22nd Century Group (NYSE:XXII) hopes the writing will soon be on the wall.
The Clarence, N.Y.-based plant biotechnology company is attempting to promote change within the tobacco industry, announcing last week that 41 public health and medical associations crafted an open letter to the U.S. Food and Drug Administration (FDA) concerning the agency’s nicotine reduction plans.
The group hopes to prompt a response from Commissioner Dr. Scott Gottlieb regarding the FDA’s next move regarding the fledgling market of tobacco harm reduction. 22nd Century, which developed a Very Low Nicotine (VLN) tobacco strain, is positioned to create a new market, minimally or non-addictive cigarettes, according to a press release.
22nd Century is marketing a strain that contains a 95-percent nicotine reduction, the company said.
Considering major tobacco companies “have a long history of manipulating nicotine levels in cigarettes to make them more addictive,” the letter requested the FDA to declare a final ruling within the next 12 months.
“22nd Century’s (VLN) tobacco makes possible the FDA’s plan to render all cigarettes sold in the U.S. minimally or non-addictive,” 22nd Century President and CEO Henry Sicignano III said.
22nd Century boasts several independent clinical trials that have demonstrated SPECTRUM, the company’s top VLN offering, helps decrease cigarette consumption and dependence, the company said.
By reducing nicotine levels in cigarettes, “massive public health benefits” would be created, the letter stated.
The letter also cited the FDA’s estimation that more than five million adult smokers would quit within a year of enforcing lower nicotine standards. It also stated 33 million would-be smokers would not acquire an addiction at younger ages over the next 82 years. Over that span, eight million individuals would not succumb to smoking-related complications.
The clinical findings formed the foundation of the FDA’s broad strategy of outlawing all U.S. cigarettes that do not possess minimal, non-addictive nicotine levels. Public health officials are lobbying the FDA to release a final ruling by March 2019, according to a press release.
Outlining the May 21 letter to the FDA, 22nd Century requested the agency to act with a “sense of urgency commensurate with the (lifesaving) potential of decreasing addictive chemicals.”
The letter also points out, SPECTRUM demonstrates the “absence of compensatory smoking, as well as demonstratable reductions in cigarettes smoked per day and (reduces) exposure to harmful smoking constituents,” according to a release.
Through plant breedings and genetic engineerings, 22nd Century produces technology to reduce nicotine levels in tobacco and cannabinoids in hemp/cannabis plants.
Founded in 1998, the company has a market cap of approximately $259.2 million.
“We urge the FDA to move forward, aggressively, to issue its final rule in this public health imperative so that millions of lives might be saved,” Sicignano said.
Here’s the full list of organizations who’ve signed the open letter:
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