Tobacco & nicotine products

Daniel 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. 

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

Daniel counsels clients on preparing submissions such as premarket tobacco product applications (PMTAs), establishment registrations tobacco product master files (TPMFs), and substantial equivalence (SE) reports. He also assists 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.

Daniel’s vast experience serves him well in advising on labeling and warning statement requirements for covered tobacco products and their packaging. When necessary, Daniel consults 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. 

Daniel 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.