December 2003

Grant Results

SUMMARY

In 1996 and 1997, St. Peter's Medical Center and the American Society of Addiction Medicine held two conferences to explore the implications of products that claimed to deliver nicotine to smokers more safely than cigarettes (e.g., nicotine patch and gum, nicotine nasal spray and, most recently, cigarette-like devices that deliver less nicotine and other harmful substances than traditional cigarettes).

Key Results

  • The first conference, "Exploring Alternatives to Abstinence for Nicotine Dependence," was held on May 23, 1996 in Newark, N.J., with 23 attendees from government, academia and nonprofit organizations.
  • The second conference, "Alternative Nicotine Delivery Systems: Harm Reduction and Public Health," was held on March 21–23, 1997 in Toronto, with almost 100 participants.

Key Recommendations
A committee revised the conference presentations and made policy recommendations for Nicotine and Public Health, a book published by the American Public Health Association in 2000. Among the recommendations:

  • No nicotine delivery device should be brought to market without prior approval by the Food and Drug Administration (FDA).
  • The regulatory system should be flexible and nonpolitical to allow for rapid regulatory changes if products previously believed safe are found to have harmful effects.
  • Terms such as "light," "mild" and "low tar" should not be used to describe or name tobacco products.

Funding
The Robert Wood Johnson Foundation (RWJF) supported the first conference with a $27,883 grant to St. Peter's and the second with a $194,135 grant to the American Society of Addiction Medicine.

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THE PROBLEM

The over-the-counter nicotine patch and gum and prescription nicotine nasal spray are examples of products recently marketed to assist smokers to stop smoking. They also can be used to make the continued ingestion of nicotine less deadly for those who cannot or will not stop using nicotine altogether.

In recent years, tobacco companies have been developing their own alternative nicotine delivery products — cigarette-like devices that deliver less nicotine and other harmful substances than traditional cigarettes. However, the public health community has made little serious study of how this approach affects the health of the public.

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THE PROJECT

These two grants supported conferences to explore the implications of alternative nicotine delivery devices and to make policy recommendations. The first grant (ID# 028627) was used for a one-day exploratory conference, "Exploring Alternatives to Abstinence for Nicotine Dependence," in May 1996 in Newark, N.J.

The principal investigator did not complete a planned paper summarizing the meeting but received a second RWJF grant (ID# 030691) to organize a longer conference to examine relevant issues in greater depth. That event, "Alternative Nicotine Delivery Systems: Harm Reduction and Public Health," was held in March 1997 in Toronto, and lasted two and a half days.

The American Society of Addiction Medicine, the Addiction Research Foundation and the Ontario Tobacco Research Unit, a unit of the Centre for Health Promotion at the University of Toronto, cosponsored the second conference.

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RESULTS

Twenty-three people from government, academia and nonprofit organizations attended the first meeting, which was guided by an agenda that considered the safety and toxicity of nicotine, the history of tobacco product design, the then current array of alternative designs, research needs and policy options. (See the Bibliography a for list of presentations.)

Almost 100 invited experts from the fields of tobacco control, harm reduction (a strategy to make the continued ingestion of nicotine less deadly for those who cannot or will not stop using nicotine altogether), public health policy, clinical medicine, epidemiology, toxicology and pharmacology, and bioethics attended the second conference. (See the Bibliography for a list of presentations.)

The agenda included a history of nicotine delivery systems, control systems for psychoactive drugs, effects of nicotine, types and characteristics of nicotine delivery systems, regulatory mechanisms and agendas for research and monitoring.

A committee of 13 members, formed after the conference, met to discuss the policy implications identified at the conference and to produce a report. (See the Appendix for membership list.)

The committee focused on three key issues:

  1. The likely public health impact of alternative nicotine delivery systems.
  2. The appropriateness, the risks and the benefits of harm reduction (also called exposure reduction) as a tobacco-control strategy.
  3. Various policy and regulatory options.

After seeking feedback from conferees and peer reviewers, the committee completed Nicotine and Public Health, a book published by the American Public Health Association in 2000, which included revised conference presentations and a series of recommendations. Several of the recommendations would require legislative action for implementation.

