Customs seize illegal knock-offs, tobacco and subsidised fuel

Customs said on Thursday they had made a number of seizures of counterfeit products, tobacco and cigarettes smuggled from the north, hookah pipe tobacco being sneaked though Larnaca airport and subsidised diesel being used in private saloon cars.

In a press release Thursday announcing their successes Customs said police on Wednesday night had stopped and searched a car with Turkish Cypriot plates being driven by a Turkish Cypriot attempting to cross into the government controlled areas through an unauthorised area.

Police discovered 102 shirts and 302 pairs of shoes, all knock-offs of famous brands as well as 800 empty watch boxes also fakes of well-known trademarks in the car. The driver was arrested and the vehicle seized for further scrutiny.

Meanwhile on Thursday morning during a check by customs officers of a passenger arriving on the Qatar flight, an undeclared quantity of 10 kilos of hookah tobacco for nargile pipes was discovered. The traveller was arrested and the tobacco seized. The man was released after agreeing to paying a €2,100 fine and forfeiting the tobacco.

Customs were also kept busy in the areas in and around the British military base of Dhekelia on Thursday when they joined up with the SBA Police to carry out checks to combat the illegal use of tax-free diesel.

A total of 35 cars were tested to see if they were being illicitly fuelled by agricultural, industrial or domestic heating diesel oil. Two of the cars tested were found to be running on industrial diesel while one contained agricultural diesel. All three vehicles were seized but were returned after a total of €2,050 in fines was paid to customs by the owners.

Near the other side of the island, again on Thursday, a coordinated operation by customs and the police took place at Zodia and Astromeritis. Two properties located near the villages, in the buffer zone were search after warrants were issued. Investigators found and seized a total of 350 grammes of tobacco and three cartons of cigarettes which appeared to have been smuggled from the north. Customs came to a €300 out-of-court settlement with the perpetrator.

Resource :http://cyprus-mail.com/2016/06/09/customs-seize-illegal-knock-offs-tobacco-subsidised-fuel/

Government cracking down on hookah bars, e-cigarettes

The provincial government will be regulating e-cigarettes, flavoured tobacco and hookah bars, in legislation, which will be debated in the House of Assembly this afternoon

In many ways, e-cigarettes will be regulated the same way as traditional tobacco products, with bans on selling to people under 19, and bans on certain forms of in-store displays like super-walls.

Flavoured tobacco, including menthol cigarettes, will also be banned.

When the law comes fully into force on July 1, 2017, the changes to the law will also ban hookah bars in Newfoundland and Labrador, and limit the sale and smoking of non-tobacco hookah products.

A few of these measures will come into effect as soon as the bill becomes law — forbidding the sale of shisha and e-cigarettes to people under 19, and smoking e-cigarettes in cars where there’s somebody under 16 in the vehicle.

The bigger chunk of the law — forbidding the sale of flavoured tobacco, banning hookah bars, and bringing e-cigarette regulation in line with tobacco — comes into force on July 1 of next year, a move which is designed to give businesses time to clear inventory.

Ministers Sherry Gambin-Walsh and John Haggie held a news conference Monday to announce the changes.

Both ministers stressed the health reasons for the changes, and Gambin-Walsh said that all the regulations are in line with what other provinces are doing.

jmcleod@thetelegram.com
Resource : http://www.thetelegram.com/News/Local/2016-06-06/article-4551008/Government-cracking-down-on-hookah-bars,-e-cigarettes/1

Tobacco-only hookah ruling misinterpreted: crusaders

The recent ruling by the Karnataka High Court stating that there is no need for a separate license for serving tobacco-only hookahs has raised many eyebrows. The anti-tobacco crusaders say that the judgment has been misinterpreted and there is a mushrooming of hookah bars in the city in the past one month. The joy of the restaurants which have started serving hookahs may be short lived as the rules surrounding serving of hookahs will just get more stringent.

Now, the state tobacco control committee has issued an advisory to the health department and the BBMP to immediately crack down on these hookah bars which are not complying with the Cigarette and Other Tobacco Products Act (COTPA) regulations.
The advisory was issued by Dr Vishal Rao, member of the committee. Speaking to Bangalore Mirror, he said, "The recent order by the High Court has clearly laid down the guidelines for the licences and necessary clarifications with regard to the usage of hookah. But this has been misinterpreted by many people. Just like cigarette smoking, hookah-smoking has been linked to oral cancers, heart disease and other serious illnesses. Many hotels and restaurants are now openly selling hookah as they are under the impression that hookahs don't require licences. This may attract a lot of youngsters, posing a threat to their lives."
The petition was filed by Diamond Enterprises at Jayanagar 4th block. The petitioner had said that when he approached the BBMP to seek a licence, the officials had told him no separate license must be obtained to serve hookah to the customers. The petitioner also appealed before the court to restrain police interference.
Rao met the health minister and the BBMP on behalf of the committee seeking intervention in controlling these hookah bars. "Even though there is no need for a separate licence for the hookah bars, they have to be strictly regulated under the COTPA Act, which has regulations that any restaurant with less than 30 seats cannot have a smoking room and therefore cannot sell hookah as well. The hotels should have separate smoking rooms and there should be nothing else served in that room which includes food and alcohol. It should not be sold within 100 yards of any educational institution. There should be no advertisement at the point of sale of hookah. Wherever there is a sale of tobacco, there should be a pictorial representation suggesting its harmful effects but none of the places that sell hookah are following these rules and this has to be stopped completely."


WHAT LAW SAYS

Even though there is no need for a separate licence for hookah bars, they have to be strictly regulated under the COTPA Act, which says any restaurant with less than 30 seats cannot have a smoking room and therefore cannot sell hookah as well. Hotels should have separate smoking rooms and there should be nothing else served in that room

Resource :http://www.bangaloremirror.com/bangalore/crime/Tobacco-only-hookah-ruling-misinterpreted-crusaders/articleshow/49219285.cms

New FDA Guidelines to Include Hookah and Cigars

ST. LOUIS (KMOX) – By now, we’ve heard all about the U.S. Food and Drug Administration’s (FDA) new e-cigarette guidelines, but did you know other tobacco products are included as well?

In 90 days, it will be illegal to sell e-cigarettes, hookah tobacco or cigars to anyone under the age of 18.

“Great progress in reducing the amount of kids that smoke cigarettes,” says FDA’s Mitch Zeller. “Here’s the problem…every single day in the United States, more teenage boys light up a cigar for the first time, then light up a cigarette for the first time. So, we have extraordinarily high use of cigars by kids.”

In addition, Zeller says a lot of kids are using hookah tobacco at parties, thinking it’s safer than cigarettes. he says a typical 45-minute hookah session can expose a user to extraordinarily high levels of carbon monoxide and nicotine.

(TM and Copyright 2016 CBS Radio Inc. and its relevant subsidiaries. CBS RADIO and EYE Logo TM and Copyright 2016 CBS Broadcasting Inc. Used under license. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

Resource : http://stlouis.cbslocal.com/2016/05/09/new-fda-guidelines-include-hookah-and-cigars/

Is Hookah Really a Safer Way to Smoke?

Great news: Cigarette smoking rates are at an all-time low. Not-so-great news: Hookah—the ancient Indian method of inhaling tobacco via water pipe—may be on the rise, according to the Center of Disease Control and Prevention. Now, you know smoking is bad for you, but how bad is hookah specifically? Answer: Pretty bad.

Researchers from the University of Pittsburgh compared one hookah session—about 45 to 60 minutes or the length of time it takes to consume one bowl or head of tobacco—to cigarettes. Turns out, just one session was the equivalent of inhaling more than an entire pack of smokes. (Of course, multiple people usually split the bowl, but that's still a lot.) Worse, one hookah bowl had 125 times the smoke, 25 times the tar, 2.5 times the nicotine and 10 times the carbon monoxide of a cigarette. The study was published in Public Health Reports.

The problem isn't just what's in the hookah; it's also how it works, says Brian A. Primack, M.D., Ph.D., assistant vice chancellor for health and society at the University of Pittsburgh, and lead researcher of the study. "Because the tobacco is moistened, sweetened, and flavored, it can't be lit on fire and burn in a self-sustaining manner," he says. "So, a piece of charcoal is lit and put on top of the tobacco, and you also inhale the combustion products of the charcoal." Fun.

Hookah is a growing health issue as people are taking up the water pipe in record numbers. This type of smoking used to be seen as a sign of prestige and wealth but has only recently become popular in the west. It's especially trendy among younger people, with the CDC reporting that for the first time in history, hookah tobacco use is higher than cigarette use among young adults. One-third of college students say they've tried it and, according to University of Pittsburgh researchers, most of those individuals were not previous users of other forms of tobacco.

