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FDA needs to extend the public comment period on PM MRTP for iQOS

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Nicotine is still nicotine, no matter the delivery system, and it’s still bad for you

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Wait, What? Tobacco Giant Backs Foundation to End Smoking

An old adage in journalism states that when a dog bites a man, it’s not news. But when a man bites a dog, now, that’s news. Well, the proverbial man just bit the dog in the form of a nearly $1 billion pledge to reduce smoking from the maker of Marlboro cigarettes.

https://www.insidephilanthropy.com/home/2017/9/18/turning-over-a-new-leaf-tobacco-giant-backs-foundation-to-end-smoking-1

Philip Morris International will donate $80 million a year for the next 12 years to the recently launched Foundation for a Smoke-Free World. The new foundation stresses independence from its donors and their agendas, but so far, the company behind Marlboro is its only backer.

The donation comes as Philip Morris is said to be preparing for a smoke-free future. More than 3 million smokers have switched to the company’s e-cigarette IQOS, according to Bloomberg. IQOS heats tobacco to produce a vapor instead of burning it, which the company believes makes it less harmful than conventional cigarettes. The company asked the FDA to approve marketing that sells the product as a device that may reduce the chance of smoking-related diseases.

Derek Yach, the man heading the new foundation, is a vocal supporter of e-cigarettes. The devices, which don’t contain tar, provide a safer alternative for smokers to use while weaning themselves off traditional cigarettes, Yach wrote in a 2015 editorial. Opponents argue that “safer” is not the same as “safe,” and claim that e-cigarettes act as a gateway drug for conventional cigarettes.

Yach is a former World Health Organization official who led the organization’s campaigns against health issues arising from unhealthy diets and smoking. He worked on a global tobacco treaty while at the organization, but has a history of making deals with the devil in the name of progress. Yach worked for PepsiCo for six years after leaving WHO, where he says he pushed the company to make products healthier, including chips with less salt and fat and drinks with less sugar. It’s hard to miss the parallels to Yach’s latest endeavor and its backer.

The Philip Morris donation to the Foundation for a Smoke-Free World was met with skepticism from some.

Deborah Arnott, the CEO of Action on Smoking and Health, a public health charity based in the U.K., criticized the announcement. “Tobacco industry claims can never be accepted at face value,” she said. “The tobacco industry has a terrible track record of funding research designed to support its efforts to block policies to cut smoking.”

Arnott has a point. The tobacco industry has a long and checkered past in meddling in medical and research fields to benefit its bottom line. From the 1920s through the 1940s, the industry leaned heavily on advertising that claimed cigarettes were “physician approved.”

More recently, the industry funded research designed to support the claim that secondhand smoke posed no danger to non-smokers, a review of millions of pages of industry documents revealed. Research proving the opposite was used to support smoking bans in public and private places.

Some worry that the new foundation bankrolled by Philip Morris will also produce research and disseminate information that misleads the public. The International Union against Tuberculosis and Lung Disease denounced the gift as “a billion-dollar bribe the tobacco company hopes will secure it a seat at the table with public health policymakers around the world… Through propaganda, it only has the potential to undermine, delay and obfuscate the work of public health policymakers and advocates who champion evidence-based measures to reduce tobacco use.” The Union said that the company will continue to spend exponentially more money to hook people in poor countries on smoking than on preventive efforts through the foundation.

Although smoking is on the decline in the U.S., tobacco use is still the leading preventable cause of death in the country, according the Center for Disease Control.

Worldwide, tobacco kills about 6 million people a year, which is more than AIDS and malaria combined. The number is projected to rise to 8 million by 2030.

Despite that, there’s not a widespread effort among funders to curb smoking, which is another reason the Philip Morris gift is notable. The two biggest names in the space right now are Bloomberg Philanthropies and the Gates Foundation. Back in 2015, the two teamed up to take on companies like Philip Morris that sue low- and middle-income countries to prevent their governments from enforcing strong tobacco control laws.

The tobacco giant’s intentions and the young foundation’s integrity remain to be seen.

Alternative tobacco product met with government scepticism

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Proposal to tax heat sticks the same as cigarettes

A proposal to tax heat-not-burn tobacco products at the same rate as combustible cigarettes is before the National Assembly, the Korea Herald reported.

http://www.tobaccojournal.com/Proposal_to_tax_heat_sticks_the_same_as_cigarettes.54292.0.html

Legislation to revise three laws governing taxation of tobacco products reportedly has been introduced by Rep Kim Kwang-lim, a member of the Liberty Korea Party. All tobacco products are harmful and should be taxed at the same rate, according to the legislation. Heat-not-burn products are taxed at about half the KRW 3,323 (EUR 2.59) rate for combustible cigarettes, the Herald said.

