbs
of Commerce, 2nd ed. File will be sent via email with installation
instructions.
2004–2005
Tonnage Survey of Select North American Wild-Harvested Plants
An up-to-date survey on United States tonnage of
botanicals including an analysis.
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2002–2003 Tonnage
Survey of Select North American Wild-Harvested Plants
An up-to-date survey on United States tonnage of botanicals
including an analysis.
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2000–2001
Tonnage Survey
by AHPA's Botanical Raw Materials Committee
A
survey on United States tonnage of botanicals including an analysis.
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1999
Tonnage Survey
A survey of United States tonnage of botanicals with
an analysis prepared by Arthur Andersen Consulting.
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AHPA's
New Dietary Ingredient Database
This database provides a concise “outcome statement” for each NDI
file that quickly summarize how FDA has responded to every notification,
and the problems, if any, that the agency identified for each.
Special introductory access fees for AHPA members are $125 per year per
site / $40 per day per site, and for non-members are $495 per year per
site / $125 per day per site.
The AHPA
NDI Database is accessible at http://ndi.npicenter.com/
This database is
not purchased through the AHPA Bookstore. AHPA member passwords do not
apply to this database; a separate login and password will be assigned
upon subscription.
|
| AHPA's
Educational Tele-Seminars and Botanical Symposia Proceedings |
cGMP
Compliance Series: Meeting Specifications: Identity Testing and Vendor Qualification
On June 25, 2010 under 21 CFR 111, the dietary supplement Good Manufacturing
Practices (GMP), you'll either be testing every lot of every component intended
to be an ingredient in your products to meet your specifications, or you'll
have a vendor qualification program in place that will:
- Allow you to rely on
vendors Certificates of Analysis for all testing other than identity
- Help ensure the quality,
safety, and an adequate, usable supply
- Protect your company
from liability
Unfortunately, the GMP
provides what amounts to only an outline for what defines an acceptable vendor
qualification program - not the details. Is it a plane ride to each and
every supplier's facility? Is it a questionnaire? Is it a list of analytical
methods? Is it hiring a natural products chemist and buying testing equipment?
Is it hiring a 3rd party lab? Should you have a contractual agreement with your
supplier? What kind of documentation should you keep? By attending this seminar,
you'll learn from experts in the dietary supplement industry the primary considerations
that make up THE DETAILS of a vendor qualification program that will likely
meet the requirements of the GMP. Specific topics will include:
- Legal Overview
- You'll learn exactly what your requirements are under the GMP, as well
as learn about the value of contracts and vendor agreements
- Identity Testing
- During this segment, you'll learn about the specific requirements regarding
establishing the identity of your dietary ingredients, what the term "scientifically
valid method" means, determine what method or methods to use, what available
resources there are, and the skills/training required for analysts
- Qualifying & Using
A 3rd Party Vendor to Identify & Test Your Ingredients - You'll be given
practical information on how, when and why to use an outside lab & other
related considerations; how to go about defining the scope of testing/methods;
contractual arrangements, timelines, QA involvement, pitfalls & benefits
of 3rd party testing, OOS or non-conforming issues, and usage of 3rd party
labs as part of a VQ program
- Supplier Qualification
- Learn about the prerequisites to supplier qualification including: establishing
adequate specifications, vendor & supplier quality agreements. Get real-world
details on the elements of a supplier qualification program including: CoA
confirmation, establishing policies, GMP requirements, and best practices;
Other topics include pre-audit questionnaires & ingredient info (SIDI),
audit questionnaires, Site visits: are they required? When do they make
sense?
- Practical application
- Suppliers - You'll get the view on supplier qualification from a raw
material supplier. This will include a discussion on: Common mistakes, OOS
materials, & issues concerning documentation.
Course materials include:
SIDI Templates (botanical & non-botanical)
Certificate of Analysis
Guideline List of pharmacopoeia available in English
AHPA White Paper on Choosing an Analytical Laboratory
AHPA GACP document (for audit development) Material Disposition example forms
Audio
CD of the AHPA event
An unedited transcript of the AHPA event
cGMP
Compliance Series: How to Conduct & Manage an FDA Inspection
For many companies who have never been through
an FDA inspection these may not only be new questions but likely nerve-racking
ones as well. Wouldn't you like to have more than "some idea" of the authority
the FDA has during an inspection, so you know what your rights are? As of
June 25, 2009, the dietary supplement cGMPs are now in effect for those companies
with 20 or more employees. This means that your facility could be subject
to an FDA inspection AT ANY TIME, if you fall into this category. You should
know what your rights are, what authority the inspectors have, and enable
your staff to better understand the process and feel confident throughout
it. This seminar will be an invaluable opportunity for you and your company
to gain insight and practical information in a cost effective manner (with
no travel costs!).
