FDA broke the law when it did not allow TPSAC to vote on whether to allow PMI to make modified risk claims for ZYN

The FDA held a meeting of its Tobacco Products Scientific Advisory Committee (TPSAC) on January 22, 2026 to discuss Swedish Match’s application to make the modified risk tobacco product (MRTP) claim for its ZYN flavored nicotine pouches “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” (Swedish Match is now owned by Philip Morris International [PMI].)

This meeting did not come anywhere near what the law requires: Family Smoking Prevention and Tobacco Control Act Section 911(f) specifically requires FDA to refer any modified risk tobacco product (MRTP) application to the Tobacco Products Scientific Advisory Committee (TPSAC) and requires TPSAC to report its recommendations on the MRTP application to FDA.

Because FDA did not allow TPSAC to vote on whether or not to recommend that FDA grant Swedish Match/PMI’s application to make reduced risk claims, FDA cannot move forward in authorizing Swedish Match/PMI’s proposed modified risk claim.  FDA must hold another TPSAC meeting where the primary agenda item is to vote on whether or not to recommend that FDA authorize PMI’s proposed modified risk claim.

The Family Smoking Prevention and Tobacco Control Act gave the FDA power to regulate tobacco products.  In particular, Section 917 created the Tobacco Products Scientific Advisory Committee (TPSAC) to

• “Evaluate the potential public health effects of tobacco products, including the effectiveness of restrictions on advertising and promotion.”
• “Provide recommendations to the Secretary regarding the regulation of tobacco products.”

In addition, Section 911(f) requires FDA to refer any modified risk tobacco product (MRTP) application to TPSAC and states that TPSAC “shall [i.e., is required to] report its recommendations on the application to the Secretary [of HHS; in practice FDA].

This mandate is different from most FDA advisory committees, where FDA has broad discretion on what to ask advisory committees.  In the case of TPSAC, Congress explicitly requires it make and reports its specific recommendation on the MRTP application.

In addition, the law requires that, “The Committee shall submit reports to the Secretary concerning its findings and recommendations.”

The only way for TPSAC as a body to make a recommendation is to vote on it. 

In addition, the law governing FDA advisory committees (Code of Federal Regulations §14.22d) is explicit: “Any matter before the advisory committee is to be decided by a majority vote of the voting members present at the time.”

In addition, the “matter” before the committee was whether or not to authorize Swedish Match/PMI to market its ZYN nicotine pouches with a specific modified risk claim.  That is what requires a vote. 

While FDA can also request recommendations regarding specific issues, it cannot legally use this process to avoid a vote on the overall question of whether FDA should say “yes” or “no” to authorizing the proposed MRTP claim.

Instead of releasing an agenda for the committee to develop and vote on its recommendation on whether or not FDA should approve PMI’S MRTP application, FDA presented an agenda in which TPSAC was asked to “discuss” four questions without making any recommendations.  “Discussing” items or asking members to sum up their personal recommendations (as FDA did at the TPSAC meeting) is not the same as the committee acting as a body to vote on a recommendation.

The failure to take a vote was not the only problem with the meeting

FDA illegally appointed two nonvoting “temporary members”

Tobacco Act Section 917(b) specifies that “the Secretary [of HHS] shall establish a 12-member advisory committee, to be known as the Tobacco Products Scientific Advisory Committee (TPSAC) that

shall be composed of

                [voting members]

1. 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;  
2. 1 individual who is an officer or employee of a State or local government or of the Federal Government;  
3. 1 individual as a representative of the general public;  

[nonvoting members]

4. 1 individual as a representative of the interests of the tobacco manufacturing industry;  
5. 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee; and
6.  1 individual as a representative of the interests of the tobacco growers.

The law specifies that the nonvoting members “shall serve as consultants,” but, according to CFR §14.86(c)(5)  “may not make any presentation to that advisory committee during a hearing conducted by that committee.”

There is no provision for FDA to appoint additional members of TPSAC, even as nonvoting members.  (The committee membership as of October 2025 is here.) 

Despite lacking legal authority to do so, FDA added two “temporary [nonvoting] members” (Neal Benowitz and Olivia Wackowski).

Had the committee or FDA wanted input from these individuals, there are various ways that they could legally have been invited to submit reports or make presentations to the committee without joining the committee.  This distinction is important because only members can participate in committee deliberations.

