Report slams child labor in tobacco fields

By Mariano Castillo, CNN

(CNN) — Children can’t light up, but there are some who suffer the effects of nicotine exposure as they labor in U.S. tobacco fields.

There is not an exact figure for how many children work in America’s tobacco fields, but Human Rights Watch interviewed nearly 150 for a new report on the dangers these workers face.

“I would barely eat anything because I wouldn’t get hungry,” one child worker, Elena G., 13, told the human rights group. “Sometimes I felt like I needed to throw up. … I felt like I was going to faint. I would stop and just hold myself up with the tobacco plant.”

Nearly 75% of the children interviewed reported similar symptoms — nausea, vomiting, loss of appetite, headaches, dizziness, irritation and difficulty breathing. These are symptoms of acute nicotine poisoning, Human Rights Watch said.

And nicotine is not the only danger.

Exposure to pesticides from adjacent fields and accidents with sharp tools are also common, the report said.

“Once they sprayed where we were working. We were cutting the flower and the spray was right next to us in the part of the fields we had just finished working in. I couldn’t breathe,” Jocelyn R., 17, told HRW. “I started sneezing a lot. The chemicals would come over to us.”

Altria, one of the biggest cigarette makers, does not employ its own farmers but maintains strict standards on the contractors it buys tobacco from, company spokesman Jeff Caldwell said.

His company’s view is not that the HRW report is critical of the tobacco industry, but that it asks for cooperation with various interests to protect the safety of workers, especially minors, he said.

“Our tobacco companies do not condone the unlawful employment or exploitation of farm workers, especially those under the age of 18,” Caldwell said.

Altria requires that its growers follow certain guidelines that specifically include best practices for labor management when it comes to harvesting tobacco. Issues such as avoiding acute nicotine poisoning and heat stress are addressed in the guidelines, he said.

U.S. tobacco companies intend to work together to further discuss the topics in the report, he said.

The study focused on four tobacco-growing states: North Carolina, Kentucky, Tennessee and Virginia.

Children can legally work in the tobacco fields, and some as young as 11 and 12 years old do. These children primarily work during the summer to help support their families. The majority of them were Hispanic children of immigrants who lived in nearby towns, the report said.

“As the school year ends, children are heading into the tobacco fields, where they can’t avoid being exposed to dangerous nicotine, without smoking a single cigarette,” Margaret Wurth, a co-author of the report, said in a news release. “It’s no surprise the children exposed to poisons in the tobacco fields are getting sick.”

Many of the children the group spoke with reported working long hours without overtime pay or enough breaks, HRW said.

One of the recommendations of the report is that no one under 18 be allowed to work in tobacco fields, due to the risks that such exposure can bring.

http://www.cnn.com/2014/05/14/us/hrw-children-tobacco-workers-report/

The Weird Link Between E-Cigarettes and Mental Health Disorders

Dan Kedmey, TIME

A new study finds elevated rates of depression, anxiety and other mental disorders among users of e-cigarettes

A new study has found that people suffering from depression, anxiety and other mental disorders are more than twice as likely to spark up an e-cigarette and three times as likely to “vape” regularly than those without a history of mental issues.

Researchers at the University of California, San Diego drew their findings from an extensive survey of American smoking habits. Among 10,041 respondents, 14.8% of individuals suffering from mental health disorders said they had tried an e-cigarette, compared with 6.6% of individuals who had no self-reported history of mental disorders.

The e-smokers’ elevated rates of mental disorders reflected the elevated rates of mental illness among smokers in general. The authors note that by some estimates, people suffering from mental disorders buy upwards of 50 percent of cigarettes sold in the U.S. annually.

Many respondents said they switched to e-cigarettes as a gateway to quitting. The FDA has not yet approved e-cigarettes as a quitting aide.

“People with mental health conditions have largely been forgotten in the war on smoking,” study author Sharon Cummins said in a university press release. “But because they are high consumers of cigarettes, they have the most to gain or lose from the e-cigarette phenomenon.”

