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Wednesday, 20 April 2022

Finland and China break new ground on regulating the vaping market

Last week two countries advanced major reforms to regulatory controls on the vaping market. On April 13th, Finland finalized changes to its Tobacco Act, a day after China finalized its first regulatory standard for e-cigarettes. This post describes some of the measures these governments are putting in place.

Finland is set to be the third country to require plain packaging of e-cigarettes

Israel pioneered
plain packaging
of e-cigarettes
In just over a year, on May 1, 2023, all brand images and logos will be prohibited on vaping product packaging in Finland, and the health ministry says that more controls will be made by regulation ( "separate provisions on the technical details related to the layout of packages and products will be issued by a decree.")

 Finland is also imposing restrictions on the shape of vaping liquid containers ("The refill container must not differ from other refill containers in shape, color, surface, color of the label or other appearance, and the appearance of the refill container must not promote the sale of the product.")  

Israel was the first country to require plain packaging of vaping products, implementing the measure in early 2020. Denmark passed legislation later that year, which comes into force this October. (The Netherlands has initiated legislation which is not yet finalized).

These are measures that are not currently in development in Canada. Although Health Canada's Forward Regulatory Plan that was released this time last year indicated regulations were being developed to "place certain limits on what promotional elements can appear on vaping product packages", this initiative was dropped in this year's Departmental Plan.

There are other measures that Finland has put in place which are not yet established in Canada. These include:

  • Finland has banned flavours other than tobacco since 2016 (the first among a growing number of countries to do so)
  • Finland requires retailers to implement "self-monitoring" plans to prevent sales to youth.
  • Manufacturers must provide pre-notification 6 months before introducing products to market. 
  • Manufacturers of cigarettes and e-cigarettes must pay regulatory fee based on sales volume.  (joining a growing number of countries which are now requiring this measure) 

China pioneers technical standards for e-cigarette manufacturers.

Although the e-cigarette is widely accepted as a Chinese innovation, it is only recently that the Chinese government has brought the e-cigarette market under public authority. Last November e-cigarettes were brought under the control of China's state tobacco monopoly. Soon afterwards consultations were launched to inform the development of the rules that would be imposed on this newly-regulated industry. Draft regulations were circulated at the World Trade Organization in early December, with a second consultation initiated in March. The final version (GB 41700-2022) was adopted on April 8 and comes into force on October 1, 2022. (The formal version is not yet downloadable, but photocopies are circulating on the web).  

China is adopting some product standards that are already in place in many other countries. These include:

  • a maximum concentration of 20 mg/ml of nicotine (now in place in 41 countries)
  • a ban on flavours other than tobacco flavour (adopted by 5 other countries)
  • a ban on additives that a mutagenic, carcinogenic or reproductive toxins (in place in the EU)
  • reporting and labelling requirements
  • ban on colouring ingredients in vaping liquids
It is also introducing measures that are less common elsewhere, including:
  • a ban on e-cigarettes that do not contain nicotine
  • a ban on refillable e-cigarettes
  • a maximum of 200 mg of nicotine per e-cigarette
  • maximum concentration of certain compounds (e.g. heavy metals, arsenic, 2,3-Butanedione)
  • a maximum level of nicotine that is released per puff 
  • a maximum temperature for aerosolizing liquids (a stunning 350 degrees celsius!)
  • a ban on additives that do not appear on the "white list" of 101 chemicals 
  • a ban on additives that increase health risks
  • a ban on additives that are not technically necessary or that are used in greater quantity than required
To implement some of these requirements (such as maximum nicotine release per puff and maximum temperatures), Chinese authorities have established testing protocols and standards, which are included by reference or as appendices to the new standard.  

Three different countreis with three different "white lists" for additives.

Although many countries have prohibited the use of certain categories of additives, such as colouring agents or reproductive toxins, only a few have moved towards prohibiting all additives other than those which are specifically permitted for us.

