FDA Tobacco Products Regulation

FDA Tobacco Products Regulation

FDA tobacco products regulation poses several confusing issues. Whether it is determining if a product is a “new tobacco product” subject to pre-market approval, or a vape or e-cigarette product (e-liquid) with labeling and ingredient question we can help.

The primary source of of FDA tobacco product regulations stems from the Family Smoking Prevention Tobacco Control Act (the Tobacco Control Act) which amended the Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products.  This results in a regulatory shift starting in 2009 that impoeses a variety of pre-market requirements. Other changes under the Tobacco Control act include ingredient disclosure, labeling, manufacture, distribution, advertising, modified risk and safety data requirements. These regulations apply to both manufacturers and importers of regulated tobacco products.

A new source of FDA tobacco regulation comes from a new rule called the “Deeming Regulation.” The proposed “Deeming Regulation,” gives the FDA authority over currently unregulated tobacco products such as electronic cigarettes and advanced personal vaporizers, dissolvable tobacco, cigars, pipe tobacco and hookah (water pipes).

Our firm offers a unique background of comprehensive experience dealing daily with the regulation of food, drugs, medical devices and dietary supplements. This unparalleled focus allows our firm to advise tobacco product companies through the maze of new FDA requirements for tobacco products. We provide legal support to tobacco product companies and their suppliers with respect to the statutory and regulatory requirements specifically imposed by the Tobacco Control Act, including:

  • Ingredient, additive, and harmful and potentially harmful constituent disclosure requirements;
  • Health document submissions;
  • Manufacturing facility registration;
  • Good Manufacturing Practice guidance;
  • Substantial equivalency determinations and exemptions;
  • Premarket Tobacco Product Applications;
  • Modified Risk Tobacco Product Applications;
  • Labeling requirements;
  • Retailer compliance issues; and
  • Tobacco product testing requirements.

FDA Tobacco Products Regulations Resources

  • ’Pre-Market
  • ’Vape
  • ’Warning
Learn more about pre-market requirements and substantial equivalence here.
Learn more about vape product regulation here
Learn more about responding to a Tobacco Warning Letter here