Tobacco & Nicotine Products

D.P. McGee Law advises companies on compliance with the requirements of FDA, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the Alcohol and Tobacco Tax and Trade Bureau (TTB), the Federal Trade Commission (FTC), as well as state and local authorities. 

We are well-versed on the Family Smoking Prevention and Tobacco Act, as well as FDA’s “Deeming Rule,” having assisted multi-national corporations before, during, and after these industry-changing regulatory events. 

We counsel clients on preparing submissions such as pre-market tobacco product applications (PMTAs), establishment registrations tobacco product master files (TPMFs), and substantial equivalence (SE) reports. We also assist clients in responding to FDA marketing denial orders, and resolving FDA Warning Letters, with appropriate corrective actions plans to prevent youth access ensuring marketing is tailored to adult consumers.

Our vast experience serves us well in advising on labeling and warning statement requirements for covered tobacco products and their packaging. When necessary, we consult with scientists and other experts to strategize on analytical and stability testing, scientific literature reviews, age-verification procedures, and environmental assessments to address potential safety and health concerns. 

D.P. McGee Law also advises clients on tobacco and vape excise taxes, the Prevent All Cigarette Trafficking (PACT) Act and state law compliance, including licensing  for manufacturers, distributors, wholesalers and retailers tobacco, vapor  and oral nicotine pouch products.