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FDA should revise its new guidance on listing of ingredients in tobacco products

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Pivotal public health step to dramatically reduce smoking rates

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601039.htm

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

When I returned to the U.S. Food and Drug Administration last year, it was immediately clear that tackling tobacco use – and cigarette smoking in particular – would be one of the most important actions I could take to advance public health. With that in mind, we’re taking a pivotal step today that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or switch to potentially less harmful products. As part of our comprehensive plan on tobacco and nicotine regulation announced last summer, we’re issuing an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels. This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country.

Despite years of aggressive efforts to tackle the leading cause of preventable disease and death in the United States, tobacco use – largely cigarette smoking – still kills more than 480,000 Americans every single year. Tobacco use also costs nearly $300 billion a year in direct health care and lost productivity. In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users. Given their combination of toxicity, addictiveness, prevalence and effect on non-users, it’s clear that to maximize the possible public health benefits of our regulation, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes.

The ANPRM being issued today provides a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard. We’re interested in public input on critical questions such as: what potential maximum nicotine level would be appropriate for the protection of public health?

Should a product standard be implemented all at once or gradually? What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result? As we explore this novel approach to reducing the death and disease from combustible cigarettes, it’s critical that our policies reflect the latest science and is informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment.

We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort. Notably, new estimates included in the ANPRM that are being published in the New England Journal of Medicine evaluate one possible policy scenario for a nicotine product standard. If this scenario were implemented, this analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation. And with this scenario, an even greater impact could be felt over time: by the year 2100, the analysis estimates that more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. And smoking rates could drop from the current 15 percent to as low as 1.4 percent. All told, this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century – an undeniable public health benefit.

No statistical model can truly capture the full impact of this effort – including the joy from years of quality life gained with a loved one, or how much pain and suffering would be avoided for millions of families across the country. But what we’re learning about the significant public health promise of this approach leaves me encouraged and optimistic. Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes. And this unprecedented public health opportunity, contrasted against the cost of doing nothing, weighs heavily on me.

We’re at a crossroads when it comes to addressing nicotine addiction and smoking in this country – with important new tools to address this devastating public health burden. And although a potential nicotine product standard for cigarettes is the cornerstone of our approach, we also continue to push forward on additional pieces of the FDA’s multi-year plan designed to work in concert to better protect kids and significantly reduce tobacco-related disease and death. We said from the outset that ours was a comprehensive approach that requires us to pursue all of its parts in tandem.

For example, our plan demonstrates a greater awareness that nicotine, while highly addictive, is delivered through products on a continuum of risk, and that in order to successfully address cigarette addiction, we must make it possible for current adult smokers who still seek nicotine to get it from alternative and less harmful sources. To that end, the agency’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms. This will be achieved through our ongoing regulatory work to develop several foundational rules, guidances, product standards and other regulations. At the same time, we plan to take vigorous enforcement steps to make sure that tobacco products aren’t being marketed to kids, including e-cigarettes. No youth should use a tobacco product.

In addition, as we advance our framework to protect public health in the evolving tobacco marketplace, the FDA also plans shortly to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use and cessation of tobacco products. A second ANPRM will solicit additional comments and data related to the regulation of premium cigars. At the same time we’re also jump-starting new work to re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches and lozenges that help smokers quit. This is a pivotal part of our overall public health approach.

Finally, we also plan to take new steps to make sure that our policies and processes for the regulation of tobacco products are efficient and predictable, and consistent with the mandate Congress gave us under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). We’re committed to making sure that we have transparent regulatory policies and best practices in place to maximize our public health impact. To these ends, we plan to issue a series of foundational rules and guidance documents that will delineate key requirements of the regulatory process, such as the demonstration of substantial equivalence and the submission of applications for new tobacco products. We also plan to release soon a framework for how we’ll address the so-called provisional substantial equivalence applications. These are for products that entered the market during a grace period set up in the law and for which companies submitted reports to demonstrate that the new product has the same characteristics as a predicate product, or has different characteristics, but such differences do not cause the new product to raise different questions of public health. These “provisional” products can remain on the market unless the FDA finds them not substantially equivalent. Our new framework aims to provide more clarity by delineating between individual provisional applications which the FDA intends to continue to review to reach a final determination on whether they can remain on the market and those provisional applications that the agency does not intend to review further and which can continue being sold.

