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E-Cigarettes: What Vaping Does to Your Body

May 16th, 2016
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http://www.livescience.com/54754-what-e-cigarettes-do-in-your-body.html

By Cari Nierenberg, Live Science Contributor

Electronic cigarettes, or e-cigs, have been on the market in the U.S. since 2008 and have gained wider use in recent years. Now, evidence is beginning to emerge on e-cigs’ short-term effects, and their positive and negative impact on people’s health.

E-cigarettes are battery-powered devices that heat a liquid — usually containing nicotine mixed with the chemicals propylene glycol and glycerin, and often flavorings ranging from bubble gum to watermelon — into a vapor that users can inhale. They deliver nicotine, a highly addictive drug, to the body without producing any smoke.

This month, the U.S. Food and Drug Administration announced that its authority to regulate tobacco products will now extend to include e-cigarettes. The devices — along with cigars, hookah and pipe tobacco — will now be regulated in a similar way to conventional cigarettes. The new rules, which take effect on Aug. 8, also banned the sale of these products to people under age 18 both in stores and online.

But because e-cigs are relatively new nicotine-delivery products, there are many unanswered questions about their safety and health impacts, including questions about their long-term use and effectiveness in helping traditional smokers to quit. What, exactly, is in an e-cigarette, and how do these chemicals affect the heart and lungs as well as a person’s overall health? Live Science asked two tobacco experts for their insight into these questions, and here is what they said.

What’s known about e-cigs

“There is no question that a puff on an e-cigarette is less dangerous than a puff on a conventional cigarette,” said Stanton Glantz, a professor of medicine and the director of the Center for Tobacco Control Research and Education at the University of California, San Francisco.

Because e-cigarettes create a vapor rather than produce a tobacco smoke, they generally deliver less nicotine to users than cigarettes do, Glantz said.

However, this doesn’t mean the devices always represent a safer step down from cigarettes. In fact, one of the most dangerous things about e-cigarettes is that they may keep people smoking conventional cigarettes longer, rather than encourage them to attempt to quit, he said. Although estimates vary, anywhere from 70 to 90 percent of e-cigarette users are “dual users,” meaning they continue to smoke regular cigarettes after they begin vaping, Glantz said.

But regardless of how the nicotine is delivered — whether through e-cigs or conventional cigarettes — it still has effects on the body. The drug is a cardiovascular stimulant, and can potentially worsen heart disease in people who already have severe heart conditions. However, it’s not known whether nicotine alone can cause heart disease in people who don’t have heart problems, said Dr. Michael Siegel, a tobacco researcher and professor of community health sciences at the Boston University School of Public Health.

But there’s some evidence that e-cigarettes can have a substantial effect on blood vessels, and may increase people’s heart attack risk in that way, Glantz said.

What’s more, nicotine is poisonous in its concentrated, e-liquid form, and there have been an increasing number of cases of infants and young children accidentally ingesting it, Siegel said.

Nicotine also has effects on reproductive health, and exposure to nicotine during pregnancy, regardless of its delivery method, can harm the developing fetus and lead to babies born with low birth weights, he said.

The use of e-cigarettes by kids of high school age has soared – CDC statistics show that 1.5 percent of high school teens had tried e-cigs in 2011, compared with 16 percent in 2015. The rise has occurred even as researchers are finding more evidence that nicotine can be toxic to a young person’s still-developing brain and body systems, Glantz said. Studies have also shown that kids who use e-cigarettes have more respiratory problems and take more days off from school, he said.

In addition to the nicotine, e-cigs’ other chemicals may also affect health. Research on the vapors emitted and inhaled from e-cigarettes has shown they deliver particles small enough to reach deep into the lungs and that they are not the “harmless water vapor” that marketers may claim, Glantz told Live Science.

