Is AI the answer to CTP's problems?
Thinking 'bout THR Newsletter May 5-13, 2025
FDA appoints its first Chief AI Officer.
On April 3, 2025, the US Office of Management and Budget (OMB) issued the memorandum, “Accelerating Federal Use of AI through Innovation, Governance, and Public Trust,” explaining that all agencies must identify a Chief AI Officer. Jeremy Walsh has been appointed as the FDA’s first Chief AI Officer.
The memorandum was issued a few days after several top IT and cybersecurity officials were relieved of their duties as part of the Department of Health and Human Services (HHS) layoff of 10000 employees.
Walsh has been the Chief Technologist at Booz Allen Hamilton for the past 14 years. Booz Allen’s website says it " works with industry leaders to rapidly integrate proven technologies, ensuring the government can act swiftly and decisively. We leverage relationships with everyone from Silicon Valley startups and Fortune 500 companies to the Pentagon and NASA.” The company has initiated several changes to conform to President Trump’s mandates to eliminate programs such as DEI.
Walsh and Sridhar Mantha will roll out a program to use AI across all FDA centers by June 30, 2025. Mantha was the Director of the FDA’s Center for Drug Evaluation and Research (CDER) Office of Strategic Programs (OSP) before his position was eliminated as part of the massive HHS staff cuts. Mantha helped develop AI policy as CDER’s AI council co-chair.
Last week, the FDA announced the completion of the first AI-assisted scientific review pilot, which allowed scientists to spend less time on redundant tasks that slow down the review process.
“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).
“I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said FDA Commissioner Martin Makary.
Much of the news coverage about the FDA’s rollout of the use of AI has focused on CDER. Makary tweeted, “We at the FDA now have to ask big questions that we’ve never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning.”
While Makary’s tweet was about medicinal products, for manufacturers of non-medical nicotine products, the question remains about why it is taking over five years for the FDA’s Center for Tobacco Products (CTP) to process PMTAs that should be ruled on within the statutory limit of 180 days. In 2021, the CTP said it needed more time to process pending applications. Many of those applications are still waiting for a final verdict.
Could AI help speed up the review process for CTP as it did for the CDER pilot? Would a standardized AI system help eliminate human biases that can bog down a PMTA or help summarize applications that involve thousands of pages? With a backlog of applications collecting dust at the FDA’s CTP, there are plenty of opportunities to give the potential of AI a workout if the systems are up and running by the end of June.
Imagine if AI could help expedite granting marketing orders for reduced-risk products to meet consumer demand. In that case, the US might see a decline in the use of unauthorized products, which are eating up a significant share of the nicotine market.
The CTP has had many opportunities to take a more helpful pathway to get products to market, but has failed to take those routes. Let’s hope technology can help regulators do the job when humans are bogged down in a bureaucratic mess and can’t.
Until next time…
P.S.: After a long couple of days consisting of a last-minute scramble to make travel and lodging arrangements and then the longest day I have ever had getting from home to DC, I finally arrived late last night. I’ll be at the FDLI Annual Conference and the E-Cigarette Summit. I look forward to seeing those of you who attend those events, and I am honored to represent those of us with lived experience.
I have no plans all day/evening on Saturday (May 17) and during the day on Sunday (May 18). If anyone is in town and wants to do something, give me a shout. I tend to be a hermit in my room unless I have someone to venture out with. This small-town lady struggles to feel comfortable alone in the big city!
Jeremy Walsh. “I’m happy to share that I’m starting a new position as Head of IT & AI at FDA!”
FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline. “To reflect the urgency of this effort, Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.”
IKE Tech Files First-Ever PMTA for Standalone Interoperable Blockchain-based Age-Gating System at Point of Use… “This marks the first ever complete PMTA submission for a standalone, scalable age-gating component that provides real-time continuous age verification at the point-of-use for electronic nicotine delivery systems (ENDS).”
