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On February 6-7, 2019, the Tobacco Products Scientific Advisory Committee (TPSAC) met to consider Modified Risk Tobacco Product (MRTP) applications submitted by Swedish Match and U.S. Smokeless Tobacco Co.

Why is this important?

By way of background, federal law prohibits tobacco and vapor companies from making “modified risk” claims (e.g. “vaping is less harmful than smoking”) about their products without such statements being approved by the FDA. Companies can submit MRTP applications in order to request such approval from the FDA. A modified risk order is not a marketing order. For products brought to market after February 15, 2007, a marketing order (i.e., substantial equivalency order or pre-market order) is still required. However, a modified risk order is a potentially valuable tool in that it allows a company to include an FDA-approved claim in its marketing materials related to the products contained in the application.

It is important to note that a modified risk order is not permanent. Companies will be required to conduct post-market surveillance and provide studies and reports to the FDA for a time period specified in the order. Modified risk orders will have to be renewed and can be revoked at any time if the FDA determines that certain conditions are not being met.

It is the worst kind of policy that prohibits a company from truthfully informing the public that its product is far, far less harmful than smoking. Because of this, CASAA monitors MRTP applications and routinely makes comments urging that modified risk orders be issued in connection with low-risk products. To date, FDA has not approved a single MRTP application, which is, at best, a betrayal of public trust.

TPSAC, as the name states, is an advisory committee. While members of the committee vote on questions provided by the FDA, these votes do not affect the status of the application they are discussing. The FDA values the committee’s discussion and thoughts, and takes those into consideration when approving or following up on an MRTP application.

As discussed below, the MRTP process has thus far imposed an impossible barrier to companies seeking to truthfully inform consumers of the relative risks of their products. If FDA refuses to issue MRTP orders for smokeless tobacco products (with decades of data to support their claim of being low risk as compared to smoking), the barrier will be even greater for the relatively new low-risk products such as vaping.

Of particular note are the comments by TPSAC committee member Ken Warner challenging the legitimacy of the MRTP process. “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.”

CASAA’s comments to TPSAC, along with a deeper dive into the MRTP applications, is provided below.

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Swedish Match began the MRTP application process in 2014. The original application sought to eliminate and make changes to certain warning labels on General Snus (and other smokeless tobacco products) that are required by federal law. In 2016, the FDA issued a response which effectively denied Swedish Match’s application. CASAA discusses this decision here.

The application currently pending with FDA is the result of an extensive dialogue between Swedish Match and FDA involving amendments to the original proposal that seek to make the following claim:

• “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

Swedish Match is seeking a modified risk order for eight variants of General Snus: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large, General Mint Portion White Large, General Nordic Mint Portion White Large, General Portion White Large, and General Wintergreen Portion White Large.

On February 6, 2019, CASAA’s CEO, Alex Clark, provided the following spoken comment to TPSAC in support of Swedish Match’s MRTP application:

• My name is Alex Clark. I am the CEO of The Consumer Advocates for Smoke-free Alternatives Association, a 501(c)(4) grassroots advocacy group promoting tobacco harm reduction as a necessary strategy to reducing the early death and disease attributed to smoking. Thank you for the opportunity to speak with you this morning.
• By way of disclosure, CASAA accepts unrestricted donations from various sources including consumer and industry stakeholders. My salary and travel expenses are approved by an all-volunteer board of directors.
• We are here on behalf of our more than 230,000 members to express support for the MRTP application from Swedish Match and urge the TPSAC committee and the FDA to expeditiously approve the proposal to market General Snus as a low-risk alternative to smoking.
• While we are supportive of Swedish Match’s marketing plan involving age-restricted social media promotion, [and print media,] we are concerned that earned media–which relies on a media that is predominantly hostile to innovative, low-risk tobacco and nicotine products–will have limited reach beyond the current population of people who use smokeless tobacco. Ideally, awareness of the low risk associated with using snus and other smokeless tobacco products will reach people who smoke who struggle with traditional cessation strategies.
• We believe that in order for any marketing campaign intended to communicate the relative risks of smoke-free tobacco products to succeed, the FDA and CDC must take immediate action to correct misperceptions about nicotine and smokeless tobacco among consumers and health professionals.
• We are not suggesting that the FDA devote resources to promoting any one specific modified risk tobacco product. Instead, we are urging the agency to do more by way of developing and promoting appropriate balancing statements that counter misperceptions about nicotine and bring consumer perception regarding the risks associated with smokeless tobacco more in line with available evidence.
• We are also taking this opportunity to echo recent statements by Senator Richard Burr of North Carolina regarding the apparent deficiencies of the MRTP and PMTA process.
  • After nine years of having authority over tobacco products, the FDA has yet to give its blessing to new, lower-risk tobacco products or modified risk marketing statements.
  • While it is correct to say that a relationship exists between a lack of MRTP & PMTA applications and a lack of approvals, it is even more clear that the burden and expense of the process is a significant barrier to participation.
  • Maximizing the public health benefit of low-risk tobacco and nicotine products is contingent on consumers choosing to use safer products that they enjoy. Providing clear guidance and streamlining the approvals process is vital to promoting diversity and innovation in the marketplace.
• People who use combustible tobacco products deserve honest communication about the availability of demonstrably lower risk tobacco and nicotine products. But it is clear that recalcitrant ideology and fear continue to be bottlenecks to the process of approving new products or allowing companies to tell the truth about relative risk–all to the detriment of public health.
• [And I would like to take just a moment to draw your attention to our written comments regarding the wording chosen in Swedish Match’s marketing claim “using general snus instead of. . .” We believe this is very deliberate and, much in keeping with meeting people where they are at, is more encouraging people to use the products rather than demanding that they switch completely. We believe that this will have a much more positive outcome.]
• Again, thank you for the opportunity to present our views on this application. CASAA respectfully urges this committee to favorably recommend Swedish Match’s MRTP application for approval.

