Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, and Rep. Duncan Hunter (R-Calif.) sent a letter Monday to Vice President-elect Mike Pence concerning the U.S. Food and Drug Administration’s regulation of e-cigarettes.
Johnson and Hunter are raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences. The lawmakers are hopeful that, under a new administration, these harmful regulations can be repealed.
Senator Ron Johnson and Congressman Duncan Hunter
“We are hopeful that through both executive and legislative action, burdensome regulations imposed by the Obama administration will be re-examined and undone,” the lawmakers wrote. “The U.S. Food and Drug Administration’s deeming regulation of e-cigarettes is an example of a burdensome rule that could eliminate an entire emerging industry. The FDA’s rule threatens to crush the e-cigarette industry and potentially hurt the public’s health by making it harder for consumers to access products that serve as an alternative to smoking.”
Dr Paul Marshall has joined the Nerudia team as a regulatory principal. His role will be to support customers with medicinal, PMTA and TPD projects. As a former senior pharmaceutical assessor for nicotine and CNS related products at the UK Medicines and Healthcare products Regulatory Agency (MHRA), he brings invaluable experience to the role.
Marshall will report to Rob Burton, Nerudia Head of Consultancy and Compliance. “We have created one of the largest teams of regulatory and scientific experts in nicotine-containing products in the world, which we will continue to strengthen by appointing top class experts,” said Burton. “We are therefore delighted that Paul has joined Nerudia and it’s a real coup for us to add such a seasoned regulator to our team.”
Marshall is an experienced regulatory scientist with a broad knowledge of regulatory strategy, Chemistry, Manufacturing and Controls, and drug development. In 11 years’ service at the MHRA he assessed over 400 Marketing Authorization (MA) applications and 1000 MA variations covering all dosage forms and regulatory submission routes. He has also been involved in over 40 formal scientific and regulatory advice meetings with companies developing products.
A registered UK pharmacist and Member of the Royal Pharmaceutical Society, Marshall contributed to the MHRA licensing procedure for e-cigarettes and other nicotine containing products. He is the chair of the British Standards Institute Electronic Cigarettes and E-liquids committee and member of European Committee for Standardization)TC/437 Working Group 4 on requirements and test methods for emissions from electronic cigarettes and e-liquids.
A few months after being suspended, a Royal Decree in Belgium published on October 28, 2016, has transposed the EU’s Tobacco Products Directive (TPD) – but with a change in the classification of vaping products, according to a story by David Palacios for ecigintelligence.com.
From January, 17, 2017, when the law comes into force, electronic cigarettes and e-liquids containing nicotine will be considered to be consumer products and their former classification as medical devices will end.
After transposition of the TPD, electronic cigarettes will no longer be sold only by pharmacists, but they will be subject to the severe retail restrictions of the TPD.
The Belgian Association of Vapers (Union Belge pour la Vape/Belgische Damp Bond) considers the new legal framework contrary to the interests of the population and it warns that with the transposition of the TPD rules vaping will come under tobacco laws.
“We believe that, in the long term, this law, if implemented as it is, will put a major strain on the expansion of the e-cig in the Belgian market”, Yves Woot de Trixhe, vice president of the association, was said to have told ECigIntelligence.
Some of Belgium’s vaping industry figures have already introduced legal action to the Council of State (Conseil d’État), the supreme administrative court of the country, which will need to deliver a verdict by December, 13, 2017.
Today, the FDA issued the revised guidance, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July of this year, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act.
The guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA.
The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.
The Vapor Technology Association’s (VTA) national legislative director, Tony Abboud, says there is no credible evidence that vapor products are a ‘gateway’ to combustible cigarettes, however, there is scientific evidence that they provide adult smokers with a safer alternative. The VTA represents the manufacturers, wholesalers, small business owners and entrepreneurs.
“Like the Surgeon General, VTA and its members are committed to the health and safety of children. The VTA supports bipartisan legislation that will ensure the safety of vapor products, and will ensure vapor products do not fall into the hands of minors.
“What the Surgeon General does not acknowledge with this announcement are the millions of adult Americans who rely on vapor products to switch away from smoking deadly cigarettes. However, as long as government agencies perpetuate false information, the United States will continue to fall behind other countries such as England, which have acknowledged the significant public health benefits of vapor products.
“VTA and our partners are committed to working together with the federal government and state legislatures across the country to dispel this false information and promote the har
Tony Abboud, national legislative director of the VTA.
m reduction benefits of vapor products so that they remain available as a lifeline to adult consumers.”
A public health expert has warned that if people believe the US Surgeon General’s report on electronic cigarettes; it is going to do a lot of public health damage.
