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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.

Justice Ministry says iQOS product will be treated as ordinary tobacco

Previously, the company asked the US Food and Drug Administration to recognize iQOS as “modified-risk product.”

http://www.jpost.com/Business-and-Innovation/Health-and-Science/Justice-Ministry-says-iQOS-product-will-be-treated-as-ordinary-tobacco-485912

The world’s largest tobacco company, Philip Morris International, faced an obstacle in Israel that has apparently influenced its position toward its heated-tobacco product iQOS.

Previously, the company asked the US Food and Drug Administration to recognize iQOS as “modified-risk product.”

Last week, Israel’s Justice Ministry notified the company that it accepted the position of three voluntary organizations in Israel that the product is actually a “tobacco product,” and all the restrictions that apply to tobacco products should apply to iQOS.

In parallel, Philip Morris reversed its previous position towards the FDA and now wants iQOS to first be recognized as a “tobacco product.”

The small Society for Progressive Democracy thus “made history,” as the new position will set the definition of the product for deliberations by the FDA.

The Israel Medical Association, the Israel Cancer Association and the small Society for Progressive Democracy thus “made history,” as the new position will set the definition of the product for deliberations by the FDA.

While the Israel Cancer Association and the Israel Medical Association sent letters to the authorities to protest against Health Minister Ya’acov Litzman for preventing restrictions on the sale and marketing of iQOS in Israel, the Society for Progressive Democracy headed by lawyer Shabi Gatenio actually applied to the High Court of Justice and asked for an Injunction againt him.

“It is a story of the little David toppling Goliath, Philip Morris,” commented lawyer Amos Hausner, the chairman of the Israel Council for the Prevention of Smoking.

The limitations that now apply to all tobacco products will include iQOS, such as prohibiting its sale to minors, prohibiting smoking it in all public places where conventional cigarettes may not be smoked, excluding it from advertising in the electronic media and media for children and teens, and other restrictions for which violators are fined.

Under the rules of administrative law, the position of Justice Ministry professionals is binding upon all governmental agencies in Israel, and their position supersedes the one expressed by any political figure – in this case, the health minister.

Attorney-General Avichai Mandelblit has yet to decide on a petition by Avir Naki, a voluntary organization that aims to fight smoking, to prohibit Litzman from having any involvement in decisions on tobacco matters.

Dubek, the Israel tobacco producer and importer, has also filed an application in the High Court against Litzman, arguing that he was giving Philip Morris benefits that Dubek did not enjoy.

Hausner said that Philip Morris “officially changed its position here while its application was pending in the FDA, as a negative consequence in Israel might have negatively influenced the company’s position in its deliberations with the US over iQOS. We clearly learn from this case that politicians cannot determine policy on major public health issues like this; they must leave it to ministry professionals to set policy.

It turned out that Litzman was more protective of Philip Morris than the company itself demanded. As to Philip Morris, Hausner said that their products should meet the requirements of professionals and not only of the politicians.”

Commenting on the Justice Ministry decision, Philip Morris Ltd.’s spokesman in Israel said that it would “continue to market iQOS in Israel in a responsible way according to law so that adult smokers would have better alternatives than continuing to smoke cigarettes.”

The ministry said in a statement after the court decision was announced that “while waiting for the FDA’s position, we plan at this stage to place on the product all restrictions on tobacco products regarding marketing, advertising and smoking in public places.”

FDA delays ‘other use’ rule for tobacco-derived products

The Food and Drug Administration (FDA) pushed back by one year a rule to clarify when products derived from tobacco face regulation as drugs or combination products.

http://www.tobaccojournal.com/FDA_delays_other_use_rule_for_tobacco-derived_products.54153.0.html

Initially set to take effect in February, the FDA first delayed implementation by one month and now intends for it to take effect on 19 March 2018. An additional comment period will expire on 19 May 2017. Additional information is available at: https://goo.gl/BrQooq

FDA’s New Database on Grandfathered Tobacco Products

Industry group offers additional clarity on resource

Thomas A. Briant

MINNEAPOLIS — Feb. 15, 2007, is an important date in the Family Smoking Prevention and Tobacco Control Act, the law that Congress passed to authorize the U.S. Food and Drug Administration (FDA) to regulate tobacco products. That date is known as the “predicate date” or “grandfather date.” Every tobacco product that was on the market as of Feb. 15, 2007, is grandfathered, which means that special applications do not need to be filed with the FDA to keep those products on the market.

Just last week, the FDA announced that it has included on its website a searchable database to determine whether a tobacco product is grandfathered. Click here to access that database. To use it, type in the tobacco product name, the name of the manufacturer, select the product category from the drop-down list and then click the search button. The search results will inform you if the product is grandfathered.

However, there is some confusion about the completeness and accuracy of the FDA’s grandfathered database. The Coalition of Independent Tobacco Manufacturers of America (CITMA), Richmond, Va., has issued a letter to its members outlining the issues with the FDA grandfathered database and allowed NATO to disseminate the letter.

Specifically, the CITMA letter indicates that a FDA grandfather determination is not required to sell a grandfathered tobacco product and this has resulted in some grandfathered tobacco products not being included in the database. This means the FDA database only includes those tobacco products that were the subject of a voluntary grandfather-determination request submitted to the agency by a manufacturer. In other words, the database does not include those grandfathered tobacco products for which a voluntary grandfather-status application was not submitted. Also, CITMA indicates that the grandfathered database does not include those tobacco products that receive grandfather status through a substantial-equivalency application submitted to the FDA by a manufacturer.

In its letter, CITMA reports that the coalition has requested the FDA to issue a statement clarifying that the grandfathered database does not include all legally marketed, grandfathered tobacco products.

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