Category: News This Week

“It’s going to be a unanimous approval,” a source close to the situation told Vapor Voice. A vote on whether to move forward with a “coordination” complaint against the U.S. Food and Drug Administration (FDA) is expected today in Hartland, Wisconsin (see update soon on vaporvoicemagazine.com). Village officials conducted a public hearing related to “coordination and lack of coordination” by the FDA and other agencies regarding deeming regulations on vapor products last week.

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.

Village officials do not believe the FDA complied with the coordination statutes. Mark Block, founder and director of the Electronic Vaping Coalition of America, wrote in a statement today that he “expect[s] the Hartland Village Board will vote this evening to forward the findings to the FDA Commissioner, the Secretary of HHS, and to the Council on Environmental Quality, within the White House.”

Several industry experts spoke during the hearings.

One down, three to go. Without some radical, last-minute change, the Cole-Bishop amendment to curtail U.S. Food and Drug Administration (FDA) regulations for the vapor industry will not be included in the U.S. Government’s 2017 budget. U.S. Congressional leaders reached a deal on a more than $1 trillion spending bill that would fund the government at updated levels through the end of September. The bill is expected to pass both the Senate and House this week and would still need to be signed by President Trump.

There is still plenty of hope for the industry, however. There are still three possibilities that could change or invalidate the FDA’s deeming rule. A vote on whether to move forward with “coordination” is expected today in Hartland, Wisconsin (see update soon on vaporvoicemagazine.com). 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.

Also, Nicopure Labs still has an ongoing lawsuit in federal court. In its original filing, Nicopure claimed the FDA’s rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the United States Constitution.

Then there is Rep. Duncan Hunter’s Cigarette Smoking Reduction and Electronic Vapor Alternatives Act, which would weaken the FDA’s deeming rule and remove vapor from standards set by the Tobacco Control Act for traditional cigarettes. Any of the three options would represent a major victory for the $4.4 billion U.S. vaping industry.

LIVE NOW: watch vapor attorney Azim Chowdhury with Keller & Heckman discuss e-cigarettes regs in Hartland Wisconsin https://www.youtube.com/watch?v=gugeJtw998Q

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.