22nd Century Group, Inc., a plant biotechnology company calling for tobacco harm reduction and very low nicotine tobacco, announced that 41 public health and medical organizations wrote an open letter to FDA Commissioner Scott Gottlieb urging the FDA to quickly implement its plan to reduce nicotine in cigarettes to minimally or non-addictive levels.
22nd Century has grown commercial crops of proprietary tobacco with nicotine levels of just 0.4mg per gram of tobacco—a 95 percent reduction in nicotine as compared to tobacco used in conventional cigarettes. Independent clinical trials using 22nd Century’s proprietary Spectrum research cigarettes have shown that very low nicotine content cigarettes reduce cravings, reduce consumption of cigarettes, and increase quit attempts.
The independent research conducted with 22nd Century’s Spectrum cigarettes provided the foundation for the FDA’s plan to mandate that all cigarettes sold in the United States contain only “minimally or non-addictive” levels of nicotine, according to the company.
In their May 21, 2018 letter to Gottlieb, the American Heart Association, the American Cancer Association, the American Medical Association, and dozens of other public health and medical organizations described the “massive public health benefits” that will result from the adoption of the FDA’s vital plan to dramatically reduce nicotine in cigarettes:
‘Every day that passes means more kids moving from experimentation to addiction and more adults who want to quit and try to quit, but remain addicted to a lethal product. We urge FDA to issue a proposed rule within six months of its ANPRM (by September 16, 2018) and a final rule six months later (by March 16, 2019). We also urge that implementation of the rule be no later than the one-year period provided for in Section 907 of the Family Smoking Prevention and Tobacco Control Act, which would allow the rule to be implemented by March of 2020.’
The letter also points to the FDA’s estimates that a new cigarette product standard could enable an additional 5 million adult smokers to quit within just one year of implementation. And, by the end of the century, the FDA’s nicotine reduction policy could prevent more than 33 million people, mostly youth and young adults, from becoming regular smokers; further, there would be 8 million fewer smoking-related deaths within that time.
The authors call for the FDA to act with a “sense of urgency commensurate with the [lifesaving] potential” of reducing nicotine to minimally or non-addictive levels.
Citing independent clinical studies made possible through the use of 22nd Century’s proprietary Spectrum research cigarettes, the authors remind the FDA that “very low nicotine cigarettes [show] the absence of compensatory smoking, as well as demonstrable reductions in cigarettes smoked per day and [reductions] in exposure to harmful smoking constituents.”
Noting that the major tobacco companies have a long history of manipulating nicotine levels in cigarettes to make them more addictive, in their open letter to Gottlieb, the public health leaders urge the FDA to issue—in less than one year’s time—its final rule on mandating very low levels of nicotine in cigarettes.
The public health and medical organizations signing the open letter to the FDA included:
Action on Smoking and Health
Allergy & Asthma Network
American Academy of Family Physicians
American Academy of Oral and Maxillofacial Pathology
American Academy of Otolaryngology—Head and Neck Surgery
American Association for Cancer Research
American Association for Dental Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College of Cardiology
American College of Obstetricians and Gynecologists
American College of Physicians
American College of Preventive Medicine
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American Society of Clinical Oncology
Association of Maternal & Child Health Programs
Association of Schools and Programs of Public Health
Association of State and Territorial Health Officials
Association of Women’s Health, Obstetric and Neonatal Nurses
Big Cities Health Coalition
Campaign for Tobacco-Free Kids
Eta Sigma Gamma—National Health Education Honorary
International Association for the Study of Lung Cancer
Lung Cancer Alliance
March of Dimes
National Association of County and City Health Officials
Oncology Nursing Society
Prevent Cancer Foundation
Society for Cardiovascular Angiography and Interventions
Society for Public Health Education
Students Against Destructive Decisions
The Society for State Leaders of Health and Physical Education
The Society of Thoracic Surgeons
Trust for America’s Health
United Methodist Church—General Board of Church and Society