Take advantage of the
expertise of these speakers:
- Staci Eisner,
regulatory affairs, quality assurance, research and development, and facility
design for ExtractsPlus/PlusPharma, Quality and Regulatory Affairs Manager,
Botanica Bioscience
- Jim Prochnow,
Esq, Greenberg Traurig, Adjunct Professor of Law at
the University of Denver Law School
- Steven Shapiro,
Esq, Ullman, Shapiro & Ullman, LLP
- Robert Ullman,
Esq, Ullman, Shapiro & Ullman, LLP
- Anthony L. Young,
Esq, Kleinfeld, Kaplan and Becker, LLP
- Mary Beth Watkins,
BS, MS, Director of Quality and Compliance for Botanical
Laboratories, Inc.
Materials in this packet
include:
- Course Outline, Speaker
Bios
- Transcripts to the
two duplicate sessions, and answers to questions posed by attendees
- Audio CD
Related materials include (can be purchased separately):
cGMP
Compliance Series: Record Keeping, Document Control & How to Write SOPs
Whether
your company is already required to be compliant with the GMP rules, or if
you're due to be in compliance on June 25, 2009 or 2010, this seminar will
benefit your company and its employees. Documents tell the true story of compliance.
Without good documents and document control all of your GMP efforts may count
for nothing. Learn how to create, manage and control documents for good GMP
practices, inspectors, auditors and safety. Topics that will covered include:
the role of the documentation manager/document control manager, general documentation
practices, writing documents & SOPs - details on components and how to,
record keeping strategies, worksheets vs. logbooks, document change control,
training records, record retention, purging and destruction and FDA Inspections.
Course materials include:
- Audio
CD of the AHPA event
- An
unedited transcript of the AHPA event
cGMP
Compliance Series: Setting
and Meeting Specifications for Contaminants in Finished Products
Dietary
supplement companies face numerous legal, regulatory and scientific questions
as they look to comply with cGMP. Under the rule, it is the responsibility
of the manufacturer to identify contaminants likely or certain to be present
in or on components received and to establish limits to prevent adulteration
of these components. How do you know what contaminants to set specifications
for? What are your testing needs? How does California’s Proposition 65 come
into play? What are the legal limits for pesticides? What is your liability
as a supplier when you enter into a contractual agreement? To answer these
questions and more, AHPA brings together an expert panel: Michael McGuffin,
AHPA’s president and editor of “AHPA’s Annotated Final Rule on Dietary Supplement
cGMP,” Aaron Secrist, Associate Director of Quality at Nature’s Way, Anthony
Young, Esq., AHPA’s General Counsel and partner at Kleinfeld Kaplan &
Becker, and Trent Norris, AHPA’s Counsel for Proposition 65 and partner
at Arnold & Palmer LLP.
Course materials include:
- Audio
CD of the AHPA event
- An
unedited transcript of the AHPA event
Sustainability
& Crafting Responsible "Green" Marketing
Here’s what the smart
companies know: it’s lucrative to be sustainable. “Potentially the richest
partnership in the history of capitalism,” that’s what Stonyfield Farm CEO
Gary Hirshberg calls nature and business in Stirring It Up: How To Make
Money and Save the World. “Waste not, want not,” right? But where do you
start? And, if you’ve already “gone green,” how do you make sure you and
nature are getting the best return on your investment? Here an expert panel
including Aveda Vice President Earth & Community Care Chuck Bennett,
United Plant Savers Executive Director Lynda LeMole and
Frontier Natural Products Co-op Vice President Sustainability Kathy Larson
will provide their practical wisdom and answer your questions about sustainability,
the bottom line and how to walk the talk in a “greenwashed” world.