Health Canada is a proponent of this approach. In its proposed flavour restrictions, published 10 months ago, it identified 82 exempted flavouring additives (40 for tobacco-flavours, and 42 for menthol-mint flavours) and proposed to prohibit all others. The Netherlands National Institute for Public Health and the Environment (RIVM) also promoted this approach, and proposed a list of 23 flavouring additives that could be approved for use as part of its proposed ban on all non-tobacco flavours. The "White List" in China's regulation (currently accessible in the draft version of the regulation) includes 101 chemicals. There is only a modest overlap in these lists: of the 182 chemicals identified in these lists, only 22 are identified by more than one country. (A combined list can be accessed here).



With its October 1, 2023 implementation date, it appears likely that China will be the first to implement a flavouring ingredient "white list".  The Netherlands has indicating that its flavour restrictions are delayed until at least January 2023 and Health Canada has not made public its implementation timeline.

A first ban on open systems and emission rates

Last  year, in its 8th report to the World Health Organization, the WHO study group on tobacco product regulation (TOBReg) recommended that governments should prohibit e-cigarettes "in which the user can control device features and liquid ingredients (that is, open systems)" and those "with a higher abuse liability than conventional cigarettes, for example by restricting the emission rate or flux of nicotine." China appears to be the first country to put such restrictions into effect. 

Wednesday, 10 March 2021

BAT's report on "Vapour in Canada" validates new provincial and federal regulations

Over the past six months, new restrictions on vaping product marketed have been implemented by the federal and provincial governments which share responsibility for public health. This post provides an update on some of these measures - and on the reasons they are needed.

BAT reports that flavours and packaging are the key to its success

In the 2020 Annual Report it published this week, British American Tobacco provided validation for these regulations -- and the need for more. (The Canadian vaping market is one where half of vapers are under 25 years of age and 4 in 10 have never once smoked a cigarette.) 

In Canada, BAT says the formula for its success is fancy packages, flavour innovations and on-line marketing that engages consumers. It also underscores that its goal for these products is "consumer retention". It makes no mention of smoking cessation, although it does identify addressing the market for recreational drug use ("sensorial experiences"):  

From BAT's 2020 
Annual Repor
t
"The rise of Vype/Vuse to the number 1 vapour brand in Canada in less than three years demonstrates an offer that resonates with the consumer. The migration to Vuse fuelled this with the introduction of award-winning iconic pack expression that set Vuse apart on the shelf and conveyed the breadth of flavours on offer.

Meeting consumers' growing demand for new sensorial experiences saw the deployment of a pipeline of unique flavours brought to life via creative technologies.

Our retail presence provided a foundation for scale to developing direct consumer engagement/offers while our e-commerce revenue growth is attributed to going beyond a transactional relationship by offering subscription, delivery and personalisation. Faced with constant regulatory changes, we have responded with speed and agility to ensure consumer retention."

Protective measures from federal and provincial governments:

* On March 1, Prince Edward Island's ban on flavoured vaping products came into force. PEI is now among a small group of national and sub-national jursidictions to lead the ban on e-cigarette flavourings: Others include Finland, Nova Scotia, Massachusetts, California, New York State, New Jersey and Rhode Island.  

* In February, Health Canada shared its plans to introduce regulations later this year on restrictions on vaping flavours and reporting requirements on vaping product suppliers. It also indicated that next year it would be proposing restrictions on package and design features. Its consultation period on a proposed 20 mg/ml cap on nicotine ended last week. 

* In December, the Quebec minister of health indicated that this province too would be restricting nicotine and would ban flavoured products. These measures were among those recommended by a panel of experts that had been commissioned earlier in the year.

* In October, Nunavut introduced legislation that would ban flavours and impose other restrictions. The legislation has received second reading. 

* In September, B.C.'s restrictions on nicotine concentration and limitation of flavours to age-restricted specialty stores came into effect. On that date, the province also required vaping produts to be sold in plain-ish packaging (using only text and images permitted by regulation). Israel is the only jurisdiction to date to require plain packaging of vaping products. 

* In September, Health Canada's restrictions on promotions came into effect. The regulations ban promotions "done in a manner that allows the advertising to be seen or heard by young persons."

Download updated fact sheets:




Tuesday, 21 July 2020

Will British Columbia be the world's second jurisdiction to require plain packaging of e-cigarettes?