FDA did not explain why they added Benowitz and Wackowski to the committee, but my guess is that they were included because both support the industry’s “harm reduction” agenda, so could serve as insurance that the committee would support the FDA’s positive position on ZYN.  FDA adding them may also have violated the Federal Advisory Committee Act (5 U.S.C. § 1004(b)(2)), which requires that advisory committees such as TPSAC must be “fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee” and should not be “inappropriately influenced by the appointing authority [i.e., the FDA] or by any special interest.”

My guess, based on the discussion at the meeting, is that TPSAC would have voted against FDA authorizing the MRTP.

FDA failed to provide the full record to TPSAC

As we usually do, my UCSF colleagues and I submitted three public comments to FDA on January 7 in advance of the meeting for TPSAC (and FDA’s) consideration:

• One on youth, showing, among other things that youth use was rapidly growing (more than doubling from 2021-2024) and was second only to e-cigarettes
• One showing that the proposed modified risk statement would likely be misinterpreted to mean ZYN has been approved by FDA for cessation and consumers do not understand that they need to switch completely to get the purported benefits
• One showing that PMI did not present data specific to ZYN showing that it actually reduced risk

All this information directly addresses FDA’s “discussion questions.”  More important, they also urged that the proposed MRTP statement be rejected.

For example, our youth comment specifically discredited FDA’s claim that “Based on the information currently available, youth use of nicotine pouches is relatively low.”  The fact that FDA’s briefing memo and presentation to TPSAC included no information about ZYN’s aggressive marketing to kids also belies FDA’s pro-ZYN bias.

Our medical comment also raised the point that FDA was basing its health risk assessment on a different product (Swedish snus) and using its badly outdated 2012 HPHC (“harmful and potentially harmful compounds”) that FDA had proposed updating in 2019 but never finished.  FDA’s proposed updated list included things in nicotine pouches.  FDA’s failure to provide this information to TPSAC is important because FDA’s Discussion Question I specifically invokes the HPHC list to justify the “accuracy” of Swedish Match/PMI’s claim.

Lauren Lempert submitted all three comments by the January 7 deadline so that they could be provided to TPSAC in time for members to read and digest them.

But, during the TPSAC meeting I got an email from a TPSAC member asking why UCSF hadn’t submitted any public comments.

While TPSAC was meeting, Lauren emailed FDA about why they had not provided TPSAC the comments and FDA distributed them to committee members during the meeting.  Needless to say, distributing 35 pages of highly technical public comments citing 154 references at 2:00 p.m. on January 22 shortly before the meeting adjourned did not allow for any meaningful consideration informing TPSAC’s discussion.

Subsequently we verified from additional TPSAC members that FDA had not provided them the UCSF comments.  (We do not know what other, if any, public comments were not forwarded to TPSAC.)

Health groups raised similar concerns with FDA 5 years ago

I am not the first to criticize FDA for ignoring the law requiring that TPSAC vote on whether FDA should approve MRTP applications.  In 2020 Tobacco Free Kids and other health groups wrote then-Center for Tobacco Products Director Mitch Zeller criticizing “FDA’s marginalization of TPSAC’s role [and] FDA’s failure to give due deference to TPSAC’s conclusions regarding Philip Morris’ application for IQOS.”

What TPSAC should do now

TPSAC voting members, ideally TPSAC Chair Cristine Delnevo, should write FDA demanding that the agency reconvene or hold another meeting so TPSAC can complete its Congressionally-mandated work.

After they vote, the decision letter need not be long since all it needs to do is transmit a “yes” or “no” recommendation on the MRTP. The FDA will have the meeting transcript to understand the Committee’s underlying logic.

What FDA should do to remedy its errors

Because of the FDA’s failure to allow TPSAC to vote on a recommendation on whether or not FDA should approve the MRTP application as well as the failure to provide the full record to TPSAC with enough time to consider it before the meeting, FDA should suspend any decision making on the ZYN MRTP application until they have received TPSAC’s explicit recommendation on whether FDA should approve the ZYN MRTP application.

And public health groups should press FDA to reconvene TPSAC so that the process complies with the law.  Indeed, as just noted, TFK has already done the legal research.

PS: I wish I could chalk up FDA’s behavior to pressure from HHS Secretary Robert F Kennedy, Jr, but FDA has consistently supported the tobacco industry’s “harm reduction” agenda since the beginning.  What we are seeing with nicotine pouches today is a repeat of FDA’s mistakes that allowed e-cigarette use to explode.

Lauren Lempert provided legal research detailed in this blog post.