Course materials
include:
- Audio
CD of the AHPA event
- An
unedited transcript of the AHPA event
cGMP
Compliance Series: Shelf Life Statements on Dietary Supplement Labels
The
new Good Manufacturing Practice regulations for dietary supplements require
that manufacturers with shelf life statements on their labels have appropriate
scientific substantiation. However, expiration dates are not required by
the rule, and the cGMPs released in June provide little to no guidance as
to what qualifies as scientific substantiation. Manufacturers are left wondering
whether it is in their best interest to provide a shelf life statement and,
if so, what the appropriate testing programs are for substantiating shelf
life – a daunting and difficult task for manufacturers and marketers of
herbal products.
To
help manufacturers and marketers comply with GMPs, the American Herbal Products
Association offers an information-packed tele-seminar, "Shelf Life Statements
on Dietary Supplement Labels."
You’ll
have a chance to gain regulatory, legal and scientific insight from these
knowledgeable speakers:
¨
Anthony Young, Esq., general counsel to AHPA and a
partner with the law firm Kleinfeld, Kaplan and Becker, LLP, Washington
D.C., will explore the dietary
supplement cGMP implications of providing shelf life statements on dietary
supplement products. Tony has practiced food, drug and environmental law
since 1974. He advises and represents domestic and foreign suppliers, manufacturers
and marketers and serves as AHPA General Counsel
¨
Michael McGuffin,
president of AHPA, is the spokesman for the herbal products industry before
state and federal agencies and has twice served on a working group and a
subcommittee of FDA’s Food Advisory Committee. Michael’s presentation will
address shelf life statements on dietary supplements from a regulatory and
practical perspective. Michael recently authored the
association’s highly praised Annotated Final Rule on Dietary Supplement
cGMP.
¨
Jeff Stassi, program manager for dietary supplement
testing at Covance Laboratories, acts as a primary liaison for dietary supplement
clients as well as providing expertise on designing comprehensive testing
programs to meet scientific and regulatory requirements. He has over 22
years of experience in laboratory operations and client management and has
set up testing programs for hundreds of clients within the dietary supplement
supply chain. Jeff will address concerns and answer questions related to
the execution and substantiation of stability studies.
Course
materials include:
- Audio
CD of the AHPA event
- An
unedited transcript of the AHPA event
Good
Agricultural and Collection Practices
The
new GMPs regulations for dietary supplements require manufacturers to establish
quality specifications for identity, purity, strength, and composition,
and limits on contaminants. For herbal products, that quality begins in
the soil and is the first link in the GMP chain. All raw materials — whether
grown on a farm or gathered in the wild — must be grown and handled properly
after harvest or collection in order to meet those GMP quality standards.
This two-hour tele-seminar provides information on getting the best quality
raw materials from the field or forest, and how the grower and wildcrafter
can meet buyers’ standards.
To help herbal ingredient
growers, collectors, brokers and manufacturers understand each others’ needs
and comply with federal and state regulations, AHPA General Counsel Anthony
Young(Kleinfeld, Kaplan & Becker); Edward J. Fletcher, COO, Strategic
Sourcing; Mark Wheeler, founder, owner & operator, Pacific Botanicals;
and Rupa Das, VP of Global Quality and Compliance, BI Nutraceuticals, presented
this highly informative two-hour educational tele-seminar, which covers
such issues as:
- Identification
- Quality Assurance
- Cleanliness
- Environmental stewardship
- Legal conformity
- Optimal harvest conditions
Course
materials include:
- Audio
CD of the AHPA event
- An
unedited transcript of the AHPA event
- Agenda
- Presenters
Bios
Debriefing
the FDA’s cGMP Implementation Seminar
In
October 2007, four months after publishing the current good manufacturing
practice (cGMP) regulations for dietary supplements in June, the Food and
Drug Administration held a multi-media educational event for stakeholders,
Overview of the Implementation of the Current Good Manufacturing Practices
for Dietary Supplements Guidance for Industry. During that event, FDA gave
some interesting and sometimes surprising insight into how they intend to
implement the new cGMP rules. AHPA was ready the very next day with this
debriefing that offers expertise to answer specific questions and dispel
any confusion that arose from the FDA overview. This important event offers
the insight you need to comply with the regs and stay in business!
AHPA understands that
the cGMPs will affect your business in many ways, and that some of these
regulations are complicated. To ensure you have the knowledge and tools
to comply, AHPA offers its expertise to answer specific questions. In order
to comply and stay in business, learn from AHPA President Michael McGuffin
and AHPA’s general counsel, Tony Young, Esq.
- Both have closely scrutinized
the GMPs throughout their development, understanding their practical applications
and legal details and providing comments on behalf of industry to shape
their final form.
