The US Food and Drug Administration will step up its crackdown on electronic cigarette sales to teens, according to a story by Robert King for the Washington Examiner quoting the head of the agency.
Lawmakers on a House Appropriations subcommittee were said to have grilled FDA Commissioner Scott Gottlieb about ‘excessive’ use of e-cigarettes among young people.
The FDA has the authority ‘to go after’ e-cigarette makers and retailers if they violate a ban on sales to people under 18, but lawmakers questioned if the agency was doing enough.
“I am concerned that FDA’s silence on e-cigarettes could open the door to the next public health emergency,” said Rep. Nita Lowey, D-N.Y.
Gottlieb replied that the FDA would crack down on young people’s use of e-cigarettes in the coming weeks.
The agency has several avenues for targeting retailers that are selling to minors. Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.
Gottlieb said e-cigarettes could offer fewer health risks than traditional cigarettes, but the soaring use among minors was worrisome. A recent study had found that e-cigarette use grew by 900 percent among high school students from 2011 to 2015 [there was no mention of the level of use in 2011].
“We can’t just addict a whole generation of young people onto nicotine,” Gottlieb reportedly said.
A study has found that the levels of three compounds in e-liquid emissions were hugely lower than those reported in a previous study, according to a ScienceDirect.com story relayed by the TMA.
The replication study, conducted by a team of researchers led by Dr. Konstantinos E. Farsalinos at the Onassis Cardiac Surgery Center and the University of Patras in Greece, is scheduled to be published in the May edition of the journal Food and Chemical Toxicology.
It tested three e-liquids from a previous study (in standard and sweetened versions) using the same device and puffing patterns, and found a 589-fold decrease in the levels of formaldehyde (8.3–62 μg/g), acetaldehyde (12.1–26.0 μg/g) and acrolein (5.4–19.4 μg/g) from those reported as part of the earlier study.
The earlier study had identified aldehyde emissions up to 10,000-times higher in flavored e-liquids than in unflavored e-liquids.
But the latest study found that aldehyde emissions from all flavored e-liquids were 79.0–99.8 percent lower than those associated with smoking.
And they were lower than commonly measured indoor levels and occupational and indoor safety limits.
The researchers said the devices tested emitted very low levels of aldehydes, and that while some flavorings might contribute to aldehyde emissions, the absolute levels were minimal.
The US Food and Drug Administration has published its revised guidance on the Listing of Ingredients in Tobacco Products.
In a note issued through the FDA’s Center for Tobacco Products, the agency said the guidance was intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act.
The guidance announces that the FDA intends to enforce the ingredient listing submission requirements of section 904(a)(1) only with respect to finished tobacco products and their components or parts that are made or derived from tobacco, or containing ingredients that are burned, aerosolized or ingested during tobacco product use,’ the note said.
‘For example, ingredients of cigarette paper should be submitted to FDA as it is burned during the use of a cigarette and produces constituents that are inhaled by the smoker.’
The note added that, for example, the FDA did not intend to enforce the ingredient listing submission requirement in respect of coils, wicks and mouthpieces.
The guidance is said to streamline the requirements for manufacturers by clarifying ways in which tobacco product manufacturers or importers can satisfy the ingredient listing requirements by providing one listing that corresponds to multiple products.
‘It explains the statutory requirement to submit a list of all ingredients in tobacco products, who submits ingredient information, what information is included in the submissions, how and when to submit the information, FDA’s compliance policies, and definitions,’ the note said.
The note issued a reminder to manufacturers and importers of ‘deemed tobacco products’ that were on the market as of August 8, 2016, that the deadline to submit ingredient listings is May 8, 2018. For small-scale manufacturers, the deadline was said to be November 8, 2018.
Halo, a Florida, USA-based e-liquid company has won the 2018 e-liquid of the year award at the Shenzhen Ecig Expo (IECIE). Founded in 2009, Halo is produced by family-owned and operated Nicopure Labs, a leader in the vaping industry. The company currently sells e-liquids in more than 90 countries.
IECIE 2018 will be the 4th edition of the show based in Shenzhen, China, the manufacturing center for the vapor industry. The first IECIE was held in 2015 and the show has expanded to 37,500 ㎡ within just three years.
