RWJF Statement on Proposed Regulation Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act

    • August 5, 2014

The following is a statement from Risa Lavizzo-Mourey, MD, president and CEO of the Robert Wood Johnson Foundation, to the Honorable Margaret Hamburg, MD, Commissioner of Food and Drugs at the U.S. Food and Drug Administration.

The Robert Wood Johnson Foundation (RWJF) is pleased to have the opportunity to comment on the Notice of Proposed Rulemaking (NPRM) deeming tobacco products to be subject to the Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act); regulations on the sale and distribution of tobacco products; and required warning statements for tobacco products. These proposed regulations are an important first step in extending the agency’s regulatory authority over all products that meet the definition of a tobacco product pursuant to the Tobacco Control Act. However, the proposed rule does not address several issues that are vital to the protection of public health, including the prohibition on characterizing flavors in products like little cigars and e-cigarettes that appeal to children. Nor do these regulations address the marketing of the newly-deemed products to young people or require that candy-flavored, nicotine-laced liquid used in e-cigarettes and similar products be sold only in child-proof containers. We believe that the FDA should investigate these important public health issues immediately and address them in the final deeming rule or in a separate regulation that can be implemented concurrently.

RWJF’s Historic Commitment to Tobacco Control

This year marks the 50th anniversary of the first Surgeon General’s Report on Smoking and Health, a landmark and scientifically rigorous account of the health harms related to smoking, including lung cancer and heart disease. Since then, 31 Surgeon General’s Reports have been released, increasing our understanding of the devastating health and financial burdens caused by tobacco use. We now know that smoking causes a host of cancers and other illnesses and is still the leading preventable cause of death in the United States, killing 480,000 people each year, and costing more $193 billion in medical expenditures and lost productivity each year in our country.1

In 1991, RWJF joined forces with researchers, scientists, tobacco control advocates, and others to address smoking, one of the most intractable problems in the field of public health. Over the next two decades, the Foundation invested significant resources, focusing on policy and systems changes, such as higher tobacco excise taxes, smoke-free indoor air laws, access to cessation treatment and the federal regulation of tobacco.2

The results have been impressive: collectively, the public health community has made significant measurable progress in driving down tobacco use. Over the past two decades, smoking rates have decreased—at least 5.3 million fewer people were smoking in 2010 and at least 60,000 smoking-attributable deaths have been averted due to these policy changes alone.3 Yet, 42 million American adults and nearly three million young people still smoke. If we are truly committed to building a Culture of Health in our communities, then we must do more to end the devastation caused by tobacco use, especially among children. Accordingly, we believe that it is imperative that FDA finalize these regulations as soon as possible and begin enforcing them to protect the public health.

Age Restrictions

RWJF strongly supports the provisions in the NPRM extending the minimum age of 18 for purchase of all regulated tobacco products and age verification for people under 27. Restricting sales of novel tobacco products, like e-cigarettes, to minors is critical to protecting their health.

Youth access restrictions and enforcement of such laws are proven interventions for preventing tobacco use among adolescents.4 That is why it is particularly troubling that only 28 states prohibit the sale of e-cigarettes to minors.5 In the remaining 22 states and the District of Columbia, e-cigarettes can be legally sold to children. Recently, the Centers for Disease Control and Prevention (CDC) found that the percentage of high school students who have ever tried e-cigarettes doubled from 4.7 percent to 10 percent from 2010 to 2011.6 Accordingly, we applaud FDA’s proposal to extend the current age and identification restrictions in place for cigarettes to e-cigarettes, cigars, and other newly-deemed tobacco products.


The NPRM includes two options for regulating cigars. The first option would allow the FDA to regulate all cigars, while the second would exempt premium cigars that are wrapped in whole tobacco leaf, are not filtered, are manually constructed, contain no characterizing flavor other than tobacco, and meet minimum price and weight requirements. We strongly favor option one. Congress clearly intended that FDA should regulate any product that is “made or derived from tobacco that is intended for human consumption.”7 That includes those products classified as premium cigars, which are addictive, toxic, and smoked by youth, as well as by adults. Based on scientific research, we know that premium cigars can cause disease. According to the National Cancer Institute, cigar smoking causes cancer, heart disease and chronic obstructive pulmonary disease. Cigar smoke contains the same toxins as cigarette smoke, and many new cigar products are more easily smoked and inhaled. Additionally, cigar smoke has higher levels of carbon monoxide and other toxins than cigarette smoke, which not only harms users but also likely creates a higher risk for those exposed to secondhand smoke from cigars.8

If FDA is to protect the public health, it is essential that the agency regulate one of the fastest growing sectors of the tobacco marketplace and one that is increasingly attractive to children. Between 2000 and 2012, cigar sales in the United States more than doubled—from six billion to more than 13 billion cigars a year. During the same period, cigarette sales declined by 33.8 percent.9 In addition to premium cigars, the cigar marketplace now consists of inexpensive, flavored cigars designed to appeal to youth. Each day, more than 2,700 kids under 18 try cigar smoking for the first time, a figure that now approaches the 3,200 kids who try cigarettes for the first time every day. In fact, cigar smoking is the second most common form of tobacco use among youth. According to the national 2011 Youth Risk Behavior Survey, 13.1 percent of all high school students and 17.8 percent of high school boys currently report smoking cigars.10

RWJF believes it is critically important to inform consumers about the health harms related to smoking cigars. The Foundation strongly supports the provision in the NPRM that requires the following warning rotational labels on cigar packaging and on point-of-sale displays at retail outlets that sell individual cigars:

WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.

