June 6, 2016

Stanton A. Glantz, PhD

The White House told FDA that Black lives don’t matter

FDA courageously stated in its final version of the deeming rule that it submitted to the White House that menthol flavored products would be treated the same as other flavored products (such as chocolate and gummy bear), and therefore all newly deemed menthol products would have been ordered off of the market by November 6, 2016.  To market a flavored (including menthol) product after that date, the tobacco and e-cigarette companies would have been required to present evidence to FDA proving that the products were entitled to receive marketing authorization because they protected the public health. As detailed below, the FDA presented overwhelming evidence, supported by comments it received on the proposed deeming rule, that menthol, candy, and fruit-flavored tobacco products attracted youth to tobacco use and deterred quitting. 
In a stunning action that prioritized tobacco industry interests over Black (and other) lives, the White House removed the overwhelming evidence presented by FDA demonstrating the impact of menthol and other flavors in enticing African Americans, as well as youth and young adults, to begin and continue smoking, and deleted the provisions ending the use of menthol and other flavors (unless the companies were granted specific permission to use them) from the final rule. See pages 167-183 of redlined version of deeming rule showing the changes that the White House made, which is available here.
The White House’s action in striking this key provision in the final deeming rule that would have removed all flavored (including menthol) newly-deemed products from the market by November 2016 will lead to thousands more preventable tobacco-related deaths among African Americans and will lead thousands more youth and young adults to become addicted to flavored e-cigarettes, cigars, little cigars, hookah, and other newly deemed tobacco products.  The White House quashed an important opportunity to protect the public health of all Americans, including African Americans and young people.
Tobacco-caused morbidity and mortality rates are disproportionately higher among African Americans compared to whites,1 and menthol cigarette smoking is disproportionately high among African Americans, which may help explain the increased health burden.[1] [2] [3] [4]   National data show that 74%-88% of African American adult smokers report smoking menthol flavored cigarettes, including 95% of black smokers aged 12-17, 94% aged 18-25, 92% aged 26-34, 90% aged 35-49, and 81% aged 50 and over who smoked menthol cigarettes in the past 30 days. 1 [5] [6]  In contrast, 26% of all whites, 51% of whites aged 12-17, 36% aged 18-25, 24% aged 26-34, 20% aged 35-49, and 21% aged 50 and over reported menthol cigarette smoking in the past 30 days.1 5 
Menthol is the most popular characterizing flavor of cigarettes in the US, with more than 90% of all cigarettes containing menthol.[7] Although all other characterizing flavors such as strawberry, grape, or cherry were banned in 2009 under Section 907 of the Family Smoking Prevention and Tobacco Control Act, menthol was excluded from this ban.  While FDA explicitly did not propose to prohibit menthol or other flavors in the deeming rule it sent to the White House, FDA intended to order all newly deemed flavored products, including menthol products, off of the market within six months of the final rule’s publication, rather than allow menthol and flavored products to enjoy the more liberal and industry-friendly “compliance policy” that permits products to remain on the market for as long as three years while awaiting FDA premarket review.
The White House OMB deleted FDA’s strong statement about the compelling scientific evidence showing menthol’s impact on tobacco products’ appeal to youth and young adults, which supported FDA’s intention to remove newly deemed menthol products from the market, along with all other newly deemed products, by November 2016:

FDA expects that the tobacco flavor in a tobacco product need not be naturally inherent to the product in order for a manufacturer to fall within the compliance policy described here, but rather may result from the addition of ingredients or other measures by the manufacturer to result in the presence of tobacco as a characterizing flavor. However, 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. We note that newly-deemed flavored tobacco products that are not grandfathered may still need to address the public health implications of any added flavors, including tobacco flavor, in their pre-market review submissions.  (Page 169 of the redlined deeming rule)

The While House also deleted Pages 175-176 presenting data confirming the appeal of menthol to youth and young adults in e-cigarettes and cigarettes:

Existing data also show that youth and young and adults are using menthol flavored products, along with other flavored products. For example, in one survey of 953 middle school and high school students who had used e-cigarettes during their lifetime, 71 percent reported having tried sweet flavors and 22.1 percent reported having tried menthol-flavored e-cigarettes (Ref. 23, Krishnan). Moreover, cigarette data also confirms the appeal of menthol to youth. Younger populations have the highest rate of smoking menthol cigarettes, and studies looking at the differences in prevalence rates, age of first cigarette, and progression to regular smoking show a greater use of menthol in younger smokers and declines in use with age from adolescent to young adults to adults (Ref. 23E, Report citing, e.g., Ref. 23F, Fernander; Ref. 23G, Hersey 2006). In fact, data analyzed from the 2006 National Youth Tobacco Survey revealed that among youth smokers who reported a usual brand, 51.7 percent of middle school smokers and 43.1 percent of high school smokers consistently reported that their usual brand was menthol (Ref. 23E, Report, citing Ref. 23H, Hersey 2010). Menthol in cigarettes also is likely associated with increased dependence, with consistent findings showing that menthol smokers are more likely to smoke their first cigarette within five minutes of waking (a well-established measure of dependence), and are less likely to successfully quit smoking (id.; citing, e.g., Ref. 23I, Nonnemaker 2013).
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). For example, researchers have found that among cigar smokers (in middle and high school), those who use flavored little cigars generally have a lower intent to quit than users of non-flavored tobacco products, which is consistent with evidence showing increased tobacco dependence among menthol smokers (Ref. 19, King). Similarly, 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).

The White House also deleted this material on pages 179-180:

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).

As the Public Health Law Center observed in its blog post entitled “FDA Overruled By White House On Removing Flavored Cigars and E-Cigarette Liquids From The Market,” the headline would have been, “FDA Proposes Sweeping Restrictions on Menthol, Other Flavored Tobacco Products” without the White House cutting all this scientific evidence and sensible regulation. 
Lauren Lempert worked with me to prepare this blog post.

[1] Alexander L, Trinidad D, Sakuma K-L, et al. Why We Must Continue to Investigate Menthol’s Role in the African American Smoking Paradox. Nicotine Tob Res (2016) 18 (suppl 1): S91-S101.doi: 10.1093/ntr/ntv209

[2] Garten S, Falkner RV. Continual smoking of mentholated cigarettes may mask the early warning symptoms of respiratory disease. Prev Med. 2003;37(4):291–296. doi:10.1016/S0091-7435(03)00116-6

[3] Garten S, Falkner RV. Role of mentholated cigarettes in increased nicotine dependence and greater risk of tobacco-attributable disease. Prev Med. 2004;38(6):793–798. doi:10.1016/j.ypmed.2004.01.019.

[4] Hooper MW, Zhao W, Byrne MM, et  al. Menthol cigarette smoking and health, Florida 2007 BRFSS. Am J Health Behav. 2011;35(1):3–14. doi:10.5993/AJHB.35.1.1

[5] Giovino GA, Villanti AC, Mowery PD, et  al. Differential trends in cigarette smoking in the USA: is menthol slowing progress? Tob Control. 2015;24(1):28–37. doi:10.1136/tobaccocontrol-2013-051159

[6] Lawrence D, Rose A, Fagan P, Moolchan ET, Gibson JT, Backinger CL. National patterns and correlates of mentholated cigarette use in the United States. Addiction. 2010;105(suppl 1):13–31. doi:10.1111/j.1360-0443.2010.03203.x

[7] Giovino GA, Sidney S, Gfroerer JC, et al. Epidemiology of menthol cigarette use. Nicotine Tob Res. 2004;6(suppl 1):S67–81. doi:10.1080/146222 03710001649696.


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