New active notes (anyone with an X account can vote on these):
Good Morning Britain. “What is happening to our children and their health and their lungs, which means vaping is causing these dangerous reactions?…"
Alabama Public Health. “Vaping is harmful in 3 ways: 1.) To the user, as harmful ingredients are not disclosed. 2.) To others, as vape clouds contain cancerous chemicals, heavy metals, and nicotine, which can be inhaled by nearby people. 3.) Through thirdhand aerosol exposure, as the chemical...”
Irish Thoracic Society - had a tweet alluding to vaping causing popcorn lung. It was deleted after receiving a community note.
Defining the Risk of Oral Tobacco Products. “Exaggeration and distortion of risks related to use of smoke-free nicotine and tobacco is more than a disservice to ballplayers, dippers, and chewers, as it dissuades inveterate smokers from making a life-saving switch.”
For several years, the American Lung Association has been urging smokers to “quit, don’t switch.” “This messaging is based on the premise that an adult who is no longer smoking cigarettes and is instead using a non-combustible nicotine product has not actually quit smoking. From ALA’s perspective, that individual has accomplished nothing.
This is ideology rather than science and it disserves adults who smoke.”
From Arielle Selya: “2 days, 2 new articles calling into the conclusion of a 2024 meta-analysis and systematic review on apparent health effects associated w/ e-cigarette use. Lessons for how to analyze to reduce bias & confounding…”
Harnessing the Power of Administrative Data in State Government. (Not nicotine specific)
Inaccurate and misleading meta-analysis of E-cigarettes and population-based diseases.
Human Factors Validation and Usability Testing of the IKE Age-Gating System.
APPG for Responsible Vaping. “As a former smoker, Baroness Fox of Buckley (Claire Fox) shared a powerful personal testimony in the House of Lords about her successful transition to vaping, made under the guidance of two doctors…” (includes a video clip of her testimony)
Jeffrey Weiss. “Intensifying since the Covid years, there is a crisis of trust in American institutions of public health, including the FDA and CDC…I believe there needs to be a consistency in how we look at all issues of public health – whether they involve our professional interests, excite our passions, or are only tangentially related to our lives. We shouldn’t demand that others uphold basic values of truth and science on their issues, while we violate them on ours…”
Reg Watch: Public Health Insider Speaks Out About the War On Nicotine. Guest: Jeff Willett
ASH webinar on preparing mental health settings for the disposable vapes ban.
Shaping Vaping. Guest: Kevin Schroth
The Pack Breakers - Ep. 16 – Harm Reduction Works, It Just Does with GrimmGreen.
Baltimore sues Zyn manufacturer claiming nicotine pouch targets kids. “The suit, filed by the city in Baltimore Circuit Court on Wednesday, accuses Philip Morris International of violating Baltimore’s Consumer Protection Ordinance through deceptive marketing practices to “peddle” Zyn oral nicotine pouches to minors, according to a Wednesday news release.” (Copy of the complaint here.)
Lawsuits Could Choke Off the Candy‑Flavored Vape Pipeline. “The strategy is already moving. New York City’s suit against Magellan Technology and other wholesalers, filed in 2023, survived a dismissal bid in May 2024 and has spun off two companion cases. In February, the New York state attorney general sued 13 of the nation’s largest vape distributors. California, Illinois and Vermont filed similar complaints this year, accusing firms of distributing unauthorized disposables into markets that ban flavored tobacco altogether.”
FDA Scores Win in Wages, but Industry Eyes Fifth Circuit Remand in Flavored Vape PMTA Denial Challenge. “The Fifth Circuit’s resolution of these issues could have sweeping implications for how FDA must evaluate future PMTAs and respond to procedural challenges under the APA. The remand also presents the vaping industry with a renewed opportunity to advance alternative administrative law claims in a court that has historically viewed FDA’s approach to flavored ENDS products with skepticism.”
James Fraser. “…the Court ruled that the Federal Food, Drug, and Cosmetic Act preempts a new Iowa statute that regulates the sale of electronic cigarettes.”
A statewide nicotine ban? Why stop there? “If we’re going to prohibit harmful things, let’s add alcohol, skiing, and sex, too…”
As Sweden regulates nicotine products, US pulls back. “But now, the U.S. is entering its own uncharted territory. Sweeping changes to the nation’s regulatory landscape could dampen the ability to authorize new products, enforce existing regulations and make progress on smoking cessation.”
