The basis of a blanket ban on electronic cigarettes imposed two months ago by the government of Karnataka, India, is being challenged by consumers, according to a story in the Times of India.
Members of Bengaluru’s vaping community are said to have taken the Right to Information (RTI) route to debunk the government’s claim that the ban was based on the evidence from scientific studies.
The RTI reply they received from the Tobacco Control Division of the Union Ministry of Health and Family Welfare said ‘no study research analysis is available’ on the harmful effects of electronic cigarettes.
The RTI application was filed by IT professional Praveen Vijayan Pillai on the basis of the justification offered by UT Khader, the then Health Minister of Karnataka on announcing the ban.
Khader said a decision on banning electronic cigarettes was taken after a study was conducted by an NGO and experts.
But the vapers believe that the reply from the Union Health Ministry has undermined the state government’s position.
And they want to know also why the Karnataka government targeted electronic cigarettes while leaving untouched traditional tobacco cigarettes.
Writing on his blog, The counterfactual, Clive Bates says that the US Food and Drug Administration’s deeming rule, which came into force on Monday, spells the end of innovation.
‘In essence, FDA requires an enormously burdensome Pre-Market Application (PMTA) to be filed and accepted by FDA for any new product from now on,’ he wrote.
‘So that’s the end of innovation, including pro-health and pro-safety innovation.
‘For all products currently on the market, a PMTA has to be filed within two years, with a further year for FDA to review – that will wipe out most products and most smaller firms and open way to black market.’
Bates is one of 16 people who have filed an amici curiae brief in the Nicopure Labs et al versus FDA legal case (http://www.clivebates.com/documents/THRamicibriefpublic.pdf).
This month, for the first time, the US Food and Drug Administration (FDA) will be able to help protect the public, and especially young people, from the dangers of all tobacco products, according to the director of the FDA’s Center for Tobacco Products, Mitch Zeller, writing an FDA blog.
‘For years, it has been illegal under federal law to sell cigarettes and smokeless tobacco to minors,’ he said. ‘Under a rule finalized in May, federal law now prohibits retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18.’
Zeller wrote that, beginning yesterday (August 8):
It became illegal nationwide to sell cigars, hookah tobacco and e-cigarettes to anyone under the age of 18 and retailers were required to check the photo ID of anyone under the age of 27.
Retailers could not give away free samples of ‘newly deemed tobacco products’.
Retailers could not sell cigars, hookah tobacco and e-cigarettes in a vending machine where anyone under the age of 18 has access at any time.
‘In 2009, the President signed the Family Smoking Prevention and Tobacco Control Act into law, giving FDA the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, Zeller said. ‘But cigar, hookah tobacco and e-cigarette markets remained unregulated, creating a market environment I have equated in the past to the Wild, Wild West.
‘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 – putting a new generation of kids at risk of addiction. E-cigarette use, for example, skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) among high school students; and hookah use also increased significantly. And every day, more teenage boys try a cigar than try a cigarette.
‘That’s why this historic rule is so important. It enables FDA to regulate all tobacco products except accessories – improving public health and protecting future generations from the dangers of tobacco.
‘In addition to restricting youth access to tobacco products, FDA will now be able to review new tobacco products not yet on the market, prevent misleading claims and help better provide consumers with information to make informed decisions about their tobacco use. This means tobacco product manufacturers will be required to register and list their products with FDA. And all newly regulated products will need to get a marketing order from FDA, unless they are grandfathered (were sold in the US as of February 15, 2007.) Manufacturers will also be required to report ingredients and harmful and potentially harmful constituents in their products.
‘Under these public-health based regulations, tobacco product manufacturers seeking a marketing order from FDA must now demonstrate what is actually in these products, and how these products impact the health of those who use them – important rules to be expected for products that expose consumers to known or potential health risks.
‘To assist companies in making the transition to an FDA-regulated marketplace, we have published several guidance documents to help businesses, big and small, meet these new requirements. We also continue to offer webinars for retailers and manufacturers and support from our Office of Small Business Assistance.
‘This historic final deeming rule is a major public health step forward. We believe by restricting youth access to additional tobacco products such as cigars, hookah, and e-cigarettes and by scientifically reviewing these products, we will reduce the public health toll of tobacco use, which remains the leading cause of preventable disease and death in the country and the world – and keep our kids tobacco-free.
A new study indicates that 95 percent of Malaysian vapers have either quit or cut down on smoking, according to a story in The Star.
More than 80 percent of the vapers reported that their health had improved.
“More than two-thirds stopped smoking altogether,” said Greek cardiologist, Dr. Konstantinos Farsalinos, in a recent interview in Kuala Lumpur. “Among the 27 percent that didn’t quit, the average consumption of cigarettes dropped from 19 to four a day.”