There may be a very important sleeper among the suite of measures to address youth vaping announced by the British Columbia government yesterday. One of the regulations introduced by minister of health Adrian Dix is a requirement that all vaping liquids be sold in plainish packages by mid-September. The regulation does not apply to packaging of the devices, but only on the packages that contain substances that produce a vapour.

Eliquids currently advertised on
Canadian Vape-shop websites


Short and sweet

This new measure is included in an Order in Council adopted by the B.C. cabinet earlier this week (July 20th OIC 426). Section 8 of the new E-Substances Regulation is clear and precise. In less than 200 words, it prohibits any text or imagery that is not specifically permitted or required under federal or provincial laws. (By comparison, the the federal plain packaging regulations for tobacco products take almost 9,000 words).

Packaging standards 

8 (1) Subject to any enactment of Canada, a retailer must not sell a restricted e-substance unless the product is packaged in a plain manner that does not contain any text or image other than as required or permitted under this section. 

(2) A retailer must not sell a restricted e-substance unless the package
(a) states the concentration of non-therapeutic nicotine in the restricted e-substance,
(b) states the total volume of restricted e-substance within the package or, if the package includes multiple cartridges or containers, the volume of restricted e-substance held or that may be held in each cartridge or container,
(c) states “WARNING: nicotine is highly addictive”, and (d) shows the warning symbol set out in the Schedule. 

(3) A retailer is permitted to sell a restricted e-substance in a package that states one or more of the following: 
(a) the name and contact information of the manufacturer;
(b) the brand name and product name;
(c) the type of product.

A different approach 

The brevity of this regulation results from the different approach taken in British Columbia than by other governments that have implemented plain packaging of tobacco products. Instead of stipulating how products must be packaged, B.C. has chosen to stipulate how they may not appear.

As a result, the impact will be different than the type of plain packaging that is now in force in Canada. There will be no standardized fonts, uniform colour or prescribed package sizes. Vaping liquids will not appear in the same olive-green colour that is now seen on packages littering Canadian streets.

Nonetheless, vaping manufacturers will no longer be able to use their packaging as mini-advertisements for nicotine use. 

Consider, for example, the current packaging for one of the leading products, BAT/Imperial Tobacco's vuse (show above). B.C.'s regulation appears to require the manufacturer to remove the patterned colours and logos, although it is not clear that they would be required to change  the background colour or to stop using distinctive (or attractive) fonts.

As companies lose the ability to put posters in retail stores, transit stations or on billboards, they can be expected to intensify their advertising in the media that remain open to them. This is exactly what happened when traditional promotions for cigarettes were curtailed 20 years ago. The package is one of the most obvious target for them to focus on. 

Learning from history? 

B.C. drafters may have drawn some inspiration from Canada's first federal law prohibiting promotions. The 1988 Tobacco Products Control Act  (s. 9) made it illegal for distributors to sell packages that had textual information other than brand names and trade-marks. The companies found loop-holes around this provision by trademarking a variety of advertising slogans and imagery. 

Sensibly, then, B.C. has not permitted the use of trademarks on packages. With the removal of trademarks on tobacco products now upheld by courts and trade tribunals across the world, they can do this with more confidence than federal regulators had in 1988. 

Canadian trademark 1011844
Tobacco companies trademarked
advertising slogans to circumvent federal
restrictions on promotional packaging


A legal challenge?

In developing this innovative approach, Health Minister Adrian Dix and his cabinet colleagues will have known that a fight with tobacco companies could be on the horizon. B.C. has already spent significant time and money fighting challenges from tobacco companies -- including their pioneering Tobacco Damages and Healthcare Costs Recovery Act and their Testing and Disclosure Regulations.

The regulations are scheduled to be implemented by mid-September. This would make B.C. the second jurisdiction worldwide to prevent text and images from being used as advertising on vaping packages.

Monday, 27 April 2020

Test your tobacco control knowledge!

How well have you been following tobacco control events in Canada? Take 10 minutes to test your knowledge of recent events.

Bragging rights are a short quiz away!....(and yes, there are some trick questions).