The study will run in the May 13 issue of Tobacco Control.

http://time.com/97414/the-weird-link-between-e-cigarettes-and-mental-health-disorders/

Grand Forks targets e-cigs: New ordinance gets early approval from city committee

By Charly Haley, Grand Forks Herald
Electronic cigarettes may soon be more regulated in Grand Forks if a recommendation for a new city ordinance is approved by City Council next week.
An ordinance prohibiting possession of e-cigarettes by minors and prohibiting vending machines that sell e-cigarettes was proposed to the City Council Service/Safety Committee by council member Bret WeberTuesday. The committee voted unanimously to support the ordinance, which will go to the full City Council next week for final approval.
E-cigarettes are not technically a “tobacco product,” which is why they aren’t regulated under existing city ordinances, Weber said.
But they are a vehicle for nicotine in a vapor form, which is still damaging to health, he said.
According to Food and Drug Administration reports, e-cigarettes can increase nicotine addiction and may lead people to try regular cigarettes, which are known to cause disease.
The proposed Grand Forks ordinance states that e-cigarettes will have the same regulations as other tobacco products.
Haley Thorson, a Grand Forks Public Health nurse, said there are only two e-cigarette shops that she knows of in Grand Forks: SnG Vapor and Vapor Stars. Some convenience stores also sell simple e-cigarettes, she said.
A big part of the problem, Weber said, is that e-cigarettes are often marketed toward youths. “There are ‘Hello Kitty,’ e-cigarettes,” he said.
Members of the Red River High School Student Council and the Grand Forks City Youth Commission attended the Service/Safety Committee meeting to support Weber’s proposal of the ordinance.
E-cigarette use among youth in North Dakota has almost tripled from 2011 to 2013, according to a report provided by the Grand Forks Public Health Department. The trend is growing nationally as well, according to the report.
In Minnesota, it is illegal by state law for minors to buy e-cigarettes, Weber said. At least eight communities in North Dakota have passed or are currently discussing ordinances that regulate sales of e-cigarettes to minors, according to the Public Health report.
http://www.grandforksherald.com/content/grand-forks-targets-e-cigs-new-ordinance-gets-early-approval-city-committee

Health Insurance Surcharge Has Vapers Fuming

By  via GOOD MORNING AMERICA

Under the Affordable Care Act, insurance companies can charge smokers and other tobacco users up to 50 percent more than non-smokers for a health insurance policy. But where do e-smokers fit in?

E-cigarettes are battery-operated nicotine inhalers that consist of a rechargeable lithium battery, a cartridge called a cartomizer and an LED that lights up during each puff. Although they contain no tobacco, the U.S. Food and Drug Administration plans on regulating them like cigarettes and cigars. This, it turns out, is complicating things for insurance companies.

While the ACA allows insurance companies to charge higher premiums to smokers and other tobacco users, the definition of a “smoker” is unclear under the law.

One way insurance companies could deal with e-cigarettes is to lump them in with tobacco products – a move that would subject so-called vapers to the same higher premiums as cigarette smokers. The companies could also swing the other way and decide to cover the cost of e-cigarettes as a means to help people quit smoking, despite a lack of evidence that the devices work as well as a patch. Insurers could also choose to ignore e-cigs altogether.

”The Affordable Care Act does not specify e-cigarette use for purposes of cessation coverage or tobacco surcharge application,” the American Cancer Society said in a statement to ABC News. “The lack of clarity may allow health plans to try to add the surcharge for e-cigarettes.”

If and when the FDA regulation of e-cigarettes goes into effect, insurance companies could change any of their current policies to reflect the agency’s direction. In the meantime, most companies claim they have too little experience with the devices to have a position, according to an informal poll by the National Association of Health Underwriters.

Carrie McLean, director of customer care for the online health insurance brokerage eHealth, said some insurers are telling their agents to add a smoking surcharge for those who vape.

