Practice Areas

Tobacco & Nicotine Products

KKB represents tobacco and nicotine product industry clients with compliance matters 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. With respect to the new and still-developing areas of the law, we have worked closely with regulators to represent our clients’ interests throughout the development of tobacco product regulations and guidance. Among other things, we have represented our clients’ positions by participating in meetings with FDA’s Center for Tobacco Products (“CTP”), the Office of Management and Budget (“OMB”) in the White House, and the Government Accounting Office (“GAO”), filing letters and other correspondence, and submitting comments to public dockets. We were instrumental in the drafting of the small business provisions of the TCA and have actively represented the interests of small business during the so-called “deeming regulation” development process.

Labeling and Advertising

KKB has extensive experience in all aspects of tobacco product labeling and advertising. We provide advice on the proper wording and formatting of elements required to appear on product packaging and in advertising (e.g., warning statements). We also counsel our clients with regard to tobacco product promotional activities and materials, including websites and social media. For example, we help clients assess whether claims could render products modified risk tobacco products, the marketing of which requires an FDA order, or could subject the products to FDA regulation under the Agency’s authorities for drugs, devices, and combination products. We have also worked extensively with companies marketing electronic cigarettes and vapor products, including in the development and review of advertising copy and claim substantiation.

Approval and Marketing Requirements

KKB’s advice covers all aspects of tobacco product premarket review and other TCA marketing requirements, including:

  • Issues related to
    • Substantial Equivalence Reports and Exemptions
    • Modified Risk Tobacco Product Applications
    • Premarket Tobacco Applications
  • Ingredient, health document, and harmful and potentially harmful constituent submissions
  • Establishment registration and product listing
  • User fees

KKB also assists clients in determining whether a tobacco- or nicotine-containing product qualifies for regulation under the FFDCA as a tobacco product or a drug or drug-delivery product. Based on this initial assessment, we then guide manufacturers, distributors, and importers through the steps required to market their products.

Delivery Sales & MSA

KKB has extensive experience in all aspects of the regulation of delivery sales of tobacco products.  We advise on issues related to:

  • Registration and reporting requirements
  • Shipping tobacco products into and within the United States
  • The PACT Act’s taxation provisions

In addition, KKB assists clients in complying 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.

Enforcement

KKB provides assistance with responding to a wide range of tobacco-related enforcement activities by FDA and other federal, state, and local regulatory agencies, including FDA Warning Letters and inspectional observations (FDA Form 483).