Propylene glycol, a chemical found in e-liquids, can irritate the eyes and airways, Siegel said. Early studies have also revealed that when propylene glycol or glycerin are heated and vaporized, they can degrade into formaldehyde and acetaldehyde, he said. Both of these chemicals are considered carcinogens, although it’s not yet clear how repeated exposure to them may cause cancer, he said. [10 Scientific Quit-Smoking Tips]

One of the biggest safety risks of e-cigarettes is the potential for their lithium-ion batteries to explode, sometimes into a person’s face or eyes, Siegel said. There is clearly a need for standards to make these batteries safer, he said.

But all in all, even if e-cigarettes involve some health risks, they are not more toxic than smoking cigarettes, and so anything that can get people away from tobacco is moving them in the right direction, Siegel said. He believes that vaping gives people a safer alternative because although users are still getting nicotine, they are getting lower levels of some of the toxic substances and carcinogens found in cigarette smoke, he said.

Eventually, the goal is to get people off vaping and to quit completely, but people have to start somewhere, Siegel said. He also acknowledged that many of his colleagues in public health don’t share his opinion. Rather, they view e-cigarettes as a gateway to smoking conventional cigarettes, especially for young people, or as a method of getting nicotine that actually diminishes people’s interest in quitting.

Glantz falls into this latter category. In an analysis he and a colleague published earlier this year, they found that adult smokers who use e-cigarettes are about 30 percent less likely to stop smoking than people who attempt to quit smoking without turning to vaping, he said. One possible explanation is that people may generally use e-cigarettes as part of a “taper-down” strategy, which is less effective than quitting cold turkey, he suggested.

The unknowns about e-cigs

Studies evaluating whether e-cigarettes are less harmful than cigarettes have been inconclusive, according to a review of studies published in the journal Tobacco Control in May 2014.

Moreover, the long-term health effects in people who get nicotine in a vaporized form over time are not known, Siegel said. It’s also unclear whether propylene glycol, a known irritant to the respiratory tract, could result in lung problems after decades of vaping, he said.

And because e-cigarettes have been on the market for only about 10 years, there have been no long-term studies of people who have used them for 30 to 40 years. Therefore, the full extent of e-cigs’ effects on heart and lung health, as well as their cancer-causing potential, over time is not known, Glantz told Live Science.

Another unanswered question is how the flavorings used in the devices may affect people’s health. Nearly 500 brands and 7,700 flavors of e-cigarettes are currently on sale, according to the American Lung Association. This wide variety of flavors has helped make vaping appealing to young people.

It’s not yet known whether these flavorings have any respiratory effects when they are vaporized and inhaled, Siegel said. More research is needed to identify any hazards associated with the potential inhalation of flavoring agents, he said.

In addition, little is known about how the flavoring agents in e-cigarettes may influence nicotine’s addictive qualities, Glantz said.

More work needs to be done to understand the dynamics between smoking traditional cigarettes and also using e-cigarettes in people who are dual users, he said. Future research also needs to look at whether using both traditional cigarettes and e-cigs interferes with the desire to quit, and whether using e-cigarettes is an effective strategy for quitting smoking compared with other methods, such as the nicotine patch and behavioral counseling, Glantz said.

The FDA has not approved e-cigarettes as a smoking cessation aid, he added.

Follow Live Science @livescience, Facebook & Google+. Originally published on Live Science.

E-Cigarettes Are No Safer, Study Shows

May 12th, 2016
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http://www.lawyerherald.com/articles/45071/20160512/e-cigarettes-safer-study-shows.htm

People get addicted on cigarettes and enjoy them up to the cigarette butt because of the nicotine craze. Although the nicotine doesn’t promote lung cancer and diseases, it’s the tar and other chemicals that do most of the damage.

A vigorous debate has been going on among public health officials if electronic cigarettes or e-cigarettes can reduce the dangers of smoking tobacco or id they should be dealt as negatively as conventional cigarettes. Countries such as Britain, authorities prefer e-cigarettes more, enticing smokers to transition to electronic from conventional.

The Food and Drug Administration issued last week new rules on e-cigarettes, prohibiting their sale to people less than 18 years of age and required adults under the age of 26 to present a photo identification to buy them, according to The New York Times.

