Matt Myers in 2003 and Today: A Pertinacious Tobacco Prohibitionist

 

Matthew Myers is a founder of the highly influential Campaign For Tobacco-Free Kids (CTFK), where he has served as president for over 20 years (here).  He claims to have “participated in virtually every major US tobacco-related legislative effort” and to have “led the effort that resulted in 2009 in the US Food and Drug Administration being given authority … over tobacco products.”

Myers and his organization are warriors for tobacco prohibition and staunch opponents of all forms of tobacco harm reduction (THR). 

At a 2003 congressional hearing titled, “Can Tobacco Cure Smoking? A Review of Tobacco Harm Reduction,” witnesses included the U.S. Surgeon General, the chairman of the Federal Trade Commission and Myers.  David Sweanor and I testified in support of THR.

Interestingly, Myers actually endorsed THR in his testimony, with a caveat.  He insisted that Congress

“grant the Food and Drug Administration comprehensive regulatory authority over all tobacco products. If we want to do harm reduction based on science, not rhetoric; if we want to make the truism that knowledge is power, then we will insure that there is a government agency that has regulatory authority over the product so that we will know and consumers will know what is in that product; so that we will know and consumers will know truthfully not just what the manufacturers want us to know but the truth, the full truth about the relative harmful effects of those products.” 

This was not an isolated statement.  In his oral and written testimony, he repeatedly expressed support for FDA-supervised THR.  Here is another excerpt:

“A discussion about harm reduction has to begin with a discussion about providing the FDA with the kind of authority that is necessary to protect consumers, verify claims, and require that all reasonable steps are taken to reduce the harm caused to smokers. Is there a role for smokeless tobacco in a comprehensive effort to reduce the death toll from tobacco overseen by the FDA? No one has the information to make that decision today. The FDA should be open to all strategies that are scientifically based and that will save lives. The decision about what role smokeless tobacco plays in that overall scheme is a decision that can only be made by the FDA after it has all of the relevant information before it.” 

Kentucky Congressman Ed Whitfield posed this question to Myers: “So is it your position that if the U.S. had a similar regulatory system that you would have no objection to products like snus or Revel?”

Myers responded, “If the U.S. had a comprehensive regulatory system, then scientists with full knowledge about the product would be able to make appropriate comparative science claims.”

Fast forward to 2019.  FDA tobacco regulation had been in effect for a decade, operating according to the legislative framework that Myers says he engineered.  This includes an onerous application pathway for manufacturers to convince the agency that their smoke-free products are safer than cigarettes.  Despite the seemingly impossible task of proving a negative, Swedish Match obtained modified risk status from the FDA for its General snus brand, allowing the company to tell smokers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” Myers had testified against the application at an FDA hearing. 

In 2020, the FDA granted Philip Morris International modified risk status for its IQOS heat-not-burn tobacco, allowing the company to tell smokers that “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.”

Myers and other tobacco prohibitionists were apoplectic about the IQOS decision, characterizing it as “a dangerous precedent that puts kids and public health at risk”, “making [kids] guinea pigs in a Philip Morris marketing experiment,” and repeating “an egregious error the FDA has made in the past” [with General Snus].  The groups’ press release concluded that “The FDA should have denied Philip Morris’ application in its entirety.” 

Make no mistake: Myers is a tobacco prohibitionist.  He gave lip service to THR in 2003, feigning support for THR contingent upon FDA regulation, as he expected to make it nearly impossible for manufacturers to convince the FDA that they had safer smoke-free products.  When companies twice succeeded, he reneged on his Congressional testimony and trashed the FDA. 

Sadly for Myers and CTFK, more smoke-free products will be approved by the FDA.  Camel Snus and Copenhagen moist snuff are already in the review pipeline, and it’s just a matter of time before dozens or more e-cigarettes, vapor products and nicotine pouches obtain safer FDA status. 

  

First Study of ZYN, A Novel Consumer Nicotine Product

The American Journal on Addictions has just published (here) an analysis by my colleagues and me of the consumer appeal of a new nicotine product, ZYN.

Swedish Match test-marketed ZYN six years ago in Colorado; distribution expanded to 11 states in the western U.S. in 2016, and nationwide in April 2019.  While ZYN marketing was limited to a website and point-of-sale promotions, press reports (here, here and here) indicated remarkable sales success. 

In 2018, the company commissioned from a private contractor two marketing surveys on ZYN perceptions and use.  Last year a research group consisting of Drs. Karl Fagerström from Sweden and John Hughes from the University of Vermont, as well as Nantaporn Plurphanswat and me from the University of Louisville, was granted full access by Swedish Match to that survey data so that we could produce an independent analysis.  Our group previously published a research article describing how proposed changes in Swedish snus warning labels would affect tobacco users’ perceptions and use of the products (here).  Other than providing us with the data, the company had no role in our analysis or reporting of the results.       

In the current study, we assess adult appeal and interest in buying ZYN, and we describe the characteristics of ZYN users and patterns of ZYN use after purchase.

We found that while nearly 90% of never and former tobacco users did not find ZYN to be appealing, one-third of current smokers, more than half of current smokeless tobacco (ST) users, and two-thirds of dual cigarette-ST users did.  More importantly, only 3% of never, and 2% of former users were interested in buying the product.

In addition, we found that the likelihood of buying ZYN compared with other tobacco products was highest among exclusive ST users.  That cohort may be more inclined to buy ZYN because its manner of use is similar to that of other ST products, i.e., placing the product between the lip and gum; additionally, Swedish Match was offering the product on stores’ ST shelves.

The vast majority of ZYN users were white men, which is consistent with ST use. About 90% used the pouches every day, and most chose the 6 mg nicotine pouch, rather than the 3 mg version.  More than one-third had used ZYN about 3-6 months.

When offered a variety of reasons for using ZYN, participants frequently chose options such as “less harmful…”, “no one can tell when using”, and “to avoid spitting”.  Among current smokers, the top answers were, “less harmful for my health than cigarettes” and “do not cause me to smell like smoke/tobacco.”

There was no information about tobacco cessation due to ZYN, and time since quitting tobacco, so we cannot know if participants used ZYN to quit other products.  We also had no information about how frequently and how many pouches were used.

ZYN’s striking entry was quickly followed by similar products DRYFT (https://getdryft.com) and On! (www.onnicotine.com ).  None of these brands contain tobacco, only pharmaceutical-grade nicotine at different levels: ZYN pouches contain either 3 or 6 mg; On! is available in 2, 4 and 8 mg strengths; and DRYFT pouches have 2 or 7 mg. The highest nicotine dose approved by the FDA for medicinal nicotine gum and lozenges is 4 mg. Higher nicotine doses in the new pouch products may explain their popularity, since medicinal nicotine offerings have proven unsatisfying to consumers who can’t or don’t want to achieve nicotine abstinence.

Our study was the first to assess interest in and actual usage of a new tobacco product, ZYN nicotine pouches.  Non-users of tobacco had little interest, and ST users constituted the majority of ZYN regular users.

 

 

 

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.