E-cigarettes Not Ticket to Smoking Cessation

FDA to Shift Tobacco Regulatory Focus Basing decisions on 'continuum of risk' from different products


Health Editor’s Note:  Bottom line, if you are a smoker, your only chance at becoming the healthy person you hope/want to be is to STOP smoking.  NO Nicotine.  Nicotine is the highly addictive compound found in cigarettes, cigars.  You have an unbelievably challenging road ahead of you.  “Nicotine is one of the most addicting agents. The US surgeon general (2010) has concluded nicotine to be as addictive as cocaine or heroin. (Indian Journal of Medical and Paediatric Oncology).” Nicotine has a rapid onset of action and is one of the most toxic poisons.

Nicotine, a strong alkaloid, which is a clear liquid that turns brown on exposure to air.  Here is how nicotine harms your body…. Nicotine is absorbed and metabolized by the liver which is the organ that works to rid the body of items that should not be there. The liver also has normal functions such as making sure you do not bleed to death, have enough sugar for your cells to function, etc.  Through body chemical means, various metabolites (a product of metabolism) are formed and this leads to removal of these metabolites (waste) from the body by excretion in the urine, saliva, sweat, etc. 

Between 5 and 10% of nicotine excretion is accomplished by the kidneys with adverse reactions occurring in the urinary bladder if the pH is high.  Bladder cancer is associated with smoking for this reason.

By inhaling smoke you are allowing the nicotine to directly move from the alveoli (little sacs in your lungs for gas- oxygen and carbon monoxide- exchange into your blood stream) and then travel to all parts of your body where it will cause your arteries to clamp down, decreasing blood supply and raising blood pressure.  

Tobacco is the leading cause of preventable cancers. Cancer is a mutated cell that was not killed by your body’s natural tumor killing cells.  Metabolic products of nicotine, allow for the over production of bad cells by decreasing the natural ability to eradicate these cells before they become cancers in the gastrointestinal tract, bladder, lungs, breasts, eyes, immune system, and pancreas. 

Nicotine is responsible for mood elevation and a feeling of improved thought processes.  Addiction to nicotine can be transmitted from mother or grandmother’s genes. Nicotine messes with dopamine production in the brain. Dopamine is associated with moods. You can see where this relationship is going.  It feels “good” to light up and smoke a cigarette.   

Nicotine in the body leads to an increase in blood pressure and heart rate by over stimulating the smooth muscle tissue of the venous and arterial systems. Blood flow is reduced to the coronary arteries (those that make sure the heart muscle has oxygenated blood) so there is a restriction in heart function. There is an ongoing contribution to coronary vascular disease.

Nicotine adversely affects all systems in the body, including the reproductive system.  We will not address the harmful effects on a developing fetus but they are devastating and can lead to very small full term infants who may have asthma and other medical issues.  Smoking around children of any age is very harmful to a child. 

Cities, work places, etc. are developing “no smoking” areas so tobacco consumption per se is being controlled, at least in social situations.  With increased demand for smoking cessation there is an ever increasing demand for fixes to help with smoking cessation. Nicotine gums, patches, e-cigarettes, and inhalation (vaping, hookas) are easily available.  These products are being promoted as remedies to help you stop smoking. Nicotine gums deliver large amounts of nicotine into the body, without actually lighting up a cigarette. But, nicotine, is nicotine, no matter the delivery method.

We at VT understand your super tough choice of with whether or not to jump on that challenging trail to living without nicotine.  One of our editors has recently stropped smoking after many years and has been successful in remaining tobacco free.  We are very happy to see this as we deeply care for this individual and want him in our lives for a long time to come

Below are two articles discussing the FDA and its regulatory focus on tobacco.  Please also read the second, most recent, article on what little has been done to find a remedy for a “better and safer” way to enjoy a life without nicotine. In the second article I strongly disagree with FDA Commissioner Scott Gottlieb, MD’s statement that “Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kills hundreds of thousands of Americans each year,” There has been far too much research to prove otherwise and to make such an outlandish statement demonstrates the need for a different FDA commissioner and involving Big Tobacco in a health issue that they have caused is just plain nuttiness…..Carol 

FDA to Shift Tobacco Regulatory Focus

Basing decisions on ‘continuum of risk’ from different products

by Salynn Boyles, Contributing Writer – January 02, 2018

Federal officials today announced a dramatic shift in tobacco policy, vowing to slash nicotine levels in combustible cigarettes to non-addictive levels while delaying key regulatory action on electronic cigarettes until the summer of 2022.