IECIE 2018 is expected to attract 50,000 professional visitors and 1,500 brands from 45 countries. IECIE covers the scales of e-cig finished products, liquids, atomizer, hardware, packaging, accessories, solutions and components, aiming to be the world class influential international e-cig exhibition.
The commissioner of the US Food and Drug Administration Scott Gottlieb has said that the agency is considering whether it could bring electronic cigarettes into the over-the-counter (OTC) regulatory pathway, according to a CNBC report relayed by the TMA.
Gottlieb said the OTC pathway would give the agency more tools to look at both safety and benefit, study whether or not an e-cigarette promoted smoking cessation, and study toxicity and the way it affects the lung.
This move was said to be part of the sweeping plan to overhaul tobacco regulation that the Commissioner announced in July.
“At the very time I am trying to take nicotine out of combustible tobacco, I don’t want to be sweeping the market of products that provide an alternative to smokers who want to get access to nicotine,” Gottlieb said.
The idea flows from the FDA’s continuum of risk policy that recognizes that conventional cigarettes are the most harmful and other nicotine products are potentially less risky.
Members of the UK’s lower and upper houses are due to congregate outside the Palace of Westminster today to call on Parliament to set an example by opening its doors to vaping.
The members of the two houses will be led by Mark Pawsey (pictured), MP for Rugby and chairperson of the All Party Parliamentary Group (APPG) for E-Cigarettes, in supporting the launch of VApril, a nation-wide campaign aimed at encouraging the UK’s seven million smokers to switch to vaping, which is now seen by many people as one of the best ways to break the smoking habit.
The campaign is being organized by the UK Vaping Association (UKVIA) and fronted by Christian Jessen, who is a medical doctor, television presenter and writer.
“Vaping is now recognised as one of the best ways to quit smoking and therefore presents a major opportunity to make a significant and positive impact on the public health of the nation,” Pawsey was quoted as saying in a press note put out by the UKVIA. “Yet only one in 10 people understand the relative minor risk of vaping compared to smoking.
“Even in our own Parliament vapers are treated the same as smokers, forced into outdoor areas far removed from their places of work. It is time we practice what we preach and make Parliament ‘vape friendly’. That is why we are seeking to change the rules in Parliament so we can set an example to the public and businesses across the country.”
Meanwhile, Jessen said that, according to a recent report by Public Health England (PHE), e-cigarettes might be contributing to at least 20,000 successful new quits per year – with the industry estimating this figure to be much higher.
“But as a doctor it’s disappointing to hear that an estimated 40 percent of smokers still haven’t even tried vaping.
“I’m delighted to be joining forces with the UK Vaping Industry Association to launch VApril. VApril is all about helping more smokers to make a successful and permanent switchover. I personally believe vaping has overwhelming potential to help smokers break their habit, and this is important because stopping the habit is the single most significant step that people can make to improve their health. We hope that smokers across the UK will put down their cigarettes for a month, take the VApril Challenge and give themselves the best chance of quitting smoking for good.”
Smokers are being encouraged to take the VApril challenge across the UK by dropping into vaping masterclasses being provided by specialist vaping stores during April. They will receive a free guide – Vape to Break the Smoking Habit – to help them transition from smoking to vaping and give them the best chance of a successful quit.
The chairperson of a committee inquiring into electronic-cigarette use in Australia has prepared a dissenting report recommending permitting nicotine use in such products, according to a story by Megan Haggan for the Australian Journal of Pharmacy.
But in its Report on the Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia, Parliament’s Health, Aged Care and Sport Committee made five recommendations.
A review of the evidence relating to the health impacts of e-cigarettes, to be updated every two years. Issues covered by the review would include: whether e-cigarettes can help people to quit smoking, the health effects of e-cigarette liquid (e-liquid) and long-term use of e-cigarettes, whether e-cigarettes could lead to more young people smoking and/or using nicotine, and the relative health impacts of e-cigarettes when compared to tobacco products.
An international meeting of health experts to discuss policy and legislative approaches to e-cigarettes.
A national approach to the regulation of non-nicotine e-cigarettes.
The Therapeutic Goods Administration’s continued role in classifying nicotine and assessing e-cigarettes.
Greater regulation of flavourings and colourings used in e-liquid.
