August 7, 2014

The Honorable Margaret Hamburg, Commissioner

United States Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Re: Docket No. FDA-2014-N-0189

Dear Commissioner Hamburg,

On behalf of 15 of the largest metropolitan health departments, representing over 40 million Americans, we would like to congratulate you on addressing the sale and labeling of tobacco products, which include electronic cigarettes or e-cigarettes, through the proposed deeming regulations. Although this is an important first step, we remain concerned that the proposed regulations fail to address important areas such as marketing and flavoring of e-cigarettes that are needed to protect the public’s health. We call on the Food and Drug Administration (FDA) to act quickly to finalize these regulations and urge you to consider a parallel Notice of Rulemaking process that would enable FDA to put meaningful restrictions in place more expeditiously.

Local health departments have a responsibility to protect the health and well-being of residents within their jurisdictions. We have extensive experience regulating tobacco products at the local level and are proud of the sustained decrease we have seen in the number of Americans who report regular use of cigarettes. However, in the ever-evolving tobacco market, we must remain vigilant in our efforts to regulate new products, especially when those products, such as e-cigarettes, are being marketed in ways that appeal to youth and could undermine existing tobacco regulations. While many local health departments have taken steps to curb the sale and use of e-cigarettes, not all localities have this regulatory authority. There are also areas, such as marketing and manufacturing, where FDA should act to fill existing regulatory gaps and to create uniform nationwide regulations.

E -cigarettes pose a potential risk to public health and FDA should act with all deliberate speed to regulate e-cigarettes as tobacco products. It has been four years since the U.S. Court of Appeals for the D.C. Circuit ruled in Sottera that e-cigarettes are tobacco products, not drug-delivery devices, when they are not marketed for a therapeutic purpose. In this short time, use of e-cigarettes has increased exponentially, especially among youth. What began as a sliver of the tobacco market is now predicted to eclipse traditional tobacco sales

by mid-century. Indeed, tobacco industry analysts have projected that e-cigarette sales will exceed $10 billion in retail sales by 2017.1

In spite of the evidence of increasing use in the US, we have no federal consumer protections in place to ensure that e-cigarettes are properly labeled and tested. FDA and other independent scientists have found numerous potentially dangerous chemicals and carcinogens as well as varying levels of nicotine that are inconsistent with the amount indicated on the labels of e-cigarette solutions. For example, a recent study of e-cigarette refill fluids found that the majority (65%) of nicotine fluids tested deviated by more than ten percent from the nicotine concentrations on the label.2 Furthermore, because e- cigarettes are unregulated, we do not know the full range of chemicals being produced by the large number of different e-cigarettes currently on the market.

E -cigarettes are both appealing and very accessible to youth. The proposed deeming regulation begins to curb youth access by setting a minimum age requirement to purchase e-cigarettes, but does not extend the current prohibition on characterizing flavors for combustible cigarettes to e-cigarettes or other covered tobacco products. While e- cigarettes have been available for sale through online retailers since 2008, only in the last three years have they become widely available in traditional retail outlets, coinciding with substantial decreases in price. The growth of the e-cigarette market may be in part due to their growing popularity among younger people, who often perceive e-cigarettes as a safer, less expensive and more appealing alternative to traditional cigarettes. The CDC’s National Youth Tobacco Survey, released in September 2013, found that e-cigarette use among young people is rapidly increasing, having doubled from 2011 to 2012. In the survey, ten percent of high school students reported having used e-cigarettes at least once.3

We know that youth-friendly characterizing flavors, such as watermelon, bubble gum and piña colada, have been used for years by the tobacco industry to entice new generations of smokers into trying tobacco products.4 Such characterizing flavors mask the taste of tobacco, diminish the harshness of the smoking experience and increase the pleasure of

1 Goodman, A. E-Cigarette Sales Are Smoking Hot – Four Ways to Invest In Them. December 5, 2013. Available at: http://www.forbes.com/sites/agoodman/2013/12/05/e-cigarettes-are-smoking-hot-4-ways-to- approach-them/. 2 Davis B, Dang M, Kim J, Talbot P. Nicotine concentrations in electronic cigarette refill and do-it- yourself fluids. Nicotine & Tobacco Research, May 26, 2014. 3 Catherine Corey, Notes from the Field: Electronic Cigarette Use Among Middle and High School Students – , 2011-2012, Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, September 6, 2013, available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm?s_cid=mm6235a6_w. 4 US Department of Health and Human Services. Preventing tobacco use among youth and young adults: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2012.

the smoking experience. The same tactic is now being used by e-cigarette companies to expand their market among youth, who are more easily addicted to nicotine and become lifelong users if hooked early enough.