Recommendations

The following recommendations were among those included in Nicotine and Public Health:

  • Policies for nicotine delivery devices should be complementary to approaches taken to promote abstinence from tobacco products. Abstinence is the healthiest solution for smokers, and potential smokers must still be discouraged from starting to smoke. But for those who cannot give up nicotine, some alternatives to cigarettes may reduce the risks of disease.
  • No new nicotine delivery device should be brought to market without prior approval by the FDA. Although the FDA regulates products that make health claims, and has used this authority to regulate some alternative nicotine delivery devices, it is not permitted to regulate conventionally marketed cigarettes, and uniform guidelines for the alternative products have not been established. Requiring that new products have FDA approval is a key way to assert regulatory authority from the start.
  • The regulatory system should be flexible and nonpolitical to allow for rapid regulatory changes if products previously believed to be safe are found to have harmful effects. It will be difficult to be certain of all the effects of a product before it is marketed.
  • Terms such as "light," mild" and "low tar" should be prohibited for use in describing or naming tobacco products. Allowing tobacco companies to market their products as "light," "mild" or "low tar" gives smokers the false belief that they are less dangerous to their health than conventional products.
  • Studies should examine the potential expansion of indications for using nicotine-replacement therapy, including temporary use when a person faces acute withdrawal from nicotine. For example, smokers admitted to a hospital often receive a nicotine patch or nicotine gum since they are not permitted to smoke. The same principle might apply to those entering alcohol or drug-abuse treatment facilities with nonsmoking policies. Studies should also examine the possibility of sustained, long-term use of nicotine-replacement therapy as a complete replacement for tobacco products.
  • Tobacco products should be regulated according to their toxicity and addictiveness. Products that are more dangerous, such as cigarettes, should have more restrictions on their marketing and packaging than comparatively less dangerous products, such as medicinal nicotine. If any of these products, such as the alternative delivery devices, are found to be highly toxic, however, they should be regulated accordingly.

Communications

More than 1,400 copies of Nicotine and Public Health were printed and distributed at the 11th World Conference on Tobacco in August 2000, to all medical libraries in the United States and Canada and to governmental officials and leaders in tobacco control.

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AFTER THE GRANT

The public health community is continuing to seek strategies for the use and regulation of alternative nicotine delivery devices. Several governmental and nongovernmental agencies, including RWJF, sponsored a meeting entitled "Reducing Tobacco Harm" in Washington in July 2001. In February 2001, the Institute of Medicine released a report entitled, "Clearing the Smoke: The Science Base for Tobacco Harm Reduction," which drew upon the book's recommendations.

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GRANT DETAILS & CONTACT INFORMATION

Project

Public Health Implications of Alternative Nicotine Delivery Devices

Grantee

St. Peter's Medical Center (New Brunswick,  NJ)

  • Meeting to Explore Public Health Implications of Alternative Nicotine Delivery Devices
    Amount: $ 27,883
    Dates: January 1996 to January 1997
    ID#:  028627

Contact

John D. Slade, M.D. (deceased)

Grantee

American Society of Addiction Medicine (Chevy Chase,  MD)

  • Workshop and Policy Panel on Alternative Nicotine Delivery Systems
    Amount: $ 194,135
    Dates: January 1997 to December 2000
    ID#:  030691

Contact

John D. Slade, M.D. (deceased)

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APPENDICES


Appendix 1

(Current as of the time of the grant; provided by the grantee organization; not verified by RWJF.)

Committee Members

John Slade, M.D. (now deceased)
St. Peter's Medical Center
New Brunswick, N.J.

Warren K. Bickel, Ph.D.
University of Vermont
Burlington, Vt.

Thomas J. Crowley, M.D.
University of Colorado School of Medicine
Denver, Colo.

Roberta Ferrence, Ph.D.
Addiction Research Foundation
Toronto, Ontario, Canada

Jack E. Henningfield, Ph.D.
Pinney Associates
Bethesda, Md.

Thomas P. Houston, M.D.
American Medical Association
Chicago, Ill.

Brenda Mitchell
Brenda Mitchell and Associates
Mount Forest, Ontario, Canada

Robin Room, Ph.D.
Addiction Research Foundation
Stockholm, Sweden

David T. Sweanor, Esq.
Non-Smokers' Rights Association
Ottawa, Ontario, Canada

Kenneth E. Warner, Ph.D.
University of Michigan
Ann Arbor, Mich.

Lynn T. Kozlowski, Ph.D.
Pennsylvania State University
University Park, Pa.

Jurgen Rehm, Ph.D.
Addiction Research Foundation
Toronto, Ontario, Canada

Bill Rickert, Ph.D.
Labstat Incorporated
Kitchener, Ontario, Canada

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BIBLIOGRAPHY

(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)

Sponsored Conferences

ID# 028627
Exploring Alternatives to Abstinence for Nicotine Dependence, St. Peter's Medical Center, May 23, 1996, Newark, N.J. Attended by 23 individuals representing academic, government and private voluntary public health organizations such as the University of Michigan, the National Institutes of Health and the Addiction Research Foundation.

Presentations and Testimony

Steven Gourlay, University of California at San Francisco (San Francisco) "Biological Safety and Toxicity of Nicotine."

George Spillich, Washington College (Chestertown, Md.), "Behavioral Safety and Toxicity of Nicotine."

William Rickert, Labstat, Inc. (Kitchener, Ontario), "Tobacco Product Modification: Historical Perspective."