In a Friday morning media call, FDA Commissioner Scott Gottlieb, MD, made it clear that the agency now considers e-cigarettes to be less harmful than conventional cigarettes and a potential tool for smoking cessation, and that it will move forward with regulation of the products with this view in mind.

Under the revised timeline for newly deemed tobacco products, applications for newly-regulated combustible tobacco products, such as cigars, pipe tobacco and hookah tobacco, would need to be submitted to the FDA by Aug. 8, 2021, and product applications for e-cigarettes currently on the market would be required by Aug. 8, 2022.

The new enforcement policy does not affect provisions of the regulatory rule that are already in place, such as mandatory age and photo-ID checks for e-cigarettes and other newly regulated tobacco products. It will also not affect future deadlines for other provisions of the deeming rule.

Gottlieb said the FDA is ready to move forward with efforts to require tobacco companies to reduce nicotine levels on combustible cigarettes to non-addictive levels, but he gave no timeline for this.

He said the evidence shows that the greatest dangers from tobacco come from smoking it. Although nicotine itself is not harmless, Gottlieb said, its most important harm is that it addicts people to smoking.

“We believe that in a world where we are rendering combustible cigarettes no longer addictive, we can take a more balanced approach to some of the newer innovations that might have the potential to help current combustible cigarette smokers transition to products that might be less harmful,” he said. “And our regulatory process will help determine whether, in fact, those products are less harmful.”

A press release issued Friday stated that the agency plans to issue an Advance Notice of Proposed Rulemaking (ANPRM) “to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.”

During the media call, Mitch Zeller, JD, who directs the FDA’s Center for Tobacco Products, said the ongoing debate in public health about whether e-cigarettes are harmful or helpful is a distraction.

“I think all sides would hopefully look at what we are doing as advancing and promoting public health, and acknowledging that there is a continuum of risk, and there are more and less harmful ways for nicotine to be delivered. In a properly regulated marketplace there is an appropriate place for the least harmful forms of nicotine delivery, whether its medicinal nicotine products or electronic cigarettes.”

“This is an opportunity to re-frame the debate,” he added. “Yes, we need to ask some tough questions about the benefits and potential risks of any new technology, but these questions should be asked through re-framing.”

Where smokeless tobacco products fit into the “continuum of risk” scheme was not addressed directly.

Eric Lindblom, JD, former director of the FDA Center for Tobacco Products’ Office of Policy, was highly critical of the FDA’s action to delay regulatory action on e-cigarettes, calling it “seriously troubling” in a press statement.

“If the FDA were truly concerned about protecting the public health, the agency would not extend the deadlines at all, or it would at least extend the deadlines only for those e-cigarettes and cigars that meet certain minimum standards and only for those smaller tobacco companies that might not have sufficient resources to meet the existing deadlines,” he said.

Lindblom currently directs the Tobacco Control and Food & Drug Law Program at Georgetown Law’s O’Neill Institute for National & Global Health Law in Washington, D.C.

He was also highly skeptical of the FDA plan to seek input on the proposed reduction of combustible cigarette nicotine levels through an ANPRM.

“FDA Advanced Notices of Proposed Rulemaking have, so far, been where good tobacco control ideas go to die or be delayed,” he said, noting that the agency has issued previous ANRPMs on control measures such as banning menthol-flavored cigarettes, with no action being taken.

“If FDA were serious about reducing nicotine levels, it could quickly issue a proposed rule now to get all the comments they would need before issuing a final rule and start saving some lives.”

Gottlieb also vowed to seek public comment through ANPRMs to further explore the role of flavors, including menthol, in attracting kids and teens to tobacco products.

The American Thoracic Society applauded the action in a statement issued Friday afternoon, while expressing concern about FDA’s role in tobacco regulation moving forward.

“While we are encouraged that FDA Commissioner Gottlieb indicated the agency intends to develop new regulations on flavored tobacco products that appeal to children and adolescents and consider banning menthol, we are concerned about the agency’s intent on tobacco regulation overall, including the signaling of potential regulatory exemptions for premium cigars. The ATS will continue to monitor the FDA’s progress to ensure the best possible outcome for children and adults,” the statement read.