The Surgeon General, Vivek Murthy, yesterday published a report entitled, E-Cigarette Use Among Youth and Young Adults.
Dr. Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said in his blog, The Rest of the Story, that the report was scientifically dishonest.
It essentially lied about the single most important fact that the public needed to understand about electronic cigarettes and vaping products: that they do not contain tobacco and that therefore vaping is not a form of tobacco use.
Michael Siegel
Later in his piece, Siegel says that if, as stated by the Surgeon General, vaping is a form of tobacco use, then so is using nicotine replacement therapy. ‘And if the Surgeon General is serious in stating that “any form of tobacco use” is dangerous, then why isn’t he warning people who are using nicotine gum and nicotine patches,’ he asked.
‘Obviously, it would be terribly misleading and deceptive to tell the public that the nicotine patch is a form of tobacco use. It would be lying to tell the public that people who use the nicotine patch are tobacco users. But the nicotine in a nicotine patch is derived from the same tobacco as is the nicotine in e-cigarettes.’
New research has proved that electronic-cigarette aerosol droplets are effectively delivered to cell surfaces in laboratory-based biological tests, according to scientists at British American Tobacco.
The result of the research is important because it helps to validate the findings from such tests.
‘There have been several studies comparing the impact of e-cigarette vapor with that of cigarette smoke on cellular models, and there are a lot of great data out there,’ said Dr James Murphy, head of risk substantiation at BAT.
‘When there is a partial response or no response at all, this can be interpreted as e-cigarette vapor having a reduced biological impact compared to cigarette smoke. But what if it just means we are losing the aerosol and exposing the system to air? We had to be sure.
‘These latest results suggest that we can be confident that we are effectively delivering e-cig aerosol to cells in biological tests and that we can be confident, therefore, in the results of our biological tests.’
The results are published today in Chemistry Central Journal (DOI: 10.1186/s13065-016-0221-9).
The cellular tests mimic key events in the development of tobacco-related diseases such as cardiovascular disease or chronic obstructive pulmonary disease. They form part of a weight of evidence approach to assess the reduced risk potential of electronic cigarettes and other next generation products.
BAT reported that two different smoking/vaping robots had been used to produce aerosol from a reference cigarette (3R4F) and Vype ePen, a commercially available electronic cigarette. The deposited particle mass in exposure chambers was measured, as well as the amount of deposited nicotine. Exposure chambers are used to expose human lung cells to aerosol in the lab and to assess the impact of that aerosol (smoke or vapor) on the health of those cells.
The results had shown that, on a puff by puff basis and at a common dilution, the electronic cigarette aerosol deposited greater mass than cigarette smoke in both systems. In contrast, nicotine delivery was much greater from the cigarette than from the electronic cigarette.
‘It may seem counter intuitive that the aerosol that delivered the most mass had the least impact, but it’s about what that mass represents,’ said Murphy.
The aerosol particles produced by smoke and vapor might appear similar but they were compositionally very different, BAT reported. Smoke was drier and stickier, and therefore lighter than were the glycerine-based electronic cigarette droplets, which were moist and tended to be heavier.
In addition, smoke droplets carried the products of combustion: thousands of chemicals and hundreds of toxicants. Whereas electronic cigarette aerosol droplets contained the aerosolised form of the four main ingredients that made up e-liquids: humectants, water, nicotine and flavouring.
BAT pointed out that many in the public health community believed electronic cigarettes offered great potential for reducing the public health impact of smoking. Public Health England, an executive body of the UK Department of Health, had recently published a report saying that the current expert estimate was that using electronic cigarettes was around 95 percent safer than was smoking cigarettes, though more research was needed. The Royal College of Physicians had said that the public could be reassured that electronic cigarettes were much safer than were traditional cigarettes and that they should be widely promoted as an alternative to traditional cigarettes.
“The long tradition of scientifically rigorous messages and reports from the U.S. surgeon general appears to have ended, lamented Edward Anselm, senior fellow at R Street, a public policy research organization promoting free markets and limited, effective government.
“The new report on electronic cigarettes focuses on youth experimentation and completely omits the opportunities for harm reduction these devices offer for adult smokers,” he said.
“Every study of e-cigarettes has shown a dramatic reduction in harmful and potentially harmful compounds that cause cancer, emphysema and heart disease. While the knowledge base is far from perfect, the Food and Drug Administration has created a roadmap to approve new tobacco and nicotine products that can be marketed as having reduced risk.
“Overall nicotine use, for both smoking and e-cigarettes, is at an all-time low. This is especially true for young people, for whom use of e-cigs exceeds use of combusted cigarettes. Young people who try e-cigarettes are more likely to experiment with other adult behaviors, including smoking. If there were no e-cigarettes, they would go straight to smoking,” said Anselm.