K. Michael Cummings and John Pauly, Roswell Park Cancer Institute (Buffalo, N.Y.), "Novel Nicotine Delivery Devices, Present and Future, from Tobacco Companies and from Pharmaceutical Companies."

Lynn Kozlowski, Pennsylvania State University (University Park, Pa.), "Research Needs."

David Sweanor, Nonsmokers Rights Association (Ottawa), "Options for Making Alternative Nicotine Delivery Devices Available in an Ideal World."

Scott Ballin, American Heart Association (Washington), "Options for Making Alternative Nicotine Delivery Devices Available in the United States, circa 1996–2000."

Books

ID# 030691

Ferrence R, Slade J, Room R and Pope M (eds.). Nicotine and Public Health. Washington: American Public Health Association, 2000.

Sponsored Conferences

Alternative Nicotine Delivery Systems: Harm Reduction and Public Health. Addiction Research Foundation, Ontario Tobacco Research Unit, and the American Society of Addiction Medicine, March 21–23, 1997, Toronto. Attended by 98 individuals from the United States and Canada representing academic, government, and nonprofit organizations, including the Canadian Council on Smoking and Health, the Medical College of Virginia and the U.S. Food and Drug Administration.

Presentations and Testimony

Lynn Kozlowski, Pennsylvania State University (University Park, Pa.), "A Brief History of Nicotine Delivery Systems."

Robin Room, Addiction Research Foundation (Toronto), "Control Systems for Psychoactive Drugs."

Neal Benowitz, University of California, San Francisco (San Francisco), "The Toxicity of Nicotine."

Steve Heishman, National Institute on Drug Abuse (Baltimore), "Cognitive and Behavioral Effects of Nicotine."

Harold Kalant, University of Toronto (Toronto), "Nicotine as an Addictive Substance."

Bill Rickert, Labstat Incorporated (Kitchener, Ontario), "Nicotine Delivery Systems: Cigarettes."

Lars Ramstrom, Institute for Tobacco Studies (Stockholm, Sweden), "Nicotine Delivery Systems: Snuff.

Donald Shopland, National Cancer Institute (Bethesda, Md.), "Nicotine Delivery Systems: Pipes, Cigars & Other Traditional Tobacco Products."

Karl Fagerstrom, Pharmacia AB Consumer Health Care (Helsingborg, Sweden), "Nicotine Delivery Systems: Nicotine-Replacement Therapies."

John Slade, St. Peter's Medical Center (New Brunswick, N.J.), "Nicotine Delivery Systems: Innovative Nicotine Delivery Systems."

Jack Henningfield, Pinney Associates, Inc. (Bethesda, Md.), "Comparing the Abuse Potential of Nicotine Delivery Systems."

Peter Reuter, University of Maryland (College Park, Md.), "Nicotine as a Replacement for Cigarettes? Lessons from Methadone Use."

Terry Pechacek, Centers for Disease Control and Prevention (Atlanta), and Roberta Ferrence, Addiction Research Foundation (Toronto), "Present Patterns of Use."

Jurgen Rehm, Addiction Research Foundation (Toronto) and Donald Shopland, National Cancer Institute (Bethesda, Md.), "Potential Future Patterns of Use and Risk Reduction."

Neal Benowitz, University of California, San Francisco (San Francisco) and Michael Russell, Maudsley Hospital Health (London; "Public Health and Levels of Nicotine: Should Nicotine Levels in Cigarettes be Minimized or Maximized?"

Kenneth Warner, University of Michigan (Ann Arbor, Mich.) and Richard Hurt, Mayo Clinic (Rochester, Minn.), "Public Health and Clinical Implications of Long-Term Maintenance of Nicotine Use."

Panels

"Regulatory Mechanisms." Matt Myers, Center for Tobacco-Free Kids (Washington); David Sweanor, Non-Smokers' Rights Association (Ottawa); and Richard Daynard, Northeastern University School of Law (Boston).

"Agendas for Research and Monitoring." Bill Corrigall, Addiction Research Foundation (Toronto, Ontario); Thomas Stephens, Thomas Stephens & Associates (Manotick, Ontario); and Neil Collishaw, World Health Organization (Geneva).

"Building a Public Health Agenda for Nicotine," Kenneth Warner, University of Michigan (Ann Arbor, Mich.); Greg Connolly, Massachusetts Department of Public Health (Boston); Matt Myers, Center for Tobacco-Free Kids (Washington); Christiane Poulin, Dalhousie University (Halifax, Nova Scotia); and Nigel Gray, Instituto Europea di Oncologia (Milan, Italy).

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Report prepared by: Susan G. Parker
Reviewed by: Karyn Feiden
Reviewed by: Molly McKaughan
Program Officer: Nancy J. Kaufman

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