WARNING: Cigar smoking can cause lung cancer and heart disease.

WARNING: Cigars are not a safe alternative to cigarettes.

WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.

WARNING: This product contains nicotine derived from tobacco. Nicotine is an
addictive chemical.

We also believe that FDA should issue regulations to extend the current flavor ban on cigarettes to little flavored cigars and issue a product standard regulation to ban menthol in cigarettes and cigars as soon as possible. (Please see RWJF comments: Docket No. FDA-2013-N-052, regarding Menthol in Cigarettes, Tobacco Products, Request for Comments). Flavors, including menthol, can mask the harshness and taste of tobacco, making flavored tobacco products especially appealing to youth. Today’s cigar market consists of an ever-expanding variety of products of all sizes and flavors, including peach, strawberry, chocolate, grape, pineapple, and watermelon. In addition to being packaged attractively, they are often displayed prominently in retail establishments frequented by youth. The trend towards youth consumption of flavored cigars is alarming. A 2013 CDC report published in the Journal of Adolescent Health found that more than two out of every five middle and high school students who smoke report using either flavored little cigars or flavored cigarettes. This article, using data from the 2011 National Youth Tobacco Survey (NYTS), also shows that among youth cigar smokers, almost 60 percent of those who smoke flavored little cigars are not thinking about quitting tobacco use, compared with just over 49 percent among all other cigar smokers.11 We believe that FDA should act immediately to address this public health risk and take decisive action to protect children from the health harms associated with flavored cigars.


E-cigarettes are devices that heat and vaporize a solution containing nicotine, flavoring and other chemicals. Contrary to claims by the tobacco industry, these products are not without significant risk. According to the CDC, nicotine itself is not a benign substance. Nicotine is a psychoactive drug with a high level of toxicity and rapid addiction.

Overdose of nicotine can lead to headache or dizziness or seizures and death. It can be absorbed through the skin, and it comes with workplace safety warnings to handle it with gloves, masks, goggles and protective clothing.12

The emissions from e-cigarettes are also not harmless water vapor. The ingredients in e-liquids can cause lung irritation in the short term, and no research has yet established their long-term safety. Vapor contains numerous known toxins and carcinogens, albeit at levels markedly lower than that found in regular cigarettes. The levels of particulates that are emitted are similar to that in combusted cigarettes.13

It is entirely appropriate for FDA to regulate e-cigarettes and to use its authorities to better understand the scientific properties of these products. Anecdotal reports and limited data suggest that e-cigarettes may help some adult smokers to reduce or quit smoking. FDA should determine through research if and how e-cigarettes can play a beneficial role in reducing tobacco-related morbidity and mortality. Conversely, the agency should also conduct or support research to identify whether e-cigarettes are used as a bridge to the smoker's next cigarette, delaying or inhibiting complete smoking cessation. Among other scientific questions the agency should answer are: whether e-cigarettes will lead to a lifetime of nicotine addiction for youth who begin using them at an early age; the health consequences of exposure to second-hand vapors; and the possibility that e-cigarettes could serve as a gateway to traditional cigarettes for children.

The need for FDA to regulate e-cigarettes has become more urgent as a result of their increasing popularity of these products, particularly among youth. According to the CDC, 6.8 percent of children between 6th and 12th grade have experimented with e-cigarettes. One in 50 children in that age group had used e-cigarettes in the past 30 days and almost as many paired them with traditional combusted tobacco products.14 The aggressive marketing of e-cigarettes and its impact on youth is particularly worrisome. The evidence is clear that tobacco advertising directly influences youth. On June 18, 2014, the Senate Committee on Commerce, Science, and Transportation held a hearing on "Aggressive E-Cigarette Marketing and Potential Consequences for Youth." Public health witnesses pointed out that e-cigarettes are being advertised with many of the same marketing strategies large tobacco companies previously employed to promote cigarettes: celebrity endorsements, gorgeous models, and event sponsorships. Witnesses representing e-cigarette manufacturers countered that their intention is not to market to children. We believe that FDA, in collaboration with the Federal Trade Commission, should evaluate whether evaluate e-cigarette marketing is indeed targeting youth, and if so, take aggressive regulatory and enforcement actions to prevent it.

RWJF strongly supports FDA’s intent to require mandatory warning labels on e-cigarettes packages and advertising related to nicotine addiction. We also enthusiastically endorse the provisions in the NPRM that prohibit free samples of e-cigarettes and vending machine sales, except in adult-only facilities. However, we also firmly believe that in the final rule, FDA should extend additional current marketing restrictions on cigarettes to e-cigarettes, including the prohibition on using brand names on non-tobacco products, the prohibition on self-service displays, and the prohibition on brand name sponsorship of sporting and cultural events.

