Comments from Richard Besser, MD, on Advanced Notice of Proposed Rulemaking on Regulation of Premium Cigars Under the Federal Food, Drug, and Cosmetic Act

    • July 12, 2018

The following comments were submitted by Richard Besser, MD, Robert Wood Johnson Foundation (RWJF) President and CEO, on the Advanced Notice of Proposed Rulemaking (ANPRM) on the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act.

The Robert Wood Johnson Foundation appreciates the opportunity to comment on the Advanced Notice of Proposed Rulemaking with respect to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act. In 2014, RWJF submitted comments to the U.S. Food and Drug Administration (FDA) encouraging the agency to extend its authority over all cigars and not to exempt so-called “premium cigars.” We were, therefore, pleased by FDA’s decision to include premium cigars within the scope of its 2016 rule (the “deeming rule”) that extended FDA oversight to all previously unregulated tobacco products, including all cigars. At the time, FDA concluded, “(1) All cigars pose serious negative health risks, (2) the available evidence does not provide a basis for FDA to conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant exclusion, and (3) premium cigars are used by youth and young adults.”1 We are aware of no new research that places these conclusions in doubt or would justify revising FDA’s prior decision to regulate premium cigars. We, therefore, urge FDA to continue to exercise its regulatory ­oversight over all cigars.

RWJF is Committed to Reducing the Burden of Tobacco on Our Nation’s Health

RWJF is the nation’s largest philanthropy dedicated to improving health and health care in the United States. Since 1972, we have worked with public and private sector partners to advance the science of disease prevention and health promotion, train the next generation of health leaders, and support the development and implementation of policies and programs to foster better health across the country, including high-quality health care coverage for all. We are working alongside others to build a national Culture of Health that provides everyone in America a fair and just opportunity for health and well-being.

Tobacco use continues to be a barrier to achieving this vision. Since 1991, RWJF has invested significant resources to combat the harm caused by tobacco products. We have made substantial progress, but we still have a long way to go. Tobacco use remains the number one cause of preventable death in the United States and disproportionately harms many marginalized populations, making it harder for those individuals to live their healthiest life.

Premium Cigars Contribute to the Burden of Tobacco on Health

Although we recognize that most of the toll from tobacco is attributable to cigarettes, cigars—including premium cigars—also pose a significant risk to public health. Cigar use is associated with increased mortality risk from oral, esophageal, laryngeal, and lung cancer even among cigar smokers who report no inhalation.2 Cigar use without inhalation can also lead to nicotine dependence.3 Finally, as FDA noted, exempting premium cigars from deeming “could mislead consumers to believe that premium cigars are safe, which contradicts the available evidence that all cigars are harmful and potentially addictive.”1

The overall prevalence of premium cigars use among adults in the U.S. is 0.7 percent,4 which based on 2017 census data,5 translates to about 1.7 million people, 6.7 percent of whom smoke premium cigars every day.6 Of adults who smoke cigars, 20 percent usually smoke premium cigars.6 Furthermore, 29.9 percent of premium cigar smokers also smoke cigarettes, which is a concern since cigar smokers who also smoke cigarettes are more likely to inhale.

FDA’s website notes that the agency “regulates tobacco products based on a public health standard that considers the risks and benefits of the tobacco products on the population as a whole.”7 Given the public health risks of premium cigars and the lack of public health benefit, we believe FDA’s standard requires it to continue to monitor and regulate premium cigars in the interest of public health.

Exempting Premium Cigars from FDA Regulatory Authority Will Likely Incentivize the Cigar Industry to Maximize the Market Share of Premium Cigars, Which Could Increase Their Burden on Public Health

FDA has noted that deeming all tobacco products, including premium cigars, would allow it to protect consumers and ensure all cigars comply with the law.1 This is a critical point as “the cigar industry has a long history of circumventing federal regulations by modifying the manufacturing, labeling, and promotion of their products.”8 For example, when the federal tax on little cigars increased in 2009, cigar manufacturers increased the weight of their products so that they would be taxed at the lower rate for large cigars.9 If FDA abandons its regulatory authority over premium cigars, the industry could again modify its products so that more of them meet the definition of a “premium cigar” and therefore would be exempted from FDA regulation. Such a move would likely increase the health burden of premium cigars.  

Conclusion: Exempting Premium Cigars From FDA Authority Would Be a Step Backward

Tobacco is the only consumer product that causes death and disease when used as intended.10 This unique status should create a heavy presumption in favor of regulating all tobacco products. We believe that FDA made the right decision when it deemed premium cigars in 2016. To exempt them now would be a step backward.

Again, we thank you for the opportunity to comment on the ANPRM with respect to the regulation of premium cigars. We look forward to working with FDA and other partners to ensure that a strong, evidence-informed final rule that protects everyone is developed and fairly implemented.

 

About the Robert Wood Johnson Foundation

For more than 45 years the Robert Wood Johnson Foundation has worked to improve health and health care. We are working alongside others to build a national Culture of Health that provides everyone in America a fair and just opportunity for health and well-being. For more information, visit www.rwjf.org. Follow the Foundation on Twitter at www.rwjf.org/twitter or on Facebook at www.rwjf.org/facebook.

References

1. US Food and Drug Administration, Final Rule, “Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.” Federal Register 81, no. 90 (2016): 28973 – 29106.

2. Chang, C.M., Catherine G. Corey, Brian L. Rostron, and Benjamin J. Apelberg. “Systematic Review of Cigar Smoking and All Cause and Smoking Related Mortality.” BMC Public Health 15 (2015) //bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-1617-5 (accessed June 2018).

3. Baker, F., Stuart R. Ainsworth, Joseph T. Dye, et al. “Health Risks Associated with Cigar Smoking.” JAMA 284, no. 6 (2000): 735 – 740.

4. Corey, C.G., Anh B. Nguyen, Cristine D. Delnevo, et al. “US Adult Cigar Smoking Patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assesment of Tobacco and Health (PATH) Study, 2013-2014.”

5. U.S. Census Bureau. “Quick Facts.” www.census.gov/quickfacts/fact/table/US/PST045216 (access June 2018).

6. Corey, C.G., Brian A. King, Blair N. Coleman, et al. “Little Filtered Cigar, Cigarillo, and Premium Cigar Smoking Among Adults—United States, 2012 – 2013.” MMWR 63, no. 30 (2014): 650 – 654.

7. U.S. Food and Drug Administration, “Implementing the Tobacco Control Act through Policy, Rulemaking, and Guidance.” www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/ucm383160.htm (accessed June 2018).

8. Delnevo, C.D., Daniel P. Giovenco, and Erin J. Miller. “Changes in the Mass-merchandise Cigar Market since the Tobacco Control Act.” Tob Regul Sci 3, no. 2 (2017): S8-S16.

9. Truth Initiative. “FDA Needs to Regulate Premium Cigars, Not Re-Open the Discussion.” truthinitiative.org/news/fda-needs-regulate-premium-cigars-not-re-open-discussion (accessed June 2018).

Media Contacts

Melissa Blair

Robert Wood Johnson Foundation (609) 627-5937

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