Philip Morris ‘tobacco sticks’ court prosecution postponed

The heat has come on tobacco company Philip Morris for importing and selling “tobacco sticks”.

http://www.stuff.co.nz/business/industries/93268568/Philip-Morris-tobacco-sticks-court-prosecution-postponed

The company is facing two charges brought by the Ministry of Health over the sticks, called Heets.

The charges were to be called in the Wellington District Court on Friday but at the last minute they were adjourned by agreement until September 7.

That date was for a case review hearing, an indication that the company would plead not guilty although it appeared no pleas were entered.

The ministry said it considered Heets fell into a category of tobacco products for oral use, other than smoking, and so were banned under the Smoke-Free Environments Act.

Heets were described as tobacco sticks heated in an electronic device, rather than being burned like a normal cigarette.

Through a code-protected invitation-only website, the company was marketing its IQOS smokeless electronic devices, which heated the sticks to release the nicotine.

In March the company said it was confident the way it was doing business was legal.

General manager for Philip Morris New Zealand, Jason Erickson, said they complied with all sections of the Smoke-Free Environments Act.

“We are currently making our IQOS device and Heets available to registered adult smokers on a website. If requested, we will provide a demonstration on how to use the IQOS device, which as the Ministry of Health has acknowledged, is a consumer electronics product.”

The two charges the company faced had a maximum $10,000 penalty.

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.

World No Tobacco Day: Effects of shisha or hookah on the heart

Did you know 163.7 million in India consume these smokeless variants and are prone to cardiac ailments?

http://www.thehealthsite.com/news/world-no-tobacco-day-effects-of-shisha-or-hookah-on-the-heart-b0517/

According to statistics, about 6 million people in India die every year due to tobacco consumption and approximately 163.7 million users consume only the smokeless variants like sheesha (shisha or hookah). But still, the number of people dying due to tobacco consumption every year is higher than that due to tuberculosis, HIV-AIDS, and malaria put together. Be it tobacco smoking or use of smokeless tobacco like hookah, every form of tobacco contains more than 30 cancer-causing substances along with nicotine which can cause irreparable damage to the body.

Effects of Shisha on the heart

Dr Manoj Kumar, Associate Director & Head, Cardiac Cath Lab, Max Super Specialty Hospital, Patparganj, New Delhi, says, ‘Smokeless tobacco and sheesha affect the heart in multiple ways. Inhalation of the high levels of carbon monoxide reduces the oxygen-carrying capacity of the blood, leading to an overall drop of oxygen circulating in the body. This causes a drastic increase in the heart rate and blood pressure leading to a lot of exertion on the cardiovascular system. People addicted to such forms of tobacco are more prone to cardiac arrest, high blood pressure, stroke, haemorrhage, blood clot and other heart-related ailments. People with a risk of cardiac ailments or a history of cardiac arrest have twice the risk of mortality if they continue the usage of snuff or other smokeless tobacco products even after an attack.” Here are more side effects of hookah.

Is a sheesha bad for you?

There is no safe form of tobacco. Smokeless tobacco and sheesha, two other variants of tobacco, are equally harmful to heart health. Those forms of tobacco which are not burnt are termed as smokeless. Sheesha, on the other hand, is a form of fruit-flavored tobacco which is roasted in a foil along with charcoal and passed into a small chamber of water through a glass-bottomed pipe, which is then inhaled slowly. The WHO points that the total volume of smoke and carcinogens inhaled during an hour-long session of sheesha is equivalent to smoking 100 to 150 cigarettes with an average sheesha user inhaling approximately one-sixth of a litre of smoke in just one inhale.

Dr Santosh Kumar Agarwal, Senior Interventional Cardiologist, Kailash Hospital and Heart Institute, Noida, says “All forms of tobacco are dangerous to smokers and non-smokers alike. The nicotine in tobacco is what makes people addicted to it. Whether it is smoking or chewing, tobacco damages blood vessels, temporarily raises blood pressure and lowers exercise tolerance. It also reduces the oxygen-carrying capacity of blood and increases the tendency for blood to clot. Blood clots in the arteries can further cause a range of heart problems, which ultimately result in a stroke or sudden death.’ Read more on hookah or cigarettes, which is more harmful?

