Ben Haas, a partner and former Global Vice Chair of Latham’s Healthcare & Life Sciences Practice, advises clients across all stages of pre- and post-market US Food and Drug Administration (FDA) regulation and compliance. 

Ben leverages extensive experience and a sophisticated understanding of FDA-regulated products to guide tobacco, medical device, pharmaceutical, biotechnology, food, cosmetic, and dietary supplement companies.

Ben is one of the most well-known and active members of the bar with respect to FDA’s ongoing efforts to implement the Tobacco Control Act and its authority over electronic nicotine delivery and other novel tobacco products, and has successfully represented several manufacturers in all types of pre-market submissions for tobacco products, including PMTAs, MRTPs, and Substantial Equivalence (SE) Reports. 

A recognized thought leader, Ben has served on multiple steering committees for the Food and Drug Law Institute and regularly speaks on FDA regulatory and enforcement matters. He also recently co-authored of “Nicotine Delivery Products: Navigating FDA’s Policies in a Dynamic Environment”, a Food and Drug Law Institute publication, the key desk reference regarding FDA’s regulation of tobacco and nicotine products.

Ben counsels FDA-regulated companies on:

  • FDA pre-market authorization for multiple nicotine products
  • Compliance of nicotine products and manufacturing facilities with FDA requirements 
  • Post-market compliance of nicotine products subject to FDA authorization and/or FDA compliance policies
  • Compliance of nicotine products with state and local requirements
  • Tobacco and nicotine research strategies, compliance, and contracting
  • Digital health and AI initiatives, particularly for emerging companies in the healthcare and life sciences sector
  • Clinical trial strategy, vendors, and sites
  • Clinical research organization and other vendor contracts and management
  • Investigations in the US and internationally involving regulatory authorities, institutional review boards, and ethics committees
  • Agreements for manufacturing and supply; licensing; joint development; and consulting, marketing, and distribution contracts across all FDA-regulated product areas

Bar Qualification

  • District of Columbia
  • Virginia

Education

  • JD, University of Virginia School of Law, 2001
  • BS, Georgetown University, 1997