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

• Issues related to
  • Substantial Equivalence Reports and exemptions
  • Modified Risk Tobacco Product Applications
  • New Tobacco Product Applications
• Ingredient and health document submissions
• Establishment registration and product listing
• User fees

KKB also assists clients in determining whether a tobacco- or nicotine-containing product qualifies for regulation as a tobacco product under the TCA or as a product regulated under the Federal Food, Drug, and Cosmetic Act. Based on this initial assessment, we then guide manufacturers and importers through the steps required to market their products