Japan Tobacco International has described the EU’s revised Tobacco Products Directive (TPD2) as ‘a raft of draconian rules that will impact consumers and businesses across the Union without meeting its intended goals’.
The comment comes on the eve of the May 20 deadline for all tobacco products on the markets of EU countries to comply with the provisions of the TPD2.
“This is yet another example of Brussels-led over-regulation,” said Ben Townsend, JTI’s EU affairs vice-president in a note posted on the company’s website.
“TPD2 will not achieve its public health goals. It will, however, stifle consumer choice and have huge consequences for local economies, jeopardizing thousands of legitimate businesses and employees, from farmers to packaging manufacturers, and tobacco producers to retailers.”
The press note said that TPD2 mandated a wide-reaching set of measures for products and packaging, including large pictorial health warnings that took up most of the pack surface – dramatically reducing the space available for product information to consumers and brand designs.
Many pack formats had been banned under the false pretext that this would drive smoking levels lower. This included the prohibition of smaller cigarette packs and fine-cut pouches, which was likely to backfire badly by forcing consumers to buy larger formats and therefore spend more money.
The Directive would outlaw also menthol cigarettes from 2020.
“TPD2 is a hugely complex, burdensome and restrictive piece of legislation,” said Townsend. “To top it off, some EU countries were encouraged to go above and beyond TPD2 requirements by introducing even more outlandish measures such as plain packaging. As a result, consumers will come across different regulations for the same product in different countries, which makes a mockery of the European Commission’s original aim to improve the functioning of the internal market”.
In a statement echoing one from Forest EU, JTI said the Commission’s initial Impact Assessment stated that TPD2 would create a two percent drop in consumption over five years to 2021, but that it had had to acknowledge that this figure was just ‘a best effort estimation’.
“TPD2 is an attack on legitimate businesses and adult consumers’ freedom of choice,” said Townsend.
“Even the President of the Commission recently said that they are wrong in over-regulating and that one of the reasons citizens are stepping away from the European project is that EU law-makers are interfering in too many domains of their private lives.
“It’s time for Brussels bureaucrats to listen; they must be held accountable when the review of the Directive is published in 2021.”
The organizers of the Global Forum on Nicotine (GFN) have said that the program for the 2017 event is complete.
The GFN is due to be held at the Marriott Centrum Hotel, Warsaw, Poland, on June 15-17.
The main GFN program, which is scheduled for June 16 and 17, will examine the rapidly developing science in relation to nicotine use and the changing landscape, including policy responses and the influence of different stakeholders in this.
The program will comprise plenary sessions, symposia, panel discussions and poster presentations – including video posters.
June 15 is scheduled to include the Michael Russell oration, and satellite and side meetings, including one for consumers organised by the International Network of Nicotine Consumer Organisations.
It will include, too, the first International Symposium on Nicotine Technology designed to showcase the latest technological advances in alternative nicotine delivery systems, next generation devices and the science behind them (http://isontech.info/).
British American Tobacco has published what it calls the first practical guide to the allergy-safe use of ingredients, such as flavourings, in e-liquids.
In a press note issued yesterday, the company said that, as with the use of many flavouring or fragrance-containing consumer products, ‘vaping’ e-liquid had the potential for causing an allergic reaction.
‘An allergic reaction is an overreaction by the body’s immune system to compounds that a person is ‘allergic’ to,’ the press note said. ‘Even if a compound has the potential to cause such a reaction (i.e. it is an allergen), that doesn’t mean it will. Whether an allergic reaction is likely, will depend on the person’s immune system and the amount of the compound used in a product.’
However, some substances were more likely than were others to cause allergic reactions, said BAT.
Flavourings were an important part of the vaping experience and some flavourings were known allergens. But currently, there were no specific allergy-related regulatory restrictions under either the Tobacco Products Directive in Europe or regulations administered by the Food and Drug Administration in the US.
