Vapor Companies Respond To FDA Warning Letters

BREAZY: One of the most straightforward responses from vapor companies came from Consumer Choice Center, whose senior fellow, Jeff Stier, applauded the FDA’s efforts. He also said that responsible regulation is possible while still offering adult consumers an alternative to cigarettes that significantly reduces the harm from smoking.

“We applaud FDA for cracking down on online and physical retailers running afoul of the law and selling vaping and nicotine-delivery products to kids under 18,” Stier said. “The presence of life-saving products like Juul and other e-cigarettes are a boon to public health. But anti-e-cigarette activists want to throw the baby out with bathwater.”

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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.

San Francisco voters chose to keep ordinance banning flavorings in tobacco products

WINSTON-SALEM JOURNAL: Jeff Stier, senior fellow with Consumer Choice Center, said he does not dispute that the ordinance is designed to help protect youths from tobacco products.

“Yet, the ordinance would change the legal status of the sale of flavored e-cigarettes to adults exclusively,” Stier said,

Stier challenged the FDA to “speak out about how a local ban on the sale of flavored e-cigarettes to adults could undermine the FDA’s comprehensive regulatory plan to fight smoking, given the role flavors in e-cigarettes play in helping adult smokers quit.”

“The FDA should alert the public to how the ordinance would undermine federal anti-smoking efforts.”

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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.

Make e-cigarettes available to fight tobacco cancer: Experts

DECCAN HERALD: Jeff Stier, a senior fellow with the pro-e-cigarettes advocacy group Consumer Choice Center (CCC) said, “The ACS took a step in the right direction by recognising this important harm-reduction method.”

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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.

The WHO Should Embrace Vaping and Harm Reduction on World No Tobacco Day

AMBULANCE TODAY: May 31st marks World No Tobacco Day. This year the World Health Organization highlights “tobacco and heart disease” and pledges to highlight policies that help to reduce tobacco consumption.

The Consumer Choice Center’s Managing Director, Fred Roeder, applauds the WHO for its focus on fighting cardiovascular diseases and the health impact of tobacco consumption, but points out the WHO missed an opportunity to promote effective policies reducing the health risks of tobacco consumption.

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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.

World No Tobacco Day 2018, here’s why you should switch to e-cigarettes

HINDUSTAN TIMES:  Jeff Stier, a senior fellow with the pro-e-cigarettes advocacy group Consumer Choice Center (CCC) said, “The ACS took a step in the right direction by recognising this important harm-reduction method.”

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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.

How Germany is smoking other countries in e-cigarette regulation

HANDELSBLATT: Regulations-heavy Germany has taken a surprisingly lax stance on e-cigarettes and vaping laws. It’s the right approach, writes a policy analyst.

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About Bill Wirtz

Bill Wirtz is policy analyst for the Consumer Choice Center, based in Brussels, Belgium. Originally from Luxembourg, his articles have appeared across the world in English, French, German, and Luxembourgish. He is Editor-in-Chief of Speak Freely, the blog of European Students for Liberty, a contributing editor for the Freedom Today Network and a regular contributor for the Foundation for Economic Education (FEE). He blogs regularly on his website in four languages.

Clearing the clouds: Reduced-risk and vaping regulation

EURACTIV: EURACTIV organised a workshop to discuss the way forward in reduced-risk and vaping regulation

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About Fred Roeder

Fred Roder has been working in the field of grassroots activism for over eight years. He is a Health Economist from Germany and has worked in healthcare reform and market access in North America, Europe, and several former Soviet Republics. One of his passions is to analyze how disruptive industries and technologies allow consumers more choice at a lower cost. Fred is very interested in consumer choice and regulatory trends in the following industries: FMCG, Sharing Economy, Airlines. In 2014 he organized a protest in Berlin advocating for competition in the Taxi market. Fred has traveled to 100 countries and is looking forward to visiting the other half of the world’s countries. Among many op-eds and media appearances, he has been published in the Frankfurter Allgemeine Zeitung, Wirtschaftswoche, Die Welt, the BBC, SunTV, ABC Portland News, Montreal Gazette, Handelsblatt, Huffington Post Germany, CityAM. L’Agefi, and The Guardian. Since 2012 he serves as an Associated Researcher at the Montreal Economic Institute.

POLITICO Pro Morning Health Care, presented by European Health Parliament: HTA — Vaccine plans — Compulsory license push in Scotland

POLITICO: Awarding a so-called harm reduction group like INNCO “would demonstrate that DG SANTE actually cares about smokers and does not want to fight an ideological war against tobacco and nicotine,” said Consumer Choice Center’s Jeff Stier.

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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.

Have Your Say on Rhode Island’s Impending 80% E-Cigarette Tax

VAPING POST: In the meantime, Senior Fellow at the Consumer Choice Center, Jeff Stier, who is a frequent guest on CNBC, and has even discussed health policy on CNN, has written to the House Finance Committee of the State of Rhode Island General Assembly, expressing his concern about this tax and explaining how it could have a detrimental effect of public health.

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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.