Wednesday, March 29, 2023

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.



Monday, March 27, 2023

American Teens’ Gross Misperception of Nicotine Leaves FDA Study Authors Unperturbed

A new study by Erin Keely O’Brien and colleagues at the FDA Center for Tobacco Products (CTP) underscores the FDA’s failure to accurately educate consumers about nicotine.  The report appears in Nicotine & Tobacco Research.

The authors analyzed perceptions of nicotine among 12-17 year-old participants during two waves of the Population Assessment of Tobacco and Health (PATH) study, in 2016-17 and 2017-18.

While their journal article includes some positive messages on tobacco harm reduction, its main finding is worrisome: 75% of surveyed youth “incorrectly responded that nicotine is the main substance that causes smoking-related cancer.”  O’Brien noted that this figure was “similar to adults.”   

O’Brien et al. do acknowledge a critical fact: “…it is tobacco combustion and the accompanying release of thousands of harmful chemicals, rather than nicotine itself, that is responsible for most [sic] of the negative tobacco-related health outcomes (eg, the myriad of cancers related to tobacco use).”  They even acknowledge that the FDA’s reduced-nicotine standard for cigarettes “would not decrease the toxicity or harmfulness” of smoking.

The authors reveal why the FDA has done so little to educate consumers about nicotine: “Among youth who did not use at [the 2016-17 wave], greater harm perceptions of nicotine in cigarettes, e-cigarettes, and NRT were associated with lower likelihood of reporting current tobacco use at [the subsequent wave].” (Emphasis added)  They call these misperceptions “protective (preventing initiation among youth who do not use tobacco),” but they also label them “harmful,” in so much as these misperceptions are “preventing youth who use combustible tobacco from switching to [pharmaceutical nicotine].”

In other words, the FDA authors think that teens who mistakenly believe that nicotine kills are more likely not to initiate tobacco.  Even more ominously, “Among youth who currently used cigarettes or e-cigarettes [in the 2016-17 wave], nicotine perceptions did not predict switching to e-cigarettes or cigarettes [in the subsequent wave].”  Of course not.  The misinformation prevents teen – and adult – smokers from switching to tobacco products that are objectively no more hazardous than nicotine medicines.

O’Brien and colleagues conclude that their “findings underscore the challenge of developing effective and comprehensive communication strategies that accurately convey the effects of nicotine without encouraging tobacco use.

Why, when 480,000 Americans die from tobacco smoke inhalation every year, are FDA officials worried more about “encouraging tobacco use” than sharing accurate information about nearly harmless nicotine?  Why do they need “comprehensive communication strategies” to simply tell adult smokers the truth?  The answers lie in the government’s obsession with creating a tobacco-free society.


Thursday, March 16, 2023

Internal FDA Report on Smokeless Tobacco Dashes Hopes for Vaping


Kudos to Greg Conley, director of legislative affairs for the American Vapor Manufacturers Association, for making public an internal FDA Center for Tobacco Products (CTP) report, titled, “Summary of Health Effects of Smokeless Tobacco [SLT] Products for Epidemiology Branch Product Application Review.”  Mr. Conley used a Freedom of Information Act request to obtain the 18-page document.

It is important to note the clear acknowledgment by FDA staff that SLT products are safer than cigarettes, illustrated in this executive summary passage:

“Though SLT products are generally considered higher-risk than NRT, they are of considerably lower risk than continued smoking. The overall epidemiological literature supports that cigarette smokers who completely switch to SLT products are likely to substantially lower their risks of cardiovascular disease, lung cancer, and respiratory disease compared to smoking.”

Despite this grudging admission, the report is grossly biased against SLT products. 

First, the authors incorrectly combined all SLT products into one “product class” which includes: “chewing tobacco [chew], [powdered] dry snuff, moist snuff [dip] including snus, nicotine pouch products, and dissolvable products such as lozenges.”  It is hard to believe that the FDA authors cannot distinguish the risks associated with dip and chew products from those of powdered dry snuff, which I have described extensively in the scientific literature (here, here and here). 

Second, the authors cherry-picked those studies that reported higher risks, while they excluded studies that reported no, or lower risks.  This is demonstrated by examining their reference list.

Of the 72 cited studies, dating from 1981 to 2020, they only included those reporting elevated risks among STP users.  More importantly, they excluded two 2019 studies, published by Michael Fisher and colleagues (here), and by my research group (here).  Fisher’s study demonstrated “a clear mortality risk differential between modern SLT products and cigarettes. Cigarette smokers had an increased overall mortality risk and risk for several disease-specific causes of death, while SLT users consistently had lower mortality risks.”  Our study found that STP users “had significant excess mortality from all causes, but not from heart diseases, malignant neoplasms, and all smoking-related diseases.  However, they had higher mortality for all other causes, which was largely seen in age 40–59 years.” [hazard ratios removed]

The most egregious example of cherry-picking involved the FDA staff’s highlighting of elevated mouth cancer risks in the 2016 study by Wyss et al.  I published a letter to the editor about this research, noting that Wyss ignored risk differences between men and women (discussed here and here).  As I wrote:

“The OR [odds ratio] among women ever snuff users (8.89, CI: 3.59, 22.0, based on 20 exposed cases and 12 controls) was an order of magnitude higher than that in men (0.86, CI: 0.49, 1.51, based on 24 exposed cases and 50 controls). 

“The striking difference between women and men reflects completely different snuff exposures.  It is widely known that in the southern U.S. women primarily use powdered dry snuff, whereas men throughout the U.S. use moist snuff.  Powdered dry snuff use is associated with excess oral cancer risk in four previous studies (Reference 2), all of which were cited by Wyss (3, 4, 5, 6).  In contrast, moist snuff is associated with minimal to no risk in eight previous studies (2).

“Wyss and colleagues are knowledgeable about the use of powdered dry snuff by women and its cancer risk; one [Deborah Winn] was first author of a 1981 study reporting that “[t]he relative risk [for oral and pharyngeal cancer] associated with snuff dipping among white [women] nonsmokers [in North Carolina] was 4.2 (95 per cent confidence limits, 2.6 to 6.7).” (4)  Subjects in that study had exclusively used powdered dry snuff.”

The FDA authors concluded: “Complete switching to SLT as a harm reduction alternative to cigarette smoking continues to be an area of active research.”

Despite decades of research demonstrating that SLT use is 98% safer than smoking, FDA staff can only say that smokeless harm reduction is “an area of active research.”  Even if similar differential risk evidence is obtained for vaping, it will never be enough for FDA harm reduction naysayers.