FDA bans some flavored tobacco product sales to kids

The FDA issued a pretty strong position on the sale of flavored tobacco products to kids: see https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625884.htm , which is basically a somewhat personalized statement by the FDA's commissioner Scott Gottlieb

Gottieb notes recent data from MMWR (see https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm ) finding:
-- from 2017-2018, a 78% increase in current e-cigarettte use among high school students (from 11.7% to 20.8%, p<0.001), and  a 48% increase among middle school students
--use of e-cigarettes: 3.05 million (20.8%, 1.5 million more) high school students, and 570,000 (4.9%, 510 000 more) middle school students
--regular e-cig users (>20 days in past month) increased from 20.0% to 27.7% (p=0.008)
--flavored e-cigs users increased from 60.9% to 67.8% (p=0.02) ; current use of menthol or mint-flavored e-cigs increased from 42.3% to 51.2% (p=0.04)
--current use of any tobacco product among high school students increased from 3.69 million (24.2%) in  2011 to 4.04 million (27.1%) in 2018; though for middle school students decreased from 870,000 (7.5%) in 2011 to 840,000 (7.2%) in 2018. both of these changes were not statistically significant
    --but, during 2017-18: overall tobacco product use increased 38% among high school students (from 19.6% to 27.1%, p<0.001) and by 29% among middle school students (from 5.6% to 7.2%, p=0.008)
 
so, FDA plans:
--all flavored ENDS products (electronic nicotine deliver systems) have to be sold in age-restricted, in-person locations (ie not sold where those under 18yo are permitted)
    --escalated enforcement against retailers who illegally sell these products to minors
    --curtailing the sale of applicable flavored ENDS products sold online without heightening age verification
--targeting e-cig manufacturers whose "products used misleading, kid-appealing imagery that mimicked juice boxes, lollipops, and other foods"
    --called on manufacturers to "step up" their voluntary actions to prevent youth access to these products
--work with on-line sales that lack heightened measures for age verification
--launch campaigns to educate teens about consequences of addiction to e-cigs
--direct the FDA's Center for Tobacco Products to revisit their compliance policy (which had been extended to 2021-2) with regards to ENDS products that are flavored
    --they are not including "tobacco, mint, and menthol flavors or non-flavored products sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification". Gottlieb sees these products as potentially useful in adults trying to get off cigarettes (see below). though he also states concern that menthol-flavored combustible cigarettes are also a common route whereby kids switch from e-cigs to regular ones.
        -- he notes that 54% of youth smokers 12-17 yo use menthol cigarettes (though  <1/3 of smokers >35yo do)
    --they will advance an Notice of Proposed Rulemaking to ban menthol in combustible cigarettes and cigars [AND, this is a tad inconsistent: they want to get rid of menthol cigarettes and cigars, since “there is no evidence to suggest that menthol-flavored cigarettes may play a role in harm reduction for adult smokers”, yet they are not restricting menthol (or mint) e-cigs because menthol-flavored ENDS “may be important to adult smokers seeking to transition away from cigarettes”…????]]
    --and they are proposing a policy to ban flavors in cigars: a higher proportion of youth who smoke cigars use flavored cigars
--Gottlieb holds out for continuing to allow ENDS products to be available as a means to decrease adult smoking, but "make no mistake. if the policy changes that we have outlined don't reverse this epidemic, and if the manufacturers don't do their part to help advance this cause, I'll explore additional actions"
    -- [as a side note here, there are some studies suggesting that e-cigarettes can help older people stop smoking: eg see http://gmodestmedblogs.blogspot.com/2016/04/e-cigarettes-as-tool-to-quitting.html  , though the data in this study on kids is pretty old.  BUT there are no studies I have seen suggesting that access to flavored cigarettes helps adults quit… and, adults do not smoke flavored cigarettes, other than menthol]

Dr. Colleen Kraft, President of the Am Acad of Pediatrics, notes that the AAP has been concerned about e-cigs for a long-time, that the current increases are staggering both in e-cig experimenters (casual users) and in those using e-cigs regularly, and that the FDA should take immediate steps to stop this trend. She commends the actions outlined, but notes that despite the new sales restrictions, "teens will still find ways to access them". the FDA "must take stronger action to protect young people. Pediatricians will not rest until these dangerous products are off the market and out of the hands of children and adolescents" (see https://www.aap.org/en-us/about-the-aap/aap-press-room/Pages/AAP-Statement-in-Response-to-New-FDA-Actions-on-Flavored-Tobacco-Products.aspx )

so, a pretty ambitious plan overall, especially on the tightening of all retail and on-line sale of ENDS to kids. but the real concern with this policy (reflected in the AAP statement) is will this really be implemented adequately and decrease the risk of nicotine addiction in children and adolescents???? And the rationale for allowing the sales of flavored ENDS is quite questionable, since these are really targeted to kids, and there are no data suggesting that they may help adult smokers quit.   ie: there is no good reason to allow flavored e-cigs to be sold at all.  And, of course, the real elephant-in-the-room not being addressed: banning tobacco use overall is the single most important thing the government could do to improve the public health, and the e-cig issue is really just a side-line….

geoff

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