U.S. Surgeon General Vivek Murthy recently released a report entitled “Eliminating Tobacco-Related Disease and Death: Addressing Disparities” on the disproportionate impact cigarette smoking has on certain communities and the associated public health implications. The report noted the laudable decreases in smoking rates, but also found that some 36 million adults continue to smoke combustible tobacco products – including cigarettes, cigars, and other smoked products – and that smoking and secondhand smoke combined cause nearly half a million American deaths every year. This reinforces two facts – we have made tremendous progress, but work remains to be done.
It‘s on the second point where the Surgeon General’s report missed a major opportunity. Absent is any mention of smoke-free nicotine products that could help reduce the harm associated with smoking cigarettes. Despite stating this past summer that e-cigarettes offer a lower risk option for adults who smoke, Surgeon General Murthy excluded this information and any reference to the potential benefits of other smoke-free products, such as heated tobacco products and nicotine pouches.
Unfortunately, this missed opportunity comes at a time when the U.S. Food and Drug Administration (FDA) has dropped the ball. FDA’s Center for Tobacco Products (CTP) is responsible for reviewing pre-market tobacco applications (PMTAs) and authorizing new tobacco products, including smoke-free alternatives such as e-cigarettes, heated tobacco products and nicotine pouches.
According to federal law, this process is supposed to take a maximum of 180 days. However, CTP misses this timeline as a matter of routine, with many reviews dragging on for more than three years and counting. Since 2009, millions of PMTAs have been submitted, yet CTP has only authorized about 50.
Simply put, CTP is preventing the development of a larger marketplace of harm-reduction products that could help adults who smoke make better choices. As former Chief Scientist at CTP, I saw the government bureaucracy up close, and know that CTP can fulfill its mission if it chooses to prioritize harm reduction and oversee a well-regulated marketplace.
The Surgeon General’s report is eye-opening in terms of the threat that smoking continues to pose to communities nationwide, but it would have been encouraging had it also highlighted that meaningful FDA reform could quickly enable industry innovations that can improve public health nationwide.
As the next presidential administration begins to take shape, President-elect Trump and the cabinet members he is assembling have a unique opportunity to support tobacco harm reduction by focusing on much-needed reforms at the FDA. President-elect Trump and his pick for Secretary of Health and Human Services, Robert F. Kennedy, Jr., have vowed to help “Make America Healthy Again.” Embracing less harmful, smoke-free alternatives and reforming the FDA to prioritize the authorization of harm-reduction products would be a tremendous step forward in that effort.
As the dust is settling on the presidential transition, the incoming Trump Administration should work with lawmakers in Congress and FDA officials to push for long-overdue reforms that would bring greater transparency into the PMTA review process and oversight of CTP. For the sake of public health, CTP simply cannot continually fail to meet its statutory requirements, particularly given that its staff has more than doubled over the past decade. Although additional resources may be helpful – one thing that is holding them back is any sense of urgency to help adults who smoke move away from combusted cigarettes.
Surgeon General Murthy’s report, though well-intentioned, presents an opportunity that the incoming administration should seize to make a real, lasting impact on the fight to eliminate cigarette smoking and make America healthy again. Driving FDA reforms that promote tobacco harm reduction and expedite the approval of innovative, smoke-free products would be a great way to show change begins with finding real public health solutions for Americans.
Dr. Matt Holman is the Vice President of U.S. Scientific Engagement and Regulatory Strategy at Philip Morris International. Dr. Holman previously served as Director of the Office of Science at the U.S. Food and Drug Administration’s Center for Tobacco Products.
