The Health Subcommittee of the House of Representatives’ Energy & Commerce Committee will hold a hearing today that will in part focus on the Food & Drug Administration’s tobacco programs. The list of officials expected to testify include Brian King, Director of the FDA’s Center for Tobacco Products.
Hopefully the hearing will have a robust discussion of proper ways to focus on Tobacco Harm Reduction, and why the CTP has failed to live up to its legally mandated role in reviewing and properly regulating product applications that feature modern technologies that help smokers stop smoking.
Tobacco Harm Reduction is a public health approach that centers on providing what millions of users have come to see as a more reasonable and realistic path for smoking cessation. As this academic paper from the Harm Reduction Journal summarizes, “[c]onventional smoking cessation policies and programs generally present smokers with two unpleasant alternatives: quit, or die.” Harm reduction involves the use of alternative sources of nicotine, including modern tobacco products that are smokeless. While nicotine dependence is a serious issue, it is the use of cigarettes—and other methods that involve combustion—that is by far the most significant factor negatively affecting users’ health.
The FDA itself is on the record on this point, previously stating that “FDA believes that the inhalation of nicotine without the products of combustion is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products.”
Congress recognized the importance of harm reduction in the Family Smoking Prevention and Tobacco Control Act of 2009. Critical to this public health goal is the process that manufacturers must go through to receive authorization for products that do not combust tobacco, called a Premarket Tobacco Product Application. The law requires CTP to decide on an application within 180 days from submission, a statutory requirement that the CTP is not fulfilling.
A group of over 60 U.S. Representatives wrote to President Biden urging that the CTP do its job. The letter includes this eyebrow-raising passage:
Since the Family Smoking Prevention and Tobacco Control Act of 2009 was signed into law by President Obama, the FDA has received over 26 million applications to market innovative smoke-free products. However, the FDA has authorized fewer than 50 product applications (of which less than 10 are commercially available products) and many other applications have been waiting over three years for official review. Meanwhile, during this same period, FDA has authorized thousands of combustible cigarette product applications, as measured by CTP’s own performance metrics.
It would be entirely appropriate for the subcommittee to inquire directly into the CTP’s failure to due the job it was established for, especially considering the public health benefits that stem from reducing the harm caused by tobacco.
A study from Georgetown University that compiled analysis from cancer researchers worldwide concluded that alternative methods of nicotine use have the potential to save 6.6 million lives over a ten years. Its hard to imagine a more compelling argument in favor of CTP changing course.
