“Any effort to treat cigarettes no differently from massively less hazardous alternatives like vaping protects the cigarette business rather than public health. It is akin to whiskey distillers wanting orange juice to be subjected to identical regulations.”
David Sweanor, University of Ottawa
(TLDR – When I started working on this piece I wanted to get a feel for the response to FDA’s unprecedented about face on tobacco regulation. Appropriate or appalling? I was surprised by the exceptionally wide spectrum of individuals, organizations, researchers, politicians, and even foreign governments that have weighed in on the subject. The diversity makes It impossible to give you guys an honest picture within the normal length of my blog posts. So my apologies for the length of this piece. But I hope that you’ll come away with a better understanding of the many different points of view on this dramatic change. D.C.)
At the 30-day mark after Dr. Scott Gottlieb’s surprise announcement outlining FDAs’ intention to regulate a reduction of nicotine in combustible cigarettes to non-addictive levels, the reactions have been revealing.
A number of research studies have been released on the heels of FDAs’ announcement.
“Though the opioid crisis is currently attracting the attention of the media and decision makers across society, smoking remains the leading cause of preventable death and disease in the United States causing more than 480,000 deaths a year. To put the scourge of cigarettes in context, smoking kills 15 times more Americans per year than opioids.” Michael P. Eriksen, Professor and Dean, School of Public Health, Georgia State University. Published August 22nd in “Business Standard”.
Researchers at Columbia University’s Mailman School of Public Health and the Rutgers School of Public Health determined that 52 percent of daily e-cigarette users had successfully quit smoking in the past five years. Success quit rate for those adults who had never used e-cigarettes – 28 percent. Daniel Giovenco, the study’s lead author and an assistant professor of Sociomedical Services at Columbia:
“While questions regarding the efficacy of e-cigarettes for smoking cessation remain, our findings suggest that frequent e-cigarette use may play an important role in cessation or relapse prevention for some smokers.”
Public Health Agencies and Organizations
In a response to an August 5th editorial in the Washington Post, Dr. Enid R. Neptune, Vice Chair of the American Thoracic Society’s Tobacco Action Committee wrote:
“The commissioner seems unconcerned about switching one form of nicotine addiction with another. Nicotine in any form is bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that nicotine can be a gateway drug. Flavoring agents and other chemicals in e-cigarettes, when vaporized, are harmful.”
In response to Dr. Neptune’s comment, Dr. Michael Siegel, Professor, Department of Community Health Sciences, Boston University School of Public Health:
“Switching from a high-risk addictive substance to a low-risk addictive substance is not a zero-sum game. It is a critical and life-saving intervention. Just as methadone maintenance programs have saved thousands of lives from heroin-associated morbidity and mortality, electronic cigarettes are saving thousands of lives from smoking-associated disease and death.”
Harold J. Farber, MD, MSPH, pediatric pulmonologist at Texas Children’s Hospital:
“This announcement indicates the FDA’s failure to protect our youth. If the FDA wanted to protect our youth they would start with a ban on characterizing flavors — which make the tobacco products essentially highly addictive candy. The real story is that the FDA is shirking the responsibility to regulate e-cigarettes and cigars — many of which come in fruit and candy flavors and are addicting our young people. Delaying regulation of these products puts our youth at risk.”
Eric Donny, PhD, professor of psychology, University of Pittsburgh and behavioral health oncology program at the University of Pittsburgh Medical Center:
“Reducing nicotine in cigarettes should minimize the chance of youth becoming lifelong addicted smokers, so I am not sure how that is failing youth. NIH/FDA has also discussed the product standards that reduce appeal, addictiveness, and toxicity are high priorities. I would predict [the FDA’s plan] would make cessation easier for young smokers because use of low nicotine cigarettes for an extended period of time reduces dependence.”
According to a Bloomberg report , Gottlieb’s proposal to reduce nicotine in cigarettes to non-addictive levels:
“…wiped about $36 billion off the value of tobacco companies in a single day, initially hitting those with the biggest U.S. exposure, such as Lucky Strike owner British American Tobacco Plc and Marlboro parent Altria Group Inc., the hardest.”
In an interview with Euronews, Andre Calantzopoulos, CEO for Philip Morris International (PMI) weighed in on Gottlieb’s proposal with a surprising response calling the FDA’s announcement:
“One of the best articulated positions in many years.”
(PMI has invested billions in their heat not burn product IQOS which has gained rapid popularity in the Japanese and other international markets. Calantzopoulos went on to say that 3 million people have switched to IQOS from regular cigarettes and 8,000 more are switching – every day.)
Public health experts in Canada, Ireland, New Zealand, Finland and the UK have responded to Gottlieb’s proposal with interest in, or proposals for, implementing similar plans for reducing nicotine in combustible cigarettes. It has been widely reported that the U.K.’s Department of Health has discussed the U.S. proposal with FDA representatives.
UK ministers want to slash smoking rates 25% by 2022 by urging millions to switch to e-cigs. The UK’s Action on Smoking and Health predicts the UK could be smoke free – with less than one in 20 lighting up – by 2030.
