What is it?
The Food and Drug Administration (FDA) announced its intention to ban menthol as a characterizing flavor in combustible cigarettes on April 28, 2022 and opened up a 60-day period of public comment on the proposed regulation. The comment period was extended for 30 days but has now since closed.
Why is the Menthol Ban Significant for Very Low Nicotine (VLN) Cigarettes?
The announcement by the FDA of the proposed menthol ban was immediately followed by a press release from 22nd Century Group dated April 29th, 2022:
This press release was to communicate clearly and publicly that the company expected VLN would be granted an exemption from the Menthol Ban, presumably stemming from close and ongoing communications between company executives and the FDA leading up to the Modified Risk Tobacco Production (MRTP) marketing order on December 23rd, 2021 permitting the marketing of VLN cigarettes with the claim that the VLN Cigarettes with “95% Less Nicotine” could be marketed along with “Helps You Smoke Less.”
Here is a quote taken from the Press Release about where 22nd Century Group stands on this issue.
“We commend the FDA for taking action to reduce tobacco-related disease and death and advance health equity. Today’s proposed menthol ban is expected to have enormous health benefits for the nearly 18.6 million current smokers of menthol cigarettes – including the millions of African-Americans who are disproportionally harmed by these products,” said James A. Mish, chief executive officer of 22nd Century Group.
“Our VLN® Menthol King reduced nicotine cigarettes are an unmatched tool for helping adult menthol smokers find an off-ramp from nicotine addiction. 22nd Century will continue to support FDA in its public health mission by providing the only alternative on the marketplace today that approaches the problem by removing the addictive element from combustible cigarettes. We fully anticipate an even more favorable regulatory environment as the FDA continues to proceed with the Agency’s Comprehensive Plan, which includes banning menthol and requiring all cigarettes to be ‘minimally or non-addictive.’ 22nd Century’s VLN® King and VLN® Menthol King are the cornerstone of FDA’s public health mission for tobacco,” continued Mish.
If indeed an exemption to the Menthol Ban were enacted, it would leave VLN Menthol King Cigarettes as the only combustible cigarette on the market. With menthol cigarettes comprising approximately 35% of all cigarettes sold, this would be a significant win for public health since smokers addicted to menthol cigarettes would only access menthol cigarettes in a non-addictive capacity.
Numerous scientific studies have shown that VLN cigarettes containing less than 95% Less Nicotine and Helps You Smoke Less.
Furthermore, it would be a massive opportunity for the company to scale out its operations and be prepared for a far more comprehensive FDA plan for a Low Nicotine standard for “all” combustible cigarettes to be non-addictive. This comprehensive plan was first announced in July 2017: FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation. Success with a low nicotine rule limited only to menthol would provide evidence for the feasibility of a low nicotine rule for potentially for “all” tobacco products.
Why is Menthol So Problematic?
The following is an excerpt from this official letter to the FDA “Re: Docket No. FDA-2021-N-1349, “Tobacco Product Standard for Menthol in Cigarettes” from various healthcare, medical, educational, and civil rights groups during the comment period the proposed Menthol Ban.
SUMMARY OF REASONS SUPPORTING A PRODUCT STANDARD PROHIBITING MENTHOL AS A CHARACTERIZING FLAVOR IN CIGARETTES
1. Menthol cigarettes increase youth initiation of smoking and addiction to cigarettes.
- Menthol in cigarettes makes it easier for new users—primarily youth—to initiate smoking.
- The tobacco industry has intentionally targeted young people with marketing for menthol cigarettes.
- Young people initiate with and use menthol cigarettes at high rates.
- Menthol in cigarettes enhances the addictive properties of nicotine and facilitates progression to regular smoking.
2. Menthol cigarettes make it harder to stop smoking.
- People who smoke menthol cigarettes are less likely to quit smoking than people who smoke non-menthol cigarettes.
- Menthol cigarettes have slowed national progress in reducing smoking.
3. Menthol cigarettes disproportionately harm the health of Black Americans and other underserved populations.
- Menthol cigarette smoking is disproportionately high among Black Americans.
- The tobacco industry has targeted Black Americans with marketing for menthol cigarettes for decades.
- Black Americans suffer a disproportionate toll of the disease and death caused by menthol cigarettes.
- Menthol cigarettes are disproportionately used by other underserved population groups.
4. Prohibiting menthol cigarettes will produce substantial public health benefits.
- Prohibiting menthol cigarettes will reduce youth smoking initiation and progression to regular use.
- Menthol cigarettes have slowed national progress in reducing smoking.
- Prohibiting menthol cigarettes will increase smoking cessation.
- Many people who smoke menthol cigarettes report that they will quit smoking if menthol cigarettes may no longer be sold.
