Author: GTNF Trust Staff

Vapor has another possible savior. Today, U.S. Rep. Duncan Hunter introduced legislation that would curtail the U.S. Food and Drug Administration’s (FDA) regulatory power over vapor products. The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act creates new regulatory framework that removes vapor from controls imposed under the Tobacco Control Act.

The legislation underscores the uniqueness of vaping technology and products, and advances vaping as a widely recognized life-saving alternative to traditional tobacco use, according to post on Hunter’s website. “This bill is the way forward for smokers who want to quit smoking and vapers who enjoy vaping,” said Hunter. “No less important, this bill will set the vaping industry on a solid path for decades to come and require consideration of the harm reduction benefits associated with vaping.

“The idea that vaping should be viewed and regulated no different than tobacco ignores the fact that countless Americans are turning to this one alternative to reduce their urge to smoke cigarettes or quit once and for all.  It’s also a fact that small businesses that sell vaping products will experience severe hardship under the existing regulatory structure and desperately need the relief and clarity that this legislation provides.

Hunter told Vapor Voice in a previous interview that he started smoking as a teenager and then quit before picking it back up serving as a Marine in Iraq and Afghanistan. “Vaping is what helped me to stop smoking and I know from the experiences of so many others that I’m not alone.  It’s time that vaping is embraced and accepted for the benefits its offers—among them harm reduction,” he said.

If enacted, the new act would allow e-liquids to be regulated by the FDA using commonly accepted industry manufacturing standards. The bill also establishes standards for vaping hardware and batteries to protect consumers.  One year after enactment, all e-liquids and vaping hardware must conform to manufacturing standards within the bill, according to the post. The legislation also requires the FDA to consider harm reduction within the scope of the Tobacco Control Act.

Reps. Tom Cole and Sanford Bishop also introduced a vapor bill in February. That bill, the FDA Deeming Authority Clarification Act of 2017, would change the predicate date in the FDA’s deeming regulations. This would allow products introduced before a new predicate date to stay on the market without having to go through the FDA’s costly premarket approval process.

A new study has found no evidence that vapor from a commercially-available electronic cigarette promotes the development of cancer in laboratory cells, whereas smoke from a reference tobacco cigarette was found to be positive for cancer-promoting activity, even at very low concentrations.

“These results add to growing weight of evidence that e-cigarettes are likely to be significantly safer than conventional cigarettes,” said Damian Breheny, lead author and adverse outcome pathway manager at British American Tobacco (BAT).

Scientists at BAT used a test called the Bhas 42 assay to compare tobacco and nicotine products. The Bhas 42 cell transformation assay assesses the carcinogenic potential of chemicals by looking for changes in a line of cells that are characteristic of tumor development.

Bhas 42 was used to compare the tumor promoter activity of vapor from a Vype ePen, one of BAT’s commercially available electronic cigarettes, and smoke from a reference cigarette (3R4F), by exposing cells to the total particulate matter collected from the vapor or smoke.

Results showed that cigarette smoke was positive for cancer-promoting activity at concentrations as low as 6μg/mL, whereas the test electronic cigarette vapor was not observed to have any in vitro cancer promoter activity at concentrations up to 120μg/mL.

The Bhas 42 assay is part of a suite of in vitro tests being developed by BAT to compare the relative biological effects of electronic cigarettes and tobacco-heating products with those of traditional cigarettes.

“This is the first study to use the Bhas assay to compare tobacco and nicotine products, and it demonstrates the potential for its future application as part of a product assessment framework,” said Breheny.

Assessment of tobacco and nicotine products has traditionally involved genotoxicity tests, which evaluate initial DNA damage that can lead to cancer. Such tests indicate that electronic cigarette vapor, in contrast to cigarette smoke, does not cause mutations and DNA damage. Using the Bhas 42 assay allows for increased understanding of potential carcinogenic risk.

Previous research conducted by BAT has shown that Vype ePen vapor contains about 95 percent less toxicants – in terms of the nine harmful components the World Health Organization recommends should be reduced in cigarette smoke (Chem. Res. Toxicol, DOI: 10.1021/acs.chemrestox.6b00188) – than does cigarette smoke from a reference cigarette.

A bill expected this week to be placed before the US House of Representatives would weaken a U.S. Food and Drug Administration  (FDA) rule governing electronic cigarettes and represent a major victory for the $4.4 billion US vaping industry, according to a story by Toni Clarke and Jilian Mincer for Reuters.