All of these efforts complement our ongoing work to educate kids about the dangers of all nicotine-containing products, limit youth access and encourage adults to quit smoking cigarettes.

We believe this unprecedented approach to nicotine and tobacco regulation not only makes sense, but also offers us the best opportunity for achieving significant, meaningful public health gain. As we move forward with these efforts, we have an opportunity to more formally solicit feedback, and we’ll continue to foster a public dialogue to re-shape our country’s relationship with nicotine and seek public input on policies that will guide us toward a healthier future.

Today’s ANPRM is a significant step in our efforts to confront nicotine addiction in combustible cigarettes. This milestone places us squarely on the road toward achieving one of the biggest public health victories in modern history and saving millions of lives in the process.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Cellular evidence on how nicotine and e-cigarettes increase cancer risk in humans (and mice)

Clear the Air says:

Without addictive nicotine content in cigarettes and electronic versions, people would not be addicted and would not need to smoke.

The ‘95% safer’ NUTT biased pushers and PHE always state: it’s not the nicotine, it’s the combustion and  tar.

As numerous new peer reviewed research articles appear on previously undiscovered pathogenic effects of vaping and nicotine, the likelihood of major lawsuits against PHE grows progressively stronger.

These recent findings (attached) show the way forward to researchers to discover how both nicotine and e-cig vapour, even without nicotine, adversely affect DNA or lead to cellular mutations, creating cancerous chemicals in the body like NNN and NNK, even though such chemicals were not present in the ingested e-cig vapour.

Such mutation evidence probably already exists within carefully hidden tobacco industry research using outside contractors.  Time to offer a Bloomberg/Gates Whistleblower Bounty?

Detailed independent research concentration on e-cig vapour and  nicotine effects on cellular level mutations in DNA could lead to a possible ban on nicotine by Governments = game over for Big Tobacco.

This is the Real End Game – Ban Nicotine.

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IQOS emissions create risks of immunosuppression and pulmonary toxicity

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Advancing Medicinal Nicotine Replacement Therapies as New Drugs

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FDA Trouble Ahead For Vaporizer Stocks?

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Is Vaping As Harmful As Smoking Cigarettes? Here’s What You Need To Know

Vaping seems to have taken the mantle of becoming the healthier alternative to smoking, along with the fact that they were designed with the motive to help smokers eventually quit.

http://www.indiatimes.com/health/healthyliving/is-vaping-as-harmful-as-smoking-cigarettes-here-s-what-you-need-to-know-324703.html

In fact, the trend has caught on so rampantly that it’s set to outsell traditional cigarettes by the end of 2023!

With the FDA regulating these products since 2016, it comes as no surprise that vaping is due to become the norm, surpassing traditional smoking in time to come.

In a report on the use of e-cigarettes in Canada, a report previously stated that “Among those whose primary reason for use is to help to quit tobacco, a similar proportion no longer smoke (24%), and this may be considered the success rate for this method of smoking cessation.”

How is vaping different from smoking?

To differentiate itself from tobacco products, vaping is the process of smoking nicotine without inhaling the other harmful substances in tobacco—out of which there 70 known carcinogens. Some products contain little to no nicotine in them. Canada for instance still does not approve of nicotine-containing e-cigarettes.

These battery-powered devices heat the liquid that contains nicotine and/or other flavours, which in turn is inhaled as the vapour.

There is no smoke without fire, however

Since the key objective of switching to e-cigarettes is to cut down the number of cigarettes you smoke, researchers have been assessing the ‘relative harm’ vaping can cause to your tissues.

