Tobacco Asia

Tobacco Asia 21 CTP is exploring ways to help consumers more easily dis- tinguish authorized products from unauthorized ones. "The unauthorized market is not just a regulatory compli- ance problem. It's also a public health problem," Koplow said. "And for companies that invested in doing things legally, it's a competitive fairness problem." FDA and US Customs and Border Protection have sharp- ly increased enforcement at the border. Koplow said import re- fusals rose from roughly 100 in fiscal 2023 to more than 9,000 in fiscal 2025, though he acknowledged that significant numbers of unauthorized products continue to enter the country. He also noted that some companies demanding tougher enforcement against illicit competitors are themselves selling unauthorized products. "What they almost always mean is that you need to do something about all of our competitors' illicit products, but not our illicit products," he said. Some companies have told FDA they believe they must participate in the unauthorized market because competitors are taking market share. "It's becoming kind of this vicious cycle," Koplow said. PMTA reviews get faster Koplow also provided details on CTP's effort to overhaul the PMTA review process. According to Koplow, more than 99% of the more than 2 million applications the agency received lacked basic information necessary for review. "It's not that we have such a high scientific standard for how we review these studies," he said. For flavored products, many applications contained no comparative evidence against tobacco-flavored products and lacked evidence of benefit, pharmacokinetic data, adequate product characterization, or information demonstrating consis- tent manufacturing, Koplow said. A significant reason for the enormous volume of appli- cations was the number submitted by vape shops that mixed e-liquids and therefore qualified as manufacturers under federal law. "They don't know how to do a pharmacokinetic study, let alone a randomized clinical trial or longitudinal cohort study," Koplow said. But he acknowledged that CTP shares responsibility for the problems applicants have encountered. "Some of that is on us too, to try to be a better educator of what we're looking for," he said. "There is a lot of room for improvement there." CTP is developing guidance, now in a "very late stage," to help applicants understand common deficiencies that have delayed otherwise successful applications. The agency is also encouraging pre-submission meetings so companies can discuss proposed studies before committing significant time and money. "If these products ultimately are APPH, we don't want to see a waste of time in bringing them to market because it's our public health mission to make them available," Koplow said. "When an applicant gets a marketing granted order, it's a suc- cess for the applicant. It's a success for us." The front end of the process is already moving more quickly. Acceptance review, which until recently could involve applications submitted years earlier, is now typically completed within one to three weeks, Koplow said. Filing review takes about 21 days. "Everything still takes longer than we want," he acknowledged. Staffing remains an obstacle. Koplow said CTP has too few scientific review teams and would like to more than double their number. Unlike other FDA centers, he said, CTP lacks the Title 21 hiring authority that would allow FDA to offer more competitive compensation to scientific personnel. "We've been losing some people to some of those other centers," Koplow said. "That's been a real challenge for us." Changing that authority would require action by Congress. A different CTP Perhaps the most consequential part of Koplow's appearance was not a single policy announcement. It was the permanent di- rector's openness to embracing tobacco harm reduction as part of CTP's mission. During the audience discussion, Brown University pro- fessor Jasjit Ahluwalia, a co-author of the recent JAMA com- munication, challenged Koplow to leverage FDA's credibility to bring major medical organizations into the harm-reduction discussion. Koplow said CTP is already developing plans to reach the medical community and is exploring partnerships he was not yet able to discuss. "This should be low-hanging fruit for us," he said. Then he acknowledged how much the language within CTP has changed. When he became acting director, Koplow said, "CTP wasn't really, hadn't used the term tobacco harm reduction," something he found frustrating. "We're going to do a lot more," he said. Koplow was also candid about the tobacco industry's damaged credibility. Medical societies often refuse to meet with tobacco companies and frequently discount industry-funded re- search, he said. "The tobacco industry is doing a lot of work here, but there is an antiquated perception of the tobacco indus- try that may have been valid years ago when the industry was more of a monolith," Koplow said. At the same time, he did not absolve the industry of re- sponsibility. "The tobacco industry in the past earned [its] lack of credibility," he said. "And we're all paying a price for that now." FDA, he argued, has the credibility to help bridge that divide. "We have a responsibility to step up," he said. Koplow concluded with a message for companies that have invested in developing products intended to reduce tobac- co-related harm. "Many of you in this room represent companies that have invested in or want to invest in developing products that can genuinely benefit public health," he said. "Many of these com- panies may be playing by the rules, submitting applications with real scientific data, perhaps for products with effective youth access restrictions. These companies are partners in the mission that we share." That mission, Koplow said, is not about company profits. "It's to reduce the harm that tobacco has caused for centuries," he said. "We have more tools to do that now than we did ever before."

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