- Both have also participated
in AHPA’s ongoing series of educational tele-seminars on GMPs.
- McGuffin authored AHPA’s Annotated
Final Rule on Dietary Supplement cGMP, which links key points and comments
found in FDA’s lengthy preamble to the final GMP rule to each specific
section of 21 CFR 111 to which it applies.
Course materials
include:
- Audio CD of the AHPA event
- An unedited transcript of
the AHPA event
- Links to FDA’s archived webcast.
cGMP
Compliance Series: Adverse
Event Reporting: Strategies for Compliance
AHPA
presents strategic regulatory, medical and legal perspectives to help companies
comply with the Dietary Supplement and Nonprescription Drug Consumer Protection
Act, which goes into effect December 2007 and requires dietary supplement
manufacturers to file serious adverse event reports (AERs) with the Food
and Drug Administration. In addition to reviewing the regulation and FDA’s
guidance document, AHPA provides practical documents and insights from these
expert speakers:
- Anthony Young, Esq, of Kleinfeld,
Kaplan & Becker LLP, and AHPA’s General Counsel — reviews your legal
obligations under the new law, the Dietary Supplement and Nonprescription
Drug Consumer Protection Act. In addition to reviewing FDA’s guidance
document, he will also describe how the law differentiates a serious AER
from an AER and a customer complaint and explain required reports and
recordkeeping requirements.
- Michael McGuffin,AHPA’s President
— focuses on how companies should communicate with their customers and
how to use the current MedWatch form. He will also discuss the information
needed to create a complete record of each report and add his insights
into the FDA guidance.
- Tieraona Low Dog, MD, Director
of Education for the Program in Integrative Medicine at the University
of Arizona, Clinical Assistant Professor in the Department of Medicine
and a Clinical Lecturer for the University of Arizona College of Pharmacy
—explains important considerations when recording adverse event history,
including how to focus on the clinical course of the reported event, medical
history, recording concomitant use of other medical products and other
relevant medical information.
Questions they answer
include:
- How do we communicate AER
information to our contracted manufacturer? Who should take those calls?
Who should follow up afterwards?
- Can we handle this task in-house,
or do we need to contract someone?
- Which MedWatch form should
we use? None of them are really for dietary supplement or OTC products.
- We don’t have doctors on staff,
so how (and who) decides if an AER is serious?
- How much should we follow-up
after an adverse event is reported?
- Do we have to show our AER
files to FDA during inspections?
- How can we get accurate information,
and how much of their medical history is important?
- What should we tell our health
food store and practitioner clients?
Support documents
to help your company comply with the law include:
- “AER vs. Customer Complaint”
— a decision-making flow chart
- Mandatory MedWatch form and
facsimile MedWatch form
- “Quick Glance Advice about
Mandatory Reporting”
- AHPA’s instructive form for
recording information concerning an adverse event associated with dietary
supplement product use
cGMP
Compliance Series: Good
Manufacturing Practice: The Final Rule
If
you’ve started to read the new good manufacturing practice rules (cGMPs)
for dietary supplements, you’ve already got questions. Chances are, AHPA
has already answered them in this educational event that will help you learn
exactly what you need to know about the new cGMPs, including the necessary
processes and procedures to comply when they go into effect.
Course
materials include AHPA’s Annotated Final Rule on Dietary Supplement
cGMP, an easy-to-read document that presents key points and comments
made by FDA in the preamble to the final rule next to the relevant sections.
Speakers include the head of the Food and Drug Administration (FDA) dietary
supplement program that wrote the new regulations as well as respected industry
professionals who were deeply involved in reviewing and commenting on the
cGMPs when they were proposed in 2003.
Speakers:
-
Vasilios
H. Frankos, MS, PhD, director of Division of Dietary Supplement Programs
in the FDA's Center for Food Safety and Applied Nutrition — responsible
for the full implementation of the DSHEA Act of 1994, Dr. Frankos directs
and coordinates policy and administrative activities within the Division.
Dr. Frankos advises on policy and management issues on dietary supplement
programs, new dietary ingredient safety assessments, good manufacturing
practice, adverse reaction monitoring, and related activities pertaining
to dietary supplements.
