UCSF submits public comment to FDA telling it to implement the rule on flavored tobacco products that Obama killed

My colleagues and I just submitted this public comment to the FDA.  The tracking number on Regulations.gov is   1k2-93bc-raaf and a PDF of the comment (which has all the footnotes) is available here.

 

FDA should implement its proposed rule that manufacturers must present scientific evidence demonstrating that any flavored tobacco product is appropriate for the protection of the public health before receiving marketing authorization to use that flavor

 

Docket No: FDA-2017-N-6565

 

 

Bonnie Halpern-Felsher, PhD; Lauren K. Lempert, JD, MPH; Shannon Watkins, PhD; Benjamin Chaffee, DDS PhD; Jeff Gotts, MD, PhD; Peyton Jacob, PhD; Lucy Popova, PhD*;

Stanton A Glantz, PhD

 

UCSF TCORS

 

* Georgia State University

 

May 23, 2018

 

            FDA’s advance notice of proposed rulemaking (ANPRM) requesting comments on the role that flavors, including menthol, play in initiation, use, and cessation of tobacco products, especially among youth, and whether and how certain flavors may help adult cigarette users switch to potentially less harmful products appropriately recognizes the role flavors may play in youth initiation, that youth and young adult smokers are disproportionately more likely to smoke menthol than nonmenthol cigarettes, that youth who initiate smoking with menthol cigarettes may be at greater risk of progression from experimentation to established smoking and nicotine dependence, and that flavors are identified as one of the top three reasons why middle and high school students initiate and continue to use e-cigarettes.  However, while it is appropriate for FDA to take “a closer look at flavors in tobacco products to better understand their level of impact…,”[1] FDA already knows the answer.

            The draft of the Deeming Rule published in May 2016[2] that was submitted for approval to the Obama administration’s Office of Management and Budget (OMB) included a well-reasoned and scientifically justified rule[3] that would have allowed manufacturers to receive a marketing order from FDA to market menthol flavored and other flavored products if the manufacturer provided scientific evidence to the FDA that the marketing of the flavored product actually benefits the public health.  

This is a sensible and appropriate policy because it focuses the discussion on specific flavors that specific manufacturers wish to use rather than attempting to forge a general policy that would apply to the tens of thousands (or more) of flavors and flavor combinations that could hypothetically be used.  It also avoids an outright ban on flavors while grounding the rule firmly in the legal standard of protecting public health established in the Family Smoking Prevention and Tobacco Control Act (TCA).

TCA section 907 gives FDA the authority to establish tobacco product standards “where appropriate for the protection of the public health,” including “provisions respecting the construction, components, ingredients, additives” and other constituents of the tobacco product, in particular flavors (TCA section 907(a)(4)(B)(i)), and provisions  restricting their sale and distribution (TCA section 907(a)(4)(B)(v)).  In determining whether the tobacco product standard is “appropriate for the protection of the public health,” FDA must consider scientific evidence concerning the risks and benefits of the proposed standard to the population as a whole, including users and nonusers of tobacco products, and the increased or decreased likelihood that existing users will stop using the products and that nonusers will start using the products. (TCA section 907(a)(3)(B)(i)) Additionally, if FDA determines that it is appropriate for the protection of public health to require the reduction or elimination of an additive or constituent (such as a flavor) because it is or may be harmful, any party objecting to the proposed standard may provide FDA with scientific evidence demonstrating that the proposed standard will not reduce or eliminate the risk of illness or injury. (TCA section 907(a)(3)(B)(ii))

The draft Deeming Rule submitted to OMB was consistent with the law, because it specifically gave manufacturers the opportunity to provide evidence that restricting the marketing of a particular flavored product would not reduce harm. 

In particular, it would also allow manufacturers to use flavors if they could demonstrate that a specific flavor helped adult smokers quit without attracting youth.