“If a consumer indicates they use e-cigarettes, the carriers are expecting them to be uprated just as if they are a smoker,” she said, noting that consumers aren’t actually asked about the type of tobacco products they use during the health insurance application process – just whether they use them at all.

America’s Health Insurance Plans, an association which represents most of the country’s large health insurance companies, recommends that agents ask about regular tobacco use in the last six months and the most recent use. However, if a consumer were to ask for clarification about whether or not e-cigarettes count as tobacco use, then an agent is obliged to add the surcharge, McLean said.

“The problem arises because most people fill out their applications online and, as of now, most applications don’t ask specifically about e-cigarettes,” McLean said. “Consumers are left to decide on their own whether or not they consider themselves a tobacco user.”

It’s an important question to settle, as the price differential can be significant.

For example, a plan for a 40-year-old non-smoker with a $35,000 income that costs $3,857 a year minus a $532 tax credit would rise to $5,254 for someone labeled a smoker, according to the Kaiser Family Foundation’s exchange subsidy calculator. In some cases, the rate increase might even be larger than the 50 percent increase the ACA allows because government tax credits only apply to the base premium and not the tobacco surcharge.

Not surprisingly, e-cigarette advocates are fired up about vaping being likened to smoking by insurance companies. Cynthia Cabrera, executive director of the e-cigarette industry organization Smoke Free Alternatives Trade Association, said that e-cigarettes and other vaping products are a healthier lifestyle choice than combustible tobacco cigarettes, and argued that it seems inconsistent to apply the same higher insurance rates to vapers.

“The SFATA does not agree with any policy that positions users of electronic cigarettes and other vapor products in the same category as smokers,” she said. “These products do not emit smoke and do not contain tobacco, tar or any of the many carcinogens known to exist in combustible cigarettes.”

But the phenomenon of vaping is so new that experts say there’s insufficient science to determine whether e-cigarettes really are a healthier alternative to traditional tobacco products.

Dr. Ravi Ram, the chief medical officer for Blue Shield of Northeastern New York, said that although New York has chosen to eliminate rate increases for e-smokers, he suspects most plans would place e-cigarettes on par with cigarettes in terms of their health risk.

“Until you have some long term data and some actuarial differences to health outcomes such as lung cancer, emphysema, heart disease and other conditions which are significantly impacted by smoking, and likely to be impacted by e-cigarettes as well, you have to rate them the same,” he said.

http://abcnews.go.com/Health/health-insurance-surcharge-vapers-fuming/story?id=23628060

 

House panel moves to block Navy proposal to ban tobacco sales on bases, ships

FoxNews.com
House lawmakers approved a measure this week that would protect tobacco sales on military bases and ships and effectively block the Navy’s plans to drop the products in a bid to get servicemembers to stop smoking.
The House Armed Services Committee added language to a fiscal 2015 defense authorization bill that bans defense officials from enacting “any new policy that would limit, restrict, or ban the sale of any legal consumer product category” on military installations, the Navy Times reported.
The Pentagon said last month that no final decision has been made about banning sales to troops, but Defense Secretary Chuck Hagel said he asked for a review to address the “astounding” health care costs associated with tobacco-related illness.
A March 14 Defense Department memo issued guidance to all service chiefs:
“Although we stopped distributing cigarettes to our Service members as part of their rations, we continue to permit, if not encourage, tobacco use. The prominence of tobacco products in retail outlets and permission for smoking breaks while on duty sustain the perception that we are not serious about reducing the use of tobacco.”
Rep. Duncan Hunter, R-Calif., who sponsored the amendment prohibiting the Navy’s plans, said the move amounts to a hand-holding of troops who are responsible adults and should be able to make their own life choices, the Navy Times reported.
“Just because you joined the service doesn’t mean you can’t live comfortably,” said Hunter, a Marine veteran of Iraq and Afghanistan. “If your goal is to make the military healthy, let’s outlaw war. That’s as unhealthy as you can get.”
The measure passed by a 53-9 vote on Wednesday, with some Democrats objecting to limits on the military’s efforts to promote health and fitness. In order for the regulation to become law, the  Senate would have to adopt the House measure.
Rep. Susan Davis, D-Calif., objected to the proposal, arguing that promoting good health is just as important as military readiness, The Washington Times reported.
“This is not telling people that they can’t use tobacco, clearly people can go across the street almost wherever they are and purchase that,” Davis said. “But we are sending a kind of double message, I think, by not saying that we recognize tobacco can cause damage, not only to a sailor, but also to their family, second hand smoke we know is a concern.”
The Navy Times reported that measure covers any product legal in the U.S. as of Jan. 1, including alcohol and sugary drinks. The measure does not cover marijuana.
Fox News’ Jennifer Griffin contributed to this report.
http://www.foxnews.com/politics/2014/05/09/house-panel-moves-to-block-navy-proposal-to-ban-tobacco-sales-on-bases-ships/

