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

Presented: June 28, 2007

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.

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 file

Member Price: $220.00
Non- Member Price: $520.00


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Seminars

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

Presented: June 28, 2007

Speakers:

Materials include: