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- House Committee on Oversight and Accountability hearing and TPMF Q and A - April 15, 2024
House Committee on Oversight and Accountability hearing and TPMF Q and A - April 15, 2024
Issue #7
Jon Dice
April 15, 2024
Happy Tax Day everyone!
Recent actions by FDA Center for Tobacco Products (CTP) indicate an increased focus on retailer enforcement actions for oral nicotine pouches. Also, recent trade press seems to be devoting more resources to investigating products like ZYN, a nicotine pouch product. Two class-action lawsuits have been filed against Philip Morris International, Inc., in District Courts in California regarding their ZYN product. The lawsuits, in the Eastern District as well as the Southern District both cite deceptive advertising and appeal to kids in their respective complaints.
The House Committee on Oversight and Accountability held a hearing titled “Oversight of the U.S. Food and Drug Administration”on April 11, 2024. Lawmakers asked FDA Commissioner Robert Califf about a pattern of issues within the FDA to ensure the FDA is completing its role of regulatory oversight of the food and drug industries, prioritizing safety and effectiveness, and incentivizing innovation.
Representative Virginia Fox (R-N.C.) asked several pointed questions of Dr. Califf regarding the ineffective processes at FDA CTP:
Rep. Foxx: “Stakeholder groups with pending pre-market tobacco product applications, or PMTAs, have been waiting for several years to a decision which far exceeds the 180-day review period written into law. […] Why has the CTP failed to comply with statutory review period despite the fact that the CTP’s staff has more than doubled in the last decade?”
Commissioner Califf: “Twenty-six plus million applications. We’re now 99 percent done and soon we will be within that timeframe.”
Rep. Foxx: “But you know among those applications are very frivolous applications. And there’s like a couple of dozen in there that are coming from legitimate places. You all should have focused your attention on those. It’s hard to believe that an agency that’s doubled its staff over a decade to over twelve hundred, receives over 700 million dollars per year in funding, is still not meeting the deadline for these PMTAs, the serious ones again. What performance metrics does the CTP have to ensure they’re being good stewards of the tobacco user fees?”
Commissioner Califf: “The numbers of applications, the time it takes to review them, the outcomes of the reviews are discussed by numerous watchdog groups that are looking at everything that we do.”
Rep. Foxx: What does the FDA doing to rectify this problem of illicit products in the market?”
Rep. Foxx: “I’d say we’re all in favor of reducing harm from tobacco. […] We have an increasing number of warning letters, civil money penalties, and injunctions now and seizures now at places of import. It is a very large number of products. There’s no question about it.”
Wall Street Journal published a video titled The Rise of Zyn: The Oral Nicotine Pouch Going Viral, a Wall Street Journal-produced video on the rise of ZYN nicotine pouches. There is brief discussion of the history of Swedish Match, the manufacturers of ZYN, and the “Swedish experience” in which the introduction of snus tobacco products in the 1970s subsequently resulted in a current smoking rate of 5% and a reduction in smoking-related cancers since the 1970s in Sweden. A scientist discusses how ZYN pouches are evaluated with mass spectrometry techniques. Ray Niaura, professor of public health at NYU, was interviewed about the public health implications of switching to Zyn from cigarettes. Self-appointed Zynfluencers like Tucker Carlson have been instructed by Philip Morris International, the parent company of Swedish Match, to cease their social media promotion to audiences under 21.
PMTA
As a part of an ongoing effort to describe specific elements of the application process to CTP and introduce strategic considerations for application development, here is a quick overview of the tobacco product master file (TPMF) process.
TPMF Common Questions and Answers
What is a tobacco product master file (TPMF)?
A TPMF is a confidential submission to the FDA that contains detailed information about a tobacco product, its manufacturing process, and other relevant data. It allows the TPMF owner to authorize other parties to rely on the information in the TPMF without disclosing it to them.
Who can create a TPMF?
Any person or entity involved in the manufacturing, distribution, or marketing of a tobacco product can create a TPMF.
What information should be included in a TPMF?