Researchers at BAT had therefore devised a practical approach to assessing and managing the allergy risk associated with e-liquid flavourings and other ingredients (Regulatory Pharmacology and Toxicology http://dx.doi.org/10.1016/j.yrtph.2017.04.003). The guide is said to be a follow-up to the company’s blueprint for the safe use of flavourings in e-cigs, which was published in Regulatory Pharmacology and Toxicology in 2015 (https://doi.org/10.1016/j.yrtph.2015.05.018).
The most common allergy was contact sensitization arising when, for example, nickel jewellery touched the skin. Much less common was respiratory allergy, or ‘chemical asthma’.
“Although respiratory allergy is much less common than skin allergy, the potential adverse effects are much more severe,” said Dr. Sandra Costigan, principal toxicologist at BAT. “Chronic inhalation of respiratory allergens can lead to symptoms ranging from mild breathing difficulties to fatal anaphylaxis.”
‘For skin allergens, the researchers propose a method for estimating the exposures to e-liquid ingredients and quantitatively assessing the risk,’ the press note said. ‘This has then allowed them to work out a concentration of an allergen that is not expected to cause allergy in the person vaping the e-liquid.
‘For skin allergens, putting this into practice is relatively straightforward, as an approach to prevent contact sensitization is well established: The stronger the allergen, the lower the supportable concentration in e-liquid.
‘Additionally, the researchers say any known allergen should be labelled as an ingredient if it is present at 0.1 percent concentration or higher, even if it is established that it can be used safely at a higher concentration. This will help those consumers who already know themselves to be sensitive to certain ingredients to make product choices.’
For respiratory allergens, the authors used a cocoa extract as a case study, because cocoa is used quite commonly in e-liquids. The case study showed the tolerable levels identified for the cocoa extract were not sufficiently high to allow it to perform as an effective flavouring in e-liquid. In the guide, the researchers discuss why this is likely to be an issue for other respiratory allergens as well. And they recommend that respiratory allergens are not used at all.
Furthermore, quoting the low occupational exposure guidelines related to respiratory allergens (aimed at protecting workers against respiratory allergy from unintended exposure to allergens in the workplace), the researchers said it was prudent to exclude all known respiratory sensitizers from e-liquids. As an additional safeguard, if natural extracts were used as flavourings and there was no specific data on whether those extracts were respiratory sensitizers or not, only protein-free versions should be used. This was because most respiratory allergens from natural extracts came from the protein parts.
Food allergens were yet another type of allergen and the researchers recommended the presence of any potential food allergens (that are not already excluded for being respiratory allergens) should be labelled.
‘No two people have the same immune response, which is why it is important to tell people about allergens in a product even if all your data says most people shouldn’t experience a problem,’ said Costigan.
The EU Commission has appointed the six members of its newly-established independent advisory panel (IAP) assisting member states and the Commission in determining whether tobacco products have a characterizing flavour.
It has published also a reserve list of suitable candidates.
The panel members were named in a Directorate-General for Health and Food Safety (DG Sante) newsletter as:
Prof. Andrea Buettner, Fraunhofer Institute for Process Engineering and Packaging, Freising, Germany and Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany;
Dr. Garmt Dijksterhuis, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands;
Dr. Jan van Amsterdam, Department of Psychiatry, Academic Medical Center, Amsterdam, The Netherlands;
Mr. Emmanuel Vanzeveren, It makes sense SPRL, Braine Le Comte, Belgium;
Dr. Wouter Visser, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands;
Assoc. Prof. Efthimios Zervas, Hellenic Open University, Patra, Greece.
‘These members are highly qualified independent experts covering the areas of sensory, statistical and chemical analysis,’ DG Sante said…
‘The members have been selected by an evaluation panel [pursuant to Commission implementing decision (EU) 2016/786], and appointed in their personal capacity to act independently in the public interest.’
The first meeting of the panel is due to take place in Brussels on June 1.
