HPM regularly advises companies on issues relating to the labeling, advertising, and promotion, including social media issues, of FDA-regulated products. HPM reviews, for example, promotional and launch materials, reminder advertisements, direct-to-consumer advertisements, and advertising in other media such as websites and infomercials, and press releases for compliance with FDA's evolving requirements and industry guidelines. Core issues for which companies frequently seek our counsel involve the distinction between labeling and advertising, the distinction between scientific and promotional material, and First Amendment concerns in the context of product claims.
Whereas the FDA is primarily responsible for product labeling, the Federal Trade Commission (FTC) primarily regulates advertising. HPM advises and represents clients in FTC matters including advertising substantiation issues. Our attorneys assist clients in resolving FTC investigations and other FTC actions including Civil Investigative Demands issued by the FTC, resolving FTC investigations and negotiating settlements with, or litigating against, the FTC. We also advise companies with respect to compliance with state consumer protection and unfair trade practices laws relating to product advertising and labeling. HPM represents companies in civil litigation involving claims of unfair advertising under the Lanham Act, and in proceedings before the National Advertising Division of the Better Business Bureau.
Primary Contacts:
- Prescription Products
- Roger Thies
- Jeffrey Wasserstein
- Alan Kirschenbaum
- Dara Katcher Levy
- Anne Walsh
- Devices
- Jeffrey Gibbs
- Jeffrey Shapiro
- Roger Thies
- Consumer Products
- Paul Hyman
- A. Wes Siegner, Jr.
- Ricardo Carvajal
Developments in the Law
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