Tobacco Asia

Tobacco Asia 13 Q&A THE TA every flavor and nicotine combination. I feel for them, but the applications are so devoid of information that it looks like our standard is impossibly high. Some of that is on us to be a better educator. We have a guidance in a very late stage that sets out the most common deficiencies that delayed products later found appropriate for the protection of public health. We're also encouraging companies to come in for pre-submission meetings so they don't waste time. When an applicant gets a marketing granted order, it's a success for them and for us, because we've helped get a product to market that will help people. Q (Beth Oliva): What has changed in how quickly applications are being reviewed? A (Bret Koplow): I've been at CTP for not even a year and a half, and we've changed a lot. We had a large backlog and have cut it by 70%. There are three phases of review: acceptance, filing, and scientific review. Until recently, we were still doing acceptance review on applications received years earlier. Now, in almost all cases, acceptance review takes one to three weeks, and filing review takes about 21 days. Everything still takes longer than we'd like. We don't have nearly enough scientists. Hiring has been really challenging, and we lost a lot of people last year. But I have not just big hopes, I have big expectations for continuing to advance things. Q (Beth Oliva): Illicit trade is real, not an industry talking point. What could industry do to help? A (Bret Koplow): We do hear from companies with autho- rized products, urging us to be more effective against the illicit market. I very much want to see that happen too. It's interest- ing that nobody asks them whether this means they aren't marketing and distributing illicit products in the United States. What they almost always mean is, "You need to do something about our competitors' illicit products, but not ours." That often goes unsaid. Some companies have told me they feel compelled to participate in the illicit market because they're losing market share. It becomes a vicious cycle, where one does it and then they all do. It's very complicated. Q (Audience member): … Will you convene the leaders of the major medical and public health organizations, many of which are hostile to harm reduction even though physicians practice it daily, and become this generation's C. Everett Koop? A (Bret Koplow): … We're actively preparing to reach out to the medical community, including some partnership ideas I can't speak to yet. This should be low-hanging fruit for us. When I started at CTP as acting director, the center hadn't uttered the term "tobacco harm reduction," which was frustrating to me. In my first week, we discussed the need for much more education, campaigns and outreach to healthcare providers, and that's been on our agenda since. Government moves slowly, and it takes a while to get these things off the ground, but we're going to do a lot more. Q (Audience member): How can the PMTA process be stream- lined to meet the 180-day statutory limit? The most recent Juul authoriza- tion took over 1,300 days, and the product had been on the European market since 2021. A (Bret Koplow): Last September we launched a nicotine pouch pilot, whose purpose was to find ways to streamline the premarket tobacco product application (PMTA) process. We chose pouches because they're the lowest-risk category. Twelve scientific disciplines are involved in scientific review, and until then we took a one-size-fits-all approach. We asked whether a pouch application really needs every discipline. We're less concerned about toxicology, for example, because there are fewer chemicals involved. We also asked whether each discipline we do need could be streamlined. We added more collaborative ad hoc discussions with applicants, so they hear about deficiencies early rather than waiting for a deficien- cy letter at the end of scientific review. Often, they had the data and just hadn't submitted it. We've now issued several packets of authorizations under the pilot. The first was in record time, under 180 days, which is a first for us. It hasn't all gone as fast as we hoped, because some applications we rushed into the pilot were less complete than we'd thought. We're now applying these lessons to other product categories. The bigger constraint is staffing. CTP is the only FDA center that can't hire under Title 21 authority, so we can't pay scientists what the device, drug, biologics and veterinary centers can. We've been losing people to them. I'd like to more than double our scientific review teams so we can review applica- tions simultaneously rather than consecutively. I've raised this at very high levels, and the Secretary's office seems supportive, but it's up to Congress to give us those hiring authorities. For a while there was a misperception that a pending application meant a product got enforcement discretion, so the industry didn't want faster reviews, since most applications would simply be denied. The enforcement priority guidance we issued in May changes that calculus. More companies now see value in quick reviews, and maybe some will tell Congress. We're also piloting a supplemental PMTA process for minor modifications to already-authorized products. We can rely on much of what we've already reviewed, including the manufacturing process, so we should be able to get more products out the door faster. It covers a limited range of products, but I'm excited about it. Q (Beth Oliva): People who smoke are almost absent from these debates, including at TPSAC (the Tobacco Products Scientific Advisory Committee). How can we bring them into the conversation to help drive change? A (Bret Koplow): That's a great question. TPSAC does have a consumer representative, but it's a fair point that we don't focus as much on individual consumers. Most of what we receive comes from manufacturers. Our resources are limited and we tend to relate to the people we're immediately required to relate to. I think "the lost smoker" is not an unfair characteriza- tion. It's an important reminder. Frankly, the fact that I'm not coming up with a great response is a sign your question was really important. Editorial note: This article is based on the audio-taped Q&A session with Bret Koplow at GTNF Lisbon in September 2026, moderated by Beth Oliva. It has been abridged and edited for clarity.

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