The IAP is tasked with issuing opinions on whether a tobacco product has a characterising flavour, and with specifying and updating, as appropriate, the methodology for the technical assessment of products as set out in the Commission implementing decision (EU) 2016/786.
In addition, the panel might be consulted by the Commission on other matters relating to the assessment of characterising flavours.
The panel will be able to request input from a technical group of sensory and chemical assessors that is still to be established by the Commission via a public procurement procedure.
Lawmakers in the US cities of San Francisco and Oakland are suggesting that these cities ban the sale of flavored tobacco products, including menthol cigarettes, blunt wraps, cigars, and cigarillos, according to a story by Malia Cohen for SFist.
‘For too long the tobacco industry has gotten a pass while they selectively target vulnerable populations with flavored tobacco products,’ Supervisor Cohen, who is proposing the legislation in San Francisco, was quoted as saying in a press note.
‘Flavored tobacco hooks new smokers and makes them lifelong users.
‘It can be more harmful and more difficult to quit than unflavored tobacco.’
Cohen went on to say that tobacco use in general remained the leading cause of preventable deaths in the US.
And she said that the proposed legislation would have a ‘tremendous impact on the disturbing disparities for tobacco-related illnesses’, and would reduce the number of new tobacco users that picked up the habit.
The Mayor of San Francisco, Ed Lee, is said to be putting his weight behind Cohen’s proposal.
He has said that if the bill makes its way through the Board of Supervisors, he will sign it into law.
A similar push to legislate against flavored tobacco products has come from Oakland city’s council member Annie Campbell Washington.
“We first took on big soda and succeeded and now we are taking on big tobacco together,” Campbell Washington said, referring to a soda tax that was imposed in Oakland and San Francisco in November.
President Donald Trump’s nominee to lead the Food and Drug Administration (FDA) refused at his confirmation hearing on Wednesday to commit to banning flavored cigars and electronic cigarettes, according to a story in The Hill.
Scott Gottlieb said he could see where flavored products might be inappropriate in one context and appropriate in another.
He indicated that he thought that FDA experts should be making those determinations.
In answer to a question from the Democratic Senator Patty Murray about the flavors gummy bears and cookies and cream, Gottlieb said he recognized there needed to be a line there somewhere, but that he didn’t know where that line was to be drawn.
“I think that line needs to get drawn by people who are experts in evaluating that science, and I want to support that,” he said.
Gottlieb said Murray was raising some imperative questions about when a reduced-harm product such as an electronic cigarette could be useful in transitioning people away from combustible cigarettes and when they might be a gateway to adolescent smoking.
“I think a properly constructed and overseen regulatory process should have the capacity under the authorities Congress gave the agency to make these determinations,” he said.
Health Canada announced yesterday a finalized amendment to the Tobacco Act that bans the use of menthol in cigarettes, blunt wraps and most cigars sold on the Canadian market.
The amendment is said to expand flavour restrictions to 95 percent of the tobacco market in Canada.
‘This amendment builds on changes that came into force in 2009 and 2015, which banned the use of certain additives, including flavours like chocolate and bubble gum, in all cigarettes, blunt wraps and most cigars (including little cigars), to make them less attractive to youth,’ Health Canada said in a press note.
‘Menthol masks the irritating effect of tobacco smoke by making it easier to inhale, which facilitates experimentation by youth.
‘Most Canadians who have smoked a cigarette did so by the age of 18 and many go on to become lifetime smokers.
‘Preventing youth from starting to smoke is one of the most effective means of decreasing tobacco use in Canada.
‘By prohibiting menthol in most tobacco products, the government of Canada is taking yet another step to reduce the appeal of smoking to Canadian youth.’
The press note included what Health Canada described as ‘quick Facts’:
‘Research has shown that an important way to curb lifetime smoking is to prevent youth from starting to smoke in the first place.
‘Despite success in reducing smoking rates among youth to a record low, recent data has shown that a significant number of youth smoke menthol cigarettes.