Should this be legal? Dickinson commissioners consider anti-hookah ordinance, but say more information is needed

By Nadya Faulx, The Dickinson Press

City Commission members are weighing options for a possible hookah bar in Dickinson, but the idea could be up in smoke before it even starts.
City Administrator Shawn Kessel told commissioners Monday that he has been getting requests for hookah bars to be built in town, but wanted to gauge members’ “desires as they relate to hookah bars.”
“Is that a business model you’d like to see in the community?” he asked.
An unnamed caller reached out to Kessel on Monday afternoon asking for information about how to open the city’s first hookah bar, where patrons could gather to smoke from the water pipes that originated in the Middle East but have become popular throughout the world — just not North Dakota.
“A hookah bar is an interesting term,” Kessel told the commission. “It goes back a long ways, and it has its roots in the Orient. And I had to look this up online, because I wasn’t exactly sure.”
The state’s first and only hookah bar, Dreas Hookah Lounge in Grand Forks, closed last month as a result of the 2012 ban on smoking in worksites and public spaces.
Any hookah bar in Dickinson would be able to serve only herbal products in lieu of the traditional shisha, or flavored tobacco.
Aside from the state smoking law, there are no other legal barriers to opening a hookah bar in the city.
“We can’t deny them,” Kessel said. “And if it’s in the interest of the City Commission to do so, I’m here to tell you that the city staff does not have that ability.”
The only way to put the kibosh on hookah would be to draft an ordinance to block the practice and hold a public hearing with input from community members.
“To get the process going, you either have to have an ordinance saying we’re going to allow these and the conditions we’re going to allow them on,” Mayor Dennis Johnson said Monday, “or you could draft an ordinance saying we’re not going to allow them, and then you get whole public comment and discussion.”
He added that he hasn’t “thought a whole lot about hookah bars.”
In an interview, Johnson said he “didn’t get the sense that anyone at the commission table knows a whole lot about the issue.”
He added: “We would rather get much better educated on it.”
Commission member Klayton Oltmanns said in an interview that there weren’t strong feelings among the commission either for or against a hookah bar, but that more information is needed before a decision is made.
“It is new to each of us as commissioners,” he said. “Just to get ahead of the game, we’re going to issue an ordinance. We’ll be able to gauge the community’s response — pro or con — and make a good informed decision based on what the community says.”
At least one community member would support the ban: Jennifer Schaeffer, tobacco prevention coordinator at Southwest District Health, said hookah smokers face numerous health risks, whether the pipes are packed with tobacco or herbs.
“Anytime you smoke something into your lungs, you’re putting your lungs and heart at risk,” she said. “We’re concerned about that.”
Hookah smoke contains nicotine, tar and carbon monoxide like cigarette smoke, and is at least as toxic, according to the Center for Disease Control.
Schaeffer said she would support the City Commission if it issued an ordinance banning the practice in Dickinson.
“As a health unit, as a tobacco prevention program, we wouldn’t be in support of having hookah bars,” she said.
But talks about the potential hookah bar are in their earliest stages, and Oltmanns said there is “still too little info” to take any definite stance yet.
City Attorney Matthew Kolling and city administration would first have to draft the ordinance, at which point it would go through a first reading and public comment. Oltmanns said the topic is expected to come up again in a June commission meeting.
“Any ordinance in its initial reading isn’t necessarily how it ends beyond that,” Oltmanns said, adding the city wants to hear a response from residents and businesses before it makes a decision.
http://www.thedickinsonpress.com/content/should-be-legal-dickinson-commissioners-consider-anti-hookah-ordinance-say-more-information

