Dear Mr. President:
The FDA is considering the creation of regulations for the premium cigar industry. These regulations will jeopardize over 85,000 American jobs, destroy America’s “mom & pop” premium cigar retailers & manufacturers, and risk over 250,000 jobs in Latin American that produce cigars, impacting the economic/political stability in the region.
We hope you will stand up for small businesses that dot Main Street America & recognize that premium cigars are enjoyed by adults, are not addictive and therefore do not conform to the Congressional intent of the Family Smoking Prevention & Tobacco Control Act.
Tell the FDA to leave our premium cigars alone. With this nation's more pressing issues, harming my simple ability to enjoy a cigar should not be a priority of the government.
Response to Petition
By Mitch Zeller
Thank you for your petition on premium cigars.
First, it's important to remember that regulating a tobacco product isn't the same as banning it. FDA is not proposing a ban on all cigars or on any type of cigar.
Second, although all tobacco products are harmful and potentially addictive, FDA has heard the input from stakeholders about the possible differences in the public health impact of premium cigars compared to other cigars. We are taking this into account as we consider potential regulatory options around the categories of cigars.
In the proposed rule, the FDA has suggested two different ways the agency could regulate cigars. One option is to regulate all kinds of cigars. The other option is to exclude premium cigars, as described in the rule, from the scope of the regulation.
Here's where you come in: We're seeking formal comments on the proposed rule as to how cigars should be regulated. You have a chance to tell us what you think of FDA's proposed rule, and comments are due on July 9, 2014. We encourage you, as well as manufacturers, retailers, and other stakeholders, to provide comments and to include any data and information you may have to support your comments.
Although tobacco products including cigars do vary, we know that cigars are not safe. All cigars, including premium cigars, contain the same chemicals and toxicants that are known to cause cancer and heart disease. FDA has several public health concerns regarding cigar use.
One major public health concern is youth cigar usage. We know that kids smoke cigars, and more research is needed about how this affects public health. Research also suggests that youth see cigars in a more positive light than cigarettes and believe cigars are more natural and less harmful; and some do not realize that cigars contain nicotine.1 Such false beliefs about product risks can be a significant predictor of subsequent use behavior.2
Here are some other health concerns about cigars, including premium cigars:
- Cigar smoking causes cancers of the lung, larynx, and esophagus, and also cardiovascular disease. Even cigar smokers who reported that they did not inhale were about three times more likely to die from lung cancer than those who have never smoked.3
- The amount of nicotine in a cigar can range from the equivalent of a single cigarette to the equivalent of an entire package of cigarettes, depending on cigar size and the amount of tobacco incorporated into its components. In addition, the concentrations of some toxic and cancer-causing compounds are higher in cigar smoke than in cigarette smoke, and tobacco smoke is a major source of fine-particle and carbon monoxide indoor air pollution.4
- Cigars can and do deliver nicotine at a level that can produce dependence. Factors -- such as the degree of inhalation, the rate of oral nicotine absorption, the development of tolerance to nicotine, the age of initiation, and the duration of exposure -- can contribute to the development of dependence.5
Here's some background on FDA's authority, which you may already know: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic (FD&C) Act to give FDA immediate authority to regulate certain tobacco products -- cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. And while it didn't apply right away to other tobacco products, such as cigars, the law gave FDA authority to cover those products through regulation.
We understand that cigar manufacturers and retailers are concerned about being subject to this type of regulation for the first time. That's why the FDA has met several times with representatives of different cigar manufacturers and their trade associations to better understand how premium cigars are made, marketed, distributed, and used. We are always open to meeting with these and other stakeholders to hear from all points of view on issues related to product regulation.
We've issued a proposed rule in the April 25, 2014 issue of the Federal Register containing two options for regulating additional products that meet the legal definition of a tobacco product. Because cigars meet this statutory definition, their potential regulation by FDA is discussed in this proposed rule.
It's important to remember that this is only a proposed rule and is not final. That's why we're seeking comments, and encouraging you, as well as manufacturers, retailers, and other stakeholders to formally provide comments through the FDA and to include any data and information you may have to support your comments. Thank you for participating in this We the People petition.
Mitch Zeller is the Director of the Food and Drug Administration's Center for Tobacco Products.
1. Office of Inspector General, U.S. Department of Health and Human Services, "Youth Use of Cigars: Patterns of Use and Perceptions of Risk," OEI-06-98-00030, 1999.
Malone, R., Yerger, V., and Pearson, C., "Cigar Risk Perception in Focus Groups of Urban African American Youth," Journal of Substance Abuse, 13(4):549-561, 2001.
2. Krosnick, J.A., Chang, L., Sherman, S.J., et al., "The Effects of Beliefs About the Health Consequences of Cigarette Smoking on Smoking Onset," Journal of Communication, 56:S18-S37, 2006.
Song, A.V., Morrell, H.E.R., Cornell, J.L., et al., "Perceptions of Smoking-Related Risks and Benefits as Predictors of Adolescent Smoking Initiation," American Journal of Public Health, 99:487-492, 2009.
3. National Cancer Institute, "Cigars: Health Effects and Trends," NCI Smoking and Tobacco Control Monograph 9, 1998, available at http://cancercontrol.cancer.gov/tcrb/monographs/9/m9_complete.PDF.
4. Iribarren, C., Tekawa, I., Sidney, S., et al., "Effect of Cigar Smoking on the Risk of Cardiovascular Disease, Chronic Obstructive Pulmonary Disease, and Cancer in Men," The New England Journal of Medicine, 340(23):1773-1780, 1999.
5. National Cancer Institute, "Cigars: Health Effects and Trends," NCI Smoking and Tobacco Control Monograph 9, 1998, available at http://cancercontrol.cancer.gov/tcrb/monographs/9/m9_complete.PDF.