"I think that people get the sense that it is healthier," says Primack. "But while the water in the base makes it cooler and easier to use, it doesn't remove the toxins." He points to overwhelmingly positive YouTube videos about hookah, and cites his previous research that 92 percent of hookah-related videos were rated as positive but only 24 percent of cigarette-related videos got the YouTube thumbs up.

Primack adds that another reason people may think it's healthier is because it tastes better. While it's illegal to have cherry-flavored cigarettes, for example, hookah tobacco comes in every flavor imaginable, including trendy ones that would specifically appeal to women.

Lastly, Primack points out that there's a fundamental difference in how we treat hookah tobacco useage. "Many indoor spaces do not allow cigarette smoking but do allow hookah smoking," he says. "This may give young people the mistaken impression that the government has decided that hookah smoking is okay."

But just because something is legal does not mean it's good for you. This is one trend you'll definitely want to skip.
Resource :http://www.shape.com/lifestyle/is-hookah-bad-for-you

Controversial shop moves out of Glen Ridge

The Glen Ridge vape shop appears to have left as soon as it arrived.

The 201 Smoke Shop in the Arcade had closed its doors by the middle of May, nearly a month after it moved into the Arcade.

The shop was met with controversy when it opened; a number of residents were concerned about the shop opening in a location close to two of the borough's schools.

Residents sent in a petition with just over 200 signatures asking Glen Ridge to revisit its ordinance on prohibited businesses in a commercial area. Glen Ridge currently prohibits businesses such as tattoo parlors, pawn shops and wholesale warehouses; the residents asked the borough to consider adding "vape shops" to that list.

Vape shops are establishments that sell electronic cigarettes (or "e-cigarettes") and similar smoking devices, as well as their accessories.

The planning board formed a subcommittee to discuss how the ordinance should be updated, if at all.

Borough Administrator Michael Rohal said on Monday that the subcommittee would be moving forward; he said that the planning board had been preoccupied with the redevelopment plan for HackensackUMC Mountainside, but would be taking a look at the prohibited business ordinance soon.

A sign on the door said that the shop would be moving to a new location in Jersey City, and until that time invited customers to visit its location at 90 W. Palisade Ave. in Englewood, the same address as the Arcade's owners. However, a Facebook page for the Glen Ridge location was still active.

Rohal said he was unaware of the reasons why the shop had closed; he himself was not aware of it until he walked past the shop and noticed the sign on the door.

Email: roll@northjersey.com
Resource:  http://www.northjersey.com/news/business/controversial-shop-moves-out-1.1612722

E-cigarette users petition parliamentary committee over possible regulations of vaporisers

MORE than 100 electronic cigarette users have petitioned a parliamentary committee not to regulate the vaporisers in the same restrictive way as tobacco products.

Among the 105 people who filled out identical proformas distributed by the Adelaide-based Smoke-Free Traders Association were at least two people who were not even cigarette smokers.

The forms were distributed to stores which sell the vaporisers and then sent to state Parliament’s Select Committee on E-Cigarettes, which is expected to deliver its final report next week.

It is understood it will make 20 recommendations, from a total of 142 submissions and in-person evidence, including on public safety measures and the need for more research into the long-term effects of using the vaporisers.

There is strong debate over whether e-cigarettes encourage the habit of smoking or help people to quit by simulating the action without delivering the chemicals.

Battery-powered e-cigarettes vaporise a refillable cartridge of solution — which can contain nicotine — to create vapour which a user inhales.

SA law prevents the sale — but not possession or use — of any product “designed to resemble a tobacco product”, such as a cigarette.

The Smoke-Free Traders Association represents online and shopfront retailers and wholesalers of e-cigarettes, batteries, tanks and other accessories.

In its submission to the inquiry, it argues its members are “completely independent of Big Tobacco”.

It says regulation should encourage the use of e-cigarettes by adults trying to “reduce or cease smoking and to prevent relapse to smoking”.

“If the regulation of electronic cigarettes becomes an expensive burden for retailers, then the only industry that will be able to afford to adhere to those regulations will be the tobacco industry,” it says.

“Adult smokers must be allowed freedom of choice.”

Smokers who filled out the association’s forms included Rodney Webb, who smoked up to 25 cigarettes a day for 30 years before switching to a vaporiser.

He wrote that it “gives me the habit (of smoking) without the health risks”.

Smoker of 16 years Jay Woolford had been using a vaporiser for two weeks when he filled out a form.

“The use of my vape pen has taken me from smoking two packs of ciggers (sic) a day to smoking next to no ciggers,” he wrote.

Peregrine Corporation, which owns 31 Smokemart stores in SA, argues in a separate submission that there is “strong anecdotal evidence that customers are using e-cigarettes as an alternative” to smoking tobacco.

However, a submission by the SA Health and Medical Research Institute warns there is “no substantial evidence that e-cigarettes are effective in assisting people to quit smoking”.

Resource: http://www.adelaidenow.com.au/news/south-australia/ecigarette-users-petition-parliamentary-committee-over-possible-regulations-of-vaporisers/news-story/a0237e3f0c0a054d95057d4e8af918a6

Mannheim Steamroller coming to Orpheum Theatre Nov. 18

SIOUX CITY | Mannheim Steamroller will perform at the Orpheum Theatre Nov. 18. Tickets go on sale at 10 a.m. July 25 at the Tyson Events Center box office, online at Orpheumlive.com or by calling 800-514-3849.

This will be the 32nd anniversary of the Christmas tour and release of Mannheim Steamroller Christmas.

Grammy Award winner Chip Davis will direct and co-produce tour performances with MagicSpace Entertainment. The show features classic Christmas hits from Mannheim Steamroller and dazzling multimedia effects in an intimate setting.

In addition to being a holiday tradition for many families, the Mannheim Steamroller Christmas tour regularly attracts repeat attendance from multi-generational guests and is one of the longest running tours in the music industry.

This year’s tour includes many of the performances in a PBS special broadcast airing this year, “Mannheim Steamroller 30/40 Live” featuring the group’s concert.

Mannheim Steamroller has sold more than 40 million albums, 28 million in the Christmas genre. Their holiday albums have become synonymous with Christmas and consistently occupy top spots on Billboard’s Seasonal Charts every year.

With 19 gold, 8 multi-platinum and 4 platinum-certified records, Chip Davis is among an elite group of artists that include U2, Jay-Z, and The Beach Boys with such certifications.
Resource:  http://siouxcityjournal.com/news/local/mannheim-steamroller-coming-to-orpheum-theatre-nov/article_30d39887-1039-5c3f-b4f8-91222a878f1d.html

Researchers emphasize need to rethink tobacco control strategies

The tobacco product landscape has changed significantly with the introduction of alternatives that are much less harmful than traditional cigarettes.

Compared to cigarettes, which kill 3 in 5 smokers prematurely, some non-combusted products — including snus, other smokeless tobacco products and electronic cigarettes or vapes — are estimated to be more than 90 percent less harmful.

But decades-old tobacco control strategies that rely on an "all or nothing" approach haven't kept up with these changes, and are confusing the general public. Writing in the journal BioMed Central Public Health, two researchers say it's time for tobacco control themes to be modernized.

"Not since the invention of the cigarette rolling machine in 1882 has the product landscape changed so dramatically. For the first time in over a century, there are products that could make the defective and deadly cigarette obsolete," says Lynn T. Kozlowski, PhD, a co-author of the paper and professor of community health and health behavior at the University at Buffalo.

"The dramatic landscape change warrants a rethinking of past tobacco control strategy, from an all-or-nothing approach to a harm-reduction approach," adds Kozlowski, who has written extensively on the need for including a harm-reduction approach in tobacco control efforts.

Kozlowski wrote the paper with David B. Abrams, PhD, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Truth Initiative in Washington, D.C.

Abrams is also professor of health behavior and society at Johns Hopkins University, and an adjunct professor of oncology in the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center.

The researchers write that the long-held tobacco control strategy that lumps all tobacco products together — regardless of the differences in harm — is negatively impacting public health.

"In the past few years, more smokers now wrongly believe that Alternative Nicotine Delivery Systems, including electronic cigarettes, are as harmful or more harmful than cigarettes and are thus less likely to switch to them to quit smoking," says Kozlowski.