How to quit smoking hookah?

Here are some tips to try and quit this deadly habit.

1. Try short-acting nicotine replacement therapies such as nicotine gum, lozenges, nasal sprays, or inhalers. These can help you overcome intense cravings.

2. Identify the trigger situation, which makes you smoke. Have a plan in place to avoid these or get through them alternatively.

3. Chew on sugarless gum or hard candy, or munch raw carrots, celery, nuts or sunflower seeds instead of tobacco.

4. Get physically active. Short bursts of physical activity such as running up and down the stairs a few times can make a tobacco craving go away. Also read about 7 simple ways to control the urge of ‘just one puff’!

Disclaimer: TheHealthSite.com does not guarantee any specific results as a result of the procedures mentioned here and the results may vary from person to person. The topics in these pages including text, graphics, videos and other material contained on this website are for informational purposes only and not to be substituted for professional medical advice.

Smokers Undeterred as Bills Keep Rising

Since the beginning of the past fiscal year (ended in March) the taxes collected on tobacco products are paid to the Health Ministry (50%), Education Ministry (25%) and Ministry of Sports and Youth Affairs (25%) for anti-smoking campaigns

https://financialtribune.com/articles/people/65335/smokers-undeterred-as-bills-keep-rising

Iranians spend $1-1.5 million (40 to 50 billion rials) on tobacco products each day and the cost of treating tobacco-related disease is almost three times more than the amount spent on tobacco consumption.

During the past five years, the rate of tobacco consumption has only slightly decreased, studies conducted by the Health Ministry indicate. The rate is still high among adolescents and young people (the peak age for first trying of smoking has decreased from 13 to 10). The figure has also increased dramatically compared to the past decade, the Persian language weekly ‘Salamat’ reported.

“In 2006, Iranians smoked 50 billion cigarettes (worth $33.3 million). The figure reached 60-70 billion cigarettes in 2016,” said Dr Mohammadreza Madani, head of the Iranian Anti-Tobacco Association (IATA).

Another concern is the high prevalence of hookah (water pipe) for smoking flavored tobacco among young people. One hour of smoking hookah exposes a smoker 100-fold to the amount of smoke inhaled from a single cigarette. Even those people around a hookah smoker inhale smoke equal to 10 cigarettes.

Every year on May 31, the WHO marks World No Tobacco Day (WNTD), highlighting the health and additional risks associated with tobacco use, and advocating effective policies to reduce tobacco consumption.

The theme for World No Tobacco Day 2017 is ‘Tobacco – a threat to development.’

But irrespective of the programs to create awareness on the harmful effects of smoking, statistics show that 14-15% of Iranians from the 80 million population are regular cigarette smokers (more than 3% are women, and 20% men).

“Though most of the cigarette smokers are men, hookah smoking doesn’t vary by gender; 21.3% of women and 21.7% of men are hookah smokers,” Madani said.

Dodging Taxes

Iran is one of the nations that has signed the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), by which a country is committed to reduce the rate of tobacco consumption every year (by implementation of both price and tax measures as well as non-price measures to reduce demand for tobacco).

Pointing to Article 8 of the National Comprehensive Law on Tobacco Control, Madani said, “According to the law passed in 2006, every year taxes on cigarettes should be increased by 10%.”

“However, there have been always obstacles in its implementation. For example, in 2010 the figure decreased to 5% due to ‘manipulative tactics’ by the powerful tobacco lobby. Tobacco producers said that high taxes on cigarettes would lead to an increase in cigarette smuggling, and thus managed to reduce the tax.”

However, in January this year, lawmakers passed cigarette and tobacco tax slabs to be implemented under the sixth five-year economic development plan (2017-22).

Based on the new law, the tax slab on locally-produced tobacco and cigarettes is 10%; for local brands jointly produced by domestic and foreign manufacturers, it is 20%; for domestically produced cigarettes with foreign brand names the slab is 25%; and for imported cigarettes and tobacco, it is 40%.

Lawmakers also mandated the Ministry of Industries, Mining and Trade to announce the retail prices of cigarettes and all tobacco products to the relevant authorities for taxation purposes and for printing the tax rates on cigarette packs.

“Since the beginning of the past fiscal year (ended in March) the taxes collected on tobacco products are paid to the Health Ministry (50%), Education Ministry (25%) and Ministry of Sports and Youth Affairs (25%). The Education Ministry is required to spend the money on increasing students’ awareness of harms associated with tobacco smoking,” Madani said.