‘Restricting the use of menthol flavouring is only one part of the government of Canada’s overall tobacco control strategy. The government of Canada continues to advance work to implement its commitment to introduce plain and standardized packaging requirements for all tobacco products, to pass new legislation to regulate vaping products, as well as supporting First Nation and Inuit communities in the development and implementation of tobacco control projects that are socially and culturally appropriate.
‘During the 75-day comment period following the Canada Gazette, Part I pre-publication of this amendment, Health Canada received 131 submissions on the menthol ban, the vast majority of which supported this course of action.’
The creation of “expert panels” to detect characterizing flavors hints at the folly of the tobacco ingredients discussion.
By George Gay
I’m fascinated by the idea of having regulations that provide for a panel of people to decide whether a tobacco product has or hasn’t a characterizing flavor other than tobacco—a judgment that will mean in the case of the former that the product in its current format is banned, while in the case of the latter the product may remain on the market.
The setting up of such a panel is provided for within the EU’s revised Tobacco Products Directive that came into force last year, though it is not clear to me when the panel might be ready to start work. Presumably, however, it won’t be anytime soon because, I assume, protocols will need to be put in place, a lexicon will have to be agreed, reference products will have to be identified, and panelists will have to be trained in the various products to be tested.
One of the fascinating aspects of this exercise for a person such as me, whose olfactory system cannot tell red wine from white wine in a blind tasting, is its apparent subjectivity. Of course, the European Commission says that the method to be used will be robust. It says that the panel, comprising experts in sensory analysis, chemical analysis and statistics, will be backed by a technical group that will carry out sensory assessments based on a comparison of the scent properties of the test product with those of a reference product. In addition, where necessary, chemical assessments will be made, in part because a flavoring is taken to mean an additive that imparts scent and/or flavor.
And the commission assures us that sensory, including scent, analysis is an established scientific discipline that applies principles of experimental design and statistical analysis to assess and describe perceptions of the human senses, including smell, to evaluate consumer products. It has been found to be a suitable method for producing valid, robust, reliable and reproducible results when assessing whether a tobacco product has a characterizing flavor, the commission says.
This sounds all well and good, but, if as I understand it, a characterizing flavor is defined as a clearly noticeable smell or taste other than one of tobacco, the question arises as to what is the need for all of these experts and the chemical analysis. If it’s clearly noticeable, any person off the street—with the possible exception of me—could handle the job.
It must surely be the case, given the presence of the experts, that while some products will have a smell clearly different from tobacco and some will smell only of tobacco, some products will be marginal in their smell, and it is these that raise the interesting questions. If it takes a panel of experts backed by technicians, chemical analysis and statistical modeling to determine whether product A has a scent beyond tobacco, what is the point in the exercise? I mean, if the different-from-tobacco scent is so difficult to pin down that it requires a trip to the laboratory, product A is hardly likely to create a stampede of smokers and nonsmokers at retail outlets. And it is largely the attractiveness of product A, especially in the case of young people, that the EU is hoping to eliminate.
Of course, it might be argued that the chemical analysis is needed because the commission’s purpose is also to guard against additives that increase the addictiveness or toxicity of the product. But is this possible? Is it meaningful? What level of addictive or toxic agents would have to be discovered so that it could be said with confidence that the product under test was more addictive and/or more toxic than was the reference product? After all, we are often told that the cigarette, in whatever form, is more addictive than heroin is, and that it is the only licit consumer product that kills when used as it is meant to be used.
If characterizing flavors are the concern that critics make them out to be, it shouldn’t take an expert panel to detect them.
