Represents clients in the tobacco and nicotine industry on matters of compliance arising under the Federal Food, Drug, and Cosmetic Act (FFDCA).
As amended by the Family Smoking Prevention and Tobacco Control Act (TCA), the Comprehensive Smokeless Tobacco Health and Education Act, the Federal Cigarette Labeling and Advertising Act, the Internal Revenue Code, the Prevent All Cigarette Trafficking Act (PACT Act), and other federal, state, and local laws regulating the manufacture, labeling, promotion, distribution, taxation, importation, exportation, and sale of tobacco products.
Our firm has been closely involved with regulators throughout the development of tobacco product regulations and guidelines by engaging in meetings with the FDA Center for Tobacco Products (CTP), the White House Office of Management and Budget (OMB), and the Government Accountability Office (GAO), and by submission of correspondence and comments.
We were instrumental in drafting the TCA Small Business provisions and actively represented small business interests during the development process of the so-called “deeming regulation.”
Our firm has considerable experience in all areas of the regulation of delivery sales of tobacco products. We frequently advise on issues related to:
- Registration and reporting requirements
- Shipping tobacco products into and within the United States
- The PACT Act’s taxation provisions
- Compliance with the Tobacco Master Settlement Agreement (MSA) and the settling states’ so-called MSA complementary statutes, as well as other state and local requirements applicable to tobacco products.