The bill, from Rep. Duncan Hunter of California (R), would reverse the deeming rule that deemed electronic cigarettes to be tobacco products, subject to the same regulations governing traditional cigarettes.

Clarke and Mincer said that Hunter’s bill, which had been reviewed by Reuters, would exempt vaping devices from many of those regulations, ‘including a requirement that new products be reviewed and authorized by the FDA before being sold.

Electronic-cigarette makers say this process is too expensive and would prevent people from gaining access to the products.

The Reuters story said the bill added momentum to a series of legal and legislative efforts by tobacco and vaping companies to derail the FDA rule, though it was unclear how much support it would garner.

A separate measure from Republican Representative Tom Cole of Oklahoma and Democrat Sanford Bishop of Georgia would exempt thousands of vaping devices currently on the market from FDA approval. The Cole-Bishop proposal is expected to be attached as a rider to President Donald Trump’s spending plan, which could be voted on as early as this week.

However, Hunter’s bill would go further, bringing the entire regulatory process to a halt.

Indiana and National vapor advocates scored a major victory on Friday night as the Indiana General Assembly voted to rewrite the state’s anti-competitive vapor industry regulations, according to a release from the Vapor Technology Association (VTA).

“The Indiana Smoke Free Alliance was formed to fight the unfair vapor products monopoly that passed two years ago; a monopoly that created significant burdens for small businesses to compete while using security provisions to create a market advantage for a few select business interests” said Amy Lane, President of the Indiana Smoke Free Alliance. Tony Abboud, executive director of the VTA, stated “The Indiana General Assembly overwhelmingly passed an overhaul of Indiana’s vapor products law.

Senate Bill 1 eliminates costly and unnecessary barriers to this emerging market while maintaining appropriate consumer safety provisions. We are honored to have had the opportunity to work with ISFA on this legislation. ISFA demonstrated professionalism, focus and steadfast resolve in the face of significant opposition. The result is that we have done what we set out to do and re-opened the state of Indiana to all vapor businesses who can now compete on a level playing field.”

Senate Bill 1 creates a path to licensure for all manufacturers, distributors, and retailers who are seeking to sell vapor products in Indiana. The bill further aligns requirements for manufacturers doing business in Indiana with the requirements of the federal deeming rule. In addition, the legislation creates a clear path forward for online sales, removes arbitrary rulemaking authority from the ATC and onerous security requirements on manufacturers which created a monopoly in Indiana for a limited group of manufacturers, according to the release.

“A special thanks to Senator Randy Head, R-Logansport, and Rep. Matt Lehman, R-Berne, for their tireless efforts along with the Vapor Technology Association, the membership of the Indiana Smoke Free Alliance, as well as Matt Norris and Mike Leppert of Krieg DeVault, LLP,” said Amy Lane, president of Indiana Smoke-Free Alliance.

Senate Bill 1 now awaits the signature of Governor Eric Holcomb.

The U.S. Surgeon General Vivek Murthy has been fired by President Donald Trump’s administration, according to a story in The Hill.

In a statement, the Department of Health and Human Services said Murthy, who was appointed by President Barack Obama’s administration in 2014, had been asked to resign, and that he would be replaced temporarily by Rear Admiral Sylvia Trent-Adams, the current deputy Surgeon General.

‘Today [Friday, April 21], Dr. Murthy, the leader of the US Public Health Service Commissioned Corps, was asked to resign from his duties as Surgeon General after assisting in a smooth transition into the new Trump Admi

nistration,’ the statement said.

‘Dr. Murthy has been relieved of his duties as Surgeon General and will continue to serve as a member of the Commissioned Corps.’

The statement said that Health and Human Services Secretary Tom Price “thanks him for his dedicated service to the nation”.

Citing a New York Times story, The Hill reported that Murthy’s sudden departure had surprised employees at HHS.

The Hill pointed out, however, that Murthy had called gun violence a health threat to the US, which had won him opposition from the National Rifle Association.

Elsewhere, press reports speculated that his sacking might have been in part prompted by his support for vaccinations, and/or for his opposition to electronic cigarettes.

It could be a major oversight by the U.S. Food and Drug Administration (FDA). The Village of Hartland, Wisconsin, USA will conduct a public hearing related to “coordination and lack of coordination” by the FDA and other agencies regarding deeming regulations on vapor products.

