Finally, U.S. House of Representatives Holds FDA Tobacco Officials Accountable for Regulatory Missteps

 

This blog has long detailed the FDA Center for Tobacco Products’ (CTP) continuing campaign against vastly safer cigarette substitutes. 

Now House Committee on Oversight and Accountability Chairman James Comer (R-KY) has written FDA Commissioner Robert Califf demanding “documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions.”  This is a key paragraph:

“In conjunction, FDA must also clearly and accurately communicate information regarding the relative risk that products, to include ENDS [electronic nicotine delivery systems] and smokeless products, pose—and do not pose—to the adult nicotine product user population. Since 2005, the percentage of adult smokers in the United States has fallen from 20.9 percent to 12.5 percent. Nevertheless, there are still 30 million adult smokers in the United States, and nearly half a million Americans die from smoking related disease every year. This is a population that could benefit from accurate information and access to potentially safer FDA authorized products.”

FDA officials will likely deflect and assert that definitive relative risk information for ENDS and smokeless products is uncertain or inconclusive.  In fact, the relative risks for smokeless tobacco products like Swedish snus and American dip/chew products are roughly 2% of those for cigarettes, and 5% or less of those for vapor products. 

I hope Chairman Comer’s letter elicits other important information, such as why FDA officials didn’t publish clear guidelines for pre-market tobacco applications (PMTAs) prior to the deadline for PMTA submissions.  The agency perversely insisted that manufacturers of each new product first prove that it was “appropriate for protection of the public health,” without the benefit of any guidance.  That process resulted in millions of applications and gross review mismanagement by FDA staff.

The agency has until April 11 to respond to Chairman Comer’s demands.  That’s about two weeks, when some 18,400 more American smokers will die.

 

 

My Commentary on FDA Regulation That the American Journal of Public Health Invited, Rejected, and Then Maligned Me For

 

Earlier this year, the American Journal of Public Health’s editor-in-chief Alfredo Morabia invited me to comment on FDA tobacco regulation.  A month later, he rejected my commentary, then in July he published an editorial effectively, and falsely, labeling me a tobacco industry shill.  I reported the details of that experience in a Retraction Watch article.  Following is my rejected but still relevant article.

Commissioned Commentary: It’s Time for Federal Officials to Save Smokers’ Lives: Switch from Prohibition to Pragmatism

Inhaling the smoke of burning tobacco kills 480,000 Americans every year.  The United States government response – regardless of the political party in power – has been the obstinate pursuit for a quarter century of an idealistic and unattainable “world free of tobacco use” (http://bit.ly/2IXyf83).  This mindset is now embodied in punitive FDA regulation of smoke-free nicotine and tobacco products, thereby ignoring the continuum of risk in the agency’s own comprehensive tobacco regulation plan (https://bit.ly/3IULLpQ ).

For all e-cigarette/vapor products, Congress requires manufacturers to submit pre-market tobacco applications (PMTAs) demonstrating that they are “appropriate for the protection of public health” (APPH).  The FDA has applied the APPH standard injudiciously.  It blamed vapor manufacturers exclusively for a so-called “teen vaping epidemic” and laser-targeted non-tobacco-flavor offerings, even though teen smoking plummeted during a 2017-19 vaping increase and during the sharp vaping decline two years later. (https://bit.ly/3INrYbJ).

Federal officials base their “epidemic” claim on the high usage numbers in the National Youth Tobacco Survey, but they ignore lower estimates from other credible federal sources (https://bit.ly/3JLHmGO ).  Regulators also ignore NYTS findings that a large majority of high school vapers, regardless of frequency, have vaped marijuana (https://bit.ly/3INrYbJ).   