More bureaucrats and consultants
OK, you could argue that this doesn’t really matter because it’s jolly interesting to have a bunch of experts sitting around sniffing and analyzing tobacco products, but it does matter. Many people living in the EU have been suffering from the effects of austerity, a system of transferring what little money the financially poor have been left with following the negligent and criminal activities of some banks to the better off, and many of these impoverished people are smokers. As I understand it, EU member states and the commission will be allowed to charge manufacturers and importers of tobacco products for assessing whether a tobacco product has a characterizing flavor, whether prohibited additives or flavorings are used, and whether a tobacco product contains additives in quantities that increase to a significant and measurable degree the toxic or addictive effect of the tobacco product concerned. But while they might charge the manufacturers and importers, the bill for these activities is going to land in the laps of smokers, and this is unfair.
This panel is like tracking and tracing in that it takes a sledgehammer to crack a nut. It is about well-off people in suits attending meetings where the coffee and biscuits are paid for by various overt and covert imposts brought down on impoverished smokers and where the discussions are all about “helping” smokers. But smokers cannot afford this sort of help. They cannot support further layers of bureaucrats, consultants and hangers-on. Surely, the EU, having convinced itself of the need for tracking and tracing, cannot be unaware that many smokers are addicted to a product they no longer can afford.
But hey, that’s their problem, right? Tobacco and tobacco consumers have been denormalized, so they cannot expect to be treated fairly, or in the same way as other products and consumers are treated. Other consumer products launched into a market system are judged by consumers so that those products that pass that judgment remain on the market while those that don’t wither and die. But, in the case of tobacco in the EU, the judgment is being passed over to people who are probably not consumers of that product and, as far as I am aware, will not test it as a normal consumer would use it. And their judgment is not about ensuring that the most attractive products remain on the market but about ensuring that some of those products are removed from the market.
The reason for turning the world on its head in this way, I guess, is that the consumption of tobacco is said to be highly risky, which it is in relation to some products, though not all. Alcohol, which is linked with at least six types of cancer and which is far riskier than is tobacco at a societal level (in terms of contributing to violence and road accidents), has no such panel sitting in judgment of it. Perhaps this is because it is accepted that, after an hour or two of work, the panel members would no longer be able to function properly, and might be tweeting inappropriately, making unwelcome sexual advances to fellow panel members and fighting in an unseemly manner.
Menthol
Of course, the tobacco smelling panel won’t have to sit in judgment of menthol because the EU has decided already that this flavoring should be banned as of 2020. This is interesting because it raises the question of prohibition. A lot of people claim that tobacco prohibition can’t be brought in because alcohol prohibition didn’t work in the U.S. But I have argued in the past that this is a false comparison. Drinkable alcohol can be produced at home and can be drunk in the evenings out of sight of prying eyes. Producing a smokable tobacco and smoking it without detection is virtually impossible.
But prohibiting only menthol cigarettes is another matter. How can this be policed when smoking most other products is still permitted? Will we have to set up a new smelling enforcement agency? For sure there will be ways of getting around the menthol ban. Some smokers will make use of the black market, while for others the commission has kindly hinted at what they might do by including in the ban the addition of flavors in cigarette components and packaging. After a little experimentation, any smoker will be able to leave her tobacco-only cigarettes overnight in a jar with some readily available menthol crystals so as to enjoy menthol cigarettes the next day. And I suppose that if our smoker had a cold, or wanted to make believe that she was smoking menthol cigarettes in the tropics, she could add some menthol crystals to a bowl of hot water, stick her head under a towel over the bowl and smoke away on her regular cigarettes. Virtual reality without having to buy a fancy gadget that makes you look like a standard lamp.
Of course, it is not only the consumer who will suffer from these flavor bans. If, as seems likely, the bans on traditional-cigarette additives in the EU start to apply downward pressure on licit cigarette sales, licit flavor companies will suffer too. And while there is always the hope that the traditional-cigarette business lost by flavor companies will be made up, or partially made up, in supplying flavors for new nicotine-delivery products, there are clouds on the horizon here too.