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Altria Client Services (ALCS) on behalf of U.S. Smokeless Tobacco Company (USSTC) is also submitting a MRTP application in order to make the following marketing claim with regards to Copenhagen Snuff Fine Cut:

• “IF YOU SMOKE, CONSIDER THIS: Switching to this product from cigarettes reduces risk of lung cancer.”

Out of all MRTP applications awaiting approval from FDA, the statement that USSTC is seeking to make in relation to Copenhagen Snuff is the most straightforward, and leaves little room for debate. Indeed, TPSAC voted 8-0 (with one abstention) in agreement with the scientific accuracy of the proposed claim. Despite the obvious accuracy of this statement (and other statements proposed in other MRTP applications), a large percentage of consumers remain misinformed about the relative risks of using smokeless tobacco and other smoke-free nicotine products.

Multiple TPSAC members hold the US Congress, FDA, and CDC responsible for spreading misinformation and myths about smokeless tobacco. In order for any modified risk statement to succeed in encouraging people who smoke to switch to a low-risk tobacco or nicotine product, federal health agencies will need to take action to correct the public’s misperceptions about smokeless tobacco and nicotine.

On February 7, 2019, CASAA’s CEO, Alex Clark, presented the following spoken comment to TPSAC in support of the MRTP application for Copenhagen Snuff Fine Cut:

• Members of the committee, thank you again for the opportunity to speak with you this morning. In the interest of time I will dispense with the formal introduction and skip right to our comment. While I am here on behalf of CASAA to express our support for the MRTP application for Copenhagen snuff, we are commenting today on the portfolio of MRTP applications currently under consideration by the FDA.
• Prevailing misperceptions about the risks of nicotine and smokeless tobacco is a dominant and recurring theme across multiple MRTP applications. All applicants note that these misperceptions are a barrier to honest and accurate risk communication. Moreover, government mandated misinformation about the risks of smokeless tobacco presents a substantial obstacle to achieving our common goal of reducing the early death and disease attributed to smoking.
• At each public comment opportunity before this committee, CASAA recommends that, in addition to approving the MRTP application, FDA and CDC take a more active role in promoting balancing and corrective statements regarding the relative risk of using smokeless tobacco and smoke-free nicotine products. But we are aware that any such action will be done with an abundance of caution and under intense political scrutiny.
• It is also clear that, due to several factors, including widespread mistrust of applicants, a single MRTP approval will do little to correct the public’s misperception of risk.
• As a potential remedy to these obstacles, we offer the following recommendation: Rather than consider each MRTP application in isolation, we urge the FDA to approve all of these applications quickly and simultaneously–sending a clear message to people who smoke that smoke-free alternatives are available and that switching is an acceptable path away from combustible products.
• Thank you for considering our comments.

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• “Q & A: Modified Risk Tobacco Products” (fda.gov)
• “FDA Advisors Undecided on Risk Status of Snus” (medpage today)
• “Altria’s Snuff Safer Than Cigarettes, FDA Panel Agrees” (medpage today)
• “TPSAC: Copenhagen Has Lower Lung Cancer Risk” (Rodu Tobacco Truth)