We call on FDA to consider prohibiting e-cigarette companies from using characterizing flavors that appeal to youth, such as candy and fruit flavors, in their products and to begin a Notice of Rulemaking that runs parallel to the deeming regulation process so that these protections for youth are put in place as soon as possible. This Notice of Rulemaking is important, because there are two primary paths to market for a new tobacco product. First, manufacturers can file a “new product” application under Section 910, in which they must demonstrate that the marketing of the product would be “appropriate for the protection of the public health.” The requirements for such a showing are stringent. Second, manufacturers can avoid having to meet this public health standard by filing a “substantial equivalence” application, in which they must show that the new product is “substantially equivalent” to a product marketed on or before February 15, 2007. Under the Family Smoking Prevention and Tobacco Control Act of 2009 (“TCA”), manufacturers filing substantial equivalence applications by March 22, 2011 could keep their products on the market while their applications are pending. Manufacturers who filed a substantial equivalence application after March 22, 2011 cannot introduce the product until FDA issues a marketing order. The experience to date with new product and substantial equivalence applications is that only four manufacturers have filed a new product application. By contrast, manufacturers submitted over 3,000 substantial equivalence applications by the March 2011 deadline. In over two years, the only decision FDA has rendered on these applications was to reject one set of applications. Despite the fact that none of the remaining 3,100 products has been found to meet the statutory standard, all of those products remain on the market to this day, and the FDA has given no indication as to its schedule for reviewing these applications.

Ads for e-cigarettes are increasing in volume and prominence and should be regulated. The proposed deeming regulation does not propose any advertising or marketing restrictions that would regulate e-cigarettes even though the FDA has the authority to do so. Big tobacco companies such as Lorillard, Reynolds and Altria have made significant financial commitments to their own e-cigarette brands in recent years and are steadily increasing their advertising budgets to promote them. By one estimate, e-cigarette companies spent more than $15 million in the first quarter of 2013 promoting e-cigarettes, compared to $2 million during the same period the year before.5 The lion’s share of advertising dollars is being spent in the television market, where ads for most conventional tobacco products have been banned since the early 1970s. Further, e-cigarette advertisements regularly employ youth-oriented marketing strategies that the tobacco industry used decades ago, such as celebrity endorsements and messages that associate

5 Elliot, S. E-Cigarette Makers’ Ads Echo Tobacco’s Heyday, New York Times, August 29, 2013. Available at: http://www.nytimes.com/2013/08/30/business/media/e-cigarette-makers-ads-echo- tobaccos-heyday.html?_r=0.

smoking e-cigarettes with themes like freedom, rebelliousness, and glamour. In addition, some e-cigarette marketing campaigns, such as Blu’s “Why Quit?” campaign, clearly discourage smoking cessation. This threatens to undermine our efforts to get smokers to quit, and it may entice former smokers to relapse.

Another troubling aspect of e-cigarette marketing is that ads continue to make health claims regarding the safety of the e-cigarettes and the effectiveness of e-cigarettes as a cessation tool without sufficient testing or data to back up these claims. Indeed, a recent study of fifty-nine e-cigarette websites found that 95 percent of the sites contained health claims, including 64 percent that mentioned cessation and 22 percent that featured doctors.6

While we understand that the deeming regulation is a necessary first step in the regulatory process, we urge you to issue a Notice of Rulemaking now so that you may begin the process of putting in place meaningful restrictions on the marketing of electronic cigarettes.