-
Marc
Ullman, Esq, partner with the law firm of Ullman, Shapiro & Ullman
— specializing in food, drug, and cosmetic law, he also provides legal
services to his clients in many other areas, including litigation support
and trademark/copyright matters. Mr. Ullman’s practice includes representation
relating to FDA compliance — including labels, labeling, claims, good
manufacturing practices, and adversarial proceedings relating to the
scope of the agency’s powers under DSHEA.
-
Michael
McGuffin, president of the American Herbal Products Association — Active
in the supplement industry since 1975, having owned both retail and
manufacturing businesses, Mr. McGuffin has been AHPA’s president since
1999. He has represented the herbal industry at state and federal hearings
on herbal regulatory issues and as a member of various FDA’s Food Advisory
Committee Working Group on Good Manufacturing Practices for Dietary
Supplements, and the Dietary Supplements Subcommittee of the FDA’s Food
Advisory Committee.
-
Event
Facilitator: Tony Young, Esq, partner with the law firm of Kleinfeld,
Kaplan & Becker
Materials
include:
-
AHPA’s
Annotated Final Rule on Dietary Supplement cGMP
-
Copies
of the cGMP rules as published in 2003 and 2007
-
Comparison
of current good manufacturing practice regulations
-
Presentations
from all speakers
-
Written
transcript, including answers to questions posed by attendees that were
not addressed during the event for lack of time
-
Course
Outline & Speakers Bios
-
Audio
CD
Structure/Function
Claims: Crafting Smart and Lawful Marketing Info and Labels
The limits placed
on what you can and cannot claim about your product are key elements of
the laws that affect dietary supplements. Every marketing plan must balance
what federal law allows, what is informative to consumers, and what may
drive sales. To help you comply with the law while maximizing sales, this
educational course presents the lead FDA official whose office reviews structure/function
claims, as well as legal expertise from an industry attorney. You will
also learn about in-house standards and policies that have been established
by major trade media and convention organizers. And you’ll also hear advice
on substantiating your claims so they do stand up to scrutiny.
Speakers:
- Robert Moore, PhD, of FDA’s
Regulations Implementation Team — describes FDA’s process for reviewing
structure/function claims — including language that pushes the agency’s
hot buttons and the level of substantiation expected to support those
claims — the agency’s enforcement actions on claims that are not lawful
for dietary supplements, how companies should respond properly to FDA
Warning letters or Courtesy letters. He also discusses resubmitting claim
notifications and disputing the FDA regarding lack of substantiation.
- Anthony Young, Esq, of Kleinfeld,
Kaplan & Becker LLP, and AHPA’s General Counsel — reviews the three
federal laws that affect dietary supplement claims and the types of allowable
product claims, outline the process of substantiating structure/function
claims and how the 30 day notification to FDA provision for such claims
works. He also details the regulatory reach of the FDA and FTC — the federal
agencies that enforce the laws on product claims — with respect to your
product labeling, third-party literature and your company website. Mr.
Young has more than three decades of experience in this arena.
- Jon Benninger, of Virgo Publishing;
Don McLemore and Michelle Kelly, both of New Hope Natural Media — representing
two of the industry's major convention organizers and media outlets, these
three speakers describe their respective companies’ standards for claims
appearing in print advertisements and trade show collateral materials,
including their review and enforcement processes and examples of non-conforming
advertising.
- Leslie A. Beyer, MS, DABT,
Senior Environmental Health Scientist with Gradient Corporation — focuses
on developing claims in a competitive world and the level of evidence
that is sufficient for substantiation, and how to use information from
traditional use, scientific research, and whether specific research information
can be used broadly to support a category of products. A senior project
manager and toxicologist with 20+ years of experience, Ms. Beyer’s projects
have covered a variety of topics including structure/function claims for
dietary supplements.
Materials include:
- Descriptions of Databases
and Information Sources: Structure-Function Claim Substantiation
- Guidance for Industry: Structure/Function
Claims, Small Entity Compliance Guide
- Guidance for Industry: Substantiation
for Dietary Supplement Claims Made under Section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act
- Substantiation for Dietary
Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
- Presentations from all speakers
- Course Outline & Speakers
Bios
Written transcript, including
answers to questions submitted by industry
- Audio CD
cGMP
Compliance: The Quality Unit
As
described in the proposed cGMP rules, your company must establish a Quality
Unit, an independent group with unique responsibilities and authority to
manage product excellence, consumer safety, compliance, company liability.