-----------------------

1. In March 2020, British American Tobacco changed its logo.
What slogan did it adopt?

a) We've come a long way, baby
b) Accelerating Delivery
c) A better tomorrow
d) I'd rather switch than fight
e) A taste you can call your own

2) The federal government recently made public its tax revenues from tobacco sales in 2018-2019 and its budget for tobacco control for 2020-2021.
Which of the following statements are true?

a) For every $1 in federal tobacco tax revenue, 1 cent will be spent on tobacco control.
b) For every Canadian smoker, the federal government will spend less than $10 per year on tobacco control.
c) The average Canadian smokers pays about $700 per year in federal tobacco taxes.
d) Federal Government revenues from tobacco sales are increasing faster than industry revenues.

3) In January the Council of Chief Medical Officers of Health recommended that governments adopt several measures to prevent youth vaping.
Which of the following did they not recommend?

a) ban all flavoured vaping products and then provide regulatory exemptiosn for a minimum sets of flavours.
b) limit nicotine levels in vaping products to a maximum of 20 mg/ml.
c) tax vaping products in a manner consistent with maximizing youth protection while providing some degree of preferential pricing.
d) promote e-cigarettes as a form of harm reduction.
e) increase the minimum age for tobacco and vaping to 21 years.

4) In December the results of the Canadian Student Tobacco Alcohol and Drug Survey were released. In only one province the rate of youth vaping had not doubled over the past 4 years.
Which province was that?


5) Plain packaging of tobacco products came fully into effect in Canada in February 2020.
Which of the following countries has not yet implemented plain packaging? (A bonus point to identify those countries which require plain packaging of e-cigarettes).

a) Turkey
b) Uruguay
c) Saudi Arabia
d) Israel
e) Singapore

6) At least 40 countries do not permit the sale of electronic cigarettes as consumer products.
Which of the following statements is not true?

a) These countries represent about one-third of the world's population.
b) Among these countries are several with advanced tobacco control strategies, including one-third of the countries which have passed plain-packaging regulations for tobacco.
c) These countries are found in each of the World Health Organization's 6 regions.
d) These countries include member states of the European Union.

7) Which of the following trademarks were not recently registered by a tobacco company in Canada?
a) World of White
b) Cool Flow
c) Press and Roll
d) Voke
e) True me

8) How many Canadian provinces have implemented a tax on vaping products?

9) The Lung Association and Heart and Stroke are sponsoring PSA to encourage governments to protect kids from vaping.
What products do they use to make their point? (no peeking!)

a) Pokemon
b) Lego
c) Ice-cream
d) My little pony
e) Fidget spinners

10) Which of the following are cities in Canada not authorized to regulate?
a) minimum prices on cigarettes
b) flavourings in vaping products
c) minimum separation distances between tobacco retailers
d) moratorium on new licenses to sell tobacco or vaping products
e) a regulatory fee to pay for cleaning up filters and e-cigarette waste

11) Which of the following countries do not allow retailers to set their own prices for tobacco products?
a) China
b) Brazil
c) France
e) Japan
e) Sweden

12) The number of tobacco retailers has fallen in Canada by how much since 2000?
a) 10%
b) 15%
c) 20%
d) 25%
e) 30%

13) Which of the following statements are not true?
a) For every post office outlet, Canadians have access to 4 tobacco retailers.
b) Canada has more tobacco retailers per capita than the United States.
c) Canada has more tobacco retailers per capita than France.
d) Canada has more than twice as many tobacco retailers as it has gas stations.

14). British American Tobacco announced that around the world it was changing the brand name of its e-cigarettes from VYPE to VUSE (the name which previously was used only in the United States).
Why did they do this?


15) Canadian provinces are currently in the 7th month of mediation talks with tobacco companies to settle the lawsuits filed by provinces over the past 2 decades.
Which of the following is not true
?

a) the provinces have claimed in excess of $600 billion in health care costs related to the companies' wrongful actions.
b) neither the Canadian companies nor their foreign owners has put money aside to cover the payments they may be required to make as a result of lawsuits.
c) the lawyers representing most of the provinces are working on a contingency basis, with agreements that will pay them up to 30% of any settlement amounts.
d) the provinces have sought advice from the health and medical communities on how to use the lawsuits to reduce smoking.

BONUS Question

16) Why did we circulate this quiz?

