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. 

  

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. 

TPSAC: Copenhagen Has Lower Lung Cancer Risk

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) met on February 6 and 7  to consider smokeless manufacturers’ advertising and marketing claims that their products are safer than cigarettes (making them modified risk tobacco products, or MRTPs).

Altria, whose U.S. Smokeless Tobacco Company subsidiary sought MRTP status for its Copenhagen snuff product, was the clear winner, as the committee approved the statement, “Switching completely to this product from cigarettes reduces risk of lung cancer.” (here)

Clearly, Altria seeks to underscore the message that their form of smokeless tobacco, which is placed in the mouth and not inhaled, eliminates the risk for lung cancer that is high with cigarette use.  This obvious but important distinction was endorsed 8-0 by the TPSAC panel, with one abstention.

Swedish Match, the other company pursuing an MRTP application (that is now almost five years old), was not as fortunate.  The panel rejected their claim 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.” 

As I commented two months ago, “The term ‘lower risk’ is an understatement, as the risk is almost zero” (here), but the diseases weren’t the problem.  Some TPSAC members thought that approval would send the message to kids that snus was “safe.”  Brian King, a deputy director at the CDC Office on Smoking and Health, expressed concern about future unknowns: “…just because [snus usage] is low now we have to completely dismiss what the relevance could be in the future.” he said. “My response to that is one word: Juul.” (here)

King also said that Swedish Match’s “continued absence of any youth data is preposterous to me.”  He seemed to be faulting the company for not surveying teens about snus products, even though, as the company pointed out, such research could run afoul of a ban on teen marketing. 

Panel member Ken Warner supported the Swedish Match application.  “I think the health (benefits) are really clear compared to smoking -- more so than for any other smokeless tobacco product.  My sense is that if this is not approved, it might be the death knell for the [MRTP] process because we would be basically saying you can't get anything through this process.”