CCC Submission to the FDA: Flavor Bans on Less Harmful Products

To:       Food and Drug Administration:

Agency/Docket Number: Docket No. FDA-2017-N-6565

RIN: 0910-AH60

From:  Jeff Stier, Senior Fellow

Consumer Choice Center

Date:   July 17, 2018

This document is in response to the FDA’s request for comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products.

The FDA should be applauded for seeking more information about flavors in combustible tobacco products and e-cigarettes as it considers how to protect public health under the Tobacco Control Act.

Flavor Bans on Less Harmful Products:

The FDA might be seeking to use this vaguely-worded ANPR to begin the process of either directly banning certain flavors in e-cigarettes, or to deny premarket tobacco applications (PMTA) for products containing certain flavors. Doing so without conclusive and comprehensive data to prove that the benefits of such bans outweigh their costs. No such evaluation could possibly take place at this time, for the reasons described below.

The city of San Francisco has already banned the sale of all flavors in e-cigarettes, even to adults. This local ban, and others that could follow, are already undermining the FDA’s comprehensive regulatory plan to fight smoking, given the critical role flavors play in helping adult smokers both reduce their cigarette use and to quit smoking completely through the use of less harmful alternatives. As Director Zeller has stated, products that are potentially less harmful than cigarettes must also appeal to adult smokers in order for them to switch. I am aware of no evidence that if certain flavors were removed from the marketplace, adult smokers would continue to use e-cigarettes instead of tobacco cigarettes.

As other submissions to this docket illustrate, there are a wide variety of preferences among adult e-cigarette users (almost entirely former smokers, or those who have significantly reduced use, many of whom are on a path to quitting), and some cite their ability to use a variety of certain flavors to keep their interest; “anything not to go back to cigarettes,” is a common refrain.

No adult smokers should be restricted from having access to lower-risk products that can help them reduce harm from smoking.

We’ve seen cigarette use decline among adults as e-cigarettes have taken market-share from cigarettes.

But a significant number of adults still smoke, even as they say they’d like to quit.

Many of these smokers have tried NRT together with counseling, and have still been unable to quit completely and permanently. For the most inveterate smokers, e-cigarettes with a wide range of flavor choices have been their only savior.  Any intervention that makes it harder for adults to quit the use of combustible tobacco is not acceptable, even if the trends of overall smoking rates is moving in a more positive direction.

We cannot be complacent with currently available NRTs, nor can we count on NRTs developed in the future, nor should we believe that currently available e-cigarettes are enough to help every smoker.  A ban on certain flavors would harm an unknown number of adult smokers, by blocking what may be their own best cessation option.

Back to Basics: Smoking Prevention and Cessation

Preventing youth initiation of cigarette smoking — as well as helping adult smokers who want to quit smoking  — should be paramount.

Far too many kids today initiate smoking combustible cigarettes and far too many adults who want to quit have not been successful.

Youth Vaping Versus Adult Cessation, a False Dichotomy:

FDA need not try to engage in the impossible task of accurately guessing whether the benefit of preventing some youth from initiating e-cigarette use by banning certain flavors outweighs the cost of preventing adults from quitting smoking by banning certain flavors.

The FDA was correct to ban the sale of all e-cigarettes to minors. The agency should use the enforcement power granted to it by Congress to prevent all e-cigarette sales to minors. The agency should also incorporate youth prevention messages with a long overdue tobacco harm reduction educational campaign, which would inform all citizens, regardless of their age, about the unique dangers posed by cigarette smoking.

The Not Yet Knowable Promise of Harm Reduction:

Given widespread misconceptions about nicotine, no current or past analysis of the efficacy of e-cigarettes to help adult smokers quit should be considered a representation of the full potential of the public health benefits of non-combustible tobacco products. These products can only reach their potential after a number of conditions are met;

  • All smokers, including vulnerable populations, are able to differentiate between the dangers of nicotine use, including from the use of non-combustible recreational products, and the dangers of smoking.
  • The market is fully mature and able to quickly adjust to always-evolving consumer preferences and new technologies.
  • Lower-risk products are given an opportunity to compete in the marketplace with already commoditized cigarettes, where the costs of innovation, regulatory compliance, and marketing are low compared to new products

Further, because PMTA guidelines need to be more transparent and because product innovation is frozen as a result of the deeming regulation, the market for e-cigarettes and other non-combustible products is not anywhere near fully developed. Look only to the FDA’s continued failure to grant modified risk tobacco product claims on snus and heated tobacco.