Producers will be required to reveal the ingredients in the liquid nicotine used in “vaping” and permit government review on how the devices are manufactured before they can be sold to adults in the U.S.

Presently, anything could be concealed inside the liquid and isn’t the only fact why children are not allowed to use e-cigarettes. Since it still contain nicotine which is an addictive ingredient associated to heart disease, it doesn’t mean even without the carcinogenic tar and smoke it is already safe to use. Harmful substances are discovered in e-cigarette “juice” like the flavoring Diacetyl linked to lung diseases, as reported by timesunion.

While tobacco products are responsible for the huge majority of the exposures, e-cigarettes are held accountable for 14% of them. But what is most worrying is the increased scale at which most young children are exposed with e-cigarettes and the serious incidents compared to tobacco product exposures, the Medical News Today reported.

Nicotine is an impetus that exists naturally in tobacco plants affecting the heart and nervous system. Even so, being exposed to small amounts can be quickly fatal.

Studies showed that using e-cigarettes is still dangerous even without the tar or even the smoke especially if young children are exposed to it meaning it was ingested, inhaled or absorbed by eyes or skin. The nicotine found in juice and other ingredients can still do harm to everyone’s health.

 

Electronic Cigarette Poisoning in Children Growing

May 11th, 2016
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Decatur- The amount of young children getting sick from electronic cigarettes has increased almost 1500% since 2012.

That’s according to a new study of poison center calls from 2012 through April 2015. The data was collected by measuring the amount of monthly calls of children ingesting liquid nicotine found in e-cigarettes. The calls went from 14 a month in 2012, to 223 a month by the end of the study in April 2015.

The children most effected were those younger than the age of 2. Professionals attribute the increase in these incidents in the way that liquid nicotine is displayed, often times coming in colorful packages.

Symptoms of nicotine exposure included an increased heart rate, fast breathing, nausea or vomiting. While most of these cases do not end up with the child being seriously harmed, one child has died from the exposure, and several have had serious complications causing comas and seizures.

According to Dr. Terry Balagna, an emergency physician at St. Mary’s Hospital, since this a relatively new epidemic, there has not been a lot of research done on the long term effects.

“Nicotine ingestion is fairly new at this point, especially for pediatrics, there have been a few studies early on, but nothing yet that shows any long term effects at this point.” he said.

Parents who use electronic cigarettes are being told to use caution when storing the liquid nicotine, so a child can not easily access it.

The FDA has recently issued new regulations that will require nicotine exposure warnings and child resistant packaging.

Flavorings in electronic cigarettes are hazardous to very young children

May 10th, 2016
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HealthDay News published a report by Randy Dotinga on May 9, 2016 noting the dangers of the nicotine in the liquid “juice” of electronic cigarettes (e-cigs). The title of the article is “E-Cigarette Poisonings Skyrocket Among Young Kids: Study”. The study showed that children under six were at the greatest risk. The study of the dangers of nicotine in e-cig liquids for small children was led by Gary Smith, director of Nationwide Children’s Hospital’s Center for Injury Research and Policy. The center is located in Columbus, OH. Smith had this to say about the conclusions of the study.

If this were an infectious disease, this would be headlines across the country . He noted that the number of e-cigarette exposures in kids jumped 1,500 percent from 2012 to 2015. E-cigarettes and liquid nicotine can cause serious poisoning, and even death, among young children. Like other dangerous poisons, they should be kept out of sight and reach of children, preferably in a locked location.

The FDA has taken responsibility for controlling all forms of tobacco, including e-cigs, cigars, hookahs, and e-cig liquids. The FDA has not extended their control of e-cig juice to eliminate the flavorings in e-cigs, which has been done for normal tobacco cigarettes. The flavorings in e-cigs are directed towards children in middle school and high school. It is these flavorings that also attract babies and primary school children. Flavor categories include tobacco, menthol, fruits, desserts, coffees, and cigars from one supplier. Tobacco cigarettes are prohibited from all flavorings except tobacco and menthol since 2009. The exception of menthol from the prohibited flavors list for cigarettes is a result of direct lobbying by the tobacco industry on the FDA. FDA studies indicate that menthol is a flavoring agent, and the FDA has still failed to eliminate flavoring agents from e-cigs.