A TPMF should include comprehensive information about the tobacco product, such as its composition, manufacturing process, quality control procedures, and any relevant scientific studies or data.
How can others use a TPMF?
Once authorized by the TPMF owner, other parties can reference the information in the TPMF to support their own submissions to the FDA without having direct access to the confidential information contained in the TPMF.
Are TPMFs mandatory for all tobacco products?
No, TPMFs are not mandatory for all tobacco products. However, they can be a useful tool for streamlining the regulatory process and protecting confidential information.
How do I establish a TPMF?
To establish a TPMF, you should follow the guidelines provided by the FDA, which include preparing a comprehensive submission that meets the requirements outlined in the guidance document.
Can I update or modify a TPMF?
Yes, TPMFs can be updated or modified as needed. It is important to keep the information in the TPMF accurate and up to date.
How long does it take for the FDA to review a TPMF?
The FDA does not provide a specific timeline for reviewing TPMFs. The review process can vary depending on the complexity of the submission and the workload of the FDA.
Are TPMFs subject to FDA inspections?
Yes, TPMFs are subject to FDA inspections. The FDA may conduct inspections to verify the accuracy and completeness of the information provided in the TPMF.
Can I withdraw a TPMF?
Yes, you can withdraw a TPMF submission if needed. However, it is important to consult with the FDA and follow their guidelines for the withdrawal process.
Policy and Enforcement
On April 4, FDA announced the issuance of 119 warning letters to, and the filing of 41 civil money penalty complaints against, brick and mortar retailers that engaged in the underage sale of various flavors of ZYN nicotine pouches between October 2023 and February 2024. FDA has also issued warning letters to three online retailers for the sale of unauthorized, flavored ZYN nicotine pouches, including Espressino, Black Cherry, Lemon Spritz, and Cucumber Lime. This marks a departure from recent enforcement actions solely focused on ENDS products.
Opinion
 | The FDA and those groups calling for a ban on menthol cigarettes claim that this will benefit public health, but it's not clear the relevant medical research supports this claim, as it is not clear that such a ban will do much to reduce smoking rates or smoking initiation. This is particularly true as some relevant research assumes that users of menthol cigarettes would be able to switch to menthol (or other) flavored e-cigarettes. This is a problem as the FDA has refused to approve any non-tobacco-flavored e-cigarettes to date. Jonathan H. Adler |
Durbin Calls FDA and DOJ Officials To Receive Briefing Of Lack Of Enforcement Of E-Cigarettes (April 12, 2024)
U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, called in Food and Drug Administration (FDA) Center for Tobacco Products Director, Dr. Brian King, and U.S. Department of Justice (DOJ) Principal Deputy Assistant Attorney General, Brian Boynton, to his Washington office yesterday to brief him on the lack of enforcement against unauthorized e-cigarettes that are addicting millions of children across America.
Recent Publications of Interest
The Federal Trade Commission today issued its third report on e-cigarette sales and advertising nationwide, which shows that the combined sales of cartridge-based and disposable e-cigarette products to U.S. consumers by nine leading manufacturers increased by approximately $370 million between 2020 and 2021, while the total topped $2.67 billion. E-cigarette companies also spent $90.6 million more advertising and promoting their products in 2021 than in 2020.
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FDA escalates enforcement against vapes WORLD REPORT| VOLUME 403, ISSUE 10435, P1434, APRIL 13, 2024. DOI: https://doi.org/10.1016/S0140-6736(24)00742-6
Brian King, Director of the FDA’s Centre for Tobacco Products, said in an interview with The Lancet on March 20 that the FDA has “escalated our enforcement efforts”. Speaking in between talks at the Society for Research on Nicotine’s annual conference in Scotland, King emphasised that “we’ve set the foundation and now we’re prepared to escalate further”.
Clinical Trials
The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. |
Arms | Sponsors and Collaborators | Estimated Study Completion Date |
|---|---|---|
-Experimental: E-cigarettes -Experimental: Nicotine Pouches | Yale University National Institute on Drug Abuse (NIDA) | January 2029 |