Their data cherry-picking morphed into deliberate deception when e-cigarettes were wrongly implicated by the CDC in a 2019-20 lung injury outbreak that stemmed from contaminated marijuana vaping products, resulting in 2,800 hospitalizations and 68 deaths (1).On September 7, 2021, the FDA revealed how it applies the APPH standard: “…only the strongest types of evidence will be sufficiently reliable and robust —most likely product specific evidence from a randomized controlled trial (RCT) or longitudinal cohort study.” (2)  These studies take years and millions of dollars to perform, but the FDA disclosure came one year after the PMTA deadline for manufacturers.

When the FDA authorized a second group of tobacco-flavored vapor products on March 24, 2022 (https://bit.ly/3JOZgIB ), Commissioner Robert Califf commented: “As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products.  We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine.”

Dr. Califf was mistaken.  The devastation, death and disability he saw was not from tobacco use, but from smoking.  Substituting the former for the latter is not accidental; it is intentional, unscientific and imprecise.  Califf acknowledged adult demand for vapor, but smokers don’t just “try to switch.”  A federal survey documented that 4 million adult vapers are former smokers (https://bit.ly/3uER9Z4 ).  Also, millions of high schoolers aren’t “getting addicted.”  Only 467,000 – 3% of high school students – vaped 20+ days in 2021 (https://bit.ly/3INrYbJ), putting them at risk for addiction.  While that number is unacceptable, it does not constitute an epidemic.

Federal officials’ obsession with the small percentage of youth who try or use smoke-free tobacco is out of proportion to far more serious high school behaviors, including using alcohol (30%) or marijuana (20%), binge drinking (14%), driving while texting/emailing (39%), carrying a weapon (16%), and considering suicide (17%) (https://bit.ly/3DwdWdt ).

The obsession is also inconsistent with the government’s official health objectives for the U.S. population (3).  Adolescent smoking and vaping rates (1.5% and 7.6%) are already lower than the 2030 targets (3.4% and 10.5%), while adult smoking (12.4%) is still far higher (5%), killing 480,000 Americans yearly.

The federal government should abandon its pursuit of nicotine/tobacco prohibition, and focus on FDA regulation of tobacco products proportionate to their risk.

Disclosure: Dr. Rodu’s research is supported by unrestricted grants from tobacco manufacturers to the University of Louisville and by the Kentucky Research Challenge Trust Fund.

References

1. Bates C. (2021). The outbreak of lung injuries often known as “EVALI” was nothing to do with nicotine vaping. Qeios https://www.qeios.com/read/ZGVHM7.3.

2. U.S. Food and Drug Administration. Sample Decision Summary: Technical Project Lead (TPL) Review of PMTAs. September 7, 2021. https://www.fda.gov/media/152504/download  (https://bit.ly/3wuPplI)

3. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.  Healthy People 2030.  Available at: https://health.gov/healthypeople .

 

IQOS Continued to Drive Down Japan Cigarette Sales in 2020; U.S. Cigarette Sales Steady

 

Japan is experiencing an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales dropped 8% in 2020, largely due to sales of reduced-risk products.  The dominant such product in Japan is Philip Morris International’s IQOS heat-not-burn HeatSticks.

U.K. veteran tobacco harm reduction advocate Clive Bates opined: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.” 

Meanwhile, the U.S. FDA finally authorized IQOS as a reduced exposure alternative to cigarettes on July 7, 2020, greenlighting these claims:

“AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.
• This significantly reduces the production of harmful and potentially harmful chemicals.
• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

The FDA advised that its approval “is expected to benefit the health of the population as a whole.”

The Covid-19 pandemic is hurting U.S. IQOS marketing and sales.  PMI’s retail program requires smokers to visit an IQOS store to get educated about the system and purchase the hardware.  After that, smokers can buy the heat sticks in convenience stores and other outlets.  PMI’s program aims to suppress teen adoption, but the added inconvenience has slowed adoption by adult smokers.  The Wall Street Journal reports that the decades-long decline of cigarette sales has ended. One hopes the trend line will improve again as the pandemic comes under control and smokers make the effort to learn about this new smoke-free alternative.