E-cigarettes are not required to display any health warnings. Cigarettes and smokeless tobacco products are required to carry health warnings. Even nicotine replacement therapy (NRT) is required to carry warnings. With the proposed deeming regulation, e- cigarettes will be required to display health warnings, although with significant delays. The delay has the potential to continue to foster the perception, particularly on the part of youth, that e-cigarettes are safe, or the misunderstanding that they have been found to be safe and effective cessation devices. The marketing of these products as a smoking alternative perpetuates this confusion.

E-cigarette refill liquids pose a poisoning risk and should be sold in childproof packaging. Reports of children (ages 5 and under) consuming poisonous liquid from e-cigarettes has risen across the country. For example, Arizona and Nebraska have released data showing alarming increases in Poison Control Center calls. Last month, Michigan released data that shows in just one year, the total number of reports of poisoning (for people under 20) jumped from just five calls to fifty. In April of this year, the increase in poisonings was so alarming that the CDC issued a new report highlighting a dramatic spike in calls to poison control centers nationally due to e-juice. Exposures were mostly among persons aged 0–5 years (51.1%) and >20 years (42.0%). E-cigarette refill liquids are sold in many different sizes. A standard bottle contains about 10ml. However, 20ml, 30ml, 40ml, and now a super-sized 50ml bottles are on the market. A standard 10 ml bottle, depending on concentration, could kill an adult or toddler who drinks it. These bottles are extremely

6 Grana R, Ling P. Smoking Revolution: A content analysis of electronic cigarette retail websites. Am. Journ. of Prev. Med. 46(4): 395-403, April 2014. 7 Respiratory Health Association. (n.d.) What you need to know about…Electronic Cigarettes. Retrieved from http://www.lungchicago.org/site/files/487/54229/372253/671850/WYTNK_E-cigarettes.pdf.

easy to open, and they come in kid-friendly flavors. It is irresponsible not to use child- proof containers for e-juice.

We urge you to act boldly and swiftly, especially given the lengthy delay in issuing your first proposed regulation. As many of our major metropolitan areas continue to act on the local level, we urge you follow our lead and use your full authority to apply all current tobacco regulations to e-cigarettes. The FDA must move quickly to address the growing concern about youth use beyond setting a minimum age requirement to purchase e-cigarettes.

The Big Cities Health Coalition truly appreciates the opportunity to provide comments on the proposed deeming regulation. We stand ready to assist you in moving forward with your regulations and are happy to provide additional information if necessary. If you have any questions, please contact Dr. Shelley Hearne, DrPH at [email protected] and (202) 463-8156.

Sincerely,

Dr. Jacquelyn Duval-Harvey, MD Dr. Barbara Ferrer, PhD, MPH, MEd Interim Commissioner of Health Executive Director Baltimore City Health Department Boston Public Health Commission Baltimore, MD Boston, MA

Dr. Bechara Choucair, MD Mr. Zachary Thompson, MA Commissioner Director Department of Public Health Dallas County Health and Human

Chicago, IL Services

Dallas, TX

Ms. Vernice Anthony, BSN, MPH Mr. Doug Linkhart Director and Health Officer Executive Director Department of Health and Wellness

Department of Environmental Health Promotion

Detroit, MI Denver, CO

Mr. Stephen Williams, MEd, MPA Dr. Jonathan Fielding, MD, MPH, MBA Director Health Officer and Director Houston Department of Health and Los Angeles County Department of Human Services Public Health Houston, TX Los Angeles, CA

Dr. Mary Bassett, MD, MPH Health Commissioner Dr. James Buehler, MD New York Department of Health and Health Commissioner Mental Hygiene Philadelphia Department of Public Health New York, NY Philadelphia, PA

Dr. Bob England, MD Dr. Thomas Schlenker, MD, MPH Director Director of Public Health Maricopa County Department of Metropolitan Health District Public Health San Antonio, TX Phoenix, AZ

Dr. Wilma Wooten, MD Dr. Tomás Aragón, MD, DrPH Public Health Officer Health Officer

County of San Diego Health and San Francisco Department of Public Health Human Services Agency San Francisco, CA

San Diego, CA

Dr. Sara H. Cody, MD Health Officer Santa Clara County Public Health Department San Jose, CA