www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Grand Rounds: Why FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health”
October 10, 2019
WO 2: 2047
Activity Coordinators:
Devin Thomas (Devin.Thomas@fda.hhs.gov)
Series Description

The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
In 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) was signed by the President "to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products…" The TCA requires FDA premarket review of new tobacco products and evaluation of whether marketing the product(s) is "appropriate for the protection of public health."
This population health standard, directing FDA to assess impact on the population as a whole and not only individual product users, required creation of a new FDA review process. Questions arise regarding how to minimize the risks while maximizing the possible benefits of allowing new tobacco products or modified risk products on the market. The scientific review process is complex and involves data from a breadth of scientific disciplines.

The Center for Tobacco Products (CTP) is responsible for carrying out the TCA. Our mission is to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and other. After a brief introduction to CTP, this presentation will provide a description of the IQOS heated tobacco products and a summary of the applications. The specific requirements of the TCA and the criteria for denying marketing authorization will be described as well as a brief discussion of FDA's understanding of what it means to be "appropriate for the protection of public health." Finally, the presentation will conclude with an explanation of the rationale for FDA's decision regarding IQOS and how this may impact future Premarket Tobacco Applications and tobacco control.
  • Family Smoking Prevention and Tobacco Control Act – An Overview; https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-to bacco-control-act-overview
  • IQOS Premarket Tobacco Application Technical Project Lead Review; IQOS PMTA TPL Review (redacted). https://www.fda.gov/media/124247/download
  • The Public Health Rationale for Recommended Restrictions on New Tobacco Product Labeling, Advertising, Marketing, and Promotion. https://www.fda.gov/media/124174/download
  • Draft Guidance, Applications for Premarket Review of New Tobacco Products. https://www.fda.gov/media/81821/download
  • Final Guidance, Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS), https://www.fda.gov/media/127853/download
Series Objectives
  • Discuss the research conducted at the FDA
  • Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe the Center for Tobacco Products and its’ responsibilities with respect to the Family Smoking Prevention and Tobacco Control Act
  • Explain the Pre-market Tobacco Product Application review process
  • Describe the IQOS heated tobacco products
  • Discuss the scientific review process as it relates specifically to the IQOS products and explain why FDA believes marketing of IQOS products is appropriate for the protection of public health
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency external scientific communities.

Lecture 1 October 10, 2019
Time Topic Speaker
12:00 - 1:00 PM Why FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health” Priscilla Callahan-Lyon, MD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-012-L04-P for 1.00 contact hour(s).
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Pharmacists will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.

  • Callahan-Lyon, Priscilla, MD, Deputy Director, Division of Individual Health Science, FDA Center for Tobacco Products - nothing to disclose

Planning Committee
  • Dinatale, Miriam, Team Leader, Food and Drug Administration - nothing to disclose
  • KEMPF, LUCAS, MD - nothing to disclose
  • Lee, Christine, PharmD, , PhD, General Health Scientist, FDA - nothing to disclose
  • Pfundt, Tiffany, PharmD, Pharmacist, FDA - nothing to disclose
  • Wheelock, Leslie, MS, RN, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team
  • Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
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