They argue that, while there is some risk in using any product that delivers nicotine, dramatic differences in harm exist between deadly cigarettes — by far the most lethal — and other products like e-cigarettes and smokeless tobacco, and that these differences need to be communicated to the public.

"Smokers who cannot, or do not, wish to quit smoking can now switch to a substantially less harmful, but reasonably satisfying, alternative way to get their nicotine. People smoke for the nicotine but die mostly from the tar," said Kozlowski.

In their paper, Kozlowski and Abrams trace the history of tobacco control strategies in the U.S. since efforts began in 1964. They discuss the push that year toward low tar — or so-called "light" — cigarettes, sales of which boomed. At the time, public health officials believed that a smoker's risk of lung cancer could be reduced by lowering the amount of tar in cigarettes.

The utter failure of these low tar/light combusted cigarettes to actually be less harmful does not mean that the same is true for modern non-combusted products like e-cigarettes, the researchers say.

In the 1980s, broader bans on cigarette advertising were proposed, and the dominant theme was that smoking is bad and there are no other product options to consider.

"Since 1964, major themes missed a core principle: The substantially greatest harm is from the toxic smoke of combusted, inhaled tobacco," Kozlowski and Abrams write.

At the same time as a harm reduction stance is adopted for smokers of deadly combusted tobacco, it is important to complement the decades of successful tobacco control, to minimize the use of any nicotine-containing products by underage youth, they say.

The new tobacco rules the U.S. Food and Drug Administration proposed earlier this month now include the regulation of previously unregulated cigars of all types, e-cigarettes and hookah.

"Despite our best efforts to prevent youth tobacco and nicotine use, most adult users will still likely have begun in their youth, and these adult users need legal options that are much less harmful than cigarettes," Kozlowski warns.

"Regulation should be used to strike the balance so urgently needed between protecting non-users, especially youth, while maximizing benefits of newly regulated non-combustible e-cigarette products that have been shown to help current smokers either to switch or, ideally, to quit," Kozlowski added.

The regulations need to be reasonable and proportionate so as not to stifle innovation or make the least harmful products subject to the most burdensome regulations, while allowing the most harmful combustible products to be subject to the most regulations, according to the researchers.

Resource:  http://www.news-medical.net/news/20160525/Researchers-emphasize-need-to-rethink-tobacco-control-strategies.aspx

OUR OPINION: Reasonable rules for e-cigarettes

    Long-awaited federal rules to keep electronic cigarettes out of the hands of children finally arrived this month, and not a moment too soon. Use of the nicotine delivery devices has been growing rapidly among middle- and high-school-aged teens in the last few years.

    The rules, in the works since 2010, put the regulation of all tobacco products – including “novel and future” ones – under the authority of the Food and Drug Administration for the first time. This is a profoundly important step in reining in e-cigarettes, a popular product with unknown long-term health effects that has been virtually unsupervised by government until now. While e-cigarettes are not specifically a tobacco product – no tobacco is used in producing the liquid used in them – they are certainly a drug-delivery device, hence subject to FDA regulation.

    Now, manufacturers will be required to disclose the ingredients in the liquid nicotine used in “vaping” and allow government review of how the devices are made before they can be sold to adults in the United States. Currently, anything could be lurking inside that liquid. Consumers taking the vapor into their lungs have a right to information about its contents.

    That isn’t the only reason children shouldn’t be using electronic cigarettes. Even without the carcinogenic tar and smoke of regular cigarettes, e-cigarettes still contain nicotine, an addictive substance linked to heart disease. Children and adolescents are especially susceptible to nicotine addiction; responsible adults – and governments – should protect them from acquiring a habit that may dog them for a lifetime.

    Adults should be wary as well. Dangerous chemicals have been found in the electronic cigarette “juice,” such as a Diacetyl, a flavoring associated with lung illness.

    The devices themselves also can pose a threat to consumers, many of whom have been injured and disfigured in a spate of explosions. The battery-operated devices heat liquid nicotine into a mist that is inhaled. But neither the liquid nor the devices, most of which are made in China, must comply with any sort of safety standards.

    The federal rules announced this month include other controls on tobacco products – including e-cigarettes – such as not allowing them to be sold in vending machines and requiring warning labels. The government chose not to prohibit the use of flavors in liquid nicotine such as “Peanut Butter Cup” and “Candy Crush” that seem clearly aimed at appealing to young users, but the age limits should get at that.

    In several ways, vaping is significantly safer than smoking traditional cigarettes. It’s the other ingredients in tobacco smoke that are responsible for the most serious health hazards, not the nicotine. Many adults have taken to vaping in order to reduce consumption of tobacco cigarettes, though more research is required before declaring it to be a proven smoking cessation method.

While anti-tobacco activists have reflexively opposed e-cigarettes, the available research supports the FDA’s more limited approach. The priority should be keeping e-cigarettes – and all addictive substances – out of the hands of children.

Resource:  http://www.patriotledger.com/article/20160518/OPINION/160516031/?Start=2

Congressional action on electronic cigarette regulations may save vapers

The Food and Drug Administration (FDA) is in the final stages of announcing a new set of regulations for all electronic cigarettes (e-cigarettes) and vapor products. Free-market innovation has resulted in significant developments in the number and quality of these tobacco-free products that are helping Americans kick the unhealthiest habit known to man – smoking. The FDA’s proposal, however, threatens the very survival of the vast majority of the vapor product industry.

For large tobacco and pharmaceutical companies, this is great news. The FDA’s proposed regulations stand to benefit both industries, which represent some of the most well-funded and powerful lobbying interests in the United States.
Vapor devices compete with products marketed by pharmaceutical companies to help people quit smoking, like Nicorette gum and the nicotine patch. These nicotine replacement products have taken a hit in recent years as many consumers have turned to vapor products after pharmaceutical options have failed them.

The emergence of vaping also has Big Tobacco concerned. America’s largest cigarette companies have released e-cigarette products, but have thus far been unable to establish dominance in the market. Overly burdensome FDA rules could be just the ticket they need. Bonnie Herzog, a senior analyst with Wells Fargo Securities, commented last week that that the FDA’s proposal is “broadly positive for the big tobacco manufacturers since it will increase the barriers to entry.”

Under the FDA’s proposal, all vapor products on the market will have to retroactively undergo a “premarket” review process. For a single product application, the FDA estimates that a manufacturer will need to put out $330,000. Within the industry, the real cost is expected to easily run into the millions of dollars. Even with the lower cost estimate, the agency’s own economic analysis spells doom for all but a couple companies. That analysis predicts that approximately 99% of products on the market will not even attempt the application process, let alone gain approval.

The FDA claims that it does not have the authority to modify the premarket review requirement under the 2009 Tobacco Control Act, which gave the FDA the authority to regulate tobacco and nicotine-containing products. The agency says that the statute requires them to consider any product that has come to market since February 15, 2007 as a “new” tobacco product. The FDA calls this February 2007 provision the “predicate date.” It is this date that would needlessly roll back technology almost a decade and close businesses.

This week, members of Congress have an opportunity to change the FDA’s direction in a way that will benefit consumers, small business, and public health. On Tuesday, the House Appropriations Committee is scheduled to take up an agriculture spending package. Harm reduction advocates are hopeful that the committee will take up and pass an amendment to the bill to modernize the February 2007 predicate date for vapor products.

Changing the predicate date will not interfere with the FDA’s ability to establish rigorous safety and manufacturing rules for vapor products. The agency will retain their existing power to set product standards. If the FDA takes this route, any standard issued would apply to all products within the agency's jurisdiction.

Without a modification of the February 2007 predicate date, Marlboro and Camel cigarettes will remain legal, but it will become a federal felony to sell tens of thousands of vapor products that are currently legally available and helping smokers quit. The status quo in the United States – smoking – will remain.

Approximately two-thirds of the vapor market is held by companies with no connections to Big Tobacco. That’s because the tobacco companies offer very few options to consumers looking to customize their quit journey. But given their ability to afford onerous regulation, Big Tobacco could be the only player left standing in the e-cigarette market.

Last year, attempts were made to change the predicate date by members of both the House and Senate. Congressional Democrats successfully killed the amendment and attacked Republicans for siding with Big Tobacco. They were misguided in that accusation. This shouldn’t be a partisan fight. Both parties should celebrate the prospect of a creation of the free market helping make cigarette companies a relic of the past.

The FDA’s current proposal will freeze innovation and kill jobs through unnecessary and costly paperwork. For the millions of Americans who try to quit smoking every year, Congress should act to ensure that overregulation does not prevent smokers from accessing effective and safer alternatives. Republicans and Democrats should welcome this much needed change.