When the FDA issued the new regulations on e-cigs and other forms of nicotine delivery, it said that more research was needed to determine the dangers of these products. This is a stalling tactic. There is absolutely no scientific ambiguity that nicotine is a poison, causes cancers of the kidney, liver and bladder, and contributes to lung and heart disease by constricting the vascular system. The Public Health Law Center has concluded that the flavorings are an attempt to create a new generation of tobacco users.

Studies show that flavored tobacco products appeal to youth, who are an enticing target market for the tobacco industry. The younger individuals are when they begin to use tobacco, the more likely they will become addicted to nicotine. For example, among adults who smoke, 68 percent began smoking regularly at age 18 or younger.

Tobacco users (particularly youth) often mistakenly assume that flavored tobacco products are safer than other tobacco products.

There needs to be an acceleration of the regulation to eliminate all flavorings in e-cigs that contain nicotine, and a prohibition of e-cig advertising that is as stringent as for tobacco cigarettes. The labeling of e-cigs should include a warning that smoking e-cigs can lead to addiction to nicotine and a substantial health risk due to the effects of nicotine.

The director of the FDA’s Center for Tobacco Products is Mitch Zeller, J.D. E-mails should be directed to ctpexecsec@fda.hhs.gov, attention Mitch Zeller, Director. The phone number is 1-877-287-1373 from 9:00 a.m. to 4:00 p.m. Eastern time. More information about the Center for Tobacco Products is available on the internet. Direct inputs to the director’s office will influence the timing of decisions to regulate e-cig flavors to decrease the appeal of the e-cig liquids to children and young adults.

E-cigarette exposure in children rises 1400% in pediatrics study, vaping industry feels the FDA heat

May 10th, 2016
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http://www.belmarrahealth.com/e-cigarette-exposure-in-children-rises-1400-in-pediatrics-study-vaping-industry-feels-the-fda-heat/

E-cigarette exposure in children rises 1400 percent in pediatrics study, even as vaping industry feels the heat from the FDA. There has been a long-running debate on whether vaping and the use of e-cigarettes is a safer alternative to traditional tobacco cigarettes. Unfortunately, the answer is yet to be known, as e-cigarettes are still a new phenomenon and research is lagging behind the instant craze of vaping. Between 2011 and 2012, the number of teens and tweens using these products has doubled, so there has been a strong push to obtain as much information as possible regarding this style of smoking.

E-cigarettes mimic traditional cigarettes as their end glows on the inhale and a cloud of smoke follows on the exhale. Inside an e-cigarette, there is a battery, a heating element, and a cartridge that holds nicotine and other liquids and flavorings.

If nicotine is used, then e-cigarettes are still addicting, and quitting e-cigarettes with nicotine can yield similar withdrawal symptoms. Some evidence supports the argument that e-cigarettes may be safer than traditional cigarettes, but other research shows they pose a risk, especially in those with heart problems. Although research suggests that e-cigarettes are less harmful than traditional cigarettes, they carry their own risk.

E-cigarettes raise the risk of nicotine poisoning in children

There is a raised risk of nicotine poisoning in children associated with e-cigarettes, according to a new study. Researcher Alisha Kamboj wrote, “The frequency of exposures to e-cigarettes and nicotine liquid among young children reported to US [Poison Control Centers] is rising rapidly. Children exposed to e-cigarette devices and nicotine liquid are 2.5 times more likely to have a severe outcome than children exposed to cigarettes, and lethal exposure has occurred.”

The researchers examined the data from the National Poison Data System (NPDS) on single exposures involving nicotine and tobacco products from January 2012 through April 2015 among children under the age of six.

During that time period, the NPDS received 29,141 calls related to exposure. E-cigarette exposure accounted for 14.2 percent of these exposures, cigarettes accounted for 60.1 percent, and other tobacco products accounted for 16.4 percent.

