Oversight Hearing on Illegal E-Cigarettes Highlights Dire Need for Reform of the FDA
COMMENTARY
The Senate deserves credit for holding a recent hearing that underscored the failure of the U.S. Food and Drug Administration’s Center for Tobacco Products to provide clear and fair regulatory pathways for smoke-free tobacco products that provide Americans with less harmful alternatives to combustible cigarettes. This hearing follows a similar hearing by the U.S. House Committee on Oversight and Accountability earlier this spring, where elected officials put the FDA on notice for failing to properly regulate smoke-free products.
This bipartisan concern of the CTP should raise eyebrows at the FDA, White House and throughout the public health policy community. These two hearings, one by a Republican House and one by a Democratic Senate, clearly show the CTP has failed in its health mission. It reminds me of a Leo Tolstoy quote that the CTP leadership should embrace: “Everyone thinks of changing the world, but no one thinks of changing himself.”
Since 2009, more than 26 million premarket tobacco product applications have been submitted for FDA review; however, in that time, the CTP has authorized fewer than 50 of those applications. Despite federal law mandating the CTP review and decide on a PMTA within 180 days, it has taken regulators nearly three years to do so in some cases.
The FDA and CTP’s inability to efficiently review and approve legitimate smoke-free tobacco products through the PMTA process is not only a market failure, it is a public health failure as well. Our friends around the globe like the U.K. and Japan have not failed like our FDA: They will end the use of combustible cigarettes within 10 years because they have approved and championed these new products.
The United States will continue to suffer the consequences of adult smokers for generations because of the CTP failure.
New, innovative nicotine delivery products that do not rely on combustion, including vapes and heat-not-burn devices, provide adult smokers with tobacco alternatives that are 90%-95% less harmful than cigarettes. Given that 28 million Americans still smoke cigarettes — and that smoking is the leading preventable cause of death and disease in the country — building a robust market of legal, regulated and less harmful smoke-free tobacco products should be a larger priority at the FDA.
Not only must the FDA overhaul the CTP’s process for reviewing and approving new, smoke-free tobacco products, but the agency should also improve education efforts regarding the relative health risks of tobacco and the importance of tobacco harm reduction. Despite the FDA recognizing that it is combustion — not nicotine — that leads to serious health consequences, namely chronic obstructive pulmonary disease and lung cancer, there is still a misconception about the role nicotine plays, even among physicians.
The FDA has a responsibility to prioritize the approval of smoke-free tobacco products that are less harmful options than traditional, combustible cigarettes. Unfortunately, that is a responsibility the agency is not living up to, posing a serious threat to public health.
Lawmakers in Congress should keep holding the FDA’s feet to the fire on this issue and push for reforms that will provide clear, achievable pathways to FDA approval for smoke-free tobacco products. By reforming the CTP’s broken review and approval process for new PMTA, the FDA can help provide tens of millions of adult smokers with more options for less harmful alternatives.
In this hyper partisan moment policymakers should take notice of Republican and Democratic agreement. We all agree the FDA has failed adult smokers.
Lindsay Mark Lewis is the executive director for the Progressive Policy Institute, which can be reached on LinkedIn.