Farsalinos, a researcher at the Onassis Cardiac Surgery Center and University of Patras, said more than 7,000 adult vapers – 97 percent of whom were male – participated in the online survey, which was conducted in English and Malay. The average age of respondents was 30.
More than 5,500 ex-smokers and more than 1,500 people who smoke and vape were asked about their experiences with electronic cigarettes, and the responses were consistent with those obtained in the US and Europe.
“Malaysian vapers, like their global counterparts, generally use advanced e-cigs and were able to reduce their nicotine consumption gradually, feel healthier and eventually quit smoking,” Farsalinos said.
‘In May, the FDA finalized its Deeming Rule regulations, which would force e-cig manufacturers to undergo an expensive and time-consuming premarket tobacco application process unless their products were on the market – or substantially equivalent to a product on the market – prior to the predicate date of February 15, 2007, long before modern e-cigs were introduced,’ the NCPPR said in a press note.
‘The high cost of the application process means most e-cig businesses will be forced to shut down, eliminating choices of dramatically safer alternatives to combustible cigarettes, which will leave smokers with fewer options to compete against the most harmful form of nicotine consumption, combustible tobacco.’ NCPPR said the brief concluded:
The FDA’s Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress’s intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act.
“E-cig technology has grown by leaps and bounds since the FDA’s arbitrary predicate date in 2007,” said Evan Swarztrauber, communications director at TechFreedom. “Setting a standard using technology from nearly a decade ago is absurd and highly stifling to innovation. The FDA should issue evidence-based regulations that address legitimate safety concerns without hindering products that improve consumer health by providing a less harmful alternative, rather than implementing a ‘Mother, may I innovate?’ approach that’s become all too common among regulatory agencies.”
Jeff Stier (pictured), senior fellow at the NCPPR, said that instead of developing science-based standards which would reduce harm, the FDA had directly admitted it didn’t understand or evaluate the potential benefits or harms of e-cigarettes. “Without that science, it relied on the ‘precautionary principle’ standard, in direct conflict with the evidence-based standard required by Congress,” he added.
And Daniel Suraci, an attorney working pro bono on behalf of the NCPPR, said regulations should be promulgated within the constraints of the rule of law, sound policy, and proportionality. “The FDA’s heavy-handed approach to e-cigarettes is an affront to smart governance as the regulations are in direct contradiction of the scientific evidence showing the public health benefits of vaping, and push the public back to cancer causing tobacco products,” he said.
On Monday, August 8, innovation in the vapor industry dies. This is the date the first phase of the U.S. Food and Drug Administration’s (FDA) rules regulating the vapor industry go into effect.
Key provisions include:
– bans sales of all deemed products that aren’t on the market on August 8, 2016,
– bans manufacturers/retailers from making truthful health claims about deemed products,
– bans free sampling of all deemed products to adults,
– bans sales of deemed products to anyone under 18, and
– requires photo ID of consumers appearing under 27 who tries purchase products
The best hope for the industry is changing the predicate date. On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by Rep. Tom Cole (R – OK) and Rep. Sanford Bishop (D – GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 “grandfather date” for currently unregulated tobacco product categories, including nicotine-containing electronic vaping devices and the “e-liquid” used in them.
E-cigarettes could lead to a 21 percent decline in deaths from smoking-related diseases for people born after 1997, according to a study published in Nicotine & Tobacco Research. Even accounting for harms people might suffer from vaping who would have otherwise not smoked at all, the researchers found a net public health gain from the presence of e-cigarettes, according to an article posted on the website InsideSources. So why is the U.S. Food and Drug Administration putting up big regulatory barriers for e-cigarettes starting Monday, Aug. 8?
The reason is simple: regulator over-caution. The FDA isn’t publicly blamed for the people who suffer and die because a drug, product or service wasn’t available due to their slow and prohibitively expensive approval process. It is, however, blamed for products that cause harm 20 or 30 years down the line. So, regulators err on the side of caution.
In the case of electronic cigarettes, they are sacrificing the millions of people who will certainly die because of their tobacco addiction for the unknown number of people who might be harmed by the long-term effects of nicotine found in vaping products.
The risks of smoking traditional cigarettes far outweigh the risks of vaping. Both contain nicotine, which is an addictive substance, but itself may be no more harmful that caffeine and might even have some benefits. But cigarettes kill 50 percent or more of its users. Vaping, though a relatively new product category, is estimated to be 95 percent less harmful than traditional tobacco products.