The researchers noted that exposure to e-cigarettes had increased by 1492.9 percent during the study period, while exposure to traditional tobacco remained the same.

Common routes of exposure as noted by the authors were ingestion, dermal, and inhalation/nasal. Children in particular may be specifically vulnerable due to their curiosity and the enticing packaging of e-cigarettes.

FDA extends regulations on all tobacco products including e-cigarettes, cigars, and hookah

The FDA has extended regulations on all tobacco products including e-cigarettes, cigars, and hookah. In the next year or so, minors will not be allowed to purchase e-cigarettes and all ingredients will have to pass FDA approval. Some vaping liquids, although they don’t contain typical cancer-causing ingredients seen in traditional tobacco products, still contain harmful chemicals.

Shop owners will now have to send applications to the FDA to have their product approved, which is not only timely but costly as well. Application estimates can range from several hundreds of dollars to the millions.

The new FDA guidelines include:

Registering manufacturing establishments and providing product listings to the FDA
Reporting ingredients, as well as harmful and potentially harmful constituents
Requiring premarket review and authorization of new tobacco products by the FDA
Placing health warnings on product packages and advertisements
Not selling modified risk tobacco products (including those described as light, low, or mild) unless authorized by the FDA
Not allowing products to be sold to persons under the age of 18 years (both in-person and online)
Requiring age verification by photo ID
Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility)
Not allowing the distribution of free samples.

On the other hand, in the U.K., the e-cigarettes are deemed safe, because – unlike in America – teenagers in the U.K. have not jumped ship on them.

The new FDA rules will be implemented by August.

 

FDA decision brings University e-cigarette simulation to attention

May 6th, 2016
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https://www.michigandaily.com/section/news/fda-decision-brings-university-e-cigarette-simulation-attention

Electronic cigarettes are more likely to encourage traditional cigarette smokers to quit than cause non-smokers to begin, according to a recent University of Michigan study.

E-cigarettes — considered an alternative to traditional cigarettes since their introduction to the market in 2003 — are battery-powered products which vaporize a flavored liquid, which is inhaled by the user. Ecigarettes are sometimes used as tools to quit smoking.

According to a 2014 survey by the Centers for Disease Control and Prevention, nearly 22 percent of adults ages 18 to 24 had tried an e-cigarette, and about four percent of adults used e-cigarettes every day or some days.

T he rising popularity of e-cigarettes has raised concern as to how e-cigarettes would be regulated and marketed, and whether they would be treated the same as traditional cigarettes with regard to public policy — despite minimal research conducted on the health effects of e-cigarettes.

For example, despite popular belief, e-cigarettes contain many of the ingredients traditional cigarettes do, such as nicotine, unknown chemicals, flavorings and colorings.

A previous University study indicated that both teenage ecigarette users and their parents wish to see e-cigarette regulation in public places, another concern that accompanies the product.

Last T hursday, the Food and Drug Administration announced that it will regulate e-cigarettes and other products — such as cigars and hookahs — in the same way it regulates traditional cigarettes and tobacco.

According to the announcement made T hursday by Secretary of Health and Human Services Sylvia Burwell and FDA commissioner Robert Califf, restrictions will be placed on the sale and distribution of e-cigarettes and other tobacco products, including age restrictions and advertising and promotion restrictions for public health purposes.

Sarah Cherng, a Rackham student and lead author of the University study, agreed that there is a large debate surrounding the potential harms and benefits of e-cigarettes.

“We’re seeing a very large increase in high schoolers and adolescents using electronic cigarettes,” Cherng said. “On one hand, there are people who are very concerned that electronic cigarettes are going to act as a gateway to traditional smoking initiation. Whereas, on the other hand, there is the harm reduction type research … (which believes) e-cigarettes can actually help with smoking cessation — help current smokers stop smoking.”

T he researchers used data from resources such as the National Health Interview and the CDC showing previous and current national rates of smoking, as well as statistics on the growth rate of e-cigarette usage, to come up with a simulation model.