- Real-world evidence demonstrates that prohibiting menthol cigarettes increases smoking cessation.
- Preventing youth initiation and increasing smoking cessation will produce tremendous public health benefits.
- Finalizing the rule prohibiting characterizing flavors in cigars will enhance the public health impacts of the menthol rule.
5. There is no public health justification for exemptions from the rule.
- No exemption should be considered for IQOS menthol or similar heated tobacco products.
- No exemption should be considered for Very Low Nicotine (VLN) cigarettes or similar products (Note: the operators of VLNSmoking strongly disagree with this point)
6. Any risks of unintended and adverse consequences from prohibiting menthol cigarettes can be ameliorated and will not outweigh the public health benefits.
- Prohibiting menthol cigarettes will not cause the emergence of an illicit market that will nullify the public health gains from such a policy.
- Prohibiting menthol cigarettes will not increase the likelihood of police abuse in Black and other communities of color.
- The need to provide sufficient resources to help people stop smoking does not justify continuing to permit the manufacture and sale of menthol cigarettes.
The letter to the FDA was undersigned by the following organizations in public health, medicine, education, and civil rights.
- Academy of General Dentistry
- Action on Smoking & Health
- African American Tobacco Control Leadership Council Allergy & Asthma Network
- Alpha-1 Foundation
- American Academy of Family Physicians
- American Academy of Nursing
- American Academy of Oral and Maxillofacial Pathology American Academy of Oral and Maxillofacial Radiology American Academy of Pediatrics
- American Association for Cancer Research
- American Association for Dental, Oral, and Craniofacial Research American Association for Respiratory Care
- American Cancer Society Cancer Action Network
- American College Health Association
- American College of Cardiology
- American College of Physicians
- American College of Preventive Medicine
- American Dental Association
- American Heart Association
- American Lung Association
- American Medical Association
- American Pediatric Society
- American Public Health Association
- American Society of Addiction Medicine
- American Thoracic Society
- Americans for Nonsmokers’ Rights
- Asian Pacific Partners for Empowerment, Advocacy and Leadership (APPEAL) Association for Clinical Oncology
- Association for the Treatment of Tobacco Use and Dependence
- Association of Black Cardiologists
- Association of Black Women Physicians
- Association of Medical School Pediatric Department Chairs
- Association of Schools and Programs of Public Health
- Association of Women’s Health, Obstetric and Neonatal Nurses
- Asthma and Allergy Foundation of America
- Big Cities Health Coalition
- Black Men’s Health Initiative
- Black Women’s Health Imperative
- Breathe Southern California
- Campaign for Tobacco-Free Kids
- CATCH Global Foundation
- Catholic Health Association of the United States
- Center for Black Equity
- CenterLink: The Community of LGBT Centers
- Commissioned Officers Association of the USPHS
- Common Sense Media
- Community Anti-Drug Coalitions of America (CADCA)
- COPD Foundation
- Emphysema Foundation of America
- First Focus on Children
- GLMA: Health Professionals Advancing LGBTQ Equality
- GO2 Foundation for Lung Cancer
- International Association for the Study of Lung Cancer
- Islamic Society of North America (ISNA)
- League of United Latin American Citizens (LULAC)
- Mesothelioma Applied Research Foundation
- National Alliance for Hispanic Health
- National Association of County and City Health Officials
- National Association of Hispanic Nurses
- National Association of Pasifika Organizations (NAOPO)
- National Association of Pediatric Nurse Practitioners
- National Association of School Nurses
- National Association of Secondary School Principals National Black Church Initiative
- National Black Nurses Association
- National Center for Health Research
- National Council of Asian Pacific Islander Physicians National Education Association
- National Eta Sigma Gamma
- National Forum for Heart Disease & Stroke Prevention National Hispanic Council on Aging
- National Hispanic Medical Association National LGBT Cancer Network
- National Medical Association
- National Network of Public Health Institutes National Partnership for Women & Families National Tongan American Society
- North American Quitline Consortium Oncology Nursing Society
- Parents Against Vaping e-Cigarettes Pediatric Policy Council
- PHS Commissioned Officers Foundation for the Advancement of Public Health Prevent Cancer Foundation
- Preventing Tobacco Addiction Foundation/Tobacco 21
- Preventive Cardiovascular Nurses Association
- Respiratory Health Association
- Save A Girl, Save A World
- Society for Cardiovascular Angiography and Interventions Society for Pediatric Research
- Society for Research on Nicotine & Tobacco
- Southern Black Policy & Advocacy Network
- Students Against Destructive Decisions
- The Center for Black Health and Equity
- The National Alliance to Advance Adolescent Health
- The Society of State Leaders of Health and Physical Education The Society of Thoracic Surgeons
- Truth Initiative
- US PIRG