This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question “Can we say that?” as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves as a practical guide to substantiating the advertising and labeling claims so fundamental to product development, including:

  • An overview of the legal and regulatory structures governing foods and other consumer health products
  • Key considerations for evaluating marketing concepts and claims
  • An outline for establishing effective pre-launch review procedures
  • A guide to determining the kinds of substantiation required to support different types of claims
  • Discussion of claims and consumer deception issues pertaining to the different categories of foods and other consumer health products
  • Discussion of how to challenge questionable claims being made by others

Co-Editors:
Sarah Roller, Kelley Drye & Warren LLP
Melanie Fairchild-Dzanis, Regulatory Discretion, Inc.

Click here to download a preview. And visit the FDLI website for more on this publication or to subscribe to the FDLI Monograph Series.