Cherng said the researchers wanted to perform a quantitative analysis to see whether e-cigarettes act as a gateway to smoking initiation or as an aid for current smokers who need to quit.

T here has so far been few studies looking into the health differences of using a traditional cigarette and an e-cigarette, as well as little research on the long-term effects of using ecigarettes as a cessation device.

According to the University study, a 20 percent increase in the rate of smoking cessation would correlate to a six percent reduction in overall smoking popluation by the year 2060. On the contrary, for smoking rates to increase by six percent in 2060, smoking initiation would have to increase by 200 percent — an unlikely occurrence, according to the researchers.

“Based on the patterning of e-cigarette use among adults right now … their use is primarily concentrated among current smokers,” Cherng said. “Any potential effects that e-cigarettes have on smoking initiation or the overall smoking prevalence in the United States is going to have a much smaller effect than if e-cigarettes have an effect on smoking cessation or an increased smoking cessation because we have so many more current smokers using e-cigarettes.”

Consistent with the team’s finding, statistics from the American Lung Association show that 76.8 percent of people who recently used e-cigarettes in 2013 also were traditional cigarette smokers.

Cherng said further research is imperative for future debates and policymaking about e-cigarettes.

“Because the evidence is so scant right now about whether or not they actually do increase smoking initiation among neversmokers versus their effect on cessation, in terms of the policy implications, it’s important to contextualize that in e-cigarette regulation,” Cherng said, adding: “if we can start focusing people towards the potential benefits of e-cigarettes and also enact legislation that helps prevent young kids from using them, then what we expect is that there is a potential of a huge benefit
resulting from e-cigarette use if they increase cessation.”

Paula Lantz, associate dean for research and policy engagement, echoed Cherng’s statements and said in an email interview that there is merit to the argument that too much regulation for ecigarettes could be detrimental.

“(Many) are concerned that the FDA might “over-regulate” ecigarettes, in that it will make it harder for e-cigarettes to be used as a harm reduction approach or smoking cessation tool for current smokers,” Lantz said. “While much more research is needed…the Cherng simulation model forecasts demonstrate quite clearly that, under any reasonable set of assumptions, the harm reduction and smoking cessation gains will significantly outweigh any increase in youth smoking due to e-cigarettes.

T his supports the concerns that over-regulating e-cigarettes will be bad for public health.”

US bans e-cigarette, cigar sales to those under 18 years old

May 6th, 2016
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US regulators on Thursday took their first steps to crack down on e-cigarettes and cigars, increasingly popular among American youth, and banned sales to anyone under age 18 in hopes of preventing a new generation from becoming hooked on nicotine.

The Food and Drug Administration’s action brought regulation of e-cigarettes, cigars, pipe tobacco and hookah tobacco in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. The new rules take effect in 90 days.

Health advocacy groups hailed the move, while industry officials said it could cripple many of the smaller companies that make e-cigarette devices they say can help traditional smokers quit. Wall Street analysts expect the regulation to herald a new wave of consolidation led by big tobacco companies.

The FDA said it will require companies to submit e-cigarettes and other newer tobacco products for regulatory review, provide it with a list of their ingredients and place health warnings on packages and in advertisements.

The FDA’s regulation had been highly anticipated after the agency issued a proposed rule two years ago on how to oversee the US$3 billion e-cigarette industry and these other products.

US Secretary of Health and Human Services Sylvia Burwell said health officials still do not have the scientific evidence showing e-cigarettes can help smokers quit and avoid the known ills of tobacco. In the interim, the quick uptake of e-cigarettes by young people has added urgency to instituting consumer protections, Burwell said.

“Nicotine does not belong in the hands of kids,” Burwell told reporters.

E-cigarettes are hand held electronic devices that vaporise a fluid typically including nicotine and a flavour component. Using them is called “vaping.”

Three million US middle and high school students reported using e-cigarettes in 2015, compared with 2.46 million in 2014, making them the most commonly used tobacco products for youngsters, according to the most recent federal data.

“This is a real epidemic and banning the sales of these products to minors, much like cigarettes, is a critical step to protecting their health now and into the future,” said Democratic US Representative Lois Capps of California.