Forum editorial: Prohibit smoking in all parks

Forum editorials represent the opinion of Forum management and the newspaper’s Editorial Board.
—–
All metro area communities, large and small, should follow the lead of Dilworth and Moorhead and ban smoking in public parks. Dilworth took the smart step last week. Moorhead parks have been smoke-free since 2011. The Fargo Park District has a limited ban that allows smoking 25 feet away from playgrounds. West Fargo allows smoking in parks.
Parks primarily are venues for families and children. Moreover, park officials champion healthy lifestyles. The sports activities that take place on park fields comport with fitness and health. Smoking should be anathema.
In addition to bans and partial bans in the metro, nearby cities that ban smoking in parks include Mayville, Kindred, Valley City, Cooperstown and Wahpeton, all in North Dakota. Dozens of Minnesota cities have bans in place.
While some smokers might see the closing off of more public spaces as a violation of their rights, that argument is nonsense. There remains a plethora of places where smokers can indulge their habit, as long as it does not threaten the health of others. The many voter-approved bans in place reflect recognition that smoking and secondhand smoke are health issues, not rights issues. Some smokers will debate that unassailable premise until they cough their lungs out, but as a matter of public policy the debate is over.
Therefore, the Fargo Park District should extend its limited ban to every square foot of park land, and West Fargo should ban smoking in every one of its beautiful, allegedly family-friendly parks.
http://www.inforum.com/event/article/id/433907/

E-Cigarette Makers Going After Youth, Report Finds

BY MAGGIE FOX, NBC News

E-cigarette makers may say they welcome regulation and don’t want to sell to teenage nonsmokers, but their advertising dollars paint a very different picture, according to a report released Thursday.

E-cigarette makers spent $39 million on ads from June through November 2013, much of it on programming targeting youth, the anti-tobacco organization Legacy found.

“Overall, these research findings indicate that, despite their publicly stated intentions, some e-cigarette companies are reaching youth with their advertising,” Legacy says in its report.

“Moreover, the only national brand owned by a major tobacco company, blu, is reaching a significant portion of young Americans with its advertising. The effects of this are apparent, with nearly all young people aware of these products and use among young people rising rapidly.”

Health officials from several major U.S. cities say that’s why federal regulators need to act. They can restrict sales and limit where people may smoke or “vape,” but they cannot restrict national ads.

“There are some areas where our hands are tied and that particularly is in marketing,” said New York City health commissioner Dr. Mary Travis Bassett.

“They need to do more to protect kids from the effects of TV,” added Los Angeles County health commissioner Dr. Jonathan Fielding.

The fear is a whole new generation of people will become addicted to nicotine before federal regulations can be written, let alone take hold, the health commissioners told a news conference. New York, Chicago, Boston and Los Angeles County are among the big city areas that have restricted sales and use of e-cigarettes.

Even some public health experts say e-cigarettes may be a useful alternative to burned tobacco cigarettes for smokers. But they also agree that it would be bad to encourage or even allow non-smoking children to become addicted to the nicotine in e-cigarettes.

Legacy was set up in 1999 as part of the Master Settlement Agreement when major tobacco companies agreed to pay more than $200 billion to states and territories. The states wanted some of the money to be used for an organization dedicated to studying and providing public education about the impact of tobacco.