The EU has not clamped down on flavored electronic cigarettes, but, in the U.S., the future for nearly all electronic cigarettes looks nonexistent under the Food and Drug Administration’s deeming regulations. And whereas moves are being made to try to take the sting out of the worst excesses of the deeming regulations as they apply to electronic cigarettes, wipeout could be replaced by death by a thousand cuts. The New Jersey Assembly health committee recently passed and sent to the Assembly appropriations committee a bill that would ban the sale and distribution of electronic nicotine-delivery devices that have characterizing flavors other than tobacco, menthol and clove. And it would be surprising if other jurisdictions didn’t follow suit—not because it is a good idea but because governments are given to bouts of collective hysteria.
Why menthol and clove, you ask? Well, there’s a logic at work there, but it has nothing to do with the health of the consumer.
The writer would like to thank Roger N. Penn, who has worked in the tobacco flavoring industry for more than 30 years, for his kind help in preparing this story.
The use of citric acid in e-liquids needs to be investigated further to understand its potential to form potentially harmful anhydrides in electronic-cigarette vapor, according to a presentation given by British American Tobacco Scientists on Friday at the annual conference of the Society for Research on Nicotine and Tobacco in Florence, Italy.
‘Citric acid occurs naturally in the body, is “generally recognised as safe” in the USA, and is used in pharmaceutical inhalation products,’ BAT said in a press note. ‘However, thermal degradation of citric acid can occur at the operating temperatures of some vaping devices. Starting at around 175-203° C, citric acid can degrade to form citraconic anhydride and its isomer itaconic anhydride.
‘These anhydrides are respiratory sensitizers—chemicals that, on inhalation, can trigger an allergic reaction varying from hay fever symptoms to anaphylactic shock.’
The scientists used gas chromatography coupled to time-of-flight mass spectrometry to analyse the vapor generated when an e-liquid containing citric acid is heated in a vaping device. The device used was a first-generation (cig-a-like) e-cigarette. The scientists were reported to have been able to measure significant amounts of anhydrides in the vapour.
“Citric acid in an e-liquid may lead to significant amounts of citraconic and/or itaconic anhydride in vapor, depending on the device,” said Dr. Sandra Costigan, principal toxicologist vaping products.
“But we believe that flavorings can be used responsibly and we have already rejected the use of some flavorings in our products. Based on this case study using a first-generation e-cigarette, we recommend that the potential for formation of citraconic and itaconic anhydrides should be investigated further before commercialisation of e-liquids containing citric acid.”
In the US, New Jersey has moved one step closer to banning the sale and distribution of most flavored electronic smoking products, according to a story by Brent Johnson for NJ Advance Media.
The state Assembly’s health committee voted 7-2, with two abstentions, on Monday to approve the bill, which would ban the sale of vaping devices and products in flavors other than clove, menthol and tobacco. Currently there are hundreds of flavors available, such as honey, chocolate and cherry.
New Jersey already bans the sale or distribution of flavored cigarettes, except those with clove, menthol or tobacco flavors.
If passed by both houses of the state legislature and then signed by the governor, the new bill would extend that law to ban electronic smoking devices, cartridges, and liquid refills with flavors other than the three allowed.
Sponsors of the bill say its goal is to prevent vaping products from being targeted at young people, and possibly luring them into smoking tobacco products.
But opponents of the proposed ban say electronic cigarettes are less risky than are tobacco cigarettes, and can help people quit smoking. Plus, they say, banning the products would cause many vape shops to close.
Kevin Roberts, a former spokesman for Governor Chris Christie who now represents Logic Technology, the nation’s third-largest supplier of electronic cigarettes, said Monday that the bill went against “public health goals and would undoubtedly push countless individuals back toward conventional cigarettes and their known harms”.
The EU Commission has appointed the six members of its newly-established independent advisory panel (IAP) assisting member states and the Commission in determining whether tobacco products have a characterizing flavour.
The use of citric acid in e-liquids needs to be investigated further to understand its potential to form potentially harmful anhydrides in electronic-cigarette vapor, according to a presentation given by British American Tobacco Scientists on Friday at the annual conference of the Society for Research on Nicotine and Tobacco in Florence, Italy.