The Quality Unit touches on nearly all manufacturing processes, from setting
ingredient standards to ensuring they are met, qualifying third-party testing
labs, packaging components and labeling, practical cost considerations and
finished product quality.
This GMP compliance
seminar focuses on establishing your company’s Quality Unit by outlining
its responsibilities and roles, and offers practical insights from experienced
experts.
What
you’ll learn from these experts to set up your company’s Quality unit efficiently
and economically:
- Warren Majerus, MS, Quality
Systems Implementation, Inc., President — With nearly 30 years of experience
in product development and Quality Control in food and supplement processing
and analytical methods, Mr. Majerus is experienced in DSHEA- and CFR 110-based
compliance auditing worldwide. He focuses on Auditor/Manufacturer/QC considerations,
which include your Quality Unit’s scope of responsibility and authority,
how to establish written specifications for materials and processes, and
those specifications’ purpose and basis.
- Daniel Stephens, MBA, Herb
Pharm, Quality Control & Laboratory Services Manager — Involved in
quality control and food safety compliance for nearly 30 years, Mr. Stephens
has instituted and managed HACCP and ISO systems and audited quality assurance
methods for production facilities, retail stores, storage sites and distribution
centers. He shares his insights on industry/practical Considerations that
the Quality Unit must address, including packaging components, raw materials,
labeling, third party testing lab qualification, and finished products.
- Anthony Young, Esq, General
Counsel, American Herbal Products Association, partner with the law firm
Kleinfeld, Kaplan and Becker, LLP — Practicing food, drug and environmental
law since 1974, Mr. Young advises and represents domestic and foreign
manufacturers with respect to compliance and defense of matters under
the statutes enforced by the FDA, FTC, DEA, EPA, and more. He discusses
the importance of the Quality Unit and legal liabilities.
If
you haven’t started down this road, these speakers will provide solutions.
And if your company already has a Quality Unit in place, these AHPA materials
will help you identify new efficiencies or areas that need more resources.
Materials
include:
- The proposed cGMP regulation
that clearly outlines the Quality Unit requirements
- Presentations by Warren Majerus
and Dan Stephens, with several supporting documents for each
- Transcript, including answers
to questions posed by attendees
- Course Outline & Speakers
Bios
- Audio CD
cGMP Compliance:
Botanical Identity & Herb Quality
How
you handle botanical ingredient identity and quality is key to the products
you’re manufacturing. Designed for companies that want to evaluate their
ingredient identity and quality assurance systems, and prepare for new demands
expected to be in FDA’s dietary supplement GMP rule. The materials from
this AHPA educational tele-seminar will help you understand FDA’s proposed
rules and how industry responded — giving you both the maximum and minimum
expected standards that are on the horizon. Making Good Manufacturing Practice
a part of your process sooner, rather than later, will ease the burden of
compliance when final cGMP rules are issued.
What you’ll learn
from these experts:
- Lynda Hammons,Vice-present
of Quality and Regulatory Affairs at Nature’s Sunshine Products — gives
practical advice on setting and using standards, how to set ingredient
specifications and select vendors, and shares a practical Raw Materials
Testing Criteria Flow Chart
- Sidney Sudberg, DC, LAc, RH
(AHG), Director of Alkemists Pharmaceuticals, Inc. — explains Good Laboratory
Practice, quality control, various analytical techniques for ingredient
characterization and standardization, and case studies.
- Roy Upton, RH (AHG), Executive
Director of the American Herbal Pharmacopoeia, Vice-president of the American
Herbalists Guild — reviews the legal requirements and expectations, and
details physical tests (macroscopic characterization, microscopy), chemical
tests (HPTLC, HPLC, FTIR, NIR), methods validation, documentation, sampling
Materials in this
packet include:
- A practical Raw Materials
Testing Criteria Flow Chart
- Course Outline, Speakers’
Presentations & Bios
- Transcript, including answers
to questions posed by attendees
- Audio CD
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Herbal
Cleanliness
Raw
material quality can make or break an herbal product. How you achieve
raw material cleanliness can make or break your company. AHPA presents
the expertise you need to establish processes to care for and control
raw materials from the field to order fulfillment. Drawing upon the
practical legal and manufacturing expertise of AHPA staff and member
companies, this educational course outlines current standards, and
identifies inspection and testing options for
- microbial cleanliness,
- heavy metal
levels,
- pesticides,
- organic ingredients.