In their dissenting report, the Committee chairman and federal member for North Sydney, Trent Zimmerman, and Tim Wilson recommended that:
Nicotine used for e-cigarettes be made exempt from Schedule 7 of the Poisons Standard.
Legislation be passed to permit the sale and use of e-cigarettes containing nicotine with a regulatory framework for their sale and consumption based on standards found in the European Union and the United Kingdom.
A notification and assessment process for colour and flavourings used in e-cigarettes.
Meanwhile, Dr. Andrew Laming was said to have provided a dissenting report recommending that vaping be legalised.
The Public Health Association of Australia welcomed the majority report, saying it and its approach closely align with the views of leading public health experts in their recommendations for an evidence-based and precautionary approach to e-cigarettes.
The PHAA says it is also pleased to see the report acknowledge the three pillars of Australia’s harm minimisation drug policy: prevention, protection and promotion; as well as its emphasis on ensuring that e-cigarette regulation is consistent with tobacco regulation.
Taiwan’s Ministry of Health and Welfare reported Sunday new data estimating that more than 52,000 teenagers in Taiwan regularly use electronic cigarettes, according to a story in The Taiwan News citing a Central News Agency report.
A poll administered by the ministry found that e-cigarette use went from 2.0 percent among middle school students and 2.1 percent among high school students in 2013, to 3.7 percent and 4.8 percent respectively in 2015.
The ministry estimates also that there are 100,000 adult – over 18-years-old – e-cigarette smokers in Taiwan.
The ministry was quoted as saying that e-cigarettes were highly addictive and that their long-term effects were not fully understood, something, it added, that posed ‘even more of a risk to young adopters’.
The story did not explain what the e-cigarette risk was being compared with. Even so, the Ministry was said to be demanding immediate attention to this problem.
Taiwan legislators continue to discuss how to regulate and manage e-cigarettes, and even ban them; however, legislation remains pending in the Executive Yuan.
New data presented at the Society of Toxicology Annual Meeting (SOT) have demonstrated the potential risk reduction offered by switching from conventional cigarettes to two different heat-not-burn tobacco products and e-cigarettes.
A PMI Science press note issued on Wednesday said that a range of studies had investigated the toxicological impact of Philip Morris International’s Tobacco Heating System 2.2 (THS 2.2), Carbon Heated Tobacco Product 1.2 (CHTP 1.2) and prototype e-cigarette products in the context of respiratory disease, cardiovascular disease, and lung cancer using several different approaches. In each case, the aerosols produced by the alternative products were said to have resulted in significantly reduced levels of biological impact as compared to cigarette smoke (CS).
‘One six-month, multi-arm exposure study compared the effects of CS with those of the aerosol from the two heat-not-burn tobacco products THS 2.2 and CHTP 1.2 using a mouse model,’ the note said. ‘In both THS 2.2 and CHTP 1.2, tobacco is heated rather than burned, resulting in significantly reduced levels of harmful chemicals emitted and inhaled as compared with CS,’ the note said.
‘Through a systems toxicology approach, combining physiological, histological, and omics [various biology disciplines] endpoints, the study found that exposure to THS 2.2 and CHTP 1.2 aerosols had minimal adverse respiratory and cardiovascular effects in comparison to exposure to CS. The findings are in line with a previous assessment of THS 2.2, demonstrating reproducibility of the results obtained. In addition, both cessation and switching to CHTP 1.2 aerosol exposure after three months exposure to CS reversed inflammatory lung responses, halted the progression of aortic plaque growth and reduced the perturbations of biological pathways in heart tissue, to levels typically seen following exposure to fresh air alone.’
PMI Science said that another study presented at SOT had assessed lung inflammation, emphysema and the underlying molecular changes typically associated with lung cancer following up to 18 months of exposure to either CS or THS 2.2 aerosol. ‘The study used a combination of traditional toxicology endpoints as well as systems toxicology techniques including histological, transcriptomic, and proteomic analysis of the lungs,’ the note said. ‘In all endpoints, the biological impact of THS 2.2 aerosol was significantly lower than that of CS.’
Meanwhile, the company said that, in line with the principles of 21st century toxicology, PMI was developing also novel in vitro methods for toxicity testing using human cells. ‘Such models have the potential to reduce the necessity for animal testing and offer more cost-efficient and timely results, as well as a detailed understanding of the biological processes underlying toxicity,’ it said.
