Advertising Law for FDA-regulated Industry

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Jun 03, 2015
60 minutes
Product Description

Understand Claim Substantiation, Endorsements, Adequate Disclosures, Native Advertising, and Puffery.

Generally, companies and individuals that are involved in FDA regulated industries are quite familiar with and concerned about FDA regulations and enforcement. However, not all of these companies and individuals may be as familiar with advertising law and enforcement by the Federal Trade Commission (FTC), despite the fact that their products are also subject to FTC jurisdiction and the FTC continues to pursue enforcement actions, often involving large monetary payments, under the Lanham Act against individuals and companies involved in advertising FDA-regulated products such as dietary supplements, foods, and cosmetics. 

In this live audio conference, expert speaker Cynthia Meyers will provide an overview of basic advertising law concepts, including claim substantiation, endorsements, adequate disclosures, native advertising, and puffery. She will also discuss specific claims such as comparative, “Made in the USA,” and environment-friendly claims, and will also include discussion of the self-regulatory body, the National Advertising Division (NAD). Cynthia will touch upon particular areas that are especially relevant for many in FDA-regulated industries.

The focus of the session is on how these concepts are particularly relevant to FDA-regulated industries. For example, when creating claims for dietary supplement products, companies must consider not only the FDA perspective (e.g., are the claims disease claims or structure/function claims?) but also the advertising law/FTC perspective (e.g., is there support for the claims?). Claims for cosmetic products such as anti-wrinkle creams must both avoid being drug claims (FDA perspective) and must not be false or misleading by implying better results than can be supported (advertising law/FTC perspective). 

What can be difficult is that the concerns from an FDA perspective and from an advertising law/FTC perspective may not overlap so well. Compliance from one perspective does not mean compliance from the other perspective, and in some cases, it may not be possible to find a commercially-desirable solution that can be compliant from both perspectives.

Additionally, if time permits, the session will also touch upon social media and native advertising concerns from an advertising law perspective.

Session Highlights:

  • Insights on the FTC, Lanham Act, and Advertising Law
  • Discussion on claim substantiation
  • Overview of Product Performance Claims, Comparative/Superiority Claims
  • Puffery—what you need to know
  • Insights on endorsements, including Consumer Testimonials
  • Discussion on the NAD and advertising self regulatory process
  • Difficulties in compliance from both an FDA and an advertising law perspective

Who should attend

This training will be useful for individuals and companies involved in marketing, advertising, or developing products regulated by the FDA, such as:

  • Individuals responsible for marketing and advertising dietary supplements, over the counter drugs, cosmetics, medical devices, or foods
  • Individuals or small companies unfamiliar with advertising law wanting to introduce a new product to market
  • Advertising agencies who work with clients in the FDA space to advertise products

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Cynthia Meyer - Pharma Guidelines Expert

Cynthia Meyer is an associate at Kleinfeld, Kaplan, and Becker, LLP, a boutique food and drug law firm in Washington, DC.  Her practice focuses primarily on counseling and advocating on behalf of companies and individuals in the pharmaceutical, medical device, food, cosmetic, dietary supplement, and alcoholic beverage industries on legal and regulatory matters involving the FDA, USDA, FTC, TTB, and other related federal and state agencies.

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