A study conducted by Jessica Wang-Rodriguez, a head and neck cancer specialist at the University of California at San Diego and her team found that cells lining human organs sustained up to twice the DNA damage seen in unexposed cells. They were also five to 10 times more likely to wither and die than unexposed cells even if the vapour contained no nicotine, the addictive ingredient in conventional and most electronic cigarettes, as reported in New Scientist.

“Without the nicotine, the damage is slightly less, but still statistically significant compared with control cells,” says Wang-Rodriguez, who led the research.

The toxins from the flavouring are another cause of concern

“E-cigarette vapour is known to contain a range of toxins which include impurities in the e-cigarette liquids and toxins generated when solutions are heated to generate vapour,” says John Britton, a toxicologist at the University of Nottingham, UK. “Some are carcinogenic, so it’s likely some long-term users of e-cigarettes will experience adverse effects on their health, and the authors fo the study conducted by Rodriguez and company are correct to point out that these products should not be considered risk-free,” he says. But if smokers can’t give up completely, e-cigarettes are safer than smoking, he says, as reported in New Scientist.

They caused considerable damage to your key blood vessels; similar to normal cigarettes

A study conducted by researchers at the European Society of Cardiology Congress in Rome states that vaping has an impact similar to the what normal cigarettes have on the stiffening of you heart’s aorta, as reported the Independent, UK.

The lead researcher, Professor Charalambos Viachopoulos of the University of Athens said, “We measured aortic stiffness. If the aorta is stiff you multiply your risk of dying, either from heart diseases or from other causes. “There could be long-term heart dangers. They are far more dangerous than people realise.”

The problem lies with the rising number of teens taking to smoking E-cigarettes

A 2014 high school survey conducted in the US found that 17 percent of 12th graders reported the use of e-cigarettes compared to 14 percent who smoked traditional cigarettes. The lower price points at which they are promoted, their perception of being safer than traditional cigarettes, the various flavours they come in and the fact they’re in trend make it a very attractive option for the youth.

Adolescents and young adults who try e-cigarettes are more than three times as likely to take up smoking traditional cigarettes as their peers who haven’t tried the devices, states a recent research review published in Reuters Health.

E-cigarette use, or vaping, was as least as strong a risk factor for smoking traditional cigarettes as having a parent or sibling who smokes or having a risk-taking and thrill-seeking personality, the researchers found.

“E-cigarette use among teens and young adults could increase the future burden of tobacco by creating a new generation of adult smokers who might have otherwise not begun smoking,” said lead study author Samir Soneji of the Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire.

“To the extent that e-cigarette use mimics the behaviour of smoking a cigarette—handling the e-cigarette, the action of puffing, and the inhalation of smoke—it sets the adolescent up for easily transitioning to smoking,” added Soneji. “Like transitioning from driving a Tesla to driving a Chevy.”

Dr Brian Primack, a researcher at the University of Pittsburgh stated that “Young people report that there is a lot of pressure among e-cigarette only users to smoke a ‘real’ cigarette,” Primack said by email. “It may be somewhat analogous to the fact that teens who use flavoured alcohol are often pressured socially to step up their game to harder forms of alcohol.”

Although e-cigarettes claim to be less harmful than conventional cigarettes it could make sense to pay heed to the lack of conclusive long-term evidence

Cigarette smokers are well aware of the perils of smoking normal cigarettes. The New England Journal of Medicine states that smoking tobacco reduces your life span by at least 10 years. But studies on smoking e-cigarettes remain largely inconclusive.

A review of studies published in the journal Tobacco Control reveals that the long-term effects of the vaporised form are not known yet. For instance, it is not known if the chemical propylene glycol, which is mixed with the other chemicals in e-cigarettes known to irritate the respiratory tract, could result in lung problems after decades of vaping, says Dr Michael Siegel, a tobacco researcher and professor of community health sciences at the Boston University School of Public Health in Live Science.

Besides, “because e-cigarettes have been on the market for only about 10 years, there have been no long-term studies of people who have used them for 30 to 40 years. Therefore, the full extent of e-cigs’ effects on heart and lung health, as well as their cancer-causing potential, over time is not known,” says Stanton Glantz a professor of medicine and the director of the Center for Tobacco Control Research and Education at the University of California, San Francisco to Live Science.