Answers 
  1. c) A better tomorrow. Accelerating Delivery was a slogan used by BAT in recent years, the others are advertising slogans for cigarettes.
  2. All but d) are true.
  3. d) The council made no reference to harm reduction.
  4. There was no increase noticed in New Brunswick because the survey was not previously conducted in that province.
  5. e) Singapore's regulations do not come into effect until July 2020, when it will be the 14th country to have put this in place. Israel has required plain packaging of e-cigarettes since January 2020.
  6. d) EU members are required to permit the sale of e-cigarettes.
  7. d) VOKE. That trademark was abandoned by tobacco company BAT, and has been picked up by Kind Consumer.
  8. a) Only British Columbia has implemented a tax on vaping products. Nova Scotia will implement its tax in September 2020. Alberta has said it will impose a tax, but has not yet set a date.
  9. c) Ice-cream. The campaign is called "Get the scoop".
  10. Cities have the power to impose all these regulations. 
  11. Japan, Brazil and France restrict retail competition for cigarettes by establishing the price which retailers must charge for each brand.
  12. e) In 2000, there were approximately 40,000 tobacco retailers in Canada, compared with 28,000 in 2018 - a 30% reduction
  13. B is not true. In the USA there are about 115 tobacco retailers for 100,000 people, compared with 71 in Canada.
  14. We don't know either. Give yourself a point. 
  15. d) Despite requests for meetings, none of the provinces has agreed to or initiated public consultations on resolving these lawsuits. 
  16. To encourage you to take note of our recently-released information products, linked below.
Score

However you scored, give yourself perfect marks for caring enough to try. 

------------------------

Information on these and other current topics in tobacco can be found in our newly-released documents:


Friday, 10 January 2020

This week Israel became the first country to implement plain packaging of e-cigarettes.

On January the 8th, several elements of Israel's law prohibiting advertising of tobacco and smoking products came into effect. Among these were requirements that tobacco products and smoking products (including e-cigarettes,  heat not burn products like IQOS, and non-tobacco products designed for smoking like shisha) be sold in generic packages.

In addition to plain packaging, the new law requires larger health warnings on cigarettes (65%) and on smoking products (30%). In September 2018, shortly after JUUL entered the market, Israel prohibited nicotine concentrations above 20 mg / ml.


The picture above, showing a before and after package of JUUL cartridge mix in Israel, is provided with the kind permission of Smoke-Free Israel.

Israel is the first country to require generic packaging of e-cigarettes, although other jurisdictions are proposing to follow suit.
E-cigarettes and liquids sold in Canada are subject to restrictions in the federal Tobacco and Vaping Products Act. As of this summer, this will require warnings and labelling that conform with the new Vaping Products labelling and Packaging Regulations, which were Gazetted on Christmas day. These include a warning that covers 35% of the principal display area.

The federal law imposes other restrictions on e-cigarette packages. It prohibits designs that suggest that the vaping liquids have banned flavours (i.e. candy or desert), as well as illustrations that "cause a person to believe that the product is flavoured if there are reasonable grounds to believe that the indication or illustration could be appealing to young persons."   

Despite these restrictions, major companies are packaging their vaping liquids in colourful packages with evocative imagery.

Wednesday, 4 September 2019

Why so anodyne? Canadians need strong, effective and truthful warnings on vaping packages

The federal government summer season of no-big-decisions usually runs from third week of June (St. Jean Baptiste Day) to the first week of September (Labour Day). On the eve of the break this year, Health Canada handed public health groups with a challenging summer task: published in the Canada Gazette on Saturday June 22 were 27 pages of proposed regulations for vaping products. Responses were due 75 days later, on September 5.

The proposed regulations are no trivial matter. They are the first significant regulatory proposals from government to constrain the way that nicotine products are packaged and labelled, or to control the amount or type of nicotine that can be sold as a recreational drug. 

For decades, nicotine other than tobacco was controlled as a medication under the Food and Drugs Act. The tolerance that was given to vape shops was so extensive that many Canadians who bought nicotine liquids for vaping devices were likely unaware that they were participating in an illegal sale.

