Published: Thursday, June 28, 2007
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.
- 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.
- 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 file
Member Price: $220.00
Non- Member Price: $520.00
The Botanical Safety Handbook, Second Edition includes:
- Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
- Information on adverse events reported in clinical trials or case reports
- Safety-related pharmacology and pharmacokinetics of each herb
- Additional information on the use of herbs by pregnant or lactating women
- Toxicological studies and data on toxic compounds
- Extensive references for each entry
The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:
Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online
Member annual subscription: $95.00
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.