Just last week, the U.S. Food and Drug Administration said it would seek to regulate e-cigarettes, because they contain nicotine, the addictive substance in tobacco. Most e-cigarette makers said they’d welcome some regulation.

Legacy did two studies looking at the marketing of e-cigarettes, and asking teens and young adults what they knew about them. It found e-cigarette TV ads reached 29.3 million teens and young adults from January through November 2013, including 58 percent of 12- to 17-year-olds.

Taken together, the two reports show e-cigarette makers using tactics that have long been banned for regular cigarettes, the report says.

E-cigarette makers dispute this. “The products are being advertised to adults,” said Cynthia Cabrera, executive director of the Smoke Free Alternatives Trade Association. “If children are watching during that time, it’s possible, but they are being marketed to adult consumers, to adult smokers.”

Public health experts say 90 percent of smokers start by the age of 20. They worry that e-cigarettes sold in flavors such as bubble gum and Gummi bear are targeted mainly to younger teens.

“While cigarette advertising is prohibited on television, it is currently fair game to use television to promote electronic cigarettes. Using broadcast and online advertising has allowed the e-cigarette industry to promote its products in a way that has broad reach and is largely unregulated,” Legacy says.

“Every day that industry is growing very, very rapidly,” LA’s Fielding said. “And you can be sure that big tobacco is going to wind up in the driver’s seat with respect to marketing. Don’t let them undo decades of efforts to de-glamorize smoking.”

http://www.nbcnews.com/health/kids-health/e-cigarette-makers-going-after-youth-report-finds-n94166

Dr. Nancy Snyderman: E-cigarette issue ‘is a big fight’

Today Show:  NBC News’ chief medical editor discusses what new FDA regulations could mean for e-cigarette consumers.