Equally as important, smokers seem willing to make the switch to vaping. A survey of nearly 30,000 European Union residents, published last month in the Journal Addiction, concluded that of the 7.5 million daily vapers, 35 percent had completely switched from traditional tobacco cigarettes. For simplicity’s sake, I ignored the 2 percent of vapers who, according to the study, were not tobacco smokers prior to vaping.
Applying these rates to American vapers (though there are certainly differences in culture and regulation), a conservative estimate is that of the 9 million regular vapers in the United States, 2,970,000 of them have quit smoking traditional cigarettes by using e-cigarettes.
Of course, some people don’t entirely quit smoking, but refuse their use of traditional cigarettes. According to the E.U. study, 32 percent of the current vapors fell into this category.
Yet, beginning on August 8, the FDA will treat these two very different products in functionally the same way. Manufacturers and importers will have two years to gain FDA approval for every device, component and e-liquid formula; a process that takes hundreds to thousands of man-hours and can cost up to $1 million per application. By the FDA’s own estimate, 99 percent of the current products on the market will not receive approval from the FDA and will disappear from the market.
The purpose of the Tobacco Control Act — which gave the FDA power to regulate tobacco — was to “provide new and flexible enforcement authority” and to aid the industry’s attempts to “develop, introduce and promote less harmful tobacco products.”
Yet, with this new rule the FDA is doing is exactly the opposite. As my organization’s founder Fred Smith once quipped, perhaps it’s the FDA that should come with a warning label, not e-cigarettes.
American health advocates should be raising a stink about the damage these new rules will do to public health. But instead they worry about vaping “re-normalizing” cigarette smoking, which they worked so hard to make taboo.
It’s too bad they aren’t following the lead of British health professionals, who embraced the scientific evidence that e-cigarettes are relatively safe and an effective way to quit smoking. They have even advised doctors to encourage their smoking patients to switch to vaping.
So, what can be done to stop the FDA for perpetrating this harm?
First, Congress should enact legislation that would change the “grandfather date” within the Tobacco Control Act to 2016. The grandfather or “predicate” date, which allowed tobacco products on the market before February 2007 (or similar to such products) to bypass the agency’s pre-market approval process, is set at February 2007. Because e-cigarettes didn’t really exist before this date no products would qualify for this exemption. Though TCA explicitly gives FDA “flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce and promote less harmful tobacco products,” the FDA indicated that it doesn’t have the authority to change the grandfather date.
To address the problem, Reps. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., introduced an amendment to the Agriculture Appropriations bill that would change the predicate date to August 2016. While not a perfect solution, grandfathering in most of the products on the market now would just bring innovation to a screeching halt, rather than throwing it back nine years.
In the long term, lawmakers should enact legislation directing the FDA to issue rules that account for the relative harm of products and make it easier and cheaper for less harmful products to get approval.
FDA’s fears about vaping products are certainly not baseless. Though they’ve been around for about a decade and are safer than cigarettes, the long-term effects of vaping aren’t known. What is known, however, is that millions of people will die because of their addiction to traditional cigarettes unless they quit or switch to another product and the FDA’s new rules will make switching more expensive, less attractive and less likely.
Even if bureaucrats at the FDA don’t get the blame, their failure to enact rules that preserve the electronic cigarette market will result in deaths that could have been prevented.
The New Zealand government has agreed in principle that, with ‘appropriate controls’ in place, nicotine for electronic cigarettes should be legally available, according to a scoop.co.nz story.
Currently nicotine may be imported only for personal use, which can create insurmountable barriers for smokers trying to switch to vaping.
“The Associate Minister of Health, Peseta Sam Lotu-Iiga has made the right decision,” said End Smoking’s chairperson, associate professor Marewa Glover. “He has listened with compassion to smokers and vapers. We are so relieved that our pragmatic nature as a country has triumphed over the negative misinformation and unfounded fears that have dominated the debate for too long.”
Long-time advocate of electronic cigarettes with nicotine, Dr. Murray Laugesen, said that he was “absolutely delighted” with the decision. “This will be a turning point that will have a significant impact on reducing the death and disease caused by smoking,” he said.
“It also gives us a real shot at achieving Smokefree 2025.”
The Ministry of Health is calling for submissions on how to legislate electronic cigarette products and what regulations or controls need to be in place.
In a note posted on its website, the ministry described electronic cigarettes as a relatively new and evolving product. ‘Currently, the sale and supply of nicotine e‑cigarettes are prohibited, while smoked tobacco, which is more harmful for users, can be sold legally,’ it said.
‘Users obtain nicotine e‑cigarettes through importation and illegal local sales.
‘The existing provisions for the regulation of e‑cigarettes, found primarily in the Smoke-free Environments Act 1990 (SFEA) and the Medicines Act 1981, are not adequate. The legal status of e‑cigarettes is currently confusing and, as a consequence, the laws are not routinely enforced.
