Detailed Bookstore Descriptions

Please browse the variety of publications that are offered on botanical science, botanical manufacturing, general botanical information and the regulation of herbal supplements.

AHPA EDUCATIONAL COURSE MATERIALS, GUIDANCE and REFERENCE BOOKS

Manufacturers are caught between pending federal Good Manufacturing Practices, California’s Proposition 65, the need to produce clean and safe products, and keeping costs in check. Even organic raw materials face issues of microbial loads and heavy metal uptake from the soil. Each company must weigh its unique quality standards and liability risk against the cost of implementing a program to ensure herbal cleanliness. Instituting an appropriate process can be a practical approach to protect your company. Not only should your system demonstrate a record of quality and safety, but a smooth and effective system also helps provide good customer service. This AHPA educational course will help you establish a process to fit your company’s needs, focusing on these topics:

• pending Good Manufacturing Practices purity specifications
• California’s Prop 65 and heavy metals
• the impact of quality and safety on industry credibility
• cleanliness standards
• pragmatic program implementation

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:

This AHPA educational session addresses how to ensure that you comply with the requirements of the Food Allergen Labeling and Consumer Protection Act of 2004. Any food (including dietary supplements) that contains a major food allergen must meet the disclosure requirements of the new law when labeled on or after January 1, 2006. A panel with legal, regulatory, and scientific expertise focus on these issues:

• The origin and rationale of the new law
• Compliance deadlines
• The major food allergens required to be labeled
• The petition and notification process for exemption from food allergen labeling requirements
• Proper labeling of major food allergens present in dietary supplements

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

Avoid government fines and sanctions by ensuring your product claims are truthful, legal and fully documented. AHPA gives you the tools you need by providing the experience and insights from this outstanding panel of experts and a wealth of resource documents that include an SOP document, letter template, guidance documents, and bibliography of selected sources of traditional use evidence according to these systems of traditional herbal medicine:

• Ayurveda
• Traditional Chinese Medicine
• Unani
• Tibetan Buddhist
• Western Europe (German)
• Western Europe (Australia, Canada, UK, and the US)

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

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

This course is designed for companies that want to evaluate current GMP systems already in place or initiate a new system as you prepare for new demands expected to be in FDA’s final rule on dietary supplement Good Manufacturing Practices. Specific topics include:

• Organizing and defining your company’s departments
• Staff job descriptions and training
• Necessary documentation, recordkeeping and SOPs
• Establishing and documenting staff safety training

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
  

cGMP Compliance: Botanical Identity & Herb Quality

As ever, AHPA provides useful information that can be put to immediate use, as well as practical advice from experienced professionals who describe both basic and advanced tools that are effective to meet your needs when it comes to:

• Cleanliness — including adulteration, pesticides and herbicides, and heavy metal testing
• Identification — providing reference resources and offering guidance on establishing specifications, macro- and microscopic examination and more
• Testing — from inspection and sampling to various analytical methods and approving or rejecting materials;
• Practical examples and solutions.

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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Adverse Event Reporting: How to Comply with the New Law

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Good Manufacturing Practice: The Final Rule

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Structure/Function Claims: Crafting Smart and Lawful Marketing Info and Labels

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Adverse Event Reporting: Strategies for Compliance

The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires that serious adverse event reports be sent to the FDA so that any public safety concerns can be identified and dealt with quickly. Learn how to navigate this new process with insights from these experts:

• 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

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Debriefing the FDA’s cGMP Implementation Seminar

Perhaps the only thing worse than waiting so long for good manufacturing practice (GMP) regs for dietary supplements is the conflicting interpretations and confusion of the recently published regs themselves. The FDA held a multi-media discussion of the new GMPs, and in this course AHPA translates their statements and dispels any confusion from the FDA overview.

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. 

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Good Agricultural and Collection Practices

Growers and collectors of herbal raw materials used in herbal dietary supplement and personal care products must make every reasonable effort to ensure that all such ingredients are fit for their intended use. Additionally, manufacturers must set specifications that communicate their needs while meeting new good manufacturing practice regulations.

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:

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AHPA's Herbs of Commerce, 2nd edition

by Michael McGuffin, John Kartesz, Albert Leung and Arthur Tucker

This book identifies over 1,500 herbs listed by their common names and Latin names. AHPA published the first edition of Herbs of Commerce as self-governing guidance in 1992 in order to reduce confusion associated with labeling of botanical ingredients. The first edition established a single "standardized" common name for each of the listed herbs. This revised 2nd edition published in 2000, was expanded and reorganized so that over 2,000 plants are now included. 

