Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products
Food and Drug Law Institute Monograph, Vol 2., No. 3
January 2011
The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) share jurisdiction over consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products - and the rules governing what can be said about these products can vary from category to category, from claim to claim, and from audience to audience. In addition to the FDA and FTC requirements, consumer health products are also subject to state and local food and drug laws, including no less than 50 state food and drug statutes and 50 state statutes that are comparable to the FTC Act. Given that these products are essential parts of daily life, consumers, industry and government agencies all have an interest in seeing that these products are labeled and advertised accurately.

Further, recent enforcement actions have evidenced a new and significant degree of cooperation between the FDA and FTC with respect to how these products are promoted to consumers. It is imperative that consumer health product marketers understand the legal and regulatory requirements for product claims.

This Monograph 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 foods and other consumer health 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

After reading this Monograph, you will be better able to:
  • Understand and evaluate the legal and regulatory considerations and risks relating to claims made for specific foods and other consumer health products

  • Determine the level of substantiation necessary for particular claims

  • Establish an effective claims development, launch and review process

  • Assess the viability and most appropriate vehicles for challenging questionable claims

Download a preview PDF below.