Resource:  http://thehill.com/blogs/congress-blog/politics/276635-congressional-action-on-electronic-cigarette-regulations-may

Smoking Age to 21, Regulate Electronic Cigarettes

The state Senate on Thursday gave final legislative approval to bills that would regulate electronic cigarettes and raise the smoking age to 21 in California, sending them to Gov. Jerry Brown for consideration.

Supporters of additional tobacco controls used the special session to advance bills that had bogged down during a regular session, moving them through new committees not controlled by opponents. The bills were approved last week by the Assembly. Most Republicans voted against both bills.

The bill on electronic cigarettes bans their use in restaurants, theaters and other public places where traditional smoking is already prohibited. Sen. Mark Leno, D-San Francisco, said his bill also significantly prohibits marketing the devices to minors.

Sen. Jeff Stone, R-Murietta, said there is concern that electronic cigarettes serve as a “gateway” to the use of regular cigarettes, especially for teenagers. “For the first time, more teenagers use e-cigarettes than cigarettes,” Stone said.
Resource: http://ktla.com/2016/03/10/california-senate-votes-to-raise-smoking-age-to-21-regulate-electronic-cigarettes/

Researchers emphasize need to rethink tobacco control strategies

The tobacco product landscape has changed significantly with the introduction of alternatives that are much less harmful than traditional cigarettes.

Compared to cigarettes, which kill 3 in 5 smokers prematurely, some non-combusted products — including snus, other smokeless tobacco products and electronic cigarettes or vapes — are estimated to be more than 90 percent less harmful.

But decades-old tobacco control strategies that rely on an "all or nothing" approach haven't kept up with these changes, and are confusing the general public. Writing in the journal BioMed Central Public Health, two researchers say it's time for tobacco control themes to be modernized.

"Not since the invention of the cigarette rolling machine in 1882 has the product landscape changed so dramatically. For the first time in over a century, there are products that could make the defective and deadly cigarette obsolete," says Lynn T. Kozlowski, PhD, a co-author of the paper and professor of community health and health behavior at the University at Buffalo.

"The dramatic landscape change warrants a rethinking of past tobacco control strategy, from an all-or-nothing approach to a harm-reduction approach," adds Kozlowski, who has written extensively on the need for including a harm-reduction approach in tobacco control efforts.

Kozlowski wrote the paper with David B. Abrams, PhD, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Truth Initiative in Washington, D.C.

Abrams is also professor of health behavior and society at Johns Hopkins University, and an adjunct professor of oncology in the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center.

The researchers write that the long-held tobacco control strategy that lumps all tobacco products together — regardless of the differences in harm — is negatively impacting public health.

"In the past few years, more smokers now wrongly believe that Alternative Nicotine Delivery Systems, including electronic cigarettes, are as harmful or more harmful than cigarettes and are thus less likely to switch to them to quit smoking," says Kozlowski.

They argue that, while there is some risk in using any product that delivers nicotine, dramatic differences in harm exist between deadly cigarettes — by far the most lethal — and other products like e-cigarettes and smokeless tobacco, and that these differences need to be communicated to the public.

"Smokers who cannot, or do not, wish to quit smoking can now switch to a substantially less harmful, but reasonably satisfying, alternative way to get their nicotine. People smoke for the nicotine but die mostly from the tar," said Kozlowski.

In their paper, Kozlowski and Abrams trace the history of tobacco control strategies in the U.S. since efforts began in 1964. They discuss the push that year toward low tar — or so-called "light" — cigarettes, sales of which boomed. At the time, public health officials believed that a smoker's risk of lung cancer could be reduced by lowering the amount of tar in cigarettes.

The utter failure of these low tar/light combusted cigarettes to actually be less harmful does not mean that the same is true for modern non-combusted products like e-cigarettes, the researchers say.

In the 1980s, broader bans on cigarette advertising were proposed, and the dominant theme was that smoking is bad and there are no other product options to consider.

"Since 1964, major themes missed a core principle: The substantially greatest harm is from the toxic smoke of combusted, inhaled tobacco," Kozlowski and Abrams write.

At the same time as a harm reduction stance is adopted for smokers of deadly combusted tobacco, it is important to complement the decades of successful tobacco control, to minimize the use of any nicotine-containing products by underage youth, they say.

The new tobacco rules the U.S. Food and Drug Administration proposed earlier this month now include the regulation of previously unregulated cigars of all types, e-cigarettes and hookah.

"Despite our best efforts to prevent youth tobacco and nicotine use, most adult users will still likely have begun in their youth, and these adult users need legal options that are much less harmful than cigarettes," Kozlowski warns.

"Regulation should be used to strike the balance so urgently needed between protecting non-users, especially youth, while maximizing benefits of newly regulated non-combustible e-cigarette products that have been shown to help current smokers either to switch or, ideally, to quit," Kozlowski added.

The regulations need to be reasonable and proportionate so as not to stifle innovation or make the least harmful products subject to the most burdensome regulations, while allowing the most harmful combustible products to be subject to the most regulations, according to the researchers.

Resource:  http://www.news-medical.net/news/20160525/Researchers-emphasize-need-to-rethink-tobacco-control-strategies.aspx

Adult smoking rate drops to another historic low of 15.1 percent in 2015

Even with the decreasing adult smoking rates, Henrico County-based Philip Morris USA, R.J. Reynolds Tobacco Co. and ITG Brands LLC continue to show quarterly and annual revenue gains, in part through per-pack list price increases to distributors that are passed on to consumers.

As has been the case for several years, explanations for the declining smoking rate vary, depending mostly on the commentator’s position on smokeless tobacco.

Anti-tobacco advocates tout several reasons, such as higher cigarette excise taxes, anti-smoking campaigns, higher retail prices, fewer places to legally smoke indoors and socioeconomic shifts.

Meanwhile, pro-smokeless tobacco advocates point instead to the increasing popularity of electronic cigarettes, vaporizers and hookahs that some analysts believe could outsell traditional cigarettes in the next five to 10 years.

The typical e-cigarette is a battery-powered device that heats a liquid nicotine solution in a disposable cartridge and creates a vapor that is inhaled. A vaporizer can be supplied and reused through the insertion of a liquid capsule.

“The fact that fewer adults are smoking is spectacular news and a credit to the combined efforts of the entire tobacco control community,” said Robin Koval, chief executive and president of anti-tobacco advocacy group Truth Initiative.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, stressed “the strong actions the Obama administration has taken since 2009 to revitalize the nation’s fight against tobacco.”

Myers cited as examples the 62-cent increase in the federal cigarette excise tax in 2009, and the Affordable Care Act requirement that health insurance plans provide barrier-free coverage for proven tobacco cessation treatments and enhancement of Medicaid coverage for such treatments.

Anti-smoking advocates cite a series of recent scientific studies, including from the Royal College of Physicians, showing that e-cigs and vaporizers could be 95 percent less harmful to smokers than traditional cigarettes.

Given those findings, anti-smoking advocates question the FDA’s commitment to its mission of reducing public harm from tobacco use within the new regulations it disclosed May 5.

The new rules include: banning the sale of e-cigs and vaporizers to those under age 18; requiring age identification to buy the products; no free samples; and no sales in vending machines unless in adult-only venues.

Myers said “public health authorities in the U.S., including the CDC and the U.S. Preventive Services Task Force, have found there is not enough evidence to conclude whether e-cigarettes are a safe and effective smoking cessation device.”

The FDA’s decision to stick with a Feb. 15, 2007, predicate date for product introductions is likely to spur multiple lawsuits from manufacturers, vape shops and advocate groups.

That’s because products introduced into the marketplace after that date — including almost every electronic cigarette — would have to retroactively go through stiffer regulatory requirements to prove they don’t cause public harm. That includes providing more detail on liquid nicotine ingredients and manufacturing details.

Analysts have said it could cost millions of dollars for each product to go through the heightened regulatory requirements. The FDA estimates it would cost about $500,000.
 

Resource: http://www.richmond.com/business/local/article_26af688e-da3e-53ad-90b6-63b29da2fb1f.html

Yanez proposes state e-cigarette regulations

A Sterling Heights state representative is hoping that a set of recently proposed bills in the state House of Representatives that would prevent minors from buying e-cigarettes will eventually become law and not vanish like a vapor.

State Rep. Henry Yanez, D-Sterling Heights, is the primary sponsor of a three-bill package of proposals, House Bills 5686-5688, introduced May 24. The bills, which have attracted co-sponsors, aim to regulate e-cigarettes and other electronic smoking devices.

