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. 

American Cancer Society Sees Zero Cancer Risk for Smokeless Tobacco

A June 11^th American Cancer Society policy paper (here) states that the Society will “focus on the primary goal of ending deadly combustible tobacco use… Given this imperative, ACS will provide smokers and the public with clear and accurate information available on the absolute and relative health impact of combustible tobacco products, nicotine-based medications, [electronic nicotine delivery systems] and other novel tobacco products…ACS will increase its efforts to guide smokers toward evidence-based cessation options that enable them to quit as quickly as possible and eliminate their exposure to combustible tobacco smoke.”

ACS researchers have estimated the number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States (available here).  They identified 17 risk factors causing 660,000 cases of cancer.  Cigarette smoking was the primary cause (responsible for nearly 300,000 cases), while herpes virus type 8 produced the fewest cases (1,040). 

Smokeless tobacco was not among the 17 risk factors – a tacit acknowledgment that the risk of cancer from smokeless tobacco is de minimis.  Taking this position, ACS seems to be abandoning its 30-year crusade against tobacco harm reduction.

Over the years, I have noted in this blog how ACS failed to provide smokers and the public with clear and accurate information about smokeless tobacco.  Rather, it exaggerated risks (here, here and here); withheld risk information (here, here, here and here ); and criticized the British Royal College of Physicians’ harm reduction report (here). 

ACS describes its new stance on eliminating combustible tobacco use as a “bold new framework for action.”  The policy paper indicates a shift to cautious support of e-cigarettes, conceding that “although the long-term effects of [e-cigarettes] are not known, current-generation [e-cigarettes] are markedly less harmful than combustible tobacco products.”

In fact, the long-term effects of smokeless tobacco use are known to be next to nil.  I hope ACS follows with bold new action explicitly acknowledging that dip and chew products are vastly safer than cigarettes. 

Premarket Study Positive for Proposed Snus Warning Label Changes

The FDA is considering a request from Swedish Match to modify federally-mandated warnings on the company’s snus packages.  The company wants to remove the current mouth cancer and gum disease/tooth loss warnings; replace the not-safe-alternative warning with the more accurate “this product presents lower [or substantially lower] risks to health than cigarettes”; and retain the current addiction warning.

In support of its application, Swedish Match funded a premarket online survey to measure perceptions of current and proposed labels among 13,200 U.S. participants.  The company’s advisory board asked me and Nantaporn Plurphanswat, my University of Louisville colleague, to analyze the survey, together with University of Vermont psychiatrist John Hughes and Swedish tobacco/nicotine researcher Karl Fagerström.  Our results appear in Nicotine and Tobacco Research (abstract here).

We classified participants according to their tobacco use: smokers, former smokers, ST users, other [combustible] tobacco users and never users.  Participants viewed only one of the current or proposed warnings, after which they were asked if the warning was believable, if snus was harmful, and if they were likely to use snus or motivated to buy snus.  

Most participants, regardless of tobacco use status, found all the current ST warnings believable.  In contrast, they were not as likely to believe the more accurate proposed labels.  The vast majority of respondents also perceived that using snus is harmful.  The perceived odds of harm were mostly lower with the proposed labels, but these differences were not always statistically significant.

These results are not surprising. American health authorities have ignored the substantial body of evidence documenting that ST use is less harmful than smoking and have promoted the message that ST is not a safe alternative to cigarettes (Enter “misinformation” in the search box on this blog for numerous examples).  As a result, most of the population equates the risks of ST use with those of smoking.   

Compared with the current not-safe-alternative warning, smokers viewing the proposed labels were significantly more likely to use or buy snus; the same was true for ST users and other tobacco users viewing the substantially lower risk label. This indicates that the proposed labels could foster a transition from cigarettes and other combustible products to snus, a result that would represent a significant health advantage for individual smokers and public health generally.

Among former tobacco users, no increases in likelihood to use or motivation to buy were seen with the proposed labels. In never users, an increase in motivation to buy snus was noted for the substantially lower risk label; neither proposed label had higher odds for likelihood to use snus.

In summary, our analysis of this pre-marketing survey suggests that tobacco users viewing the proposed relative-risk labels are more likely to perceive snus as less harmful than cigarettes and may be more likely to use and buy snus.