Federal and state statutes require administrative agencies to “coordinate” with local governments in developing and implementing plans, policies and management actions. These statutes create a process allowing local governments to have an equal voice in negotiations, especially on issues related to a community’s economic stability and social and cultural cohesiveness. 

The hearing board will consist of elected and appointed officials representing the Village of Hartland and surrounding areas, and will begin at 5:30pm on April 27 in the board room of the Heartland’s municipal building, (210 Cottonwood Avenue, Hartland, Wisconsin, 53029).

According to a release from David Cox, village administrator for Hartland, the meeting will allow officials and citizens to question and present evidence regarding government action on six major issues stemming from the FDA’s deeming rule, including:

1) Whether the federal Food and Drug Administration coordinated with the Village of Hartland and other local governments regarding the implementation of the FDA Deeming Regulations

2) Whether the FDA Deeming Regulations are based on sound science verified under the federal Data Quality Act

3) Whether the Food and Drug Administration vetted its Deeming Regulations under and within the provisions of the Regulatory Flexibility Act

4) Whether the Food and Drug Administration established a standard by which its Deeming Regulations were developed and whether within the Regulations there is created a standard by which their impact can be measured for purposes of the due process clause of the United States and State of Wisconsin Constitutions and the provisions of the United States Civil Rights Act of 1866.

5) Whether Food and Drug or any other agency including but not limited to the Environmental Protection Agency has coordinated with the Village of Hartland regarding the Executive Order 13777 as to review of all regulations from the standpoint of adverse impact.

6) Whether other issues regarding the regulations may impact the communities and the rights of businesses and individuals affected thereby.

Anyone who wishes to testify should contact David Cox, Village Administrator, at 262.367.2714 or by email at davidc@villageofhartland.com no later than thirty minutes prior to the start of the hearing.

Cigarette smokers in the U.S. prefer electronic cigarettes to Food and Drug Administration-approved (FDA) quit methods, according to a tobacco harm reduction expert citing a research brief authored by the Centers for Disease Control and Prevention’s Office on Smoking and Health, RTI International and the University of North Carolina.

Writing on the Heartland Institute website, Dr. Brad Rodu, who holds the Endowed Chair in Tobacco Harm Reduction Research at the University of Louisville’s James Graham Brown Cancer Center and who is a Senior Fellow of the Heartland Institute, said that, using a nationally representative online survey of 15,943 adult smokers who tried to quit during the past three months, the researchers found that 75 percent used one or more methods to quit, and 25 percent used only one method.

‘E-cigarettes were far more popular single quit aids for partial or complete substitution (2.2 percent), compared with nicotine patches/gum (0.8 percent) or other prescription medicines (0.4 percent),’ Rodu wrote. ‘They were also more popular when more than one aid was used.

‘Participants here were current smokers.  A similar analysis performed on former smokers will show even more impressive effects from vaping.’

Rodu was disappointed by the survey authors’ response to the findings.

‘Despite the current study’s evidence of vaping’s popularity among smokers, the authors’ summation was understated: “Given that our data show that e-cigarettes are more commonly used for quit attempts than FDA-approved medications, further research is warranted on the safety and effectiveness of using e-cigarettes to quit smoking”.

‘The fact is that the CDC has documented with real-world data that e-cigarettes are preferred smoking cessation aids, negating the argument that evidence is merely “anecdotal”.

‘Our government should adopt the UK Royal College of Physicians’ position that “the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5 percent of the harm from smoking tobacco”.

‘In Britain e-cigs have been the leading quit-smoking aid since 2013.’

The Heartland Institute piece is at: http://blog.heartland.org/2017/04/cdc-e-cigarettes-more-popular-than-fda-approved-quitting-aids/.

It was first published at Tobacco Truth at http://rodutobaccotruth.blogspot.com.

New research by British American Tobacco (BAT) comparing the effects of cigarette smoke and electronic cigarette vapor has shown that, at equivalent or higher doses of nicotine, acute exposure to electronic cigarette vapor has very limited impact on gene expression when compared to the impact of cigarette smoke.

A BAT press note said that the human genome had tens of thousands of genes, and that the profile of genes that were switched on and off could be used to understand whether exposure to an aerosol had had a toxic effect.

‘Scientists at British American Tobacco used nicotine as a reference point and exposed MucilAir, a realistic in vitro 3D model of a human airway, to e-cigarette vapor and cigarette smoke to assess their comparative effect on gene expression,’ the press note said.