The proposed legislation defines an electronic smoking device as “any device containing or delivering nicotine or any other substance intended for human consumption through the inhalation of vapor or aerosol from the product.”

Yanez said the bills would ban e-cigarette sales to minors and include e-cigarettes under the label of “tobacco products,” thus regulating them as such. The proposed legislation would also put a tax of 32 percent of the wholesale price on electronic smoking devices as defined in the text, which is similar to the tax on some other forms of tobacco, he said.

In addition, the proposal package, if made law, would restrict e-cigarette sales in vending machines and would mandate child-resistant packaging for electronic smoking devices.

Yanez said some of the tax money that could be raised from e-cigarettes and their fluids would go to a First Responder Presumed Coverage Fund to help firefighters fight work-related cancer. Funds could also go toward a state smoking prevention program and the Healthy Michigan Plan, which aims to offer low-cost health care coverage for qualified individuals, he said.

In explaining his reasoning behind the bill’s support, Yanez said e-cigarettes are not harmless and they can be a “gateway” that leads to smoking the real thing.

“Nicotine is extremely addictive, and it can actually lead to people beginning to smoke,” he said.

Yanez also said Michigan is the only remaining state to not ban sales to minors.

“I’m sorry to say that Michigan is the last state to allow minors to buy e-cigarettes,” he said. “If you’re a minor, a 13-year-old, you can go to the store and buy e-cigarettes.”

According to a statement from Gov. Rick Snyder’s office, the governor vetoed e-cigarette legislation in January 2015 because that proposed legislation didn’t put e-cigarettes under the definition of tobacco products.

“We need to make sure that e-cigarettes and other nicotine-containing devices are regulated in the best interest of public health,” Snyder said in the statement. “It’s important that these devices be treated like tobacco products and help people become aware of the dangers e-cigarettes pose.”

Yanez said the latest bills fixed that concern and are the result of much work.

“It’s a very technical bill, so it was very difficult to get the language well,” he said.

He said the American Cancer Society, the American Heart Association and the American Lung Association offered input on the proposed legislation and the way to craft it. He said the groups wanted the bills to be comprehensive and to put up as many roadblocks as possible to prevent young people from using e-cigarettes.

Yanez said he tried to work with Snyder’s office to resolve any remaining concerns that the governor might have had.

“Unfortunately, we had one conversation with them and they never got back with us,” Yanez said.

Upon asking Snyder’s office to comment on Yanez’s bills, Snyder’s press secretary, Anna Heaton, said in an email that the governor doesn’t take a stance on bills this early in the legislative process since they tend to be altered through that process.

“If this bill package comes to his desk, he will give it a thorough review before deciding whether or not to sign it into law,” she said.

An emailed statement attributed to Cynthia Cabrera, president and executive director for the Smoke-Free Alternatives Trade Association, responded to the news of the proposed bills. The statement said that vapor products are not tobacco products “as they contain no tobacco.”

“Regulating them the same has a host of consequences for small- and mid-sized businesses throughout the state, plus hundreds of manufacturers, distributors and related businesses that contribute to the local economy, generating taxes and thousands of jobs,” the statement said.

“Some of those consequences include the potential to be denied workers’ compensation and product liability insurance, as well as being forced out of financial institutions and merchant service agreements.”

Cabrera said the vapor industry has been in favor of “reasonable regulations” such as age restrictions and child-resistant packaging. But she said politicians should not demonize vapor products as an option for combustible cigarette smokers.

“Seeking to economically penalize a smoker attempting to switch to what science says is a less harmful alternative is counterproductive to public health,” she said.

A spokesman on behalf of SFATA said child-resistant packaging regulations became law nationally in 2016, and the U.S. Food and Drug Administration ruled in 2016 that — effective in August — its regulatory authority would extend to e-cigarettes, including the ability to ban sales to minors online and in person.

In a press release, Yanez said it’s still a good idea to change the state’s law for taxation and regulatory reasons even if the FDA’s e-cigarette ruling holds.

“The state of Michigan still has an important role to play in this issue and we need to act now,” he said.

In response to whether the bills’ electronic smoking device definition could inadvertently include nebulizers or inhalers for lung issues, Robert Becker, Yanez’s legislative director, said the issue came up, and there is no intent to tax medical supplies as opposed to smoking devices for recreational use.

But Becker said he didn’t believe that the bills’ text could be interpreted toward taxing asthma inhalers or nebulizers. For instance, he said the definition goes on to define examples, such as vape pens, e-hookahs “or any other similar device.” He also said the American Cancer Society found the bills’ language satisfactory.

Learn more about the bills by visiting www.michiganlegislature.org. Contact state Rep. Henry Yanez by visiting housedems.com/state-rep-henry-yanez or by calling (517) 373-2275. Learn more about the Smoke-Free Alternatives Trade Association by visiting sfata.org.
Resource: http://www.candgnews.com/news/yanez-proposes-state-e-cigarette-regulations-93495

Monroe County legislator proposes licensing of e-cigarette sellers

Rochester, N.Y. (WHAM) - A Monroe County legislator announced legislation Tuesday to license stores that would sell electronic cigarettes.

The bill, sponsored by Justin Wilcox (D-Brighton) would require e-cigarette vendors to abide by the same rules as traditional tobacco vendors.

"Until New York State enacts a common-sense licensing program for e-cigarette retailers, we need to do everything we can to ensure these products are sold safely and in a manner consistent with existing public health goals," Wilcox said.

Vendors which fail to abide by the law would have their license revoked or suspended. If a vendor was within a quarter-mile of a school, they would be prohibited from selling e-cigarettes.

E-cigarettes would also be banned on school grounds.

"By establishing a system to revoke the permits of those dealers who would sell to minors, we are sending a strong message to these retailers," said Katy Kuczek, a member of Brighton Neighbors Against Vaping.

The Monroe County Medical Society also issued a statement, praising the bill and citing the dangers of liquid nicotine poisoning, according to the American Academy of Pediatrics.

The Medical Society also stated "the long-term health effects to users and bystanders are still unknown."

Earlier this year, the FDA announced sweeping new regulations on the sale of e-cigarettes. Local vape shops and e-cigarette retailers are mixed on the decision.

The bill will be submitted to the Legislature and be considered by a standing committee at a later date.
Resource: http://13wham.com/news/local/monroe-county-legislator-proposes-licensing-of-e-cigarette-sellers

E-cigarette Australia: Victorian Government to treat vaping as tobacco; New laws to come into effect in 2017

E-cigarettes will be treated as tobacco in Victoria. The Victorian Government is extending the smoking ban to e-cigarettes too. New anti-smoking laws will be introduced in Victorian Parliament to ban e-cigarettes in Victoria’s smoke-free places.

The new anti-smoking measures will be announced by Victoria’s Health Minister, Jill Hennessy, ahead of the legislation to be introduced into parliament next week. The electronic smoking devices will also be banned inside cars carrying children, in restaurants and enclosed workplaces. The new laws will come into effect next year.

Children under 18 years of age won’t be able to buy e-cigarettes. Health experts have argued that smoking e-cigarettes, also known as vaping, may turn young people into smokers. Moreover, the laws will provide more clarity to restaurants and workplaces. Although the exact health risks related to e-cigarettes are not clear, every year, around 4,000 Victorians die from tobacco-related illnesses.

“We're going to regulate them like they are a tobacco product and also make sure that we're not really using e-cigarettes as a starting point for people to get a habit to then start cigarettes and then get addicted to nicotine,” Hennessy told the ABC.

She also added that e-cigarettes should not be used to glamorise smoking by youngsters. In the absence of exact health risks of vaping, the government is being extra-cautious in its approach. Health experts are divided in their opinion as to the benefits/risks of e-cigarettes.

Some debate that e-cigarettes actually help in quitting smoking while others believe that it only glorifies smoking and even induces young people to take up smoking. Until the government receives confirmation of e-cigarette benefits, it would continue treating them as other tobacco products.

“We want to give certainty to people who don't know whether or not e-cigarettes should be allowed to be used in enclosed workspaces and at restaurants, people walking through airports for example with e-cigarettes,” Hennessy added.
Resource: http://www.ibtimes.com.au/e-cigarette-australia-victorian-government-treat-vaping-tobacco-new-laws-come-effect-2017-1516417

Indiana vape shop owners say new FDA rule will crush industry

Vape shop owners already were dreading the implementation of an Indiana law that would severely restrict the products they sell. But the Food and Drug Administration took their concern to a new level Thursday, issuing guidelines that many say likely will put them out of business.

