Submission on Draft Vaping Products Labeling and Packaging Regulations

The Vaping Industry Trade Association (VITA)[FR: ARIV] appreciates this opportunity to respond to Health Canada’s consultation on the draft Vaping Products Labelling and Packaging Regulations under the authority of the Tobacco and Vaping Products Act (TVPA) and the Canada Consumer Product Safety Act (CCPSA).

VITA/ARIV is a new non-profit trade association of some of the largest vaping industry stakeholders, including Dvine Laboratories, JUUL Labs Canada Ltd., Valor Distributions, Imperial Tobacco Canada (Vype), Atelier de Saveurs LaVapeShop, and JTI Canada Tech Inc. (Logic). As Canada’s largest Trade Association representing the industry’s manufacturers, importers, distributors and retailers, VITA is committed to working with governments to set and uphold regulations for vaping products in Canada. Our mission is to promote the interests of the vaping industry and advance tobacco harm reduction by ensuring the responsible manufacture, distribution and sale of vaping products.

This submission will address the issues surrounding child resistant vaping products, while also providing feedback and suggestions surrounding nicotine measurements, and vaping product labelling. The submission makes five key recommendations, which will be elaborated on throughout.

1. Caution should be exercised in applying a child-resistant standard to open tank systems as it would significantly distort the market and seriously undermine the specialty vape shop channel, offering less choice to the vaper. If a standard is to be applied, a period of two years should be introduced to allow for market adjustments to maintain consumer satisfaction and to provide enough time for the research and development activities required to permit industry compliance.

2. Section 50(2) should be amended to prevent inappropriate classification of ingredients under the descriptor flavour and instead mandate the disclosure of information more relevant to the consumers while protecting proprietary flavour formulations. The Association has offered amendments to the wording in accordance with this suggestion.

3. All vaping substances containing less than 0.1 mg/mL of nicotine should be classified as not containing nicotine.

4. Section 11(2) should be amended to refer to a nicotine measurement method that is fit for purpose. In absence of such a possibility, a more complete validation of method C57.1 should be performed, including an estimation of the reproducibility using multiple labs. A wide tolerance factor based on the validation results, probably in excess of 50%, should be used for regulatory enforcement and