Monday, June 26, 2023

FDA Poisons the Promise of E-Cigarettes With Its Latest No-Context Report

 

The FDA Center for Tobacco Products on June 23 published a report titled, “E-Cigarette–Associated Cases Reported to Poison Centers.”  Examining data for the most recent full year, they found that the total (n=7,043) represented “a further increase in the number of e-cigarette exposure cases, particularly among children aged <5 years” (6,074 cases or 88% of the total).

The document wrongly implies the existence of a poisoning nightmare: “Health care providers; the public health community; e-cigarette manufacturers, distributors, sellers, and marketers; and the public should be aware that e-cigarettes have the potential to cause poisoning exposure and are a continuing public health concern.” 

Furthering its effort to eliminate e-cigarettes and vaping products, the agency published its data with no context, and amplified it with a sky-is-falling press release (here).  Following is that missing context with full-year numbers from the most recent National Poison Data System annual report.

In 2021, there were 2,080,917 cases of human exposure reported to poison centers.  The five substances most frequently involved were analgesics (283,000), household cleaning products (189,000), cosmetics/personal care products (148,000), antidepressants (142,000) and sedatives/hypnotics/antipsychotics (116,000).  With the exception of cleaning products, those exposures total 689,000 cases, and the FDA has direct regulatory authority over all of them.

The NPDS report also traces deaths, and for e-cigarettes/vaping products there was one death.  For the other three FDA-regulated categories there were 804 deaths (720 for analgesics, 10 for cosmetics, 44 for antidepressants and 30 for sedatives). 

Tobacco products were involved in 13,142 cases, or just 0.63% of all poisonings, and e-cigarettes’ share of the total was 0.26%.   

Now let’s look at children age 5 years and under. (The FDA report defines this category as “under 5 years,” whereas the poison reports use “5 years and under;” I’ll use the latter.).  There were a total of 883,822 exposures, and cosmetics/personal care products took 1st place (96,000), followed by cleaners (94,000), analgesics (72,000), dietary supplements/herbals/homeopathic (62,000) and foreign bodies/toys/miscellaneous (57,000).  Compared with poisonings at all ages, tobacco products had a slightly larger share of children’s exposures (n=10,249), at 1.17%; the e-cigarettes share was 0.47%. 

The FDA report furthers the agency’s misinformation campaign casting vaping as a public health crisis.     

 

Tuesday, June 13, 2023

Nature Nurtures Nicotine Nonsense

 

The prestigious scientific journal Nature draws considerable attention to its articles from scientists and others worldwide.  That makes it imperative that we point out the many serious flaws in a recent article, misleadingly titled, “Is nicotine bad for long-term health? Scientists aren’t sure yet.”

At this writing, MEDLINE, “the world's leading bibliographic source for biomedical scholarly literature and research,” offers citations to 28,241 articles with the keyword “nicotine”.  While it is true that science always demands additional research, one can reasonably assume that there is sufficient data on nicotine effects to draw meaningful conclusions about its safety.

Apparently, the authors of the Nature article went to great lengths to secure comments from what is surely a minuscule community of “unsure” scientists and from entrenched opponents of recreational nicotine consumption and tobacco harm reduction. 

Aruni Bhatnagar, who runs a tobacco regulation and addiction center sponsored by the American Heart Association, is quoted saying, “We believe that much of the cardiovascular effects of smoking are because of nicotine,” and he postulates that the drug can change the timing of electrical signals in the heart.  This sounds ominous, but the article includes a refutation of these comments by Neal Benowitz, a recognized nicotine authority: “Nicotine is a minor player with respect to smoking-induced cardiovascular disease.”  Benowitz points to “studies of snus – a chewable tobacco product that is popular mainly among men in Sweden and is gaining traction elsewhere – which do not generally show a detectable rise in heart problems among people who use it.”