In addition to prohibiting sales to minors, the FDA rules now require that all electronic cigarette products made after 2007 receive government approval, a move that many shop owners fear will shutter the industry. The regulations apply to both electronic cigarettes that resemble traditional cigarettes and vaporizers.

“It’s the final coffin nail,” said Evan McMahon, chairman of Hoosier Vapers, a statewide industry and consumer advocacy group. “Everybody universally understands that this is not a regulation. This is a prohibition.”

About 200 to 250 specialty vape shops, many of them mom-and-pop businesses, exist in Indiana. Some of these make their own so-called e-juice, the liquid that goes inside the vaporizer. It comes in many different flavors, such as cookie dough and apple breeze, and often contains nicotine. McMahon said a recently-passed state law would restrict all but only a handful of companies from producing e-liquids used in vaping products.

While two lawsuits are pending to block the state law, McMahon said the latest word from the FDA would likely force the majority of shops to close once the federal regulation goes into effect two years from now.

“I don’t normally give recommendations to businesses, but I’m making one now, which is: When your lease runs out, don’t renew,” McMahon said.

David Cohn, owner of World of Vapor Indy in Irvington, already figured out how he could remain open with the new state law, which requires that any e-liquid manufacturer have a contract with a security company that meets specific qualifications that few such companies now have.

Fulfilling the FDA requirements is far more challenging. One aspect of the FDA regulations, requiring products to contain labels that say nicotine is addictive, would be onerous but doable, Cohn said. But the FDA requirement that all products that have hit the market since 2007 receive federal approval would likely be too burdensome for most e-liquid manufacturers to stay in business. The American Vaping Association has estimated that receiving approval for just one flavor would cost more than $1 million.

“Will I stay the two years? Yes, probably so,” Cohn said. “After that? I had plans on expanding and opening up more stores and hiring more people. I don’t think that’s a realistic goal at this point.”

For now, Mark Davidson, owner of Red Crane Vapors in Shelbyville, is taking his direction from industry experts like McMahon. Davidson said he had not even looked through the tome of regulations the FDA issued.

That offers little solace.

“I’m extremely nervous,” he said. “It’s my livelihood.”

It’s also his ticket out of smoking, Davidson said. After smoking for 22 years he quit about four years ago, which he said he would never have been able to do without the e-liquid alternative.

Vaping advocates often cite studies that suggest their products are safer than traditional cigarettes. And the British government agrees — they provide e-cigarettes as a cessation tool.

Not everyone sees the vaping industry as a healthier alternative to tobacco. The FDA emphasized concerns about the increase in youths using e-cigarette products, and it fears that, for many, use of e-cigarettes eventually translates into traditional smoking.

A number of state attorneys general, including Indiana’s, have been asking the FDA to issue stronger regulations on e-cigarettes for two years.

FDA oversight will create a level playing field so youth will not be able to take advantage of different local laws as a way to buy these products, said Bryan Corbin, public information officer for Indiana Attorney General Greg Zoeller in an email.

However, he declined to speculate on what the new rules might mean for the industry.

“No one can predict the retail sales situation years into the future, and it is unknown what might occur with legal challenges in court, or legislation before Congress. That could complicate that picture,” Corbin said.

McMahon, who manufactures 37 flavors of e-juice, is not optimistic. In the best-case scenario, he said, prices for these products will likely increase while most ofthe industry is forced out. The only winner in this picture, he said, is Big Tobacco, which already has made some forays into the e-cigarette industry.

“People are upset because their government just told them, ‘We want you to go back to smoking,’” he said.

repost:http://www.indystar.com/story/news/2016/05/08/indiana-vape-shop-owners-say-new-fda-rule-crush-industry/84036264/

Resource: http://www.joinnest.com/indiana-vape-shop-owners-say-new-fda-rule-will-crush-industry.html

OUR OPINION: Reasonable rules for e-cigarettes

Long-awaited federal rules to keep electronic cigarettes out of the hands of children finally arrived this month, and not a moment too soon. Use of the nicotine delivery devices has been growing rapidly among middle- and high-school-aged teens in the last few years.

The rules, in the works since 2010, put the regulation of all tobacco products – including “novel and future” ones – under the authority of the Food and Drug Administration for the first time. This is a profoundly important step in reining in e-cigarettes, a popular product with unknown long-term health effects that has been virtually unsupervised by government until now. While e-cigarettes are not specifically a tobacco product – no tobacco is used in producing the liquid used in them – they are certainly a drug-delivery device, hence subject to FDA regulation.

Now, manufacturers will be required to disclose the ingredients in the liquid nicotine used in “vaping” and allow government review of how the devices are made before they can be sold to adults in the United States. Currently, anything could be lurking inside that liquid. Consumers taking the vapor into their lungs have a right to information about its contents.

That isn’t the only reason children shouldn’t be using electronic cigarettes. Even without the carcinogenic tar and smoke of regular cigarettes, e-cigarettes still contain nicotine, an addictive substance linked to heart disease. Children and adolescents are especially susceptible to nicotine addiction; responsible adults – and governments – should protect them from acquiring a habit that may dog them for a lifetime.

Adults should be wary as well. Dangerous chemicals have been found in the electronic cigarette “juice,” such as a Diacetyl, a flavoring associated with lung illness.

The devices themselves also can pose a threat to consumers, many of whom have been injured and disfigured in a spate of explosions. The battery-operated devices heat liquid nicotine into a mist that is inhaled. But neither the liquid nor the devices, most of which are made in China, must comply with any sort of safety standards.

The federal rules announced this month include other controls on tobacco products – including e-cigarettes – such as not allowing them to be sold in vending machines and requiring warning labels. The government chose not to prohibit the use of flavors in liquid nicotine such as “Peanut Butter Cup” and “Candy Crush” that seem clearly aimed at appealing to young users, but the age limits should get at that.

In several ways, vaping is significantly safer than smoking traditional cigarettes. It’s the other ingredients in tobacco smoke that are responsible for the most serious health hazards, not the nicotine. Many adults have taken to vaping in order to reduce consumption of tobacco cigarettes, though more research is required before declaring it to be a proven smoking cessation method.

While anti-tobacco activists have reflexively opposed e-cigarettes, the available research supports the FDA’s more limited approach. The priority should be keeping e-cigarettes – and all addictive substances – out of the hands of children


Resource:  http://www.patriotledger.com/article/20160518/OPINION/160516031

FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products

Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule.

On May 10, 2016, the U.S. Food and Drug Administration (FDA) published the long-anticipated final “deeming rule,” which extended the FDA’s tobacco product authorities under the federal Food, Drug, and Cosmetic Act (FDCA) to all products meeting the statutory definition of “tobacco product,” including, among others, e-cigarettes, gels, e-vapor, dissolvables, pipe tobacco, hookah tobacco, cigars, and novel and future tobacco products. 1 Simultaneously, FDA announced the availability of several guidance documents related to premarket tobacco product applications for electronic nicotine delivery systems, 2 tobacco product master files3 and the deeming regulation,4 as well as a user fee rule5 (and accompanying small entity compliance guide6 ) for domestic manufacturers and importers of cigars and pipe tobacco. The flurry of regulatory activity is the latest and most significant step in FDA’s evolving authority over the tobacco industry and several novel “tobacco” products which, to date, have escaped FDA oversight.

Overview of the Deeming Rule

The FDCA, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), authorized FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. Under this authority, FDA first released its proposed deeming regulation on April 25, 2014, which floated the possibility of excluding so-called “premium cigars” from the final rule. 7 Ultimately, no exemption for “premium cigars” was included in the final rule as FDA determined that all cigars pose serious negative health risks, youth and young adults use premium cigars, and the available evidence provides no basis for FDA to conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant exclusion.8

Under the deeming rule, all products that meet the statutory definition of “tobacco product” 9 in the FDCA are subject to FDA’s authority to regulate tobacco products, except for accessories of newly deemed tobacco products. Notably, components and parts of newly deemed tobacco products are subject to FDA’s tobacco product authorities, but the accessories of newly deemed tobacco products are not. To illustrate, e-liquids, tank systems and vials that contain e-liquids are components and parts (and subject to regulation as tobacco products), while screwdrivers and lanyards are accessories exempt from regulation as tobacco products.

Click here to view table.

Once the regulation is effective, deemed products will be subject to the same FDCA provisions that govern currently regulated products (e.g., cigarettes), such as the prohibitions against adulteration or misbranding tobacco products, as well as the prohibition on unauthorized use of modified risk descriptors (e.g., “light,” “low” and “mild” descriptors) and claims. The final rule also subjects deemed products to FDA’s requirements governing ingredient and product listing, reporting harmful and potentially harmful constituents (HPHCs), establishment registration, premarket review and compliance with any applicable tobacco product standard.