‘In collaboration with the Institute for In Vitro Sciences (IIVS), one study presented at the SOT evaluated the performance and reproducibility of three new in vitro assays. Six laboratories conducted comparison of the assays and found that these non-animal test systems may provide consistent human-relevant data corresponding to key events involved in respiratory disease. A further in vitro methodology using human bronchial epithelial cells was used in a study assessing the effects of THS 2.2 aerosol and CS.’
“The multi-lab comparison of these non-animal systems paves the way for more robust and meaningful strategies for toxicity testing,” said Dr. Holger Behrsing, principal scientist, IIVS. “They allow us to generate human-relevant data that will be of interest not just to industry and research scientists, but also to regulatory bodies. In order to develop these assays and ensure they reach their fullest potential, collaboration is key. Working with PMI and a range of different laboratories has allowed us to leverage expertise across the field and demonstrate the reproducibility of our findings. In the spirit of open science, we hope that this will open the door to further collaborations in the investigation, development, and validation of novel in vitro systems.”
In the assessment of three prototype e-cigarettes, biological changes following three-week’s exposure to the either the e-cigarette aerosols or CS were assessed using traditional and systems toxicology endpoints. CS exposure was found to induce biological responses associated with smoking-related diseases in the respiratory tract, while e-cigarette aerosol exposures, even at higher levels of nicotine delivery, resulted in substantially reduced molecular and microscopic changes. Two additional e-cigarette studies assessed the biological effects of flavor compounds typically added to e-cigarette liquids, demonstrating the potential to establish a scientifically substantiated list of minimally-toxic flavor ingredients.
PMI said it was leading a full-scale effort to ensure that heat-not-burn tobacco products and e-cigarettes ultimately replaced cigarettes.
Further information on PMI’s Reduced-Risk Product development and assessment program can be found at www.pmiscience.com.
A study undertaken by British American Tobacco has shown that teeth exposed to cigarette smoke over a period of two weeks became ‘very discolored very quickly’, whereas teeth exposed to e-cigarette vapor or vapor from glo, a heat-not-burn product, did not. After two weeks of almost continuous exposure, the teeth exposed to vapor were almost indistinguishable from teeth that were not exposed to anything at all.
‘Smokers get “stains”, turning teeth from a healthy-looking white to an unhealthy-looking yellow/brown color,’ BAT said in a press note. ‘Although this staining is commonly referred to as nicotine staining, it is not caused by nicotine, but by tar in smoke.
‘As part of a wider study on oral health, scientists at British American Tobacco studied discoloration in teeth. A prototype Vype e-cigarette and a tobacco heating product, glo, were assessed for tooth discoloration and the impact on teeth compared to that of cigarette smoke.
‘A puffing robot was used to puff on the products to produce smoke and vapor. In each case, the smoke or vapor was collected onto a filter pad (Figure 2B) and then a solvent was used to extract the solid material from the filter pad. The impact of the extracted material (extract) on tooth discoloration was then tested using cows’ teeth.
‘Cows’ teeth are routinely used in laboratory experiments in lieu of human teeth. They are used for example to test oral hygiene products like toothpaste and mouthwash.
‘The teeth were prepared by polishing them using fine sandpaper to create a surface more like that of human teeth. The teeth were then incubated at body temperature in human saliva to create an environment mimicking that in the human mouth. This incubation results in the creation of the so-called pellicle layer on the teeth, which is the smooth film you can feel on your teeth when you rub your tongue over them. It is the normal protein layer that forms on teeth when certain molecules in saliva bond to the tooth enamel.
‘The teeth were incubated in an oven at body temperature and exposed to the various extracts from the cigarette smoke or e-cig or THP vapor. Some teeth were also incubated in solvent with no extract at all to act as a control/blank.
‘After the first day, the teeth exposed to the smoke extract started to change colour and over the course of 14 days, these teeth got darker and darker in color. Even with the naked eye, the color changes with the cigarette extract could be easily seen after one day. The exact color change was also measured in the laboratory using a special camera that can detect tiny changes in hue. In contrast to teeth exposed to smoke those exposed to e-cigarette or THP vapor exhibited minimal change in color, similar to untreated teeth.’
These results were presented on Saturday at the annual conference of the American Association for Dental Research in Florida, US.