FDA’s proposed rule does not address the widespread availability of candy-flavored, nicotine-laced liquid used in e-cigarettes and related products in containers that are not child-proof. These products have been found to be hazardous to children. Earlier this year, CDC reported that the number of e-cigarette exposure calls per month to poison centers rose from one per month in September 2010 to 215 per month in February 2014. More than half of these calls to poison hotlines were to report incidents involving children under the age of five.

Further, in May, The New England Journal of Medicine reported the first case of a 10-month-old boy who was rushed to a Philadelphia hospital after ingesting the refill liquid used in e-cigarettes. Thankfully, the child recovered. But the consequences of children accidently consuming the nicotine in these refill vials can easily become tragic, given that just "one teaspoon of a 1.8 percent nicotine solution could be lethal" to a 200-pound person.15 Given the urgency of this threat to our nation’s children, we believe that FDA should immediately issue a proposed rule to require child-resistant packaging of e-liquids and related products so a final rule on child-proof containers can be issued concurrently with the final deeming rule.

Conclusion: Regulating Additional Tobacco Products is Essential to Building a Culture of Health

In addition to these comments, RWJF is submitting two Foundation-funded studies to the public docket for the agency’s consideration. The first is a health policy brief on e-cigarettes published in Health Affairs on July 10, 2014. The second relates to economic analyses of major tobacco regulations. The Foundation hopes that each will help inform the agency’s final rule.

Finally, given the importance of this regulation to protecting the public health and the nation’s children, RWJF urges FDA to issue a final rule within the 12 months from the publication of the proposed regulation.



1 Centers for Disease Control and Prevention, “Economic Costs Associated With Smoking,” Cigarette Smoking in the United States,” February 6, 2014 (Accessed June 2014)

2 Grob G, “RWJF's Tobacco Work, Major Programs, Strategies and Focus Areas,” Robert Wood Johnson Foundation, April 2011 (Accessed June, 2014)

3 Chaloupka, FJ, Levy D and Huang, “The Impact of Tax and Smoke-Free Air Policy Changes,” RWJF Retrospective Series, April 2011 (Accessed June, 2014)

4 National Institutes of Health, ‘‘NIH State-of-the-Science Conference Statement on Tobacco Use: Prevention, Cessation and Controls,’’ 2006 (Accessed June, 2014) SOS029html.htm;
Substance Abuse and Mental Health Services Administration: Center for Substance Abuse Prevention: Division of State Programs, ‘‘FFY 2008 Annual Synar Reports: Youth Tobacco Sales,’’ 2008 (Accessed June 2014); and Stead, L.F., T. Lancaster, ‘‘Interventions for preventing tobacco sales to minors (Review), "Cochrane Database of Systematic Reviews, Issue 1, Article No. CD001497, 2005.

5 National Conference of State Legislatures, “Alternative Nicotine Products, E-Cigarettes,” April 3, 2014 (Accessed July 2014)

6 Centers for Disease Control and Prevention, Notes from the Field: Electronic Cigarette Use Among Middle and High School Students—United States, 2011–2012; MMWR62(35);729-730, September 6, 2013 (Accessed July 2014)

7 Tobacco Control Act, §101(a), 123 Stat. at 1783 (codified at 21 U.S.C. § 321(rr)(1)).

8 National Cancer Institute (NCI), Cigars: Health Effects and Trends, Smoking and Tobacco Control Monograph No. 9, 1998, (Accessed July 2014)

9 U.S. Alcohol and Tobacco Tax and Trade Bureau Statistics. “Tobacco Statistics,” December 2013 (Accessed July 2014)

10 Centers for Disease Control and Prevention, “Youth Risk Behavior Surveillance –United States, 2011,” MMWR61(SS4) June 8, 2012 (Accessed July 2014)

11 King, B, Dube, S and Arrazola, “Flavored-Little-Cigar and Flavored-Cigarette Use Among U.S. Middle and High School Students, Journal of Adolescent Health, Volume 54, Issue 1 October 23, 2013 (Accessed July 2014)

12 Centers for Disease Control and Prevention, NICOTINE : Systemic Agent , June 18, 2013 (Accessed July 2014)

13 Gana, R, Benowitz, N and Glantz,“E-cigarettes: A Scientific Review,” U.S. Library of Medicine, National Institutes of Health, May 12, 2013 (Accessed July 2014)

14 Centers for Disease Control and Prevention, “Notes from the Field: Electronic Cigarette Use Among Middle and High School Students—United States, 2011-2012,” September 6, 2013 (Accessed July, 2014) 

15 Bassett, R, Osterhoudt, K and Brabazozn, “Nicotine Poisoning in an Infant,” New England Journal of Medicine 2014; 370:2249-225, June 5, 2014DOI: 10.1056/NEJMc1403843 (Accessed July, 2014)

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