Unfortunately, under the Obama administration, the OMB deleted FDA’s well-conceived evidence-based regulation, resulting in flavored e-cigarettes, cigars, hookah and other newly deemed tobacco products (including menthol flavored tobacco products) that especially appeal to youth and young adults continuing to be sold today.  Indeed, had the Obama OMB allowed the FDA to move forward, the March 2018 ANPRM would be unnecessary.  Prior to the long rule-making process for the Deeming Rule, FDA’s own scientists and Tobacco Products Scientific Advisory Committee had already determined the public health impact of menthol in cigarettes and concluded that the removal of menthol cigarettes from the marketplace would benefit public health.[4]

            Scientific evidence supporting FDA’s initial and correct conclusion that flavors in tobacco products appeal to youth and young adults and may contribute to initiation and continuation of tobacco use continues to grow, and is documented below. This new information further strengthens the FDA’s original proposed rule. FDA should prohibit the use of all flavors unless manufacturers submit scientific evidence demonstrating that a particular flavored tobacco product appropriately protects the public health, considering its health impacts on current users, non-users, and former users, as the law requires.

FDA’s Deeming Rule originally stated, “Given the attractiveness of flavors, especially to youth and young adults, and the impact flavored tobacco products may have on youth initiation, the Agency is not extending its compliance policy for premarket review to flavored new tobacco products…. Consequently, as of 180 days after publication of the rule, any non-grandfathered, newly deemed flavored tobacco products on the market will be subject to enforcement.”[5] Further, FDA stated,“menthol-flavored products will be treated the same as products with characterizing flavors other than tobacco for the purpose of this policy, because when it is used as a characterizing flavor, menthol has a similar impact on a product’s appeal to youth and young adults as such other characterizing flavors.”[6]  FDA recognized the import of its proposal, stating, “FDA recognizes that this will result in numerous flavored newly deemed products (that are not grandfathered) coming off the market within 180 days after the publication date of this final rule and that this will significantly impact the availability of flavored tobacco products at least in the short term.  This rule and its associated compliance policies are not banning flavored newly deemed products; a manufacturer of a flavored newly deemed product can market the product after receiving marketing authorization [which requires demonstrating that the product is appropriate for the protection of the public health] or if the product is grandfathered.”[7]      

            This rule should be extended to all tobacco products and favors, including menthol in cigarettes and smokeless tobacco, as well as all forms of electronic cigarettes currently on the market and those coming to market.

Flavors and Characterizing Flavors in Tobacco Products

With the exception of menthol, the 2009 Family Smoking and Prevention Tobacco Control Act (TCA) banned use of characterizing flavors in cigarettes.[8] Use of characterizing flavors in other tobacco products (e.g., electronic cigarettes [e-cigarettes], cigars, and smokeless tobacco) continues to be permitted and is widespread. Moreover, flavors are still allowed in cigarettes as long as they are not used to "characterize" the products.

The FDA noted in the version of its Deeming rule submitted to the Obama OMB[9] and posted in May 2016 that flavored tobacco products have the potential to lower barriers to nicotine addiction for youth and young adults. At page 170, FDA stated, “Flavoring also can make these products easier to use and increases their appeal among new users, most notably among young people (Ref. 9, Carpenter; Ref. 10, Cummings; Ref. 11, Manning)”[10]; at page 176 FDA reported, “a study of youth and young adults found that flavored tobacco use facilitates nicotine dependence among young smokers, despite low smoking frequency (Ref. 15A, Huh).”[11] After reporting data from the 2011-2014 National Youth Tobacco Surveys showing that in 2014, about 2.2 million students currently used more than two tobacco products, and of current tobacco users, 2.4 million used e-cigarettes, FDA noted at page 173, “These figures are particularly concerning given the attractiveness of flavored e-cigarettes to youth and young adults and the potential for youth e-cigarette users to move on to the use of combustible tobacco products.”[12]  FDA further recognized that while flavors attract youth to tobacco products, removing flavors may reduce the attraction. FDA stated at page 176, “Focus group data also has suggested that removing flavors from tobacco products may reduce young adults’ intentions to try these products and subsequently use them (Ref 13, Choi).”[13]

Today the evidence supports a stronger conclusion: Flavored tobacco products directly contribute to youth tobacco initiation, continued use, and nicotine addiction. 