To view video:  http://www.today.com/video/today/55025322#55025308

Proposal would ban e-cigarette sales to minors, allow advertising

By: Reuters, INFORUM
WASHINGTON – The U.S. Food and Drug Administration proposed rules on Thursday that would ban the sale of e-cigarettes to anyone under 18, but would not restrict flavored products, online sales or advertising, which public health advocates say attract children.
The long-awaited proposal, which would subject the $2 billion industry to federal regulation for the first time, is not as restrictive as some companies had feared and will likely take years to become fully effective.
Bonnie Herzog, an analyst at Wells Fargo, said the proposal is “positive for industry.”
But public health advocates lamented the fact that the proposal does not take aim at e-cigarette advertising or sweetly-flavored products, which they say risk introducing a new generation of young people to conventional cigarettes when little is known about the long-term health impact of the electronic devices.
“It’s very disappointing because they don’t do anything to rein in the wild-west marketing that is targeting kids,” said Stanton Glantz, a professor at the Center of Tobacco Control Research and Education at the University of California, San Francisco.
FDA Commissioner Margaret Hamburg said at a briefing on Wednesday that the proposal represented the first “foundational” step toward broader restrictions if scientific evidence shows they are needed to protect public health.
That declaration worries some companies.
“The window is still open for a more draconian approach,” said Jason Healy, president of Lorillard Inc’s blu eCigs unit, which holds roughly 48 percent of the market. “I think the proposal shows a good science-based reaction here from the FDA, but there is a lot we have to go through during the public comment period.”
Lorillard, together with privately-held NJOY and Logic Technology account for an estimated 80 percent of the market. Other big tobacco companies, including Altria Group Inc and Reynolds American Inc, are also entering the market.
E-cigarette advocates welcomed the FDA’s light touch.
Dr. Michael Siegel, a professor of community health sciences at Boston University, said a ban on flavorings would have “devastated the industry, as the flavors are a key aspect of what makes these products competitive with tobacco cigarettes.”
Similarly, a ban on all e-cigarette advertising “would have given tobacco cigarettes an unfair advantage in the marketplace,” he said.
NO FREE SAMPLES
A law passed in 2009 gave the FDA authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco and stipulated the agency could extend its jurisdiction to other nicotine products after issuing a rule to that effect. E-cigarettes use battery-powered cartridges to produce a nicotine-laced inhalable vapor.
In the short term, the new rules would prohibit companies from distributing free e-cigarette samples, forbid vending machine sales except in adult-only venues and prohibit sales to minors.
Companies would also be required to warn consumers that nicotine is addictive, but no other health warnings would be required. The addiction warning would have to be added no later than two years after the rule is set and the e-cigarette companies would not be allowed to make health claims in any advertising.
The proposal is subject to a public-comment period of 75 days.
Vince Willmore, a spokesman for the Campaign for Tobacco Free Kids, said the proposal “by no means does everything we think needs to be done, but it starts the process. What is critical now is that they finalize this rule and then move quickly to fill the gaps.”
He said the FDA should aim to establish the rule within a year, but many are skeptical the agency will act that quickly.
“The reality of these things is that every step takes years,” said UCSF’s Glantz. “By not addressing the youth-directed marketing it means it won’t be addressed for a very long time.”
Some e-cigarette companies that sell primarily through convenience stores were surprised at the lack of restrictions on online sales, since it can be difficult to verify a customer’s age over the Internet.
“The Internet thing is very surprising to me,” said Miguel Martin, president of Logic Technology. “It reduces the visibility of the sales of the products and the type of products that the government has awareness of.”
The new rules would also require companies to submit new and existing products to the FDA for approval. They would have two years to submit applications from the time the rule goes into effect. Companies may continue selling their products and introducing new products pending the FDA’s review.
In the meantime, e-cigarette companies would be required to register with the FDA and list the ingredients in their products. They would not be required to adhere immediately to specific product or quality control standards. That could come later, Hamburg said.
THE “VAPING” INDUSTRY
E-cigarettes and other “vaping” devices generate roughly $2 billion a year in the United States, and some industry analysts expect their sales to outpace the $85 billion conventional-cigarette industry within a decade.
Advocates of e-cigarettes claim they are a safer alternative to conventional cigarettes, since they do not produce lung-destroying tar, though long-term safety data is thin.
The FDA’s proposal leaves many questions unanswered about how new products would be regulated over the long run. One key question relates to how products are approved.
Under current law, new tobacco products can be approved if they are “substantially equivalent” to a product that was on the market before Feb. 15, 2007. It is unclear whether any e-cigarettes were on sale before then, to be used as a benchmark.
Mitch Zeller, head of the FDA’s tobacco division, said at a briefing that the agency would be seeking more information during the public-comment period on whether the “substantial equivalence” pathway is even valid for e-cigarettes.
If it is not, e-cigarette companies would have to use a different process, which would require them to prove their products are appropriate for public health, a higher hurdle to clear.
Also up in the air is the regulatory fate of some cigars. The current proposal would include e-vaping products and other tobacco products, but premium cigars may be excluded.
The FDA said it would seek public comment on whether all cigars should be regulated equally. One option proposed by the agency is to regulate them all. The other is to define a category of premium cigars that would not be subject to the FDA’s authority.
Physicians said the possible exemption of premium cigars from regulation was troubling.
“Any exemption for any kind of tobacco product proven to cause lung and heart disease and cancer is unacceptable,” said Harold Wimmer, chief executive of the American Lung Association.
Cigar companies, backed by some members of Congress, had lobbied heavily for a regulatory carve-out for premium cigars. In a December 2013 letter to Hamburg and Sylvia Mathews Burwell, director of the White House’s Office of Management and Budget, 24 Republican lawmakers asked that premium cigars be exempt.
“As you know,” they wrote, “premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings.”
Under the proposed rule, premium cigars are considered those wrapped in whole tobacco leaf, made manually by combining the wrapper, filler and binder, have no characterizing flavor, have no filter, tip or non-tobacco mouthpiece and are relatively expensive.
http://www.inforum.com/event/article/id/432967/group/homepage/