Therefore, because it is impossible to fully ascertain how many smokers could quit smoking through the use of certain e-cigarette flavors, it is impossible at this time to consider the public health costs of banning the sale of certain flavors to adults, even if those flavors contribute to the appeal of e-cigarettes among youth, especially given the fact that sales of e-cigarettes are already forbidden to minors.

It is not acceptable for youth to use e-cigarettes. Period.

But this does not mean that banning certain flavors because they may appeal to youth is justified, regardless of the fact that doing so would undermine cessation either now, or when conditions for harm reduction to achieve its potential are met.

Less Intrusive and More Effective Interventions to Prevent Youth Vaping:

The FDA must also recognize the role of parents, families, school, and communities to prevent youth e-cigarette use, or far worse, youth smoking.

Product bans are the most blunt tool available to regulators. And they come with a potentially very high cost to those truly in need of better choices: adult smokers, a segment of the population that has been shunned, heavily taxed and literally forced out into the cold, but not helped by regulators.

A ban on certain flavors will prevent a currently unknowable number of adult smokers from quitting, while illicit youth vaping will continue. Harming adult smokers by preventing them from legally purchasing appealing lower-risk alternatives in the name of potentially protecting some youth is not an acceptable trade, especially when a more narrowly-tailored regulatory option is already in place, even though enforcement efforts have been insufficient to prevent all illicit sales to minors.

Marketing Restrictions, Not Flavor Bans:

This does not mean that, short of more effective enforcement and educational efforts, there are no other appropriate regulatory tools available to prevent youth use of e-cigarettes.  The agency should distinguish between regulating certain flavors and regulating the marketing of e-cigarettes to reduce the appeal to youth. For instance, even though many adults enjoy the taste of gummy bears, the FDA could consider regulating products marketed as “gummy bear” e-cigarettes, without banning the actual flavor used in those products, which appeal to adult smokers.  This is not to say that e-cigarette companies shouldn’t be allowed to market their products with fun and imaginative names to attract adult smokers. In fact. marketing is essential to appeal to smokers— and e-cigarette advertising effectively and narrowly targeting adult smokers amounts to private-sector funded smoking cessation campaigns that achieve more than scolding and fear-inducing ads ever could. However, if the FDA finds it necessary to take additional regulatory action to prevent youth e-cigarette use, it could do so in a way that advances this worthy objective in a way that limits the harm caused to adult smokers.

Menthol:

The FDA is also considering whether to regulate menthol in combustible cigarettes.

The Tobacco Products Scientific Advisory Committee report on menthol steered clear of making a policy recommendation to the FDA. The report addressed a number of unintended consequences on a ban on menthol, but the FDA has not yet produced sufficient evidence to address these concerns to consider a rule on menthol.

The FDA also issued a report, “PRELIMINARY SCIENTIFIC EVALUATION OF THE POSSIBLE PUBLIC HEALTH EFFECTS OF MENTHOL VERSUS NONMENTHOL CIGARETTES: but the report stated that it did not “constitute a decision about what regulatory action, if any, FDA might take with respect to menthol in cigarettes.” This is appropriate, since the question of menthol versus nonmenthol cigarettes is very different than the question of what impacts, including unintended ones, a ban of the sale of menthol cigarettes would have on the population.

