Federal Regulation of the Tobacco Industry

As part of most scrutinized industry in the world, tobacco product manufacturers face a unique set of legal challenges. Troutman Sanders’ attorneys have been advising clients specifically regarding FDA tobacco requirements since before the enactment of the Family Smoking Prevention & Tobacco Control Act in 2009 (giving the FDA the authority to regulate tobacco products) and collectively have decades of experience in this industry. They also often team with the attorneys in our Life Sciences practice to assist clients in this arena.

In light of the newly-released FDA deeming regulations, which will affect e-cigarettes and premium cigars, among other products, our attorneys have been assisting manufacturers that will be affected by these regulations in taking early steps toward planning for the regulations.

Our attorneys are known for working closely with clients in all aspects of the tobacco industry to assist them in developing business strategies especially designed for navigating the complicated regulatory process, including:

  • Formulating plans for meeting the requirements of the FDA, which regulates the manufacture, packaging and sale of tobacco products in the US
  • Preparing FDA submissions, such as premarket review and substantial equivalence submissions
  • Assisting with drafting remarks and suggestions to FDA during applicable comment periods
  • Filing warning plans and ingredient lists
  • Preparing FDA submissions including registration product list and ingredient list
  • Advising regarding FDA marketing requirements
  • Advising regarding FDA inspections
  • Representing electronic cigarette companies with respect to regulatory issues, including issues with the FDA.
  • Advising clients concerning other federal requirements, such as the PACT Act, Contraband Cigarette Trafficking Act and import/export requirements


Practice Highlights