In addition to the FDCA provisions that apply automatically to the deemed products, FDA also has authority to place “restrictions on the sale and distribution of a tobacco product” if FDA determines the restrictions are appropriate for the protection of the public health. Thus, the final deeming rule subjects the deemed products to additional sale and distribution requirements, including minimum purchase age and identification; mandatory display of health warning statements on product packages and advertisements; prohibitions on vending machine sales (except in adults-only facilities); and distribution of free samples. According to FDA, these additional restrictions are necessary in light of the impact of nicotine on youth and young adults; the health risks of the deemed products; consumer confusion; and misinformation about certain deemed products.

Premarket Review and Authorization Requirements

Deemed products are subject to the same premarket review provisions of Sections 905(j) and 910 of the FDCA that govern currently regulated tobacco products, meaning that manufacturers of newly deemed products will be required to obtain premarket authorization through one of three premarket pathways: SE Exemption Requests; SE Reports; or Premarket Tobacco Product Applications (PTMAs). In the final rule, FDA reiterated its previously articulated position that FDA lacks authority to change the “grandfather date” from February 15, 2007, as the date is specified by statute. Because most e-cigarette and vapor products were commercially marketed after the grandfather date, the deeming rule effectively mandates that these products will be subject to the PMTA review process. That said, in the final rule, FDA identified “a nonflavored e-cigarette (also marketed as an ‘e-cigar’) that may have been on the market on February 15, 2007,” and observed that “this product may possibly be able to serve as an appropriate predicate for purposes of the SE pathway.”12

Under the deeming rule, manufacturers of all newly deemed tobacco products will have a 12, 18 or 24- month initial compliance period in which to prepare applications for marketing authorization, as well as a 12-month continued compliance period after those dates in which to obtain FDA authorization (resulting in a total compliance period of 24, 30 or 36 months during which FDA does not intend to take enforcement action for failing to have premarket authorization). After the continued compliance period ends, new tobacco products on the market without authorization will be subject to FDA enforcement. Importantly, the aforementioned compliance policy applies only to products that are commercially marketed as of the effective date of the deeming rule (i.e., August 8, 2016): any new tobacco product not on the market as of the effective date is not covered by the compliance policy and is subject to enforcement if marketed without premarket authorization.13

Click here to view table.

Tobacco Retailers

Certain aspects of the deeming regulation will be of particular interest to retailers. For example, the deeming regulation renders all cigarettes, smokeless tobacco and covered tobacco products in a retailer’s establishment subject to the same age and identification requirements (18 years, as verified by photo ID, but there is no requirement to verify the age of a person older than 26 years). In addition, the final rule prohibits vending machine sales of newly deemed products, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time. Finally, the deeming regulation includes retailer exceptions limiting liability for the sale or distribution of non-compliant packaging that (i) contains a health warning; (ii) the manufacturer, importer or distributor supplied to the retailer; and (iii) the retailer has not altered in a material way. 14

Vape Shops Acting as Manufacturers

Under the final rule, establishments that mix or prepare e-liquids or create or modify aerosolizing apparatuses for direct sale to consumers for use in electronic nicotine delivery system (ENDS) products are tobacco product manufacturers under the FDCA and, accordingly, are subject to the same legal requirements that apply to other tobacco product manufacturers.15 As such, under the rule, the tobacco products that vape shops mix and/or prepare are new tobacco products within the meaning of section 910(a)(1) of the FDCA. Vape shops acting as manufacturers are therefore required to obtain premarket authorization for each non-grandfathered product (i.e., e-liquid) they prepare for sale or distribution to consumers, subject to the compliance policy outlined above.

Flavored Products

Flavored tobacco products are subject to the premarket authorization requirements applicable to other deemed tobacco products. In the final rule, FDA expressed concern that some tobacco products, such as e-cigarettes and cigars, are being marketed with characterizing flavors, and that these flavors can be especially attractive to youth, potentially placing youth at risk of tobacco-related disease and death. However, the final rule also acknowledged the “emerging evidence that some adults may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”16 Although the deeming regulation does not ban flavored tobacco products, the final rule does announce that FDA intends to issue a proposed product standard that would “eliminate characterizing flavors in all cigars including cigarillos and little cigars.”17

Small-Scale Tobacco Product Manufacturers

Under the final rule, “small-scale tobacco product manufacturers” — manufacturers of any regulated tobacco product that employ 150 or fewer full-time equivalent employees with annual total revenues of US$5 million or less — are provided with additional time to comply with certain provisions of the rule (i.e., additional time to respond to SE deficiency letters, an additional six-month compliance period for the tobacco health document submission requirements and additional time to submit ingredient listings). 18

Implications of the Deeming Rule

As a practical matter, manufacturers of newly deemed tobacco products will likely scramble to market new tobacco products in advance of August 8, 2016 — the effective date of the deeming regulation — to ensure that they receive the benefit of FDA’s premarket authorization compliance policy. Even so, absent legislation moving the grandfather date, the deeming rule will impose severe burdens on manufacturers and retailers of ENDS products. Indeed, the final rule acknowledges that imposing the regulatory regime “inevitably will lead to some market change and consolidation.” 19 In light of the pending regulatory changes, it is incumbent on industry to consider the implications of the new requirements and the means to ensure compliance with evolving FDA regulation.

This article is made available by Latham & Watkins for educational purposes only as well as to give you general information and a general understanding of the law, not to provide specific legal advice. Your receipt of this communication alone creates no attorney client relationship between you and Latham & Watkins. Any content of this article should not be used as a substitute for competent legal advice from a licensed professional attorney in your jurisdiction.

To view all formatting for this article (eg, tables, footnotes), please access the original here.

Resource: http://www.lexology.com/library/detail.aspx?g=d3dcc8eb-d7f1-465a-bfbf-391df5d66493

Researchers emphasize need to rethink tobacco control strategies

The tobacco product landscape has changed significantly with the introduction of alternatives that are much less harmful than traditional cigarettes.

Compared to cigarettes, which kill 3 in 5 smokers prematurely, some non-combusted products — including snus, other smokeless tobacco products and electronic cigarettes or vapes — are estimated to be more than 90 percent less harmful.

But decades-old tobacco control strategies that rely on an "all or nothing" approach haven't kept up with these changes, and are confusing the general public. Writing in the journal BioMed Central Public Health, two researchers say it's time for tobacco control themes to be modernized.

"Not since the invention of the cigarette rolling machine in 1882 has the product landscape changed so dramatically. For the first time in over a century, there are products that could make the defective and deadly cigarette obsolete," says Lynn T. Kozlowski, PhD, a co-author of the paper and professor of community health and health behavior at the University at Buffalo.

"The dramatic landscape change warrants a rethinking of past tobacco control strategy, from an all-or-nothing approach to a harm-reduction approach," adds Kozlowski, who has written extensively on the need for including a harm-reduction approach in tobacco control efforts.

Kozlowski wrote the paper with David B. Abrams, PhD, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Truth Initiative in Washington, D.C.

Abrams is also professor of health behavior and society at Johns Hopkins University, and an adjunct professor of oncology in the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center.

The researchers write that the long-held tobacco control strategy that lumps all tobacco products together — regardless of the differences in harm — is negatively impacting public health.

"In the past few years, more smokers now wrongly believe that Alternative Nicotine Delivery Systems, including electronic cigarettes, are as harmful or more harmful than cigarettes and are thus less likely to switch to them to quit smoking," says Kozlowski.

They argue that, while there is some risk in using any product that delivers nicotine, dramatic differences in harm exist between deadly cigarettes — by far the most lethal — and other products like e-cigarettes and smokeless tobacco, and that these differences need to be communicated to the public.
"Smokers who cannot, or do not, wish to quit smoking can now switch to a substantially less harmful, but reasonably satisfying, alternative way to get their nicotine. People smoke for the nicotine but die mostly from the tar," said Kozlowski.

In their paper, Kozlowski and Abrams trace the history of tobacco control strategies in the U.S. since efforts began in 1964. They discuss the push that year toward low tar — or so-called "light" — cigarettes, sales of which boomed. At the time, public health officials believed that a smoker's risk of lung cancer could be reduced by lowering the amount of tar in cigarettes.

The utter failure of these low tar/light combusted cigarettes to actually be less harmful does not mean that the same is true for modern non-combusted products like e-cigarettes, the researchers say.