 

The Law on Labels

Noah Steinsapir, general counsel for Kretek International, offers a legal look at what the FDA’s new warning label requirements mean for manufacturers and retailers.

http://tobaccobusiness.com/fda-law-on-warning-labels/

The FDA’s Deeming Regulations are now in full swing, and several deadlines have come and gone since its implementation on August 8, 2016. Currently, the tobacco industry is working hard to comply with the imminent deadlines in connection to the FDA’s new labeling requirements. Manufacturers/importers of cigars are required to submit a rotational warning plan in compliance with FDA regulations by May 10, 2017, and the new labels must be implemented and in commerce no later than May 10, 2018.

The material aspects of the new FDA warning plan are fairly straightforward. Manufacturers and importers of cigars must rotate six warnings:

  1. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale;
  2. WARNING: Cigar smoking can cause lung cancer and heart disease;
  3. WARNING: Cigars are not a safe alternative to cigarettes;
  4. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers;
  5. WARNING: Cigar use while pregnant can harm you and your baby; or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth, and Low Birth Weight; and
  6. WARNING: This product contains nicotine. Nicotine is an addictive chemical.

These rotated warnings must be permanently affixed to the cigar packaging and advertisements. For packaging, the warning must encompass no less than 30 percent of the two principal display panels of the product’s packaging (a principal display panel being defined by the Deeming Regulations as the panels of the package that are most likely to be displayed, presented, shown or examined by the consumer) and no less than 20 percent of the total display area of the advertisement, with the caveat that the warning on advertisements appear in the upper portion of the advertisement within the trim area of the advertisement. The warnings have some other requirements such as font size, capitalization and color.

Although the rule is relatively straightforward, the industry still remains confused in connection with two looming issues: First, how will this warning coalesce with California’s current Proposition 65 warning requirements? Second, how will the timing of selling through products with older warnings on them work?

Prop 65 vs. FDA Warning

For Prop 65, certain industry groups are working to devise a plan. The purpose of California’s Proposition 65 is to warn the consumer and the public at large that tobacco products contain toxic chemicals. The new FDA warning plan achieves California’s objective and does so in a meaningful manner such that 30 percent of the principal display panels of the product’s packaging will notify the consumer of the health warnings of the tobacco product. In terms of size and visibility, the FDA’s rule goes above and beyond what is required by California’s Proposition 65. Therefore, a proposed and reasonable outcome is that California determines that the additional Prop 65 warning is unnecessary, duplicative and may cause customer confusion in light of the new federal guidelines that require such a clear and conspicuous warning. In either event, hopefully the State of California will provide clarity in connection with this issue.

Products Already in the Retail Pipeline
Another common concern is that the May 10, 2018 deadline for implementing the new warning scheme may create challenges in light of the fact that product can sit in a warehouse or on a retail shelf for extended periods of time. This may result in the sale of product without the adequate warning to the consumer after the May 10, 2018 deadline, which would not be the fault of the manufacturer/importer or the retailer. While the answer is not crystal clear yet, the Deeming Regulations appear to have considered this issue and provide a safe harbor to both the manufacturer/importer, as well as to the retailer. The manufacturer and importer appear to be allowed to introduce product without the current warning requirements into commerce up until May 10, 2018. They then have an additional 30 days after this deadline as a safe harbor to continue selling the last of the product.

In addition, retailers appear to be provided a safe harbor as long as the retailer purchased the product from a licensed manufacturer, the packaging contains some type of health warning, and the retailer has not altered the packaging. Both the FDA and the industry want to provide clear and conspicuous warnings so that consenting adults may make informed decisions. With time, the new FDA warning plan will be further clarified.