In its version of the Deeming Rule submitted to the Obama OMB, FDA provided four pages of scientific evidence supporting its conclusion that youth and young adult tobacco users are more likely to use flavored tobacco products than adult tobacco users:[14]

4. Youth and Young Adult Tobacco Users are More Likely to Use Flavored Tobacco Products Than Adult Tobacco Users


Many comments provided data and information regarding youth and young adult use of flavored tobacco products in recent years, including examples of the different flavors used in many of the newly deemed products including:

• Cigar products: Strawberry, Blueberry, Grape, Peach, Cherry, Cream, Vanilla, Chocolate, Honey, Mango, Piña Colada, Tequila, Rum, Sour Apple, Watermelon 

• Waterpipe tobacco products: Chocolate, Cherry, Champagne, Cinnamon, Clove, Grape, Mango, Lemonade, Piña Colada, Pineapple, Watermelon, Raspberry, Cola, Irish Cream, Key Lime Pie, Peach, Root Beer, Hazelnut, Butter Scotch, Chai 

• E-cigarette products: Peppermint Party, Piña Colada, Very Vanilla, Cherry Crush, Peach Passion, Bazooka Joe Bubble Gum, Cotton Candy, Mojito, Chocolate, Mango, Strawberry, Gummy Bear, Peanut Butter 


            Researchers have concluded that flavored products are likely to influence patterns of tobacco use, particularly among youth and young adults (Ref. 12, Villanti). For example, the American Legacy Foundation’s Young Adult Cohort Study reported that 18.5 percent of young adults (aged 18-25) in a national sample were currently using a flavored tobacco product, and the prevalence of flavored brand tobacco use when examined by product type was most common for waterpipes (59 percent). Waterpipe tobacco smoking is becoming more popular among youth and young adults, and it is believed that the waterpipe smoking experience (i.e., less physically harsh and easier to inhale compared to cigarette smoke) coupled with the appeal of flavored tobacco are some of the reasons for the growing popularity of waterpipe tobacco (Ref. 14, Primack). After waterpipe tobacco, the prevalence of flavored brand use was followed closely pipes (50 percent) and little cigars, cigarillos, and bidis (47 percent) (id.). The prevalence of flavored brand tobacco use was reported as 20 percent for cigars, while 17 percent of young adults reported using flavored e-cigarette brands (id.).


Researchers also have concluded that youth and young adults are more likely to use little cigars and cigarillos that have flavors (Ref. 12, Villanti) and are more likely to use such products than adults. For example, an analysis of the 2009-2010 National Adult Tobacco Survey found that flavored cigar use decreases with increasing age, with 9.1 percent of respondents aged 18-24 using flavored cigars and cigarillos, and only 1.4 percent of adults aged 45-64 using flavored cigars and cigarillos (Ref. 12A King). The CDC also has found the prevalence of flavored cigar use among cigar smokers decreases with increasing age, with 57.1 percent of 18-24 year old cigar smokers reporting use of flavored cigars in comparison to 43.2 percent of cigar smokers age 25-44, 28.9 percent of cigar smokers age 45-64, and 13.4 percent of cigar smokers over age 65 (Ref. 16A, King).

