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  Allowable Claims and Claim Substantiation: How to Comply with the Law & Maximize your marketing

August 3, 2006

Many companies have learned the hard way that the Federal Trade Commission (FTC) does not send Warning Letters. If your claims are out of compliance, FTC is going to file a complaint. And, unfortunately, in the past few years, dietary supplement companies have also learned the hard way that the Food and Drug Administration (FDA) is not going to sit on its hands if the agency is unhappy with the response it gets after issuing a Warning Letter. In Both cases, a redistribution of wealth is looming on the horizon, and it will likely be more than the "cost of doing business."

Featuring Representatives from FDA, FTC, Ullman Shapiro & Ullman

Materials in this packet include:

  • Complete presentations with audio

Member Price: $220.00

Non-Member Price: $520.00

  Claims Substantiation: How to Ensure Your Dietary Supplement Product Claims are Truthful & Legal

March 3, 2006

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 file


Member Price: $220.00

Non-Member Price: $520.00

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

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

  Sustainability & Crafting Responsible "Green" Marketing

September 18, 2008

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 file of the AHPA event
  • An unedited transcript of the AHPA event

Member Price: $220.00

Non-Member Price: $520.00

 



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