All this changed when the federal Tobacco and Vaping Products Act was approved by Parliament and proclaimed in May 2018. The legalization of nicotine changed the commercial market, bringing nicotine into the Fast Moving Consumer Goods (FMCG) market. Convenience stores became the route to market for multinational tobacco companies to compete for this new market. (Picture below courtesy of Toronto area South Bayview Bulletin Board).




Health Canada has yet to make public whether or how it will regulate the types of ads that appear in many convenience stores (several provinces have banned them). Their first priority was to develop labelling requirements and child-resistant container requirements. As Health Canada describes them, 

The proposed labelling requirements include a list of ingredients, and, depending on the presence of nicotine and its concentration, a health warning that nicotine is highly addictive, the concentration of nicotine, and warnings regarding the toxicity of nicotine when ingested. In addition, the proposed Regulations would set out expressions that may be used on the product or package to indicate when a vaping product is without nicotine. The proposed Regulations would also require refillable vaping products, including devices and their parts, to be child resistant.

Why so anodyne?

Health Canada's proposals for package warnings for vaping products are surprisingly unambitious for a country which invented graphic health warnings. The regulations require a only a text warning, only for one health effect and only on one side of the package. They are arguably less powerful than the warnings currently placed on a voluntary basis by the industry. 


Canada can do better 

This proposed warning seems even more  milquetoast now than it did when it was first Gazetted in June. South of the border, health authorities have spent the summer snarling at nicotine companies and expressing concerns about potential acute risks for young people who vape:
* top medical authorities issued unequivocal warnings that vaping products are "not safe" for non-smokers, 

Admittedly, only one other country currently requires graphic health warning messages on vaping product packages (South Korea). Admittedly, it is important to design them thoughtfully -- and that takes more than the 75 days given to respond to the proposed regulations. Admittedly, Health Canada should not leave the packages of these risky products unregulated for any longer than necessary.   

For that reason, we are proposing that in the short run, Health Canada require a strengthened and more prominent version of its warning be on all packages as soon as possible. Within the next year, however, it should be possible to refine and adapt a series of rotating messages which provide Canadians with the information about the range of health risks associated with vaping to which they are entitled. One of our suggestions on how to do this is shown below.



How much is too much? How fast is too fast? 

The proposed regulation also sets limits on how much nicotine is permitted in the liquids or cartridges used with vaping devices. The level -- at 66 mg / mL -- is much higher than any of the major products currently on the market. This is in stark contrast to the European Union, Israel, Korea, and Iceland where the maximum level allowed is 20 mg/mL. 

Nor does the regulation address the additional risks of nicotine salts -- which are shown even by the industry research to reach the brain more quickly than those which do not use this 'protonated' technology. It does little to respond to increasing concerns about the collateral damage of the nicotine arms race that is happening between JUUL and its imitators.

A time for sober second thought

More often than not, the final version of regulations varies little from the version that is initially published. Concerns about departmental regulation making once resulted in Parliament being given an opportunity to vet Tobacco regulations before they came into effect. This provision was removed when the law was updated  to include vaping products last year.

So the only recourse left is for a change of opinion by the department and the central agencies (Treasury Board, Privy Council Office, Cabinet) to which it reports. Cross your fingers!

Our submission

Physicians for a Smoke-Free Canada's full response to the proposed regulation can be downloaded here. Our key recommendations are:

1. Vaping packages should carry warnings of the following risks:
  • Vaping products may increase the risk of cardiovascular diseases.
  • Vaping products may increase the risk of lung diseases.
  • Vaping products are not effective smoking cessation devices for most people.
  • Dual use of vaping products and combustible cigarettes increases the risk of disease compared to exclusive use of either product.
  • Use of vaping products during pregnancy may harm the fetus
  • Young people who vape can harm the parts of their brain that control attention, learning, mood and impulse control.
  • Nicotine can harm adolescent brain development, which continues into the early to mid-20s
2. Manufacturers should be required to place warnings on at least 50% of the top of two principal display surfaces, with one side each for English and French.
3. Graphic health warnings for vaping product packages should be developed. 
4. Plain packaging of vaping products should be required.
5. The maximum allowable nicotine concentration should be set at 20 mg/mL.
6. The impact of the introduction of nicotine salts on youth vaping should be reviewed.