New York City’s Campaign Against Vapes Will Cost Lives. “Every one of those groups is Bloomberg-funded. Morse’s department received $100,000 from the Health Cities Initiative in 2024, “to combat the harms of commercial tobacco and nicotine products, like e-cigarettes (vapes).”
Snus-style pouches will be included in ‘smokefree generation’ law, says minister. “Public Health Minister Jenni Minto said she agreed that more needs to be done on such “novel products”.
She said: “That is exactly what this Bill is aiming to do, bring products like heated tobacco and snus as you’ve talked about into the legislation to ensure that we do have better powers to reduce their availability to young people and older people.” (UK)
Iraqi Parliament Votes to Ban Electronic Cigarettes. “In a press release, Shingali emphasized that the committee’s decision aligns with international trends, citing Britain’s decision to ban vapes starting June 1 of this year.
“Even a country like Britain, with its advanced research and studies, has moved toward banning vapes,” he said…Speaking in a televised statement, Kilani said, “The law will categorically prohibit the import, trade, and sale of electronic cigarettes,” adding that it includes strict enforcement mechanisms such as penalties, fines, and confiscation of the products.”
EU neighbours slam Spain’s pouch ban plan. “According to documents seen by El Confidencial, Italy, Sweden, Greece, the Czech Republic, Hungary, and Romania have all issued reasoned opinions on the Spanish proposal. This effectively triggers a standstill period of at least three months, during which the Spanish government must address the concerns raised by these member states.”
The UK’s Impending Disposable Vapes Ban Looks Unenforceable. “That’s a rosier picture than the DEFRA projection of a large-scale return to cigarettes. But the UCL study also found that total vaping prevalence among British adults stayed flat in the year ending January 2025, after rising rapidly before then. Other research has found that smoking cessation has stalled in England since 2020.
A chilling effect from negative messaging on vapes surrounding the disposables ban could be playing a role here.”
GA Awards Grant to Northwell Health to Integrate Tobacco Harm Reduction into Queens Health Care Center. “At Northwell, we believe in meeting people where they are—not where we think they should be. This grant allows us to build on our long-standing commitment to smoking cessation by expanding the tools we offer—especially for those who've tried to quit and felt dismissed or unsupported by the system."
World Vape Day 2025: 20 Years of Facts and Life-Changing Innovation. “World Vape Day 2025, on 30 May, spotlights one of the most significant shifts in public health: the rapid decline in smoking rates wherever harm reduction and vaping are embraced. As countries like Sweden near smoke-free status and New Zealand records historic drops in smoking, this year’s theme—“20 Years of Facts”—highlights the science and lived experiences behind vaping’s impact.”
More news:
Nicotine in their notebooks: The rise of teen vaping in Bengaluru. “In Bengaluru, the vape market for school students doesn’t operate in the open. It doesn’t have to. Students aged 16 and 17 have built an access system that’s decentralised, informal, and disturbingly efficient – one that runs through Telegram menus, backroom shop counters, and entire networks of teenagers who know how to ask, whom to ask, and exactly what they’re paying for.”
From LinkedIn: Rise Recovery. “Recent reports reveal a troubling trend: out of 3,565 vaping incidents in San Antonio-area schools last year, approximately two-thirds involved THC—the psychoactive component of marijuana. This means thousands of students faced felony charges, highlighting the severity of the issue. (San Antonio Express-News)…”
How a fix for smoking sparked a new crisis. “…Given all of this, the question remains: Is vaping a net improvement overall? Or have we, in trying to solve one public health crisis, inadvertently created a new one?”
Final thoughts…
Empathy, compassion, and kindness.
Notes:
I create these newsletters as a personal project. They are not affiliated with any current or past employers or groups with which I volunteer. I receive no financial compensation for my efforts to create these newsletters.
My blog, Skip's Corner, has an X/Twitter account. My personal accounts are on BlueSky, LinkedIn, and X (Twitter).