A letter to Gottlieb dated August 4th and signed by thirteen Democratic Senators states in part:
“Many of us wrote to you in May urging you to steadfastly implement the FDA’s deeming rule, which- for the first time ever-enacted oversight over e-cigarettes, cigars, and other tobacco products, helping to protect public health and prevent tobacco use by young people. Instead, last week’s announcement indicates that you intend to delay implementation of key provisions of the deeming rule, giving e-cigarette and cigar manufacturers- including flavored products – a free pass to stay on the market for years with minimal oversight and restrictions. This is a step backwards and contradicts years of data demonstrating the danger these products pose to public health.”
(I would be interested in hearing the Senators thoughts on why the deeming rule contained no “key provision” regarding Big Tobacco’s combustible cigarettes. A “free pass” for the deadliest consumer product ever created to remain on the market forever with minimal oversight and restrictions. A step backwards that contradicts years of data demonstrating the exponentially greater danger these products pose to public health versus electronic cigarettes and other smokeless products.)
Opinions and Editorials
In an Op-Ed piece published in the New York Post, Jeff Stier, head of the Risk Analysis Division at the National Center for Public Policy Research writes:
“The US and UK governments see lower-risk nicotine products as a tool to bring smoking-related diseases down to levels not seen in generations.”
Guy Bentley, Reason Foundation in a piece published in the Washington Examiner titled “ Evidence over prejudice: Ending the anti-vaping hysteria ”:
“By highlighting the role that reduced risk products like e-cigarettes can play in helping people quit smoking, Gottlieb is sending the message that a policy that fails to recognize relative risk and the potential for harm reduction will be a failure.”
On August 4th the Washington Post wrote in an opinion piece :
“The Food and Drug Administration unveiled last week what may be one of the most important public-health initiatives of this century: an ambitious long-term strategy to finally end tobacco’s cycle of addiction and death, a scourge that has taken the lives of millions of Americans over centuries of cultivation and consumption.”
In a recent editorial published in BMJ Journals, Dr Robert N Proctor, Department of History, Stanford University:
“Overall, though, this new FDA plan is certainly a breath of fresh air. If carried through with courage and conviction, it could save more lives than any other act of a governmental agency in all of human history. The magnitude of the harms is that great. We hear a lot about tobacco endgames: this one could be a game-changer.”
David Sweanor, Adjunct Law Professor, University of Ottawa and the author of several e-cig studies:
“The key thing in my view is what (Gottlieb) is saying on continuum of risk, encouraging innovation, backing off from onerous requirements on alternatives to cigarettes, etc..”
“This is a huge switch from the tobacco-free world/abstinence-only/quit or die approach to tobacco and nicotine by U.S. government agencies. It will now be very hard for instance, for the Centers for Disease Control and Prevention, to continue engaging in misinformation campaigns on relative risks.”
(Apparently Sweanor hit the nail on the head when it comes to the CDC. My research has not turned up a single statement from the CDC regarding the FDA’s new direction. The former CDC Director, Thomas Frieden would have been pouring out misinformation campaigns to every media outlet in the country. The new Director, Dr. Brenda Fitzgerald was only appointed on July 7th. The big question? Will Dr. Fitzgerald allow politics to overrule science as her predecessor did? Or will she envision CDC’s role as a true public health advocate?)
Matthew Myers, President of the Campaign for Tobacco-Free Kids reacted to the FDA’s proposal by saying it:
“…represents a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and death.”
Myers then quickly added that the extension of e-cigarette deadlines:
“will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight.”
In a separate statement, Myers is quoted as saying the proposal could lead to:
“The most fundamental change the tobacco industry has ever seen.”
Last but not least, any coverage of responses to FDA actions would be remiss without mention of the predictable rantings of Stanton Glantz, University of California, San Francisco:
“I think this announcement is good news and bad news. I think that the FDA moving forward to regulate the levels of nicotine delivered in combustive cigarettes can be a good thing. If they do it right, it could be a very good thing and could have a lot of positive public health benefits. But the other thing that they did, which was to basically back off any type of meaningful regulation of e-cigarettes is just a public health nightmare, completely at variance with what science shows and generally appalling.”
(The scientific community has, on numerous occasions, been appalled at what Glantz regards as “science”.)
By offering something to both camps in the tobacco controversy, the new FDA Commissioner has demonstrated a keen awareness and understanding of the politics surrounding tobacco regulation.
Nicotine’s addictiveness is the root of the problem. But not the source of the death and disease caused by smoking. Reduce the level of nicotine in combustible tobacco to non-addictive levels and a reduction in smoking will follow. If there is an alternative source of nicotine.
Nicotine’s addictiveness is also the root of the solution. One that does not involve combustion and the staggering death toll caused by smoking.
Public health nightmare? A plan that could save more lives than any other act of a governmental agency in all of human history? Appropriate or appalling?
We are about to find out. Once and for all.