‘The MucilAir human respiratory tissue was exposed to smoke from a reference cigarette (3R4F) or vapor from an e-cigarette (Vype ePen) continuously for an hour. Two doses of vapor were tested, matching or doubling the amount of nicotine reaching the cells compared to smoke. Then, to measure the cell response, the scientists mapped the genes that were switched on and off at 24 hours and 48 hours after the one-hour exposure.

‘In the tissue exposed to smoke, the scientists found 873 and 205 genes were affected after 24 and 48 hours of recovery, respectively. However, significantly fewer genes – only 3 and 1, respectively – were affected after exposure to e-cigarette vapor.’

Further analysis was said to have revealed that the exposure to cigarette smoke had caused changes in the expression of genes involved in the development of lung cancer, inflammation and fibrosis, while the test electronic cigarette vapor had caused only minor changes in genes known to be involved in cell metabolism and oxidative stress mechanisms.

“Our results clearly show that cigarette smoke has an adverse effect on cells, triggering a robust gene expression response,’ said Dr. James Murphy, head of reduced risk substantiation at BAT. “However,” he said, “even at equivalent or higher dose of nicotine, acute exposure to the test e-cigarette vapor has very limited impact on gene expression compared to cigarette smoke exposure – it’s a striking difference.”

These results, which were published in Scientific Reports (DOI: 10.1038/s41598-017-00852-y), were said to add to an increasing weight of evidence that electronic cigarette vapor caused less damage to cells than did cigarette smoke.

‘Previous research conducted by British American Tobacco has shown that Vype ePen vapor contains around 95 percent less toxicants (Chem. Res. Toxicol, DOI: 10.1021/acs.chemrestox.6b00188) compared to cigarette smoke from a reference cigarette (in terms of the priority list of nine toxicants which the World Health Organization recommends to reduce),’ the press note said.

Switching from smoking to vaping greatly reduces the risk of dying in a fire, according to a Fire Magazine story citing London Fire Brigade figures.

While traditional tobacco cigarettes were the biggest cause of fatal fires, there had been no recorded deaths or injuries because of fires caused by electronic cigarettes.

During the past three years in London, UK, the Brigade had recorded 14 fires caused by electronic cigarettes compared to just over 3,500 smoking-related fires.

London Fire Brigade’s Assistant Commissioner, Dan Daly, said the best course of action was to quit smoking, but that switching to vaping also greatly cut the risk of fires.

The fire risks presented by electronic cigarettes usually arise from people using the wrong power source to charge them; so the Brigade has issued the following advice to avoid fires:

• Only use the battery and charger that is provided with the electronic cigarette, and buy these items from a reputable vendor;
• Keep electronic cigarettes away from heat sources, and keep them uncovered while charging;
• Never use a damaged electronic cigarette,  and never leave one on charge while unattended, including while asleep;
• Never use electronic cigarettes close to medical oxygen because of the danger of ignition;
• Damaged or old batteries should be replaced because they can lead to a fire caused by a short circuit, overheating or mechanical damage;
• Don’t leave batteries in a car, or in a pocket with loose change or keys; always use an approved case.

A US public health expert has described as absurd a suggestion that smoking cannot be said to be any more hazardous than is vaping.

Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, reported on his blog that an expert at Penn Medicine, the University of Pennsylvania’s health care system, was telling the public that smoking cigarettes, such as Marlboros, Camels, and Newports, might be no more hazardous to their health than was vaping a tobacco-free e-liquid.

“We know that cigarettes are unsafe after 40 years of exposure,” the expert was quoted as saying. “We don’t have 40 years of exposure to e-cigarettes to know what the danger is. We don’t know the safety profile, so we can’t say that e-cigarettes are safer than traditional cigarettes.”

Siegel said that if the expert was saying that it couldn’t be said that electronic cigarettes were safer than were traditional cigarettes, then the expert was saying was that it couldn’t be said that smoking was any more hazardous than vaping.

‘This is an absurd statement, completely in conflict with scientific evidence, and not even the tobacco companies would make such a claim,’ Siegel wrote…

‘In other words, the statement of this expert is essentially a huge advertisement for tobacco cigarettes, the most deadly consumer product on the market in terms of its toll on the lives and health of Americans.’

Siegel’s blog, The Rest of the Story, is at: http://tobaccoanalysis.blogspot.co.uk/2017/04/penn-medicine-expert-smoking-may-be-no.html