FDA Regulation of

Tobacco

Washington, DC

October 21, 2015

The Impact of MRTP – A look at the MRTP process, and the impact on products

Denny Henigan, Director, Legal and Policy Analysis, Campaign for Tobacco Free Kids

Raymond S. Niaura, PhD, Associate Director for Science, Schroeder Institute for Tobacco Research and Policy Studies

David Sweanor, Adjunct Professor, Faculty of Law, University of Ottawa

Moderated by Jim Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America

THE IMPACT OF MRTP A Look at the MRTP Process and

the Impact on Products

Moderated by Jim Solyst

Vice President, Federal Regulatory Affairs

Swedish Match North America

Status of the Swedish Match MRTP Application

• Submitted to FDA in June 2014 and determined to be complete in late August.

• The entire application, except for proprietary information, was made publicly available and there was an extended (nearly six months) review and comment period.

• As required by the Act, the FDA Tobacco Product Scientific Advisory Committee (TPSAC) met on April 9-10, 2015 to review the application and address questions posed by FDA CTP.

• Swedish Match and FDA provided briefing documents to the TPSAC. The Swedish Match document provides a readable version of the scientific evidence. The FDA document posed questions for the TPSAC to consider, and more importantly gives a sense of the Center’s thinking.

• FDA determined there needed to be a review and comment period for the eight “amendments” submitted by Swedish Match at the request of FDA.

Possible Decisions and What Is Success?

• FDA could reject the MRTP application entirely; or decide to grant a MRTP order and accept the three suggested warning label changes.

• Or the decision will be something in between.• Granting a MRTP order, with or without the proposed warning label

changes, would be a historic development and certainly a “success” for proponents of tobacco harm reduction.

What Would a MRTP Order Mean to Swedish Match?

• Would require a postmarket surveillance program.• Would allow the Company to communicate the meaning of the

MRTP order to the public and stakeholders.• Swedish Match would work with FDA to determine exactly what can

and cannot be communicated, but by granting a MRTP order, FDA has determined that:– Switching from cigarettes to General snus reduces an individual’s risk;

and

– The order benefits the health or the overall population.

Evidence-Based Risk Communication: Right-to-know the Relative Risk

Ray Niaura, PhD

Director of Science and Training

Schroeder Institute for Tobacco Research and Policy Studies

Truth Initiative

Risk Perceptions: Why?

Lights

PREPs

Snus

E-cigs/ENDS

MRTPs

Winning hearts and minds?

Tan ASL, Bigman CA. E-cigarette awareness and perceived harmfulness: prevalence and

associations with smoking-cessation outcomes. Am J Prev Med 2014; 47: 141–9.

Perceived e-cig risk in young

British smokers

Trends in electronic cigarette use in young people in Great Britain over 2013-2014

Arnott, Britton, Cheeseman, Dockrell, Eastwood, Jarvis, & McNeill ASH, CR-UK, PHE

2014

9

10

The Impact of MRTP-A look at the MRTP process, and the impact on

products

David SweanorAdjunct Professor, Faculty of Law

University of Ottawa

WARNINGS AND MODIFIED RISK TOBACCO PRODUCTS

Dennis Henigan

Director, Legal and Policy Analysis

Campaign for Tobacco-Free Kids

SMOKELESS WARNINGS SOUGHT BY RJ REYNOLDS CITIZEN PETITION

• WARNING: This product can cause mouth cancer.

• WARNING: This product can cause gum disease and tooth loss.

• WARNING: This product is not a safe alternative to cigarettes.

• WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.

• Or WARNING: No tobacco product is safe; however, exclusive use of smokeless tobacco products presents substantially less risk to health than cigarettes.

• WARNING: Smokeless tobacco is addictive.

SMOKELESS WARNINGS SOUGHT BY SWEDISH MATCH MODIFIED RISK

APPLICATION

• WARNING: This product can cause mouth cancer.

• WARNING: This product can cause gum disease and tooth loss.

• WARNING: This product is not a safe alternative to cigarettes.

• WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.

• WARNING: Smokeless tobacco is addictive.

Source: Swedish Match Premarket Consumer Perception Survey Protocol, Appendix B: Research Stimuli