FDA authorizes two more RJR tobacco e-cigs and lets menthol remain on the market, ignoring its own conclusion that menthol reinforces nicotine addiction in kids’ developing brains

Today (May 12, 2022) FDA announced that it was authorizing the sale of two additional RJR e-cigarettes, Vuse Vibe (a vape pen) and Vuse Ciro (similar to previously authorized Vuse Solo). FDA didn’t act on RJR’s most popular Vuse product, Vuse Alto, so it continues on the market. Following FDA’s de facto policy, both were authorized in tobacco flavor and non-menthol flavors were denied. FDA let menthol stay on the market by simply not acting.

Like Vuse Solo and NJOY, the FDA’s inaction on menthol allows the tobacco companies to sell the authorized tobacco e-cigs side-by-side with the unauthorized menthol e-cigs which are, technically, illegal to sell.

Also following recent practice, FDA refused to release anything of substance on the scientific basis for its decision, citing trade secret concerns. This is a lame excuse because FDA was able to post more details of its justification for several earlier products, including redacting alleged trade secrets. In addition, the 4 page (out of 56 pages) in the new Vuse authorization that FDA released are redacted for trade secrets, shown as “b(4).”

The FDA’s real goal is to avoid criticism for the shallow analysis of the effects on kids and FDA’s consistent failure to say how many newly addicted kids they are willing to tolerate for the theoretical benefits to adults, which the FDA has never actually quantified.

FDA is ignoring its own publicly stated conclusion that menthol makes nicotine more addictive for youth and young adults

The FDA’s continued punting on menthol also ignores the strong well-supported conclusions it drew about how menthol reinforces nicotine in its recently proposed rules banning menthol in cigarettes and cigars.

In particular, FDA wrote:

Menthol is a flavor compound that is added to cigarettes, which produces a minty taste and cooling sensation when inhaled (Ref. 2). These sensory properties contribute to smoker perceptions that menthol cigarettes are easier to inhale, are less irritating, have a better taste, are smoother and more refreshing than non-menthol cigarettes (Refs. 3-5). Menthol’s flavor and sensory effects reduce the harshness of cigarette smoking among new users and facilitate experimentation and progression to regular smoking of menthol cigarettes, particularly among youth and young adults (Refs. 6-7, 5, 8). As a result, the brain is repeatedly exposed to nicotine and susceptible to nicotine addiction (Ref. 9). …

In addition to its flavor and sensory effects, menthol contributes to a greater risk of nicotine dependence by enhancing the addictive effects of nicotine in the brain by affecting mechanisms involved in nicotine addiction (Refs. 10-13).  Clinical data show that menthol cigarette smokers have higher levels of brain nicotinic receptors compared to non-menthol smokers (Ref. 14). Studies demonstrate that menthol, like nicotine, binds to nicotinic receptors in the brain (Refs. 15 and 16), and menthol alone can increase the number of nicotinic receptors in the brain (Refs. 10 and 11). Evidence demonstrates that the combined effects of menthol and nicotine in the brain are associated with behaviors indicative of greater addiction to nicotine compared to nicotine alone (Refs. 10 and 12).

Youth and young adults are particularly susceptible to becoming addicted to nicotine. Due to its ongoing development, the adolescent brain, which continues to develop until about age 25, is more vulnerable to nicotine’s effects than the adult brain (Refs. 17-19). The combined effects of nicotine and menthol in the developing brain make youth who smoke menthol cigarettes particularly vulnerable to the effects of menthol on nicotine dependence. (pages 11-12)

Data from multiple studies across different populations and time periods demonstrate that menthol cigarettes contribute to greater nicotine dependence in youth and young adults than non-menthol cigarettes (Refs. 20-28). Menthol is a significant contributor to experimentation and progression to regular cigarette smoking among this population (Refs. 25, 29-31, 8). This is of particular concern since the vast majority of smoking initiation occurs during adolescence (Refs. 32, 8, 31, 33) and youth and young adults are more likely to try a menthol cigarette as their first cigarette than a non-menthol cigarette (Refs. 8, 31, and 33).

… (page 13) Prohibiting menthol as a characterizing flavor in cigarettes would help to decrease the nicotine addiction resulting from menthol cigarette use, and thereby, decrease disease and death. [pages 11-13; emphasis added]

While these statements are about cigarettes, there is no reason to expect that these biological interactions between nicotine and menthol would be any different in e-cigarettes. There is nothing about the differences in heating in e-cigarettes (a heater coil) and cigarettes (combustion) that would fundamentally change the chemical structures of menthol and nicotine in a way that would affect menthol’s reinforcing role for nicotine as an addictive agent.

By leaving menthol e-cigarettes on the market through inaction, the FDA is in fact acting to continue this cycle of addiction and disease. The fact that menthol will be the “only” flavor ensures that more kids will use menthol e-cigs than the large number that do now.

Someone in Congress needs to call the FDA in to explain in a public forum why it is ignoring what it wrote in its menthol cigarette rule when sitting back and leaving menthol e-cigs on the market.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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