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AHPA's Botanical Safety Handbook

by Michael McGuffin, Christopher Hobbs, Roy Upon and Alicia Goldberg

AHPA’s Botanical Safety Handbook is a comprehensive reference book that provides safety information on more than 600 species in trade as ingredients in dietary supplements. An essential reference for healthcare providers, consumers, retailers and manufacturers of herbal products, its safety classifications are frequently cited in other publications. The BSH lists specific information on the safe use of herbs, including labeling recommendations, dose limits, and possible adulteration.

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AHPA's Guidance Documents for the Manufacture and Sale of Botanical Extracts, the Standardization of Botanical Products and Manual for Alcohol Tax Drawbacks

A collection of five documents that set forth guidelines for procedures and issues encountered in the manufacture, sale and labeling of herbal extracts.

The first three documents consist of Guidance for the Manufacture and Sale of Bulk Botanicals Extracts, Guidance for the Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts, and Use of Marker Compounds in Manufacturing and Labeling Botanically Derived Dietary Supplements. by the Botanical Extracts Committee of the American Herbal Products Association

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.

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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A Diggers Guide to Medicinal Plants

by Allen Lockard and Alice Q. Swanson

Guidelines for conservation practices and for harvesting, cleaning, drying and preparing plants for market.


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by Mark Blumenthal, senior editor
1998, Hardcover, 712 pages

In 1978, the German government established an expert committee, the Commission E, to evaluate the safety and efficacy of over 300 herbs and herb combinations sold in Germany. The results were published as official monographs that give the approved uses, contraindications, side effects, dosage, drug interactions and other therapeutic information essential for the responsible use of herbs and phytomedicines. For the first time, the complete set of Commission E monographs has been compiled, translated into English and edited for use by physicians, pharmacists, health professionals, researchers, regulatory agencies, consumers and the herb industry.

• 380 Herb Monographs with Therapeutic Information: Uses, Dosage,
• Contraindications, Side Effects, Drug Interactions and Pharmacological Actions
• Easy-to-Use Therapeutic and Chemical Indexes
• Glossary of Medical, Pharmaceutical, and Technical Terms
• Excerpts from European Regulatory Literature
• Analysis of Market Trends and Regulatory Issues
  
  
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Herbal Medicine: The Expanded Commission E Monographs

by Mark Blumenthal, senior editor
2000, Hardcover, 544 pages

This reference updates 107 monographs from the original Commission E translation by the American Botanical Council, expanding each to include the following:

• In-depth overviews
• Information on clinical research
• Expanded sections on chemistry and pharmacology
• Additional information on dosage and administration
• Extensive references
• Full color photos
  
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The ABC Clinical Guide to Herbs: Continuing Education Module & Reference Book

by Mark Blumenthal, senior editor
2003, Hardcover, 512 pages

How does the healthcare professional effectively respond to patient inquiries on the use of herbal supplements? What clinical research has been conducted? How is safety evaluated? This science-based educational course answers these and other questions for healthcare professionals, pharmaceutical companies, health management companies, policy makers, the dietary supplement industry and consumers. It is also the first such reference to offer national continuing education credit in five healthcare professions.

The entire work has been peer reviewed by experts, including healthcare professionals in allied health fields as well as those selected by the accrediting agencies. This book contains:

• 29 single herb profiles
• 13 proprietary product monographs

Each herb profile includes:

• a comprehensive clinical monograph which is fully referenced and contains a table of clinical studies
• a Clinical Overview for quick reference
• a Patient Information sheet for duplication

Herbs: Bilberry, Black cohosh, Cat’s claw, Cayenne, Chamomile, Chaste tree, Cranberry, Echinacea, Eleuthero, Ephedra, Evening primrose oil, Feverfew, Flax, Garlic, Ginger, Ginkgo, American ginseng, Asian ginseng, Goldenseal, Hawthorn, Horse chestnut, Kava, Licorice, Milk thistle, Peppermint, Saw palmetto, St. John’s wort, Black and green tea, Valerian

Understand the Research and Safety of Herb Combinations: Many products on the market are based on combinations of herbs. A chapter presents monographs on numerous herbal combination products that have undergone human clinical studies.

Proprietary Products: Pycnogenol®, Alluna, Esberitox®, Euvegal® forte, Hochu-ekki-to®, Hova®, Liv. 52®, Mastodynon®, Nutrilite® Saw palmetto with Nettle Root, Padma® Basic/Padma® 28, Phytodolor®, Prostagutt® forte, Sinupret®

Identify Products Backed by Clinical Research: One of the most useful and innovative features of the comprehensive clinical monograph is a table which reviews many of the clinical studies conducted on the herb, study design, and brands used in the studies. Practitioners have been requesting this information. Separate tables in the book summarize all of the brands mentioned in the book and include brand name in the United States, foreign product brand names, company names and company contact information.


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