‘The risks and benefits of e‑cigarettes are uncertain but there is emerging evidence that e‑cigarette use may substantially reduce the burden of disease caused by smoking.’
The ministry went on to say that it was consulting on policy options for the regulation of e‑cigarettes, including possible amendments to the SFEA. This consultation aimed to clarify the legal position.
Written submissions should be emailed to ecigarettes@moh.govt.nz.
Mistic has made sub-ohming simple. Today, Ballantyne Brands, parent to Mistic, is reinventing the vaping experience with the introduction of the Mistic 2.0 POD-MOD, a sleek and powerful closed-ended personal vaporizer that enables consumers to quickly and easily change flavor tanks using the company’s pre-filled pod technology.
Selling for $39.99 at drug, mass and convenience retailers nationwide, Mistic’s new pre-filled vape system starter kit comes in two color options (matte black and matte white), each packaged with two free (a $40 retail value) pre-filled 10 mL flavor pods (matte black: tobacco/strawberry and matte white: menthol/cherry).
“This product simplifies the vaping experience covering the full spectrum of vape consumers,” said John Wiesehan Jr., CEO of Mistic. “It gives the experience, flavor profiles, and vapor production that mod users are accustomed to and also provides ease of use to cig-alike users who haven’t upgraded because they didn’t want to deal with the hassle
of bottles and tanks. With a simple pick, click and vape, users can experience different flavors at a moment’s notice.”
Available in a compact, ergonomically designed rechargeable 30-watt unit with an automatic shut-off feature, Mistic 2.0 delivers a robust and satisfying vape from a 1700 mAh battery with the convenience and no-hassle of a cig-alike. The battery also has an on-off option as well as stand-by mode to help conserve power.
Offered in 10 mL child-resistant, tamper-proof pre-filled pods, Mistic 2.0 high-end e-liquids (80 VG/20 PG ratio) are made in the USA and available in 4 mg nicotine strengths (4 percent by volume) and 10 flavors: cherry, coconut cream, creamy cantaloupe, fruit mix, java, mango, menthol, strawberry, tobacco and watermelon.
Selling for $19.99, each Mistic 2.0 pre-filled pod has its own built-in coil that provides 0.3 ohms of resistance for maximum sub-ohm vapor production. Each self-contained pod is easily interchangeable for vapers on the go or those wanting to effortlessly experience various flavor profiles.
British American Tobacco said today that it was leading efforts to develop and harmonize standards around vaping products to further reassure consumers of these products’ potential ‘in reducing the harm from smoking’.
The company said that this effort was being made against a backdrop of a growing number of electronic cigarette users globally. It cited the Ernst & Young’s May 2016 report, E-cigarettes: an emerging category, as saying that the number of electronic cigarette users in seven examined countries grew by 86 percent to 5.1 million in 2015.
Marina Trani, Head of R&D at Nicoventures (a wholly owned subsidiary of BAT) will tell delegates at the EuroScience Open Forum 2016 (ESOF 2016) on July 26 that standards need to be harmonised in order to promote innovation, according to a BAT press note. Different rules in different jurisdictions made it overly burdensome and expensive, especially for smaller companies. It stifled growth and innovation, which in turn could stifle the potential these products had for reducing the harm of smoking.
The EU and the US, for example, were worlds apart in terms of how they regulated electronic cigarettes. Draft regulations in the US, to be enacted in August, would require pre-approval before any change was made to a vaping product. Whereas, the EU Tobacco Products Directive required a less-restrictive, six-month prior notification (rather than approval) for ‘substantial modification’.
There was a growing body of evidence that electronic cigarettes were substantially safer than were cigarettes, the press note said. Kevin Fenton, Public Health England’s Director of Health and Wellbeing, had said recently, “The wider body of evidence consistently finds that e-cigarettes are less harmful than smoking”.
BAT said that in 2013 it had become the first tobacco company to launch an electronic cigarette and that it had been proactive in both developing the first voluntary product standard with the British Standards Institute (BSI) and advocating for more harmonised standards. It was currently contributing to the European standards development work.
BAT said too that it had taken a ‘particular leadership position’ in toxicological risk assessment through the publication of its 2015 best practice guide for how to comply with that aspect of the BSI guidelines. The guide helped ‘to safety assess’ flavours for inhalation rather than ingestion. It set out a scientific rationale that would help determine if particular flavours could be used safely.
Trani is due to tell the ESOF that the vaping industry should continue on a journey towards standards that can protect consumers, increase understanding of next generation products, and that are clear and harmonized globally while not inhibiting innovation.