Materials include
a critical-point process flowchart to help identify risk issues and
intervention points.
Take advantage
of the expertise of these speakers:
- Angie Brackhahn and
Kevin Ernst,both of Trout Lake Farm
- Josef Brinckmann andKatie
Huggins, both of Traditional Medicinals
- Steven Dentali and Michael
McGuffin, both of AHPA
- Loren Israelsen, of
the United Natural Products Association
- Nancy Linde, of The
Toxicology Group of NSF International
- Trenton Norris, Esq,
of Bingham McCutchen, and Anthony Young, Esq, of Kleinfeld, Kaplan
and Becker
Materials in this
packet include:
- A critical-point process
flowchart to help identify risk issues and intervention points
- Tables of Recommended
Maximum Microbial Limits, both those presented at the event (2004)
and an updated version (2006)
- A detailed document,
Background on California Proposition 65: Issues Related to Heavy
Metals and Herbal Products, produced by AHPA and updated for
this educational event
- Course Outline, Speaker
Bios
- Transcripts from the
two duplicate sessions, and answers to questions posed by attendees
- Audio CD
Federal Food
Allergen Labelling & Consumer Protection Act Seminar
This AHPA tele-seminar features a range of experts
on the legal, regulatory scientific, and medical aspects of the new
law. This is your company’s chance to receive targeted and instructional
information so that you can efficiently learn the relevant components
of the law, become trained to set up a compliance program, and hear
what is at stake if products do not meet the new policy.
What you’ll learn
from these experts:
- Anthony Young, Esq,
of Kleinfeld, Kaplan and Becker, LLP, & AHPA’s Legal Council
— discusses the law, its history and the significance of compliance
from a legal and regulatory perspective
- Robert S. Donofrio,
MS,Director of the microbiology and molecular biology laboratory,
NSF International — outlines various testing methods for the allergens
listed in the law, and advises how to set up testing and compliance
program within your company
- Mary Hardy, MD, Member
of the Human Nutrition Division at the UCLA-based David Geffen School
of Medicine, and Medical Director of Cedars-Sinai Integrative Medicine
Program — with her extensive training in botanical and western medicines,
she gives a clinical perspective on the risks of food allergens
and the risk of non-compliance
- Rhonda Kane, MS, RD,
Consumer Safety Officer with the FDA — reviews "FDA’s Q & A
on the Food Allergen Labeling and Consumer Protection Act", which
she co-authored
- Robert J. Moore, PhD,
Team Leader for Compliance and Enforcement in the Division of Dietary
Supplement Programs, Office of Nutritional Products, Labeling and
Dietary Supplements, FDA — answers questions about compliance and
FDA enforcement of the new law
Materials in this
packet include:
- Text of the Food Allergen
Labeling and Consumer Protection Act of 2004, and related FDA guidance
- 10-page NSF International
template: Dietary Supplements In-Plant Audit Checklist
- List of Allergen Test
Kits, arranged by major allergen groups, that includes details on
detection limits, equipment requirements, cost and time requirements
- Bibliography of key
articles on food allergen research and findings
- Course Outline, Speakers’
Presentations & Bios
- Transcript, and answers
to questions posed by attendees
- Audio CD
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Claims
Substantiation: How to Ensure your Dietary Supplement Product Claims
are Truthful and Legal
The
FDA and FTC have stepped up their enforcement activities against unlawful
drug claims and unsubstantiated structure/function claims made by
supplement marketers. To give you the information and tools that will
set your mind at ease about your product claims, AHPA offers advice
and documents from a panel of experts who are actively involved in
all aspects of claims substantiation for dietary supplements. These
experts address the legal standards, the necessary support evidence,
and the painful consequences of noncompliance.
