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Click on the links below to reach descriptions, prices and other detailed information about these items.
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
AHPA REFERENCE BOOKS and RESOURCE MATERIALS
EDUCATIONAL SEMINAR & SYMPOSIUM PROCEEDINGS & MATERIALS
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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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.
by the Liquid Extracts Committee of the American Herbal Products Association
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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.
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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 metal analysis and interim recommended limits for botanical 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.
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| 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.
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| AHPA's Educational Tele-Seminars and Botanical Symposia Proceedings |
cGMP Compliance Series: How to Conduct & Manage a 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!).
Course materials include:
- Audio CD of the AHPA event
- An unedited transcript of the AHPA event
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
Setting and Meeting Specifications for Contaminants in Finished Products Under cGMP
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
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.
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
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:
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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.
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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.
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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.
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Event Facilitator: Tony Young, Esq, partner with the law firm of Kleinfeld, Kaplan & Becker
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AHPA’s Annotated Final Rule on Dietary Supplement cGMP
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Copies of the cGMP rules as published in 2003 and 2007
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Comparison of current good manufacturing practice regulations
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Presentations from all speakers
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Written transcript, including answers to questions posed by attendees that were not addressed during the event for lack of time
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Course Outline & Speakers Bios
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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:
Adverse Event Reporting: How to Comply with the New Law
When the Dietary Supplement and Nonprescription Drug Consumer Protection Act goes into effect in December 2007, dietary supplement and OTC drug companies will be required to submit serious adverse event reports (AERs) to the FDA so that any public safety concerns can be identified and dealt with quickly. To help companies train staff and put policies in place as you prepare to comply with the new law, AHPA offers this educational program that explains the new law, and educates companies on how to take any reports of serious adverse events associated with your products. Expert speakers clearly define a serious adverse event, and enable companies to handle an adverse event call properly — in particular ensuring that you know how to complete FDA’s mandatory MedWatch form by asking callers the right questions in the right way.
What you’ll learn from these experts to set up your company’s AER system efficiently and economically:
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Tony Young, Esq. — general counsel to the American Herbal Products Association and the Pharmaceutical Distributors Association, partner with the law firm Kleinfeld, Kaplan and Becker, LLP. He has practiced food, drug and environmental law since 1974, representing ingredient and product manufacturers, developers and distributors. In 2004, Mr. Young testified about mandatory AER reporting before a U.S. Senate subcommittee, focusing on the scenario that the new law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, will put into place when it goes into effect in December 2007. In this course, he explains companies’ legal obligations, including the practicalities of submitting AERs, recordkeeping requirements, and more.
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Michael McGuffin — president of AHPA, Mr. McGuffin led the supplement industry toward recognizing the need for mandatory AERs, and was deeply involved in ensuring that the new law provide the same protections that the pharmaceutical and medical device industries have had in their respective AER systems. Active in the supplement industry since 1975, having owned both retail and manufacturing businesses, he has been AHPA’s president since 1999. He reviews the MedWatch forms, explains how to handle customer AER calls, and offers a step-by-step guide to creating a complete record.
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Paula Gardiner, MD, MPH — research fellow at the Division for Research and Education in complementary and Integrative medical therapies at Harvard Medical School’s Osher Institute, Dr. Gardiner’s work focuses on dietary supplement safety issues, including interactions with prescription medicines. She is also a member of the U.S. Pharmacopeia’s Dietary Supplements Expert Committee, where she has worked to improve adverse event reporting. In this course, she focuses on how to gather important medical details, including medical history, concurrent use of other medical products, and other relevant information.
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“AER vs. Customer Complaint” — a decision-making flow chart
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AHPA’s AER MedWatch Worksheet — AHPA’s instructive form for recording information concerning an adverse event associated with dietary supplement product use
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Presentations from all speakers
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Written transcript, including answers to questions posed by attendees
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Course Outline & Speakers Bios
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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 and Katie 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
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How to Conduct an FDA Inspection
Is your company prepared for your next FDA inspection? Do you know the current federal laws that determine what an inspector can do during a facility inspection? If your answer is “No” to either of these questions, or a hesitant “Yes,” you will want these AHPA course materials to gain a better understanding of your rights and obligations. Materials include AHPA's Guidance for Addressing FDA Inspections of Dietary Supplement Facilities, an invaluable resource to have before the FDA inspector arrives.
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:
- AHPA's Guidance for Addressing FDA Inspections of Dietary Supplement Facilities, a 42-page document containing four sections, presented in question and answer formats, and two appendices:
- Part 1 is an overview of FDA’s inspection authority, which derives from both the Federal Food, Drug and Cosmetic Act and the Bioterrorism Act.
- Part 2 is the shortest but perhaps most essential section of this Guidance, as it provides suggestions on the steps that a firm should take in advance to be prepared for an FDA inspection.
- Part 3 provides guidance on what should be expected during an inspection by FDA personnel.
- Part 4 discusses the observational findings that follow an inspection and the need to maintain a thorough internal record of each inspection.
- Appendix 1 is a template for establishing a written standard operating procedure for FDA inspections. This template incorporates much of the information contained in the main section of this Guidance.
- Appendix 2 provides the actual relevant text of the Federal Food, Drug and Cosmetic Act and the Bioterrorism Act upon which FDA’s inspection authority is based.
- A template for establishing a written standard operating procedure for FDA inspections. This template incorporates much of the information contained in the main section of the Guidance
- Course Outline, Speaker Bios
- Transcripts to the two duplicate sessions, and answers to questions posed by attendees
- Audio CD
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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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Introduction to cGMPs: Strategies for Compliance
In this educational course, AHPA assembles a panel of experts to help your company lay the groundwork to start complying with what will likely be included in FDA’s final cGMP regulations. These experts share strategies to help you attain a meaningful internal GMP program and help you demonstrate that you have control of your product throughout your processes. Practical information will help you improve what you have already established or help you to jumpstart a GMP program. Be ready before FDA knocks on your door!
What you’ll learn from these experts:
- Michael McGuffin, AHPA President — reviews FDA’s proposed dietary supplement cGMP regulations, compares them against current food GMP rules and industry’s proposed dietary supplement GMP rules
- Carl Reynolds, Senior Consultant with ASC/Kendle Regulatory Affairs and former Director of CFSAN’s Field Programs Office — outlines company segments and their responsibilities, documentation and records, variances and deviations, stability issues, inspection management
- Mary Beth Watkins, BS, MS, Director of Quality and Compliance for Botanical Laboratories, Inc. — explains documentation requirements (policies, SOPs, control systems and review) records (batch, packaging), log books
Materials in this packet include:
- Sample documents and forms — SOPs, document draft logs, distribution logs, revision logs, master batch records
- Documents that provide detailed analyses of FDA’s proposed cGMP rules
- Course Outline, Speakers’ Presentations & Bios
- Transcript, including 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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