In the 1980s, broader bans on cigarette advertising were proposed, and the dominant theme was that smoking is bad and there are no other product options to consider.

"Since 1964, major themes missed a core principle: The substantially greatest harm is from the toxic smoke of combusted, inhaled tobacco," Kozlowski and Abrams write.

At the same time as a harm reduction stance is adopted for smokers of deadly combusted tobacco, it is important to complement the decades of successful tobacco control, to minimize the use of any nicotine-containing products by underage youth, they say.

The new tobacco rules the U.S. Food and Drug Administration proposed earlier this month now include the regulation of previously unregulated cigars of all types, e-cigarettes and hookah.

"Despite our best efforts to prevent youth tobacco and nicotine use, most adult users will still likely have begun in their youth, and these adult users need legal options that are much less harmful than cigarettes," Kozlowski warns.

"Regulation should be used to strike the balance so urgently needed between protecting non-users, especially youth, while maximizing benefits of newly regulated non-combustible e-cigarette products that have been shown to help current smokers either to switch or, ideally, to quit," Kozlowski added.

The regulations need to be reasonable and proportionate so as not to stifle innovation or make the least harmful products subject to the most burdensome regulations, while allowing the most harmful combustible products to be subject to the most regulations, according to the researchers.

Resource: http://www.news-medical.net/news/20160525/Researchers-emphasize-need-to-rethink-tobacco-control-strategies.aspx

Electronic Cigarettes Put Kids at Risk

Electronic cigarettes are exposing young children in the United States to dangerous levels of nicotine.  A new study in the journal Pediatrics found the number of poison control cases involving children swallowing the devices’ liquid nicotine has steadily been on the rise since 2012.

“Exposures to e-cigarette liquid continue to go up,” says Barbara Crouch, executive director of the Utah Poison Control Center. “In 80 percent of the cases we are consulted on involving e-cigarette liquid, a child under the age of six is involved.”

The liquid nicotine in e-cigarettes is highly concentrated and contains anywhere from six to 36 milligrams of nicotine per unit. Swallowing nicotine can cause vomiting, rapid heart rate, seizures and possibly death, depending on the amount and concentration. “For a small child, that amount could be less than a teaspoon,” says Crouch.

Nicotine can also get into the system through the skin, so a child playing with an e-cigarette may be exposed even if they do not swallow it. Nicotine also can be absorbed through the eyes, and can cause eye irritation as well.

Complicating the problem is the fact that the nicotine in e-cigarettes is more attractive to children than that in regular tobacco products. Nicotine liquids may be flavored and smell pleasant. The packaging often is brightly colored and sometimes looks like candy. It was only recently that the Child Nicotine Poisoning Prevention Act went into effect, mandating that e-cigarette liquid packaging be child-resistant. The Food and Drug Administration announced it will begin regulating the devices, but those regulations are not yet in place and the devices still are widely available.

“The most important thing to remember is that nicotine is a poison and should be treated as such,” says Crouch. “Parents need to keep these devices up and out of reach of children – preferably in a locked cabinet. If a child is exposed, the poison control center should be called immediately to determine a course of treatment.”
About the author:

Libby Mitchell is the Social Media Coordinator for University of Utah Health Care. Follow her on Twitter @LibbyMitchellUT.

Resource: http://healthcare.utah.edu/healthfeed/postings/2016/05/e-cigs.php

Decatur will consider banning electronic cigarettes in parks, booting reforms

The Decatur City Commission is considering updates to the city’s clean air ordinance that would ban electronic cigarettes in public parks.

There’s also an item on the agenda that’s intended to rein in some of the aggressive booting of people who illegally park in private lots.

The meeting begins at 7:30 p.m. and will be held at City Hall, located at 509 North McDonough Street. All meetings are open to the public. There will be an opportunity for public comment before the commission votes on either measure.

Under the updated ordinance, the definition of smoking would be expanded to include, “inhaling, exhaling, burning or carrying any lighted cigar, cigarette, e-cigarette, oral smoking device, or pipe containing any weed, plant, nicotine based liquid or other combustible substance in any manner or in any form.”

The city’s current definition of smoking does not include e-cigarettes. It also adds the definition of a public park. A public park would be defined as, “any public park, playground, greenspace, plaza or outdoor recreation area maintained and operated by the City, including but not limited to, all city parks, the MARTA Plaza, the Decatur Cemetery and the Old Courthouse lawn.”

The revised ordinance “closely follow” the DeKalb County clean air ordinance, a memo attached to the City Commission agenda says. To read the full list of proposed changes, click here.

Commissioners will also take up proposed changes to the city’s booting ordinance. The changes would make it easier to identify booting companies patrolling private lots and would cap fees at $75. Currently, people who are booted are paying around $100

The changes are in response to aggressive enforcement by parking attendants.

Decatur’s City Manager recently called some of the parking enforcement behavior “predatory.”

For instance, there are drivers say they’ve paid to park and have been punished anyway. In another case recounted at a recent City Commission meeting, a driver was booted after they left the property to get cash because the credit card machine wasn’t working.

A Decaturish investigation found that Decatur Police officers called to intervene in booting disputes are busier than ever. Calls to resolve these disputes increased 188 percent from 2014 to 2015, records show.

City Commissioners were considering capping the fees at $40, but the proposed changes were tabled after one of the booting companies objected. Capping the fees at $40 would make the enforcement contracts unprofitable, company representatives said.

Recommended changes include:

– Requiring the name of the booting company be included on signs in parking lots.

– Requiring the name of the owner of the lot to be included on the signs.

– Requiring an ID badge to be worn by operators of mechanical locking devices.

– Requiring that pay stations in parking lots must be in working order.

To see the full list of proposed changes to the booting ordinance, click here.

In other business, the City Commission is considering an agreement with the Georgia Department of Transportation for federal money to improve the railroad crossings at Candler and McDonough streets.
Resource: http://www.decaturish.com/2016/05/decatur-will-consider-banning-electronic-cigarettes-in-parks-booting-reforms/

What's Causing E-Cigarettes' Trail of Injuries?

An electronic cigarette  exploded in the face of a man in Albany, New York, recently, leaving him with a hole his tongue and burns on his hand, CNN reported. The explosion also knocked out several of the man's teeth.

But this is far from the first injury caused by an exploding e-cigarette, or e-cig.

The battery-powered devices work by heating a liquid, which typically contains nicotine as well as other chemicals, into a vapor that a user then inhales. But the lithium-ion battery that heats the liquid within an e-cig poses a big safety risk: The batteries have the potential to explode, Dr. Michael Siegel, a tobacco researcher and professor of community health sciences at the Boston University School of Public Health, told Live Science recently. [E-Cigarettes: What Vaping Does to Your Body]

Last month, a teen in New York City was hospitalized after an e-cig exploded while he was testing it out in a store, according to CBS News. The explosion damaged both of the teen's eyes.

And in November 2015, an e-cig explosion left a Tennessee man potentially paralyzed, the Huffington Post reported. The explosion fractured the man's vertebrae and bones in his face, and knocked out a tooth.

In July 2015, a young man in Alabama was airlifted to a hospital and placed on a ventilator after an e-cig blew up in his face. In addition to first-degree burns on his face and chest, the explosion left the young man with a hole in the roof of his mouth that made it difficult for him to eat, according to AOL News. 

And earlier last year, a man's exploding e-cig was powerful enough to shatter glass in the Southern California store he was in, NBC Los Angeles reported. After the blast, the man was rushed to the University of California San Diego Burn Center for treatment.
Why e-cigs explode

In a 2014 report, the U.S. Fire Administration examined e-cig explosions between 2009 and 2014. Lithium-ion batteries in other devices such as cellphones and laptops have also been known to cause fires, the report said. But the design of e-cigs—with their cylindrical shape, and the weakest structural point at their ends—makes these devices more likely than others to explode if the battery fails, according to the report.

The fires start in the battery. While all batteries contain electrolyte solutions (this is an essential part of how they work), the solutions used in lithium-ion batteries are different from those in regular batteries because they are flammable, the report said.

In a lithium-ion battery, the solution can become overheated, reach its boiling point and then rapidly expand and catch fire, causing the battery to explode, according to the report. Laptops and other devices have rigid plastic cases that prevent an exploding battery from doing much damage. But in an e-cig, the explosion can lead the cylindrical container of the device to explode, too, causing the device to "be propelled across the room like a bullet or small rocket," the report said.

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Resource: http://www.scientificamerican.com/article/what-s-causing-e-cigarettes-trail-of-injuries/