Shocking FDA TPSAC Meeting on PMI General Snus modified risk application

I spoke at the FDA Tobacco Products Scientific Advisory Committee meeting held yesterday (June 26, 2024) to consider Philip Morris International’s (PMI) Modified Risk Tobacco Product (MRTP) application to renew authorization to make modified (read “reduced”) risk claims about its Swedish Match General Snus.  I expected the meeting to end with TPSAC voting on a recommendation that FDA approve or deny PMI’s application.

The law requires that TPSAC “shall report its recommendation on the application” to FDA, but there was no vote on whether FDA should renew that “modified risk” authorization.

Instead, the FDA seemed to be doing its best to manage the committee to make sure it had a nice scientific discussion, but didn’t make any clear recommendations that could create political difficulties for the Center for Tobacco Products.  The FDA ended its presentation with two “questions” for TPSAC to answer,  but, rather than posing the obvious question “Does TPSAC recommend that the FDA accept the PMI application to continue making modified risk claims for its General Snus?” FDA only asked the committee to “discuss” some issues.

Campaign for Tobacco Free Kids VP for Legal and Regulatory Affairs Dennis Henigan stressed the need for a vote in his public comment at the meeting (reproduced in full below).  Given Henigan’s public comment that was made before the committee discussion, I was surprised that none of the members asked why they weren’t voting.

What question should FDA have asked TPSAC to vote on?

Family Smoking Prevention and Tobacco Control Act, section 911(g)(1) requires that to be granted a renewal of its MRTP order permitting Swedish Match to market its products with its modified risk claim, the company must demonstrate that the product, as actually used by consumers, will continue to both:

1. Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
2. Benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.

Therefore, FDA should have asked TPSAC to vote “yes” or “no” to the following question:

Did PMI provide convincing scientific evidence that, as actually used, allowing Swedish Match General Snus to continue making the modified risk 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”:

1. Significantly had and would likely continue to reduce harm and the risk of tobacco-related disease to individual tobacco users; and

2. Had and would likely continue to benefit the health of the population as a whole, taking into account both users of tobacco products (including cigarettes and other combustible tobacco products, and e-cigarettes and other non-combustible tobacco products) and persons who do not currently use tobacco products (including youth, former users, and other non-users).

Based on the discussion among TPSAC members – many of whom were very critical of the scientific quality of the application – my guess is that at least 5, and likely more, of the 9 voting members would have voted “no.”

Even without a vote, the FDA can and should use the critical comments by TPSAC members to reject PMI’s application.  

While Philip Morris International would be able to use the discussion at the meeting to work to improve its application, it is not FDA’s job to give them specific assistance in doing so.  In addition, as I said in my testimony at the meeting, FDA should not use its “enforcement discretion” to allow PMI to continue making modified risk claims about General Snus while PMI works to remedy the serious problems with its application.

FDA Center for Tobacco Products Director Brian King already questioned TPSAC not voting

In 2019, Brian King was an ex officio member of TPSAC while working at the Centers for Disease Control and Prevention.   At the February 6-7, 2019 meeting where FDA presented an amendment to the Swedish Match MRTP application, King asked why there wasn’t any type of vote on the Swedish Match amendment (Footnote 12 on page 4 of TFK 2020 letter to FDA ). 

FDA’s Dr. Benjamin Apelberg responded that the Agency “felt what would be most useful was to really just have the qualitative discussion [because] it’s the richness of the discussion that’s really the most useful and informative.”

As someone who has served on committees similar to TPSAC, I can translate this into English:  “We understand that neither the public, the media, or members of Congress are unlikely to penetrate the complicated technical discussion we just had. But FDA can summarize the discussion however it wants.  Most important, we don’t want to have to publicly explain any potentially embarrassing votes that we prefer to ignore.”

FDA CTP Director King has the power to salvage the meeting and CTP’s reputation.    

1. He should use TPSAC’s criticisms recorded in the meeting transcript to justify rejecting the proposed renewal of PMI’s permission to make modified risk claims about Swedish Match snus.
2. Going forward, he should see that TPSAC votes on scientific issues raised in future MRPT requests, including up or down votes on whether or not to recommend that FDA authorize proposed modified risk claims.

Here is Dennis Henigan’s public comment, made in person at the June 26, 2024 meeting:

REMARKS AT TPSAC MEETING ON SWEDISH SNUS

INTRODUCTION

• Dennis Henigan, VP for Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
• Thank FDA and TPSAC for opportunity to speak
• Will address issue relevant not only to Swedish Match renewal application, but to all modified risk applications:  role of TPSAC in FDA’s consideration of modified risk products.

2020 LETTER TO FDA

• In an October, 2020 letter to then-CTP Director Zeller, the Campaign and five other public health organizations expressed view that FDA had relegated TPSAC to a role in modified risk proceedings that is inconsistent with letter and spirit of Family Smoking Prevention and Tobacco Control Act.
  • I believe that conclusion is valid today.

• I start with the text of the statute.  It not only requires FDA to refer every modified risk application to TPSAC, but also provides that not later than 60 days after referral TPSAC “shall report its recommendation on the application” to FDA.

• The final decision to issue or deny a modified risk order rests with FDA, but it seems clear from this language that no modified risk application may be acted on by FDA without TPSAC making recommendations on whether to grant or deny the application and on the scientific issues necessary to make such a determination.

• To date, TPSAC had held five meetings to consider modified risk products; FDA has yet to ask TPSAC to make a recommendation on the disposition of any application.

• It also appears that TPSAC’s role has increasingly been marginalized, as reflected in the number of scientific issues which have been subject to votes by the Committee, as opposed to general discussion.

• In TPSAC’s first modified risk meeting (April, 2015), which concerned General snus products – the same products at issue here – TPSAC took votes on 10 scientific questions.

• In its next two modified risk meetings – to consider the IQOS system and Camel snus products – TPSAC took votes on 9 issues and 8 issues respectively.

• In the last two meetings  (in February 2019 and February 2020), which addressed three different products, TPSAC voted on only one issue. 
• It is apparent that TPSAC’s role has evolved from being asked by FDA to vote on key scientific issues to being simply a discussion forum on those issues.

OTHER ADVISORY COMMITTEES

• This is in stark contrast to the role of other FDA Advisory Committees, which routinely vote on the ultimate regulatory issue of whether a product should be approved.  Earlier this month, an   Advisory Committee voted to recommend approval of an Alzheimer’s drug as safe and effective.

• I realize that the role of FDA advisory committees in general is subject to debate, as revealed in FDA’s recent “listening session” on subject. 

• But the particular role of TPSAC in modified risk proceedings should give due regard to considerations unique to tobacco regulation, including the mandatory nature of TPSAC’s role under the Tobacco Control Act and the history of public health harm from tobacco products marketed with claims of lower risks to health than other tobacco products.

CONCLUSION

• Since taking over as CTP Director, Dr. King has repeatedly and appropriately made clear that FDA decision-making is to be guided by the science.  He said it again in remarks today.
• The best way to make that happen in modified risk proceedings is to ensure that CTP’s independent scientific advisors are given the opportunity to clearly communicate their collective judgments on the science to FDA and to the public at large.  This is not happening.
• Thank you.

A footnote:

We submitted two public comments to TPSAC before the meeting, in addition to speaking during the public comment period:

• FDA should not renew its authorization allowing PMI to claim modified risk for its Swedish Match General Snus
• FDA should consider the significant public health issues, especially for youth, created by PMI co-marketing of its Swedish Match General Snus and ZYN oral nicotine products and not reauthorize modified risk claims for General Snus