Other groups including American Academy of Pediatrics also lauded the FDA move. However, public health advocates have also urged the agency to ban the use of flavoured nicotine liquid in e-cigarette and personal vaporisers.

They say the flavours, which can range from bacon to bubble gum, are a major draw for youngsters to take up vaping. FDA officials said they would consider future regulation on flavours based on further study of the potential risks and benefits of vaping.

In 2009, Congress allowed the FDA to extend its oversight to all tobacco products. The agency began focusing on e-cigarettes, which were quickly gaining traction in the US market.

Cigars had previously not been regulated by the FDA. Their makers had lobbied for their more expensive, typically hand-rolled products to be excluded from such oversight. The agency’s new rules ban flavours in cigars, in another effort to prevent youth use.

Erika Sward, Assistant Vice President for National Advocacy at the American Lung Association, described the regulations as “a win for public health.” She said that the association was disappointed that while the FDA relied on anecdotal information to ban flavours on cigars, it did not use the same metrics regarding e-cigarettes.

The FDA will review products introduced after February 15, 2007, but will give e-cigarette manufacturers up to two years to submit their applications. E-cigarette makers can continue to sell those products while the review is pending.

Agency officials expect that most products on the market will require its review, a costly prospect for the many smaller manufacturers of vaping devices.

“The winners are the large tobacco manufacturers, primarily Altria and Reynolds (American), which have the experience and financial wherewithal” to deal with FDA processes, said Adam Fleck, an equity analyst at Morningstar. “The net result is a very fragmented e-cigarette market is likely to be consolidated.”

Shares in Altria and Reynolds were little changed on Thursday.
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Source URL: http://www.scmp.com/lifestyle/health/article/1941593/us-bans-e-cigarette-cigar-sales-those-under-18-years-old

FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

May 5th, 2016
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Rule extending oversight to all tobacco products, including e-cigarettes, allows agency to address public health concerns such as youth access to tobacco products

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm

Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Tobacco use is a significant public health threat. In fact, smoking is the leading cause of preventable disease and death in the United States and responsible for 480,000 deaths per year. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors consistently cited as a reason for use.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

• Not allowing products to be sold to persons under the age of 18 years (both in person and online);
• Requiring age verification by photo ID;
• Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
• Not allowing the distribution of free samples.

The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

For decades, the federal government and the public health community have fought to protect people from the dangers of tobacco use. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with smoking, significant progress has been made to reduce smoking rates among Americans. In fact, tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress took a historic step in the fight for public health by passing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products to protect the public health.

Today’s action marks a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

• Registering manufacturing establishments and providing product listings to the FDA;
• Reporting ingredients, and harmful and potentially harmful constituents;
• Requiring premarket review and authorization of new tobacco products by the FDA;
• Placing health warnings on product packages and advertisements; and
• Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

To assist the newly-regulated tobacco industry in complying with the requirements being announced today, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

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

E-Cigarettes to Be Regulated as Tobacco Products

May 5th, 2016
by Editor.
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E-cigarettes, hookah tobacco and cigars are now officially under the purview of the FDA

http://time.com/4319285/ood-and-drug-administration-e-cigarettes-cigars-regulated/

E-cigarettes will be regulated as tobacco products, federal authorities announced on Thursday.

In a long-awaited ruling, the U.S. Food and Drug Administration (FDA) finalized rules that give the agency authority to regulate all tobacco products including e-cigarettes, cigars, hookah tobacco and pipe tobacco, as well as other products. Until now, e-cigarettes were not regulated by the FDA and there was no national law to prohibit the sale of e-cigarettes, hookah tobacco or cigars to people under 18.

“The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks,” the agency said in a statement.

The new rule means the agency will have to approve all products that made it to market as of Feb. 15, 2007—a point at which the e-cigarette market was virtually non-existent. “What we know is absence of federal restriction means that enforcement is uneven and at times nonexistent,” HHS Secretary Sylvia Burwell said during a news conference.

