Wednesday, October 30, 2019

U.S. Military’s Misbegotten Message to Troops: Cigarettes Are Safer Than Vape Products

With regard to tobacco products, the U.S. Department of Defense isn’t serving the health interests of those who serve.

As I have documented many times (here, here, here and here), in pursuing a tobacco-free fighting force, DOD has grossly misinformed American service members about the relative safety of smokeless tobacco and e-cigarettes. 

David Sweanor recently posted the photo at left from an Army and Air Force Exchange Service store. 
Even worse is this Military Times article from September 24,
about the removal of vaping products from Army, Air Force and Navy exchanges by October 1, owing to “the outbreak of mysterious vaping-related lung injuries.” 

Actually, that mystery has been solved.  CDC Principle Deputy Director Dr. Anne Schuchat said on October 25, “The vast majority of patients with [lung injuries] including those who died…, had a history of use of e-cigarette, or vaping, products that contained THC.”

DOD removed products that we now know did not kill 34 Americans who were instead vaping contaminated marijuana liquids, yet DOD continues to sell cigarettes, which have, in fact, killed 380,000 Americans so far this year.

In this case, military intelligence is an attribute of our proud troops, but not of their health officers or administrators.  The Military Times notes:

“Vaping now appears to be more common in the military than smoking regular cigarettes, according to results of the most recent Defense Department Health-Related Behaviors Survey of Active-Duty Service Members. The results of that survey, conducted in 2015, showed 11.1 percent of troops said they were daily e-cigarette users, compared to 7.4 percent who said they smoked cigarettes daily.  In the junior enlisted ranks, nearly 20 percent said they were current e-cigarette smokers.”

The troops have made the switch to vastly safer smoke-free tobacco at far higher rates of use than are seen in the general U.S. population

So far, the Marine Corps, which at 16% has the highest prevalence of vaping among the military branches, continues to permit the sale of vaping products, signalling semper fidelis to harm reduction. 

The Army, Air Force and Navy exchanges should immediately reverse their egregious decision and return e-cigarettes and vaping products to their shelves.

Friday, October 25, 2019

FDA Awards “Modified Risk” Status to General Brand Snus Products from Swedish Match

“The U.S. Food and Drug Administration announced [on October 22] that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the ‘General’ brand name” (from the FDA press release). 

The FDA authorization allows Swedish Match to use this statement: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”  The approval will be in place for five years, but the agency can remove it at any time if it decides that it “no longer benefits the health of the population as a whole.”

It took the FDA over five years (during which 2.56 million American smokers died prematurely) to approve this truthful statement that I have documented for 25 years.  Note, however, that the tobacco control act stacked the deck against harm reduction by mandating the term “modified risk” instead of the more accurate “reduced risk.”

The FDA announcement received favorable media attention, with one analyst calling it a “gamechanger.”  While that may be true, there are some important things to remember.

1. The company filed its original application in 2014 to change the FDA’s mandated but grossly inaccurate smokeless tobacco warning labels.  The FDA, using flawed analysis, rejected that application in December 2016, and signaled that it would not jettison the required warnings, “cause mouth cancer” and “not a safe alternative to cigarettes.”  Swedish Match then filed an amended application with the statement that was approved.

2. The approved warning refers to “lower” risk of disease, which implies that risks are still present, when, in fact, snus has no risk for mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.  Even worse, the FDA’s “not safe alternative” warning covering a large part of the package and advertisements annuls the “lower” risk statement from Swedish Match. 