What you’ll learn
from these experts:
- Anthony Young, Esq,
of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel
— explains today’s regulatory environment and the risks and liabilities
marketers face if claims are not supported adequately
- Richard Cleland, Esq,
Assistant Director, US Federal Trade Commission Division of Advertising
Practices — provides FTC’s perspective, recent enforcement actions,
and the level of substantiation that the respondents in those actions
possessed or did not possess
- David Mark, PhD, President,
DMark Consulting LLC — discusses general claim substantiation, including
what kind and how much support is needed, who should review the
evidence, advertising implications, and more
- Josef A. Brinckmann,
Vice-president of Research and Development, Traditional Medicinals
— focuses on substantiation of traditional use claims, including
guidance on what a substantiation file should contain and how it
should be structured, guidance from domestic and foreign government
agencies, reliable resources
Materials in this
packet include:
- AHPA resource document:
Outline for Issues to Address in Creating a ‘Standard Operating
Procedure’ for Making Dietary Supplement Structure Function Claims
with Appropriate Substantiation Files, and an example of a Structure/Function
Filing Letter
- Bibliography of internationally
recognized and respected substantiation resource documents for traditional
herbal medicine as practiced in a variety of cultures
- FTC’s Dietary Supplements:
An Advertising Guide for Industry
- FDA’s Draft Guidance
for Industry: Substantiation for Dietary Supplement Claims
- FDA’s Fact Sheet
on FDA’s Draft Guidance for Industry: Substantiation for Dietary
Supplement Claims
- AHPA’s Comments on FDA’s
Draft Guidance for Industry: Substantiation for Dietary Supplements
- Course Outline, Speakers’
Presentations & Bios
- Transcript, and answers
to questions posed by attendees
- Audio CD
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Navigating
FDA’s New Dietary Ingredient (NDI) Notification Requirements
If your products
include ingredients that came on the market after DSHEA was
passed in 1994, you may have a serious problem. All herbal and dietary
supplement companies must understand FDA’s NDI notification requirement
so you may ensure that the ingredients in your products are lawful
and not NDIs that have never been filed with FDA. Further, the success
rate for those who do file these "75-day notices" is very low, often
due to fundamental mistakes made when preparing notifications.
AHPA has committed
to becoming the supplement industry’s expert on NDIs, and you benefit
from that expertise. Analyzing NDI submissions and FDA responses has
led to the AHPA NDI Database, which cuts through the confusion of
the FDA dockets. And AHPA has now published a practical guidance document
to help companies increase their success in filing NDI notifications.
AHPA’s Interim Guidance for New Dietary Ingredient Notifications
for Manufacturers of Distributors of New Dietary Ingredients
explains the NDI regulations, details what information to include
(and exclude) in a notification, and provides three practical hands-on
worksheets:
- Determination of Requirement
to Submit
- Submission of NDI Notification
- Cover Letter Template
for Notification Submission
What you’ll learn
from these experts:
- Anthony Young, Esq,
of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel
— defines an NDI and outlines what’s at stake for your company in
today’s regulatory climate, what "filing without comment" means,
the meaning of a negative response from FDA, and more
- Marc S. Ullman, Esq,
of Ullman, Shapiro and Ullman — provides insight into the FDA NDI
review process and describes common mistakes by submitters, how
FDA seems to try not to approve NDIs, and FDA limitations on NDIs,
even those that are filed "without comment"
- James T. Heimbach, PhD,
FACN, President of JHeimbach Food and Nutrition Consulting — discusses
the types of safety substantiation that FDA has found to be adequate
to allow an NDI notification to be accepted without FDA comment
- Michael McGuffin, AHPA
President — describes the AHPA NDI Database, which provides detailed
analysis of NDI notifications as well as links to all of the FDA
files containing those notifications
In this packet,
materials include:
- AHPA’s Interim Guidance
for New Dietary Ingredient Notifications for Manufacturers of Distributors
of New Dietary Ingredients
- Food and Drug Law
Journal article reprint by McGuffin and Young, Premarket Notifications
of New Dietary Ingredients: A Ten-Year Review
- Course Outline &
Speakers Bios
- Transcript, including
a link to an online Macromedia Flash tour and demonstration of AHPA’s
NDI Database, and answers to questions posed by attendees
- Audio CD
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Educational
Symposium
Women's Health
Includes all proceedings
and presentations.
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Educational
Symposium
Ephedra
Includes all proceedings
and presentations.
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Educational
Symposium
Garlic
Includes all proceedings
and presentations.
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Educational
Symposium
St. John's Wort
Includes all proceedings
and presentations.
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Educational
Symposium
Saw Palmetto
Includes all proceedings
and presentations.
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Educational
Symposium
Echinacea
Includes all proceedings
and presentations.
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| General
Botanical Reference |
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A
Digger's Guide to Medicinal Plants, 2nd edition
by Allen Lockard and Alice Q. Swanson
A handy,
essential guide for every digger's backpack.
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All
prices include shipping within the U.S. Shipping costs will be added
to international and overnight orders.
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