Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents
By James M. Solyst
The October 22, 2019 Food and Drug Administration (FDA) decision to authorize the marketing of the Swedish Match USA line of General snus products as Modified Risk Tobacco Products (MRTPs) was a much-needed statement of support for tobacco harm reduction amidst a climate of controversy. The decision demonstrated that the MRTP process works, provided the applicant has extensive evidence on an established product and is willing to stay the regulatory course.
Although inspiring to many stakeholders, the decision did not receive the level of attention due a truly historic statement. The lackluster response was caused in part by the inevitability of the decision: the widespread notion that if Swedish Match snus did not receive an MRTP certification, then no company or product would. For many, the question was not if, but when, a General Snus MRTP would be announced, particularly after the products received Premarket Tobacco Applications (PMTA) approval in November of 2015. The sense of inevitability was strengthened by the encouraging discussion during the February 2019 Tobacco Product Scientific Advisory Committee (TPSAC) meeting and the positive tone of the FDA-prepared TPSAC Briefing Document.
Given the predictability of the decision, it is understandable that many stakeholders glossed over the core FDA decision document—the Technical Project Lead (TPL) report—or just read the executive summary and quickly concluded that the main take away was after five years of rigorous review and interaction with the applicant, FDA was able to make the long-awaited decision. But the story told in the TPL and related documents is much more than that, and this article will examine a few of the key highlights and insights from the TPL and a resultant communication article.
MRTP DECISION AND COMMUNICATION DOCUMENTS
The General Snus MRTP decision was communicated by FDA in a few different written formats, ranging from the comprehensive and detailed TPL to a much more public-friendly question and answer presentation of the information.
The TPL issued in 2019 is the latest of three such reports that convey General Snus-related decisions. The first TPL was for the November 2015 PMTA authorization for the General Snus products, followed by a December 2016 partial MRTP decision rejecting the proposed claim requesting removal of existing warning labels and adding a “substantially less risky” warning. FDA specifically denied the request to remove the tooth loss and gum disease label and strongly suggested that the other warning label requests would be denied. In September 2018, Swedish Match submitted an MRTP Amendment that addressed the deficiencies cited in the 2016 partial decision. This Amendment is the basis for the 2019 TPL.
A Technical Project Lead report is the format used by the Center for Tobacco Products (CTP) to document regulatory decisions. As the name indicates, it is a technical report that presents the Center’s justification for approving or denying an application. The term “Lead” refers to the fact that the document is signed by the lead official involved in the analysis who considers the scientific opinions expressed by the leaders of the various scientific disciplines such as chemistry, epidemiology, addiction, etc. The TPL is the one essential document for knowledgeable stakeholders who are seeking to understand the justification for a regulatory decision.
In contrast to the TPL is a companion piece prepared by the CTP communications team titled “FDA Authorizes Modified Risk Tobacco Products,” which supplements the TPL General Snus document but is clearly intended for a lay audience and presents information and messages in a more digestible manner. Although it is a reader friendly document, it does provide valuable insight into the CTP risk communication messages.
2019 Technical Project Lead Report
The 2019 TPL documenting the MRTP certification of General Snus products is a dry and cautious document, as would be expected from a formal report with the term “Technical” in its title. However, it is very necessary and useful as it provides comprehensive documentation of the General Snus MRTP process, starting with the initial application in June 2014. Of course, the history of the General Snus MRTP experience may not be of great interest to even the most ardent stakeholder, but the point of this article is to demonstrate that a document as dry as the TPL can contain information and messages that provide insight into the regulatory science process.
The bulk of the 2019 TPL is presentation of background information and a summary of the new scientific evidence. The Background section is essentially a chronology of the General Snus MRTP experience, as documented in previous TPLs, and reinforces a fundamental reality of the MRTP process: that it is a long journey in which the applicant must always initiate the process, starting with the first application, followed by amendments (as was the case for General Snus), and continuing with the postmarket surveillance plan.