The following is the what has happened within these past five month:  

FDA’s Tobacco Policy Pivot, Five Months Later

Not much movement on making cigarettes non-addictive

by Salynn Boyles, Contributing writer  January 02, 2018

In late July, FDA Commissioner Scott Gottlieb, MD, announced a major pivot in tobacco policy aimed at shifting the federal government’s regulatory focus from nicotine to combustible tobacco products. Click here to read MedPage Today’s original report on the announcement. In this follow-up story, we review what has transpired in tobacco regulation since then.

In that announcement, Gottlieb outlined a multi-pronged strategy:

  • Reducing the nicotine in traditional cigarettes to non-addictive levels
  • Increasing the number of approved nicotine replacement therapies (NRT)
  • Acknowledging the potential of other, non-combustible nicotine-delivery products to help smokers quit — recognizing a “continuum of risk for nicotine-containing products,” as Gottlieb put it

“The regulatory framework for reducing harm from tobacco must include nicotine — as a centerpiece,” Gottlieb wrote in an editorial explaining the policy shift published in the New England Journal of Medicine.

“Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kills hundreds of thousands of Americans each year,” he wrote. “The FDA’s approach to reducing the devastating toll of tobacco use must be rooted in this foundational understanding: other chemical compounds in tobacco, and in the smoke created by combustion, are primarily to blame for such health harms.”

Specific actions outlined by the agency in the late July announcement included a plan to formally seek input on dramatically lowering nicotine levels for combustible cigarettes under an Advanced Notice of Proposed Rule Making, and the delay of key regulatory actions on electronic cigarettes, cigars, and previously unregulated tobacco products.

Movement ‘Slower than Promised’

The comprehensive tobacco policy was generally praised by anti-tobacco groups at the time as a potentially positive step forward for reducing tobacco-related death and disease in the United States, while they uniformly criticized the plan to delay key deadlines for the regulation of electronic cigarettes and other tobacco products that came under the FDA’s authority in 2016.

In a press release issued in response to the FDA’s shift in tobacco policy, Robin Koval of the anti-tobacco group Truth Initiative agreed with Gottlieb’s conclusion that reducing the addictive ability and appeal of combustible tobacco products “is a cornerstone of protecting the public health.”

“Ultimately, while we are strongly supportive of the goals set forth by Commissioner Gottlieb today, our optimism is tempered by the ongoing delays in implementing measure that will have an impact on the death and disease caused by tobacco.”

Campaign Tobacco-Free Kids’ (CTFK) president Matthew Myers called Gottlieb’s sweeping tobacco regulatory agenda “a bold and comprehensive vision with the potential to accelerate progress” in reducing tobacco-related disease and death.

But, in a press release, Myers also noted that with regard to implementing the vision, “the devil is in the details.”

Five months later, Myers says that, while there are signs the FDA moving forward with key areas of the agenda, it’s been slower than promised.

“I would now say the devil is in the follow-up,” Myers told MedPage Today in a Dec. 27 telephone interview.

He said the FDA had promised to issue an Advanced Notice of Proposed Rule Making (ANPRM) by the end of the year to formally begin the dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.

Other proposed ANPRMs include seeking public comment about whether FDA should eliminate flavors, including menthol, from little cigars and other tobacco products and seeking comment on whether the agency should reconsider its jurisdiction over certain forms of cigars.

Myers said CTFK received notice about a week ago that the ANPRM proposals have been sent to the Office of Management and Budget, but they have not been published yet.

“The public hasn’t seen them, so it is impossible to know how effectively they will move the ball forward,” Myers said.

“Whether Dr. Gottlieb’s July announcement turns into a significant and meaningful step forward depends on what happens in 2018 — not what he said in 2017,” Myers added.

NRT Steering Committee Appointed

One step forward came late last month. Gottlieb, along with Mitchell Zeller, JD, and Janet Woodcock, MD — heads of the FDA’s tobacco and drugs divisions, respectively — announced formation of a Nicotine Steering Committee with the aim of increasing the number of nicotine replacement therapies (NRTs) available for smokers who want to quit.

The FDA officials noted that while around 70% of adult smokers in the U.S. report wanting to quit and nearly half try to quit each year, only a small percentage succeed.

Myers said the goal of streamlining the reviewing process for NRTs regulated under Woodcock’s Center for Drug Evaluation and Research is a good one.