3. Swedish Match’s success was supported by a wealth of published epidemiologic research demonstrating snus’s negative impact on smoking and smoking-related diseases among Swedish men.  While Swedish boys use snus just like their fathers, use among American youth is nearly nonexistent.  These factors set a high standard of evidence for other current MRTP applications from Philip Morris International (IQOS), Reynolds (Camel snus) and and US Tobacco (Copenhagen moist snuff).   
  • IQOS heat-not-burn tobacco.  Years of extensive research demonstrate that IQOS vapor is vastly less hazardous than smoke.  However, there is no epidemiology on the health effects of IQOS use, and there won’t be any for at least two decades.  In other countries, PMI sells IQOS devices only to adult smokers in special stores, so youth don’t have access.  PMI’s FDA application is now almost three years old (corresponding to 1.44 million dead smokers).
  • Camel snus.  Produced in the same manner as Swedish snus, Reynolds’s Camel product should qualify for MRTP status with similar labeling, but Reynolds has no epidemiology for a product introduced in the U.S. around 2005.  The MRTP application is two and a half years old (1.24 million dead smokers).
  • Copenhagen moist snuff.  The U.S. Smokeless Tobacco Company took a minimalist approach in its FDA MRTP application for this statement: “Switching completely to this product from cigarettes reduces risk of lung cancer.”  Still, the FDA, concerned with under-age use of dip products, claims that 350,000 “youth under 18 years of age use smokeless tobacco for the first time” yearly.  The agency will likely cite the youth issue to deny any statement about vastly lower risks, including lung cancer.  The MRTP application is one year, seven months old (760,000 dead smokers).
  • E-cigarettes and vapor products.  The chances of these products getting an MRTP are approximately zero.  Research at American universities funded by the federal government is focused only on risks, epidemiologic studies are nonexistent, and federal officials consider vape products to be the cause of an exaggerated teen epidemic and mischaracterize them as the cause of lung injuries and deaths.  Manufacturers must first navigate widespread flavor and product bans, and then complete Premarket Tobacco Product Applications, a feat accomplished only by Swedish Match for General Snus and PMI for IQOS. 
Swedish Match should be commended for establishing a precedent for successfully navigating the Reduced (not merely modified) Risk Tobacco Product Pathway. 

Friday, October 11, 2019

Age Counts: Who Vapes (Tobacco/Nicotine) and Who Gets Lung Injuries

Federal officials, most notably at the Centers for Disease Control and Prevention, continue to be remarkably vague about the cause of 1,299 acute lung disease injuries and 26 deaths among people who have vaped.  This ambiguity, which I believe is out of sync with normal CDC investigations, has led to a media frenzy and partial or full bans on e-cigarette sales in many localities.  Major retailers are scrapping e-cigarettes while continuing to sell cigarettes, which have killed 368,000 smokers already this year. Making vastly safer cigarette substitutes unavailable to 8 million adult vapers will inevitably increase cigarette consumption, driving the death count even higher.

Officials have disclosed few details about the lung injuries and deaths.  On October 10, the CDC posted a report, once again highlighting “e-cigarettes, or vaping products” in the title while relegating critically important information about contaminated marijuana products to the fine print.

CDC’s data on 1,043 cases confirmed that the injuries are concentrated among younger age groups.  If nicotine vaping was the cause, the age distribution of lung injuries would be similar to the age distribution of vapers.  I used the tobacco questions in the 2018 National Health Interview Survey and in the 2018 National Youth Tobacco Survey to generate estimates of the number of current adult and underage vapers (here).  The table shows the distribution of lung injuries compared with the distribution of current (tobacco/nicotine) vapers.

Age Distribution of Lung Injury Cases and Current Vapers
Age (years)Lung Injury Cases* Percent (number)Current Vapers** Percent (millions)

Less than 1815% (156)8% (0.7)
18 to 2021% (219)11% (1.0)
21 to 2418% (188)14% (1.2)
25 to 3426% (271)27% (2.4)
35+20% (209)40% (3.5)

All100% (1,043)100% (8.8)

**Based on tobacco questions in the 2018 NHIS (18+ years, vaping every day or some days) and 2018 NYTS (< 18 years, vaping 20-30 days in past month)

The table reveals starkly different age distributions.  While 36% of lung injuries affected those under 20 years, that group constitutes only 19% of all current vapers.  Forty percent of the 8.8 million current vapers were over age 35, compared with only 20% of lung injury patients. 

The table underscores another striking comparison.  The main rationale for punitive action against e-cigarette retailers is the so-called teen vaping epidemic, which I have discussed previously (here, here and here).  But federal surveys show that underage teens make up only 8% of the 8.8 million current vapers, or about 736,000 individuals.  Of those, about 59% (430,000) are current cigarette and/or cigar users.  

Here’s the tradeoff: 92% of current U.S. vapers are adults, most of whom are either current or former smokers (here).  Federal and state actions that prohibit vape products to “save the children” will predominantly and permanently injure their smoking parents and grandparents who are desperate to stop.

In summary, the age distribution of lung injury cases is considerably different than that of vapers, with injuries weighted toward the younger cohort.  This supports the emerging evidence that the outbreak is not related to commercial e-cigarettes and vape products, but rather to black market offerings.  Importantly, the misdirected campaign against the former threatens to disrupt availability to adult vapers, who desperately need them.