Comments to FDA on Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
by Jeff Stier
Submission to FDA
July 10, 2018
The FDA's consideration of a product standard to set a maximum nicotine level for cigarettes is a dangerous experiment justified only by good intentions and faulty research. Further, even if the FDA's scant research were validated with the substantial research that is necessary to implement such a risky proposal, especially at a time when smoking rates continue to decline at an an unprecedented rate, implementation would not be appropriate until a robust array of satisfying lower-risk products were available to adult smokers who understood the differences in risk.
Good intentions, Unintended Consequences:
A ban on today's cigarettes could have significant unintended consequence, leading to compensatory smoking, where smokers inhale more dangerous chemicals in an effort to get the nicotine they crave. The agency's only science to support this risky policy is based on unvalidated modeling.
The agency also fails to address the obvious risk that this potential change would cause an explosion in the already-significant illicit trade in cigarettes. Because nicotine is so addictive, especially in cigarettes, smokers would find a way to get the cigarettes they prefer, even if it requires going to the black market.
Although the FDA is, as required by law, seeking comments on these issues, the agency's haste in advancing this plan before the science exists to validate it, is troubling.
The FDA was in such a rush to move forward with the announcement of this ANPR, that my meeting with the Office of Management and Budget's Office of Information and Regulatory Affairs, which was confirmed in writing on February 21st, was cancelled just in time for the FDA's announcement that the ANPR was moving forward.
Contrast this hastiness with the FDA's ongoing failure to keep its promise to develop product standards for ENDS, to fully and in a timely way grant PMTA and MRTP to snus and to heated tobacco. Without transparent rules which would make it easier to bring lower-risk non-combustible nicotine products such as e-cigarettes and heat-not-burn tobacco to market, adult smokers faced with a dramatic reduction will have only the black market to turn to.
The agency must also do a better job making sure consumers are fully informed about the differing risks of an emerging and diverse range of lower-risk nicotine products. In order for that to happen, the FDA, the Centers for Disease Control, local governments and leading public health organizations will have to correct the widespread misperceptions they have created about lower-risk "tobacco" products.
Scant and Faulty Research:
On June 18th, 2018, Commissioner Gottlieb stated, "As we evaluate the best ways to regulate tobacco products, based on scientific evidence as well as the law, we depend on rigorous science to inform our policies and save lives."
Yet to date, the preliminary science behind a nicotine rule is anything but rigorous. It relies on assumptions plugged into simulation models that are not based on real-world evidence of how smokers would respond to dramatic reductions in cigarettes- because no such evidence exists at this point in time.
It appears that the FDA is pushing a policy agenda and looking for the science to support it. Shouldn't it be the other way around?
On July 28, 2017, the FDA extended timelines for premarket tobacco applications for non-combustible products, such as e-cigarettes, until August 8, 2022. The agency did so "In order to allow the FDA to encourage innovation that has the potential to make a notable public health difference—and to inform future policies and efforts that will protect kids and help smokers quit cigarettes."
The FDA stated at the time, nearly one year ago, that it plans to issue "foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while (emphasis added) upholding the agency's public health mission."
The use of the word "while" suggests that issuing those rules could somehow undermine the agency's public health mission. Yet in fact, it is the lack of such rules that are inconsistent with the agency's public health mission. A robust market of lower risk-recreational nicotine products that have completed the PMTA process must be in place before the FDA implements a nicotine rule for combustible cigarettes.
Furthermore, the agency must take proactive steps to increase awareness of the promise of tobacco harm reduction. Studies have found an increase in the proportion of U.S. adults who incorrectly believe e-cigarettes to be as harmful as combustible cigarettes.
The agency promise that, "Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS."
But to date, it has not issued anything along these lines, while at the same time it has rushed forward the nicotine rule.
On March 15, 2018, Commissioner Gottlieb stated that "We said from the outset that ours was a comprehensive approach that requires us to pursue all of its parts in tandem." Yet the agency's actions belie this commitment.
The FDA is correct that in order for a nicotine rule to potentially be effective, if backed up by rigorous science, there must be a range of lower-risk nicotine products available under PMTA and MRTP. However, the reverse is not true. In order for a tobacco harm reduction strategy to advance public health, it is not necessary to reduce nicotine in combustible cigarettes. I concede, that if unintended consequences of such a rule can be eliminated, it is clear how both prongs can work together to accelerate smoking cessation, with a two-pronged approach. But if the science, when it is complete, not support the dramatic reduction of nicotine in cigarettes, tobacco harm reduction is still absolutely in the interest of public health. While an incentive (non-satisfying cigarettes) would be eliminated, the most powerful incentive for most people is the will to live and to minimize harm to their own health. In order to reduce smoking rates, it is critical that the FDA fosters innovation through the PMTA and MRTP as required by Congress.
Congress did not authorize the FDA to properly implement PMTA and MRTP only if it is able to dramatically reduce nicotine in cigarettes. In fact, Congress required FDA to implement PMTA and MRTP. It only authorized FDA to reduce nicotine in cigarettes. The idea that "you can't have one without the other" is a gross misrepresentation of the Tobacco Control Act.
The agency should prioritize the development of a product review process for lower-risk products to be more efficient, predictable, and transparent for manufacturers, in order to truly advance the agency's public health mission.
This part of the comprehensive plan needs to be in place first, giving time for investors to invest, allowing innovators to innovate, manufacturers to comply with the regulatory process, and the agency and public health groups to undo misperceptions about nicotine, before nicotine levels in cigarettes might be lowered. Doing so is essential in order to minimize a black market for full nicotine cigarettes. The agency should look to Public Health England for guidance on how this can be done effectively, given the UK's recent unprecedented successes in reducing smoking rates by embracing tobacco harm reduction.
At the same time, the agency should begin to develop rigorous, comprehensive and unbiased science that either supports, or doesn't support, the policy put forth in the ANPR. Because the agency's apparent intent to advance the rule even before a scientific basis exists, the agency will have to take extraordinary steps to insulate the entire research effort is free of confirmation bias.
Consumer Choice Center
New York, NY
July 10, 2018
Submission to the Food & Drug Administration
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