“We have over 36 million smokers, yet during the last 15 years there have only been three products approved to help smokers quit,” he said. “FDA has to do more to encourage innovation for smoking cessation.”

But he added that any effort to recognize electronic cigarettes or other recreational, non-combustible devices as nicotine delivery therapies for smoking cessation would be premature.

The studies examining the potential of e-cigarettes to help smokers quit have been contradictory and, Myers said, largely poor in quality.

“The bias of the researcher going in is the biggest predictor of what they will find,” he said. “It’s the FDA’s job to be the independent arbiter and demand good science. So far, it has been slow to do that.”

Tobacco researcher Stanton Glantz, PhD, told MedPage Today that while the research conducted to date suggests e-cigarettes can help a subset of smokers quit, they also have been shown to suppress smoking cessation among a larger group of adult smokers and promote the initiation of cigarette smoking among teens.

Glantz, who has long been critical of nicotine products, directs the Center for Tobacco Control Research and Education at the University of California San Francisco.

“If the FDA comes to the conclusion that smokers should be encouraged to shift to these less dangerous forms of nicotine, that would be inconsistent with what the evidence shows,” he said.

Considering Approval of ‘Heat-not-Burn’ Products

The FDA is currently reviewing tobacco giant Philip Morris’ proposal to sell its ‘heat-not-burn’ product IQOS in the U.S., and to market it as a reduced-harm device for nicotine delivery.

While news reports suggest that approval could come as early as February, both Myers and Glantz indicated that this timeline is wildly optimistic, given that the application is not complete and has not been considered by the FDA’s tobacco science advisory committee.

“Anyone who makes that prediction is shilling for the company,” Myers said. “Philip Morris International is spending literally millions of dollars to promote the notion that [IQOS] should and will be approved. There is no objective evidence that FDA has a point of view on this product yet.”

Earlier this month, Reuters published an investigative report detailing Philip Morris’ efforts to promote IQOS to health officials around the world as a safe alternative to combustible cigarettes.

Reuters said it “identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials that underpin the tobacco giant’s application to the FDA.”

Glantz recently sent a letter to the agency’s Tobacco Products Scientific Advisory Committee (TPSAC) urging it to delay action on the application until all public comments have been submitted and the application process is complete.

The TPSAC is scheduled to meet late next month to consider the IQOS application.

Reference:  Indian J Med Paediatr Oncol. 2015 Jan-Mar; 36(1): 24–31.

Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.

She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – two daughters-in-law; Suzy and Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with husband Gordon Duff, many cats, two rescue pups, and two guinea pigs.

Carol’s Archives 2009-2013

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  1. Nicotine and cocaine/crack addiction should not be compared. Almost everyone who has used both finds nicotine more addictive – only because it is legal does it cause less social damage.

    I have seen enough penniless persons digging cigarette butts out of public ash trays to pick out the bits of unburned tobacco to roll a smoke to never want to go near the stuff.

    As for cigars, I would rather smell burning household rubbish than cigar smoke.

  2. I loved smoking but quit when my son was two. I smoked until bedtime put a 21mg patch on my shoulder, so I would wake up with some nicotene in my system, and never smoked again. I did the 21mg patch for two weeks then the fourteen and finally the seven. After five days on the seven I said to myself f— this I’m done. You get real moody and fussy; probably written up at work. But most people will be very supportive in your endevour. Best wishes to anyone out there that tries to quit. I thought I would share what helped me to quit. I will say this; to this day, tobacco still scares me. I want nothing to do with it and hate second hand smoke. A friend once admonished me that the second hand smoke avoidance was nonsense and I replied that I don’t like the smell of dog shit either, again, best of luck to anyone quitting.

  3. Eduardo, There are no addictive additives added to tobacco. Nicotine is its own drug and one of the most addictive. Carol

  4. cinthiamaccioli, Many people drive without wearing seat belts and if they are not in an accident, no one is any the wiser and well, they never needed that seat belt anyway because they were not going to be in an accident, and…..and…..You advocate for big tobacco to control the health, lives, money for millions because you think tobacco is not a real threat to the human body. I don’t know…maybe we should not worry about global warning since this also has been hammered into our brains. Smoking is a conscious choice and sometimes, just sometimes someone will have a second thought about his or her choice and will get rid of a sure fire health insult. Nothing gets a free pass around here. Carol

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