FDA regulations for e cigarettes released.

By Dr Deepu

After years of debate about the health risks of electronic cigarettes, the federal government on Thursday made it final: They need to be regulated and kept out of the hands of children.

The Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them.
Statistics about the Use

More than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014.
 Sixteen percent of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year.
During 2011-2015, e-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6 percent to 5.3 percent among middle school students.
In 2013-2014, 81% of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.
 In 2014, 12.6% of U.S. adults had ever tried an e-cigarette, and about 3.7% of adults used e-cigarettes daily or some days.
In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigs), e-pipes, and all other ENDS. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS* but excludes accessories.
However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.
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CDC: Teen Smoking Rates Declining, Marijuana Use On The Rise

By Dr Deepu

HealthDay (10/16, Reinberg) reports that according to today’s MMWR, the CDC says that smoking among teenagers has dropped 64 percent in recent years, but marijuana use has more than doubled. Investigators “tracked teen smoking rates from 1997 to 2013.” The researchers found that “overall, the number of teens who smoked cigarettes or cigars dropped from 20.5 percent to slightly more than 7 percent, while marijuana use went from 4 percent to 10 percent.”

Experts question the evidence underpinning e-cigarette recommendations

By Dr Deepu

Concern over Public Health England's recent support for e-cigarettes

Public Health England (PHE) recently endorsed the use of electronic cigarettes as an aid to quitting smoking. But in The BMJ this week, experts question the evidence on safety and effectiveness underpinning the recommendations.

Professor Martin McKee at the London School of Hygiene The BMJ Tropical Medicine and Professor Simon Capewell at the University of Liverpool, argue that the available evidence about e-cigarettes "suggests that the debate is far from over and questions remain about their benefits and harms."

The PHE report concludes that e-cigarettes are much safer than conventional cigarettes. It also says there is no evidence that e-cigarettes give children a "gateway" into smoking.

Some of the findings have been welcomed by Action on Smoking and Health (ASH) and the Royal College of Physicians of London. But other leading health bodies - including the British Medical Association, the US Centers for Disease Control and Prevention, and the World Health Organization - have expressed caution.

So does the available evidence show clearly that e-cigarettes are as effective as established quitting aids, ask McKee and Capewell.

Unfortunately not. For example, a recent Cochrane review, widely cited in the PHE report, concluded the available evidence was of "low or very low quality" by recognised standards.

And a recent systematic review, which the PHE report surprisingly fails to cite, also found serious methodological problems in many of the studies it reviewed, and noted that one third of the studies (34%) it reviewed were published by authors with conflicts of interest.

The headline message from the PHE report is that "best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes." Yet McKee and Capewell point out that this figure comes from a single meeting of 12 people, involving several known e-cigarette champions and sponsored by companies with links to the tobacco industry.

The PHE report also asserts that the available evidence suggests that e-cigarettes are not currently re-normalising smoking among children and young people in the UK. But McKee and Capewell point out that experimentation with e-cigarettes among young people in England is "worryingly high" and "this remains a major concern for health professionals and parents."

They describe the report's dismissal of the possibility that e-cigarettes may be a gateway to smoking as "premature." And they argue that the report has many other omissions, such as concerns about product safety, and the lack of evidence of risks from long term dual use with conventional cigarettes.

Finally, the PHE summary states, "The accuracy of nicotine content labelling currently raises no major concerns." Surely, England's leading public health agency cannot be indifferent to a situation in which consumer product information is known to be wildly inaccurate, they ask.

In 2017, the European Union Tobacco Products Directive will come into force, with substantial restrictions on e-cigarettes. "These restrictions will hopefully limit the negative effect of this flawed PHE report," say TheBMJ article's authors.

"Meanwhile, directors of public health and the wider community desperately need advice on e-cigarettes that is evidence based and free from any suspicion of influence by vested interests," they conclude.

Link to full article

Study: Long-Lived Smokers May Be Biologically Distinct

By Dr Deepu

The Washington Post (9/11, Cha) reports that “in an intriguing study published this week by University of California at Los Angeles researchers delved into the genetic makeup of long-lived smokers...and found that their survival may be due to an innate resilience they were born with.” While “on average, smokers’ life expectancy is 10 years less than non-smokers...the long-lived smokers are the exception and the researchers said that their findings suggest that they may be a ‘biologically distinct group’ that is endowed with genetic variants that allow them to respond differently to exposure.”

Study: E-Cigarette Use Reduces Carbon Monoxide, Acrolein Exposure Even For Occasional Smokers

By Dr Deepu

Reuters Health (9/10, Rapaport) reports on a study that found that smokers who switched to exclusive use of e-cigarettes were 80% less exposed to carbon monoxide and acrolein after four weeks while those who vaped and smoked reduced their exposures by 52% and 60% respectively. The authors noted that the most significant finding was that those who used both cigarettes and e-cigarettes showed significantly lower acrolein levels despite the presence of vegetable glycerin in the e-liquid, which could have increased exposure.

Varenicline May Not Increase Risk Of Heart Attack Or Depression, Study Suggests

By Dr Deepu

Reuters (9/8, Kelland) reports that a 150,000-participant study published in The Lancet Respiratory Medicine found that the smoking cessation medication Chantix (varenicline) does not raise the risk of heart attack or depression, despite prior reports to the contrary.

Chantix reduces both the craving for and pleasurable effects of cigarettes and is used by heavy smokers who find it difficult to quit. It is one of the biggest-selling stop-smoking drugs in the United States and Britain, and generated $647 million in revenue in 2014.

The latest research, published in The Lancet Respiratory Medicine journal, studied patients who had been prescribed either varenicline or Zyban, an anti-smoking drug from GlaxoSmithKline known generically as bupropion, to help them quit, or had used nicotine therapies such as patches, gum or lozenges.