The risks of e-cigarettes has been a public health debate for some time and the FDA initially announced its proposal to increase its jurisdiction in 2014. The HHS and FDA said on Tuesday that surveys show 1 in 4 high school students and 1 in 13 middle schoolers report being tobacco users. 16% of high schoolers also reported using cigarettes in 2015, a 900% increase from 1.5% in 2011. While e-cigarettes do not contain the same carcinogens as traditional cigarettes, they do contain nicotine, which is addictive. Early research has also cast doubt on the safety of some of the chemicals used inE-cigarettes when inhaled into the lungs.

Small and medium sized e-cigarette companies have responded to the news with concerns that undergoing the new approval process will be costly. “This gigantic price tag is affordable to Big Tobacco companies, but small and medium-sized businesses will be crushed,” said Gregory Conley, President of the American Vaping Association. “If the FDA’s rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years.”

Burwell addressed these concerns during a news conference with reporters, saying the agencies understand the concerns small businesses will have, and that the FDA will allow them to have more time to comply.

The FDA says after 90 days they will begin enforcing portion of the rule that says the products cannot be sold to people under 18. This rule also requires ID to purchase tobaccos products and bans sales in vending machines as well as free samples

“The health of the nation will continue to suffer the consequences of any further delay in implementing a law intended to protect public health,” Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement.

Appropriations Trickery in Congress

May 2nd, 2016
by Editor.
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http://www.nytimes.com/2016/05/02/opinion/appropriations-trickery-in-congress.html?_r=0

It is an old congressional ritual: loading up vital spending bills that are meant to keep the government running with dangerous amendments aimed at satisfying ideological causes and benefiting special interests.

The Republicans have become adept at this practice in recent years, and this year is no different. Legislative riders attached to appropriations bills would undermine the Iran nuclear deal, weaken highway safety and reduce the Food and Drug Administration’s authority over tobacco products.

These measures would be unlikely to succeed as stand-alone bills, either because they could not get enough votes on their own or because President Obama would veto them. So better to sneak them in without even holding hearings to make a case on their behalf.

Thankfully, Democratic lawmakers and public interest groups are calling attention to these stealth attacks. In the Senate, Democrats managed on Wednesday to block a vote on a water and energy spending bill after Senator Tom Cotton, Republican of Arkansas, tried to attach a provision that would have dealt a severe blow to the Iran nuclear deal. Mr. Cotton’s measure would have blocked the administration from purchasing heavy water used in Iran’s nuclear facilities. Iran has to get rid of the water to comply with the deal. By denying Iran an American market, Mr. Cotton and other Republicans hoped to undermine the deal, which they hate.

The Senate will soon consider a transportation bill containing a rider that could prevent the Department of Transportation from reinstating a rule aimed at making roads safer by requiring that truckers get adequate rest — two nights of rest after working 60 hours over seven consecutive days or 70 hours over eight consecutive days.

The rule took effect in July 2013, but it was suspended by Congress in December 2014. The rider bars the administration from reinstating the rule unless it can show that it produced a “statistically significant” improvement in safety and driver health during the brief time it was in place.

That is a ridiculously high burden to meet. If the provision becomes law, it will be impossible for the government to issue basic regulations to make sure compa…..

And the House Appropriations Committee recently passed an agriculture and food spending bill that would make it very hard for the F.D.A. to regulate tobacco products. A rider attached in committee would forbid the agency from regulating “large and premium cigars”; another would rewrite a 2009 law that gave the agency the authority to approve or reject tobacco products that have entered the market after Feb. 15, 2007. This would include electronic cigarettes, for which the agency has proposed regulations.

To prevent the agency from taking e-cigarettes off the market and effectively grandfather them in, Republican lawmakers want to require pre-approval only for products that come out after the F.D.A. issues its final e-cigarette rules, which could be later this year. A recent study by the Centers for Disease Control and Prevention found that the devices are now more popular than conventional cigarettes with middle- and high-school students.

Riders like these are not harmless passengers on legislative vehicles. They can and will do real damage if they are allowed to succeed.

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