At all steps along the way, the applicant submits evidence and methodologies and FDA responds by citing deficiencies and offering suggestions. This may appear to be a somewhat controlling approach by FDA, but another way to look at it is FDA is providing increasingly specific, and thus useful, guidance as the process evolves. Thus, a principal insight from the background section is that FDA can provide guidance and encouragement to an applicant, even if it rejects (or partially rejects) the applicant’s initial marketing claim.
That was the case with the December 2016 TPL that rejected part of the Swedish Match marketing claim and cast doubt on the entire claim but did suggest a path forward. A key sentence that was originally presented in the 2016 TPL and included in the 2019 TPL is the following:
For example, you may consider pursuing explicit claims that appear outside of the health warning, elsewhere on the label or in advertising, providing information to consumers concerning the differences in mouth cancer risks between the eight General snus products and other tobacco products.
Swedish Match interpreted this suggestion to mean that FDA believed the submitted evidence was better suited to a disease-specific health claim rather than a broader claim such as “substantially lower risk.”
Summary of Scientific Evidence Section
The Summary of Scientific Evidence section of the 2019 TPL provides an overview of evidence analyzed in the previous TPLs and assesses new evidence, particularly the Perceptions and Behavior Intentions (PBI) study conducted by Swedish Match. The FDA assessment of the PBI and how it applies to the proposed health marketing claim provides significant insight into what FDA is looking for in an MRTP consumer perception study. This section of the TPL (pages 29–42) could be the basis of a separate Update magazine article analyzing how FDA assessed an applicant-developed consumer perception program.
The scientific evidence section also provides a description, and more importantly a characterization, of the February 6, 2019 TPSAC meeting. The characterization is significant because there was no vote taken during the meeting; rather, FDA was seeking a “thoughtful engagement and discussion.” How FDA viewed the discussion is summed up in the following sentence: “In general, TPSAC felt that the applicant’s study was reasonable and its proposed modified risk claim seems to convey an accurate message.”
The TPSAC meeting is also cited in a sub-section on the importance of the epidemiological literature based on Swedish and Norwegian studies and the connection to the Swedish Match internal quality program GOTHIATEK®. The FDA message appears to be that the Swedish/Norwegian experience is applicable to products with low levels of tobacco-specific nitrosamines, benzopyrene, and other HPHCs (Harmful and Potentially Harmful Constituents)—levels required pursuant to GOTHIATEK®. The TPL states that during the TPSAC meeting, “the applicant described the GOTHIATEK® standard as one that has changed over time with the inclusion of new HPHCs and the reduction of maximum allowable levels of HPHCs.”
The TPA states that the Swedish/Norwegian evidence is “particularly relevant to the assessment of the long-term health risks of the General snus products” and seems to imply that the evidence is applicable to other pouched products that comply with or are guided by the GOTHIATEK® standard.
Appendix-The Public Health Rationale for Recommended Restrictions on Modified Risk Tobacco Product Labeling, Advertising, Marketing, and Promotion
The Appendix is essentially a stand-alone report, more of a review memorandum than a commentary on the General Snus MRTP. It appears that FDA used the MRTP decision opportunity to address the controversial issue of youth usage of alternative tobacco products.
The core message of the Appendix is that no product will receive an MRTP unless there are assurances that the applicant will not engage in practices that contribute to youth usage. Equally important, FDA will require those companies that have received an MRTP order to submit planned labeling, advertising, marketing, and promotional materials and plans, and for FDA to place restrictions on the marketing of such products. Put another way, the MRTP order is just the beginning of another phase to the MRTP process.
FDA Authorizes Modified Risk Tobacco Products
One of the important considerations in the MRTP process is the extent to which FDA communicates the decision to a lay audience, particularly adult nicotine consumers. The challenge FDA faced was how to communicate that switching completely from smoking cigarettes to General Snus lowers the risk of certain health effects, yet also ensure that non-users are not enticed to start using nicotine products, including lower risk products.