This story first appeared in the May/June 2017 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma

https://academic.oup.com/jnci/article-abstract/109/12/djx075/3836090/Cigarette-Filter-Ventilation-and-its-Relationship?redirectedFrom=fulltext

The 2014 Surgeon General’s Report on smoking and health concluded that changing cigarette designs have caused an increase in lung adenocarcinomas, implicating cigarette filter ventilation that lowers smoking machine tar yields. The Food and Drug Administration (FDA) now has the authority to regulate cigarette design if doing so would improve public health. To support a potential regulatory action, two weight-of-evidence reviews were applied for causally relating filter ventilation to lung adenocarcinoma. Published scientific literature (3284 citations) and internal tobacco company documents contributed to causation analysis evidence blocks and the identification of research gaps. Filter ventilation was adopted in the mid-1960s and was initially equated with making a cigarette safer. Since then, lung adenocarcinoma rates paradoxically increased relative to other lung cancer subtypes. Filter ventilation 1) alters tobacco combustion, increasing smoke toxicants; 2) allows for elasticity of use so that smokers inhale more smoke to maintain their nicotine intake; and 3) causes a false perception of lower health risk from “lighter” smoke. Seemingly not supportive of a causal relationship is that human exposure biomarker studies indicate no reduction in exposure, but these do not measure exposure in the lung or utilize known biomarkers of harm. Altered puffing and inhalation may make smoke available to lung cells prone to adenocarcinomas. The analysis strongly suggests that filter ventilation has contributed to the rise in lung adenocarcinomas among smokers. Thus, the FDA should consider regulating its use, up to and including a ban. Herein, we propose a research agenda to support such an effort.

Big Tobacco Attacks Sensible F.D.A. Rules on Vaping

As smokers turned to electronic cigarettes to reduce the health risks of smoking, big tobacco companies started buying e-cigarette makers and producing and selling their own. Now those companies are lobbying Congress to prevent the Food and Drug Administration from regulating electronic cigarettes and cigars, as it does conventional cigarettes. If they succeed, they will be able to sell and market addictive nicotine products to young people with few restrictions.

https://www.nytimes.com/2017/04/19/opinion/big-tobacco-attacks-sensible-fda-rules-on-vaping.html?_r=1

While promoters of e-cigarettes and e-cigars, which provide nicotine in vapor form, say they can help people quit conventional tobacco products containing harmful tar, there is not a lot of evidence for that claim. In addition, the devices are dangerous to young people because the nicotine they provide “can cause addiction and can harm the developing adolescent brain,” according to a 2016 report by the surgeon general, Vivek Murthy. Health experts also say that the vapor those devices produce can contain carcinogens and metal particles.

Another government report found that 16 percent of high-school students said they had used e-cigarettes in 2015, up from just 1.5 percent in 2011. The industry sells these products in a broad array of flavors, like gummy bear and cotton candy, designed to appeal to young people when they are more susceptible to becoming dependent or addicted to nicotine.

After years of deliberation, the F.D.A. said last May that it would begin regulating the manufacturing, sale, packaging and advertising of e-cigarettes, and all tobacco products, under a 2009 federal law that authorized it to do so. Specifically, the agency said it would begin reviewing the health risks of e-cigarettes introduced since early 2007, and potentially ban specific flavors and products that it deemed harmful. The tobacco lobby wants Republicans to amend a vital appropriations bill to exempt products that were introduced before May 2016 from F.D.A. review.

The push to undermine the F.D.A.’s authority began even before the agency had finished its rule. One Republican lawmaker, Representative Tom Cole of Oklahoma, introduced a bill in 2015 that was identical to a draft circulated by the Altria Group, the country’s biggest tobacco company and a marketer of vaping products. In addition to its legislative effort, the industry has also filed several lawsuits in federal courts challenging the rule.

Tobacco companies complain that the F.D.A.’s rule amounts to “retroactive” regulation because many of the e-cigarettes and e-cigars it will regulate have been on the market for years. But the industry has known for years that government officials were developing this rule. Large bipartisan majorities in Congress voted in 2009 to hand the agency the authority to evaluate and approve new tobacco products introduced on or after Feb. 15, 2007. The F.D.A. is simply doing its job by protecting public health.