Earlier, the tax money was given to the ministries of health and sports and youth affairs.

Facts About Tobacco

There are more than 7 million deaths from tobacco use every year, a figure that is predicted to cross 8 million by 2030 without effective and intensified action. Tobacco consumption is a threat to any person, regardless of gender, age, race, cultural or educational background. It brings suffering, disease, and death, impoverishing families and national economies.

Tobacco use costs national economies enormously through increased healthcare costs and decreased productivity. Some 80% of premature deaths from tobacco occur in low- or middle-income countries, which face increased challenges to achieving their development goals, the WHO website reports.

Tobacco growing requires large amounts of pesticides and fertilizers, which can be toxic and pollute water supplies. Each year, tobacco growing uses 4.3 million hectares of land, resulting in global deforestation between 2% and 4%. Tobacco manufacturing also produces over 2 million tons of solid waste.

By increasing cigarette taxes worldwide by $1, an extra $190 billion could be raised for development. High tobacco taxes contribute to revenue generation for governments, reduce demand for tobacco, and offer an important revenue stream to finance development activities.

Rise in Lung Adenocarcinoma Linked to ‘Light’ Cigarette Use

A new study shows that so-called “light” cigarettes have no health benefits to smokers and have likely contributed to the rise of a certain form of lung cancer that occurs deep in the lungs.

http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=1618

For this new study, researchers at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC–James) and five other universities/cancer centers examined why the most common type of lung cancer, called adenocarcinoma, has increased over the past 50 years, rather than decreasing as smokers have been able to quit. Other types of lung cancer have been decreasing in relationship to fewer people smoking, but not lung adenocarcinoma. Because of this, lung adenocarcinoma is now the most common type of lung cancer.

Results confirm what tobacco-control researchers have suspected for years: There is no health benefit to high-ventilation (light) cigarettes–long marketed by the tobacco industry as a “healthier” option–and these cigarettes have actually caused more harm. Holes in cigarette filters were introduced 50 years ago and were critical to claims for low-tar cigarettes.

“This was done to fool smokers and the public health community into thinking that they actually were safer,” said Peter Shields, MD, Deputy Director of the OSUCCC–James and a lung medical oncologist. “Our data suggests a clear relationship between the addition of ventilation holes to cigarettes and increasing rates of lung adenocarcinoma seen over the past 20 years. What is especially concerning is that these holes are still added to virtually all cigarettes that are smoked today.”

The FDA was given the authority to regulate the manufacture, distribution, and marketing of tobacco products through the Family Smoking Prevention and Tobacco Control Act in 2009. Current regulations ban tobacco companies from labeling and marketing cigarettes as “low tar” or “light.” Study authors, however, say that given this new data, the FDA should take immediate action to regulate the use of the ventilation holes, up to and including a complete ban of the holes.

“The FDA has a public health obligation to take immediate regulatory action to eliminate the use of ventilation holes on cigarettes,” added Shields. “It is a somewhat complicated process to enact such regulations, but there is more than enough data to start the process. We believe that such an action would drive down the use and toxicity of conventional cigarettes, and drive smokers to either quit or use less harmful products. There are some open questions about unintended consequences for enacting a ban, which provides for an important research agenda.”

A team made up of lung oncology, public health, and tobacco regulation researchers conducted a comprehensive, multi-faceted analysis of existing literature that included chemistry and toxicology studies, human clinical trials and epidemiological studies of both smoking behavior and cancer risk. They studied scientific publications in the peer-reviewed literature and internal tobacco company documents.

Researchers hypothesized that the higher incidence rates of lung adenocarcinoma were attributable to the filter ventilation holes, which allow smokers to inhale more smoke that also has higher levels of carcinogens, mutagens and other toxins.

“The filter ventilation holes change how the tobacco is burned, producing more carcinogens, which then also allows the smoke to reach the deeper parts of the lung where adenocarcinomas more frequently occur,” explained Shields.

To date, all the scientific evidence involves the adverse impact of adding ventilation, but not removing it. Additional research is needed to confirm that the addictiveness of the cigarette or toxic exposures from cigarettes would not increase with elimination of the ventilation holes. The OSUCCC–James and researchers at the University of Minnesota, Roswell Park Cancer Institute, Virginia Tech, Harvard University and Medical University of South Carolina are conducting additional research to reconcile human biomarkers studies and smoke distribution/exposure in the lung.