Wiley Rein LLP


Advertising | FDA REGULATION

Partners James N. Czaban, Bert W. Rein and William A. McGrath regularly represent clients before the FDA, which has jurisdiction over prescription drug advertising. Wiley Rein thus provide clients with an in-depth understanding of the close working relationship between that agency and the FTC, which has applied some FDA food labeling rules and regulations to advertising for food products.



Representative experience includes:

  • Advising clients in the food & beverage, nutritional supplement, cosmetic and consumer product industries on the development of claims that will avert FDA scrutiny as potentially qualifying the product as a drug or device, violating nutritional content or health claim limitations or otherwise implicating FDA regulatory requirements.
  • Working closely with clients to ensure that direct-to-consumer prescription drug campaigns provide fair balance and otherwise comply with all FDA requirements and advocating in front of FDA.
  • Advising clients on permissible product claims under OTC monographs or dietary supplement “structure/function” requirements.
  • Counseling clients on avoiding potential false advertising litigation for FDA regulated products based on FDA claims regulation and consulting with product liability counsel where such claims have generated class action suits under state Unfair Trade Practice laws.

Contact Us
Hugh Latimer
202.719.4989 | hlatimer@wileyrein.com




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