Maciej Goniewicz of the Roswell Park Cancer Center in Buffalo offers insignificant insights, such as, “[Nicotine] changes lots of functions in our bodies, it’s not a harmless compound.”  That can be said of everything humans consume.  Goniewicz also muses, “Someone chronically exposed to nicotine might have chronic inflammation. There is speculation that it might contribute to increased risk of cancer. [Emphasis added] From animal and cell studies, yes, nicotine is doing something. How this translates into a risk for the [human] user, we don’t know.”  Benowitz counters: “the evidence, for me, is not convincing in tying [nicotine] to cancer in humans.”  The evidence for a nicotine-cancer link is next to nil.

Frequent nicotine critic Laura Crotty-Alexander of the University of California San Diego notes, “We’ve underplayed the role that nicotine has in the health effects of tobacco products.”  Basing her opinion on her own research, in which cells and animals are tortured with nicotine (more info here and here), she offers a weak indictment of the drug, saying, “I’ve been more and more surprised at the changes I’m seeing when I expose cells to nicotine.”

One of the most extreme views in the Nature article comes from Kjersti Aagaard, a maternal-fetal doctor at Houston’s Baylor College of Medicine: “No amount of nicotine is known to be safe in pregnancy. None. If you are exposed to nicotine in the womb, there could be lifelong consequences.”  Aargaard implies that failure to meet that standard could have criminal consequences for the pregnant woman, but the journal contrasts those remarks with the position of the UK National Health Service, which “describes e-cigarettes as safer than smoking for pregnant women, but it notes that there is little research to support the safety of e-cigarettes beyond that. It recommends pregnant women use nicotine patches and gums to stop smoking.”  This is but one example of the startling differences between prohibitionist American and science-based British positions on vaping.

Despite the Nature article’s complaint that “the lack of knowledge about whether nicotine contributes to the damaging health effects of smoking is becoming more worrying,” there is a wealth of knowledge supporting the finding that the effects of nicotine on health are minimal to nonexistent. 

 

   

Monday, June 5, 2023

Is Industry to Blame for Teen Substance Use?

 


I’m a member of a tobacco policy discussion group that has focused many times on the so-called epidemic of teen vaping.  One recent exchange centered on how e-cigarette and vape manufacturers and retailers might demonstrate to government regulators and policymakers that they are serious about not marketing their products to children.  Frankly, I take issue with the underlying assumption that the industry is actually responsible for teen behaviors.

First, let’s define the so-called epidemic.  The first chart at left represents “current” – that is, past-30-day – nicotine vaping prevalence rates among U.S. high school seniors, according to the federal Monitoring the Future (MTF) survey.  In 2017, the first year the MTF collected this information, 11% of seniors vaped.  Over the next five years, the percentage spiked to over 25%, then settled at around 20%.  A similar pattern is seen in National Youth Tobacco Surveys covering 2013 to 2022 (here). 

Now, ask yourself: Do vape companies play any role in this teen vaping “epidemic”? 

If you answer NO, I agree with you, but if you answered YES, please examine the next chart.

 

Here we see the same vaping numbers, but with the addition of current alcohol use rates for the past 32 years.  Although the trend is going in a welcome direction, 28% of high school seniors in 2022 were current drinkers, putting them at far greater risk than the smaller percentage who were vaping.  Note that all of these teens were under the legal age to purchase alcohol or vape products.

Does the alcohol industry play a role in teen drinking?

Oddly, in contrast to the obsession with vaping, little is said about teen drinking, despite widespread alcohol advertisements and the more immediate and greater dangers posed to underage drinkers.  Parents Against Vaping E-cigarettes (PAVE) and the Campaign for Tobacco-Free Kids (CTFK) portray nicotine vaping as the ruination of an entire generation.  Where are the pressure groups for teen drinking and binge drinking?

If you still blame corporate America for teen alcohol use, consider the next chart. It includes marijuana use, the rate of which has remained above 20% for high school seniors since 1995.

 

 

What industry is responsible for teen marijuana use?  

Until recent years, marijuana, which is still federally illegal, was prohibited in all 50 states, so there were no corporations producing or marketing it.  Industry would appear to be blameless for any underage consumption.

Conclusion

The explanation for teen substance use is that adolescents are strongly attracted to adult behaviors and adult products.  Blaming the vape industry while giving the alcohol industry a pass is illogical.  Teen marijuana use underscores the fact that young people will adopt adult behaviors regardless of industry marketing.