Data from the 2010 and 2011 NSDUH also illustrates this flavor preference for youth and young adults. Black & Mild, a brand which includes both flavored and non-flavored cigars and is well-known for its flavored little cigars (including cherry and vanilla), was the most popular cigar brand among 12 to 17 year olds participating in these national surveys (Ref. 21, SAMHSA 2010; Ref. 22, SAMHSA 2011). The two other top youth cigar brands, Phillies (available in flavored and nonflavored varieties) and Swisher Sweets, come in flavors such as grape, sweet chocolate and strawberry (Ref. 21, SAMHSA 2010; Ref. 22, SAMHSA 2011). Additionally, reporting usual use of a brand that makes flavored cigars decreased significantly with age in this survey, with 95 percent of 12 to 17 year olds reporting a usual brand that makes flavored cigars compared with 63.2 percent of cigar smokers aged 35 years and older (Ref. 16, Delnevo). Results from the 2009-2010 National Adult Tobacco Survey (NATS) also indicated that prevalence of flavored cigar use was highest among 18 to 24 year olds compared to all other adult age groups (Ref. 15, King, 2012). The Surgeon General has noted that, with one exception, the top cigar brands preferred by adolescents and young adults “include various flavorings, such as peach, grape, apple, and chocolate” (Ref. 141 at 164, 12 SG). Given that cigar smoking was the second most common form of tobacco use among youth in 2013, with 11.9 percent of high school students reporting smoking cigars in the past 30 days (Ref. 20, Arrazola), FDA remains concerned about the impact of these flavored products on youth initiation and use.

Further, e-cigarettes are available in numerous flavors including candy, fruit, peach schnapps, bubblegum, and cola (Ref. 23A, ACS; Ref. 23B, AAP), all of which may be particularly attractive to youth and young adults. Following the release of research from the 2011 and 2012 National Youth Tobacco Survey noting the increased prevalence of e-cigarette use in middle school and high school students, students have been quoted as noting that classmates use e-cigarettes and prefer flavors like gummy bears “because it tastes really good” (79 FR 23142 at 23157; Ref. 23C, Bolario). A focus group study conducted with young adults (18-26 years old) on new tobacco products (e-cigarettes, snus, dissolvable tobacco products) found that participants generally reported positive perceptions of the new products, particularly because they came in flavors (Ref. 13, Choi).

Recent data, as well as studies included with comments, illustrate that youth are particularly attracted to flavored ENDS products. As a result, one tobacco company's website acknowledges that youth like flavors when it states, "kids may be particularly vulnerable to trying e-cigarettes due to an abundance of fun flavors such as cherry, vanilla, piña colada and berry" (Ref. 16D, Lorillard). According to 2014 NYTS data, 5.9 percent of U.S. middle and high school students reported using flavored e-cigarettes in the past 30 days (citation pending). Preliminary data from the national Population Assessment of Tobacco and Health (PATH) Study also demonstrate the popularity of flavored e-cigarettes among youth. Researchers found that 85.3 percent of youth aged 12 to 17 who used e-cigarettes in the past 30 days reported using flavored e-cigarettes (e.g., menthol, mint, clove, spice, candy, fruit, chocolate, wine, cognac, or other flavors) (Ref. 16E, Ambrose). Moreover, of those youth reporting having ever used an e- cigarette, 81 percent reported that their first e-cigarette was flavored (id.). This data also shows that 81.5 percent of current e-cigarette users (defined as those who used an e-cigarette in the past 30 days) stated that they used e-cigarettes because it “comes in flavors I like” (id.).

Results from small cross-sectional studies also suggest that flavored e-cigarette use is popular among youth. Several comments included a study that was under review for a peer- reviewed publication and has since published. In this survey conducted in four high schools and three middle schools in Connecticut in 2013, 25.2 percent of high school students reported trying e-cigarettes in their lifetime and 12 percent reported using e-cigarettes in the past 30 days, while among middle school students, 3.5 percent reported trying e-cigarettes in their lifetime and 1.5 percent reported using e-cigarettes in the past 30 days (Ref. 23, Krishnan). Among the 953 lifetime e-cigarette users interviewed, 71 percent reported having tried sweet flavors, and 22.1 percent reported having tried menthol-flavored e-cigarettes. In terms of preferred flavors, 56.8 percent reported preferring sweet flavors, while 8.7 percent preferred menthol e-cigarettes (Ref. 23, Krishnan).

Nothing published since FDA reached these conclusions contradicts this summary.  The evidence on the importance of flavors being important factors in recruiting youth to nicotine addiction has only grown stronger.