“Regarding indoor air quality, the Department of Housing and Urban Development recently reviewed the literature and determined that there was insufficient evidence to support bans on indoor use of e-cigarettes in residential settings.
“Smoke-free environments in the home or in workplaces are well-grounded in science. People who live with smokers or work in close proximity acquire the same diseases. There is no scientific literature to show the toxicity of vapor. By highlighting the mere presence of toxic substances, the surgeon general again deviates from science.
“While the future health of children is vital to us all, the imbalance of this report does the science and the crucial policy issues a disservice.”
The U.S. Surgeon General is due to release a report on e-cigarette use today. Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research, a nationally-recognized authority on e-cigarette policy, says the topic should be of particular interest as the Trump transition team considers key appointments at the U.S. Food and Drug Administration (FDA), as well as when the time comes to appoint a new Surgeon General.
Dr. Vivek H. Murthy’s report concurs with the research consensus that e-cigarettes are less harmful than cigarettes because they don’t combust. But he said there isn’t enough evidence supporting the effectiveness of e-cigarettes as an aid for quitting conventional cigarettes. His report concludes that e-cigarette use among young people is strongly associated with the use of other tobacco products, including traditional cigarettes.
In anticipation of the release, Stier says, “If Surgeon General Murthy only addresses the serious risks of e-cigarette use by minors, something we all agree on, but fails to provide much-needed education about their benefits to adult smokers who would like to quit, he’ll have missed an important opportunity.”
Murthy writes in his report that e-cigs “are now the most commonly used form of tobacco among youth in the United States, surpassing conventional tobacco products, including cigarettes, cigars, chewing tobacco and hookahs.” The report claims that the use of e-cigarettes among high school students increased by 900 percent from 2011 to 2015.
Further, says Stier, “If the Surgeon General goes on to make policy recommendations based only on the risk part of the equation, without considering the benefits, he will have failed his fundamental obligation of improving public health. Without a deep and thorough analysis of the issue, the Surgeon General’s approach becomes little more than platitudes.”
In the report, the Surgeon General called for federal, state and local action immediately, such as including e-cigarettes in smoking bans as well as significant increases in taxes and the price of e-cigarette products.
While Murthy raised concerns about flavors that appeal to young users—such as gummy bear, cotton candy and chocolate—he stopped short of recommending restrictions on flavoring. The FDA has said it is looking at flavors that might appeal to youth.
The Surgeon General would have been wise to adopt the clear approach used by the Royal College of Physicians in its landmark report last year, by saying, “It’s very simple: adult cigarette smokers who switch to e-cigarettes dramatically reduce their risk, by using nicotine without smoke,” according to Stier.
That report avoids mentioning the role e-cigarettes most likely played in reducing combustible cigarette smoking by youth and young adults. Vaping among young adults between 18 and 24 years old more than doubled from 2013 to 2014, according to the report, while cigarette use has plummeted. However, it does note older adults are more likely to report using e-cigarettes to wean themselves off conventional cigarettes.
Murthy also writes that nicotine can damage the developing teen brain while leading to addiction. “Compared with older adults, the brain of youth and young adults is more vulnerable to the negative consequences of nicotine exposure.”
“This is just another politically motivated attack on an industry that is helping people to quit,” said Gregory Conley, president of the American Vaping Association, an vapor advocacy group.
Philip Morris International (PMI) has filed its highly anticipated Modified Risk Tobacco Product (MRTP) Application with the U.S. Food and Drug Administration (FDA). The company is seeking the right to make a health claim on its iQOS heat-not-burn vaporizer.
Filing the MRTP application keeps PMI on track with its goal to file by year end. If approved, the firm would be able to market iQOS in the U.S. as a modified exposure or a modified risk product.
The FDA has 60 days (“at minimum”) to accept the application for substantive review and then up to one year to make a final decision (early 2018). The application is rumored to be more than 2 million pages in length.
To commercialize iQOS in the U.S., PMI will need an approved Pre-market Tobacco Application (PMTA), which PMI is planning to file in the first quarter of 2017 with a decision expected as early as July 2017. A PMTA would allow iQOS to be marketed in the U.S. without a health claim, similar to how iQOS is currently being marketed in many countries, including Japan, with great success.
“While this designation could be very powerful from a global public health standpoint, PMI will need to file a Premarket Tobacco Product Application (PMTA) to actually commercialize the product in the U.S. via an exclusive licensing agreement with Altria,” said Wells Fargo analyst Bonnie Herzog. “We are encouraged by the timeliness of PMI’s first FDA application submission.”