Adding to the evidence against a ban on menthol cigarettes, in 2015, the National Academy of Sciences published a report, “UNDERSTANDING THE U.S. ILLICIT TOBACCO MARKET Characteristics, Policy Context, and Lessons from International Experiences,” which reported that:

On the question of reducing menthol in cigarettes, the research has been limited to consumer surveys and short-term laboratory studies of U.S. smokers using nonmentholated products. That research suggests most smokers would consider legal alternatives, including switching to a nonmentholated cigarette or quitting. Some may choose some kind of self-mentholation technology if the option is available. This research also indicates that highly addicted smokers and daily users would be more likely than other smokers to seek mentholated cigarettes through the illicit market. 

To date, the FDA has not addressed the points made in the NAS report with regard to the efficacy of any proposed menthol ban, or such a ban’s effect on the illicit market. Currently, the literature suggests that while a ban might curb some smoking among less addicted menthol smokers, it would also increase the size of the illicit market and come with the wide range of costs associated with that, which include an increased rate of youth initiation of cigarette smoking.

Incorporation of Earlier Comments:

The FDA received 174,466 in response to the now closed 2013 docket on menthol in cigarettes, Docket ID: FDA-2013-N-0521. Because the current docket addresses many topics, including menthol in cigarettes, the FDA should incorporate all comments from Docket ID: FDA-2013-N-0521 into the current docket in order to fully understand the issues as it considers this ANPR. Little has changed in terms of policy considerations or the science of menthol in cigarettes since the earlier docket, and those who commented at the time may no longer be available to comment in the current docket, or they may have a reasonable expectation that the prior comments are taken into to account in the current ANPR, since the same issue is under consideration. Further, since there have been personnel changes at both the FDA, and at OMB, which must evaluate the rule, it is important that those comments be incorporated into the current docket.

Jeff Stier

Senior Fellow

Consumer Choice Center

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About Jeff Stier

Jeff Stier is a Senior Fellow at the Consumer Choice Center. Mr. Stier has been a frequent guest on CNBC, and has addressed health policy on CNN, Fox News Channel, MSNBC, as well as network newscasts. He is a guest on over 100 radio shows a year, including on NPR and top-rated major market shows in cities including Boston, Philadelphia, and Sacramento, plus syndicated regional broadcasts. Jeff’s op-eds have been published in top outlets including The Wall Street Journal, The Los Angeles Times, The New York Post, Forbes, The Washington Examiner, and National Review Online.

FDA’s Possible Maximum Nicotine Mandate Could Be Dangerous For Consumers

LUND REPORT: The Consumer Choice Center’s Senior Fellow Jeff Stier criticized the move in his official submission to the FDA, stating that the FDA is seeking science to back up its policy, rather than crafting policy based on science. Stier explained “It seems that FDA is pushing a policy agenda and looking for science to support it. Shouldn’t it be the other way around?”

READ MORE

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About Jeff Stier

Jeff Stier is a Senior Fellow at the Consumer Choice Center. Mr. Stier has been a frequent guest on CNBC, and has addressed health policy on CNN, Fox News Channel, MSNBC, as well as network newscasts. He is a guest on over 100 radio shows a year, including on NPR and top-rated major market shows in cities including Boston, Philadelphia, and Sacramento, plus syndicated regional broadcasts. Jeff’s op-eds have been published in top outlets including The Wall Street Journal, The Los Angeles Times, The New York Post, Forbes, The Washington Examiner, and National Review Online.

CCC Comments to FDA on Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

Jeff Stier

Senior Fellow

Consumer Choice Center

New York, NY

July 10, 2018

Submission to the Food & Drug Administration

Submit your own comments:  https://www.regulations.gov/document?D=FDA-2017-N-6189-0001

 

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?

Premature:

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.

Recommendations:

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.

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About Jeff Stier

Jeff Stier is a Senior Fellow at the Consumer Choice Center. Mr. Stier has been a frequent guest on CNBC, and has addressed health policy on CNN, Fox News Channel, MSNBC, as well as network newscasts. He is a guest on over 100 radio shows a year, including on NPR and top-rated major market shows in cities including Boston, Philadelphia, and Sacramento, plus syndicated regional broadcasts. Jeff’s op-eds have been published in top outlets including The Wall Street Journal, The Los Angeles Times, The New York Post, Forbes, The Washington Examiner, and National Review Online.