Youth are Attracted to Flavored Tobacco Products

Nearly all tobacco users begin as an adolescent or young adults.[15] In order to attract young and new users, the tobacco industry adds characterizing flavors like mint, menthol, fruit, and candy to tobacco, often using the same flavorants that are in fruit-flavored candy such as Jolly Ranchers, and sometimes used in higher doses.[16] These flavors appeal to new users by masking the harsh taste of tobacco. Despite historic tobacco industry claims that menthol simply adds flavor, tobacco industry documents have revealed that the industry manipulates menthol levels to control a cigarette’s intensity to cater to new and long-term smokers.[17]

Menthol and other characterizing flavors appeal to new users by masking the harsh taste of tobacco, and bright packaging associates flavored tobacco with candy and other appealing flavored products.[18]^,[19] Additionally, tobacco products with a characterizing flavor, including fruit-flavored e-cigarettes[20] and menthol cigarettes,¹⁴ are perceived to be less harmful than unflavored or tobacco-flavored products. Youth shown tobacco packages (primarily snus and dissolvable tobacco) with or without a flavor descriptor are more likely than older adults to associate the flavor descriptor with better taste, more appeal, and lower health risks.[21] In addition, there is some evidence that menthol cigarettes are harder to quit.[22]^,[23]

Flavor or “taste” is one of the most common persuasive marketing techniques used to promote food (mostly candy and snacks) to children on TV.[24] Exposure to ads for flavored products is positively associated with youth consumption,[25] and most money spent by youth is on food or beverages, particularly sweets.[26] Research on e-cigarettes comports with these findings, concluding: flavors play an important role for online e-cigarette marketing and boosts user interaction and positive emotion;[27] flavored (vs. unflavored) e-cigarette ads elicit greater appeal and interest in buying and trying e-cigarettes and the appeal of ads for flavors is linked to rapid and persistent adoption of e-cigarettes among youth;[28] and 75% of US youth stated they would not use e-cigarettes without flavors.[29] In another recent study, middle and high school students who used flavored tobacco products were asked if they would continue to use those products if flavors were not available: most youth reported that they would no longer use the product if it were not flavored, including for cigarettes (54%), e-cigarettes (78%), cigars (81%), and hookah (74%).[30]

The majority of youth in the US who try tobacco initiate with flavored tobacco products, including 81% of e-cigarette ever users, 65% of cigar ever users, and 50% of cigarette ever smokers.[31] Adolescents are more likely to report interest in trying an e-cigarette from a friend if it is menthol-, candy-, or fruit-flavored than if unflavored.[32] Most adolescent current tobacco users cite flavors as a reason for use (including 81% for past 30-day e-cigarette users; 74% for past 30-day cigar users).¹⁰ Youth and young adult tobacco users are more likely than older adult tobacco users to use flavored products, including menthol cigarettes,[33] flavored smokeless tobacco,[34] and flavored cigars.[35] Young smokers (age 12-17) are three times as likely to smoke menthol cigarettes as are smokers 35 and older.[36] Adolescents are more likely to report interest in trying an e-cigarette from a friend if it is menthol-, candy-, or fruit-flavored than if unflavored,[37] and three quarters of adolescent and young adult flavored tobacco product users reported they would quit if flavors were unavailable.[38]

Youth Believe Ads for Flavored E-cigarettes Target Them

In a study[39] of California youth and young adults (mean age 17.5, SD = 1.7), participants were asked to indicate whether eight different ads for flavored e-cigarette products (Figure 1), randomly displayed, target someone younger than them, their age, someone a little older, or someone much older like their parents. Participants felt the ads were for someone just a little older than them (age 18 – 26; not for someone much older). More than half of participants felt ads for cherry, vanilla cupcake, caramel, and smoothie flavors were for someone their age. Ads were also seen as targeting an audience younger than them.  These findings suggest that while the tobacco industry argues that flavored tobacco products, including sweet and fruit flavored products, are not meant to attract youth, they do. These and similar findings indicate that the FDA should prohibit flavors in e-liquids and other products especially sweet (e.g., dessert, fruit) flavors, and prohibit marketing of these flavored products unless the manufacturers can provide specific evidence that allowing the use and marketing of that specific flavor avoids these problems with youth.