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  1. OII Inspectorates

Division of Tobacco Inspectorate (DTI)

The Division of Tobacco Inspectorate (DTI), within the Office of Inspections and Investigations (OII)/Office of Field Operations & Response (OFOR)/Office of Field Regulatory Operations (OFRO), conducts inspections and investigations aiming to ensure that the tobacco industry follows the law and regulations designed to reduce the health burden of tobacco use. DTI protects the public and creates a healthier future for all Americans by enforcing the laws and regulations outlined in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act was signed into law on June 22, 2009, which gives FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products.

DTI is comprised of highly specialized Investigators who are geographically dispersed and conducts domestic and international inspections and investigations. The DTI Investigators collect evidence during their inspections and investigations and work in partnership with the Center for Tobacco Products (CTP) regarding enforcement actions pertaining to violations of the Tobacco Control Act.

DTI collaborates with CTP on the implementation of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) by:

  • Conducting biennial domestic inspections of the tobacco regulated industry
  • Conducting investigations at events where tobacco product manufacturers distribute free samples
  • Conducting investigations where adverse health events have occurred involving tobacco products
  • Assisting and investigating industry compliance related to product recalls
  • Inspecting foreign or domestic manufacturing facilities as part of a Premarket Tobacco Application (PMTA) or a Modified Risk Tobacco Product Application (MRTPA)
  • Collecting samples for analysis
  • Performing field examinations
  • Prepare reports on findings of each inspection 
  • Evaluate inspectional and analytical findings and recommends appropriate follow-up
  • Recommend legal action to the CTP in response to regulatory activities

DTI’s Mission

Our mission is to conduct rigorous, transparent, and science-based inspections, investigations, and assessments, providing real-time evidence and insight essential in empowering fact-based regulatory decisions of firms that manufacture, distribute, and market tobacco products to protect public health.

Key Contacts

TitleNameEmail
Division DirectorCDR Hristu (Chris) Chepa, Actinghristu.chepa@fda.hhs.gov 
Branch ChiefCDR Arthur (Grant) Hurst, Actingarthur.hurst@fda.hhs.gov 
Branch ChiefWayne Fortenberrywayne.fortenberry@fda.hhs.gov 

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