The CTP communications staff used the TPL as the basis for developing the communication piece titled “FDA Authorizes Modified Risk Tobacco Products,” which follows a Q & A format and provides practical information about the products and touches on the continuum of risk. The article includes several cautionary notes, such as that the products are not safe or “FDA approved”, but there is also some breakthrough, albeit carefully crafted, statements characterizing the General Snus products as low risk.
The first section, What is a modified risk tobacco product?, briefly describes MRTP statutory provisions, focusing on the concept of benefiting the public health. The most intriguing language is in the third paragraph, which starts with the sentence: “FDA recognizes that tobacco products exist on a continuum of risk, with combustible cigarettes being the deadliest.” What is not stated but seemingly implied, is that an MRTP product should be placed lower on the continuum of risk.
The second section, What is snus?, is simply a short paragraph followed by a photo of a can of snus. But it is significant, because it provides practical advice: “[I]t is placed in the mouth, typically between the lip and gums, but users do need to spit,” and the photo gives the products an identity that is not included in the TPL.
The article includes a section on youth (Is FDA concerned that youth might start using snus because these products are advertised as lower risk?), which states that evidence provided by the applicant demonstrates the products will not increase youth usage: “The modified risk claim did not make them more likely to buy the products.” Seemingly to provide some reassurance, the article states that Swedish Match “is required to restrict youth access and exposure to the marketing of General Snus.”
The General Snus MRTP decision is a historic event, which is fully documented in the 2019 TPL and communicated to a lay audience in the “FDA Authorizes Modified Risk Tobacco Products” article. Neither are adventurous documents; the TPL by design is a dry chronology that includes an analysis of some new evidence, and “FDA Authorizes” is very cautious in its presentation of basic information. However, both contain useful insights.
For the knowledgeable stakeholder, the TPL provides useful insights into the MRTP process, assesses consumer perception evidence, and offers some clues regarding the applicability of epidemiological evidence. In addition, it includes an appendix that is necessary reading for anyone interested in FDA’s evolving position on youth usage.
For the general public and particularly for cigarette smokers, “FDA Authorizes” provides much needed information and characterization of lower risk products. It provides mixed messages—for every pro harm reduction statement, there is seemingly a cautionary message—but it is a step in the right direction.
 Premarket Tobacco Application (PMTA): Technical Project Lead (TPL) Review, Center for Tobacco Products, U.S. Food and Drug Administration (2015), https://www.fda.gov/media/94582/download.
 2019 TPSAC Meeting Materials and Information, U.S. Food and Drug Administration, https://www.fda.gov/advisory-committees/tobacco-products-scientific-advisory-committee/2019-tpsac-meeting-materials-and-information.
 FDA Briefing Document, February 6, 2019 Meeting of the Tobacco Products Scientific Advisory Committee (TPSAC), Center for Tobacco Products, U.S. Food and Drug Administration, https://www.fda.gov/media/122005/download.
 Scientific Review of Modified Risk Tobacco Product Application (MRTPA) Under Section 911 (d) of the FD&C Act – Technical Project Lead, U.S. Food and Drug Administration (2019), https://www.fda.gov/media/131923/download [hereinafter 2019 TPL].
 FDA Authorizes Modified Risk Tobacco Products, U.S. Food and Drug Administration, https://www.fda.gov/tobacco-products/advertising-and-promotion/fda-authorizes-modified-risk-tobacco-products.
 2019 TPL, supra note 4, at 15.
 Id. at 20.
 Transcript of Tobacco Products Scientific Advisory Committee Meeting, February 6, 2019, Center for Tobacco Products, U.S. Food and Drug Administration, https://www.fda.gov/media/122002/download.
 2019 TPL, supra note 4, at 19.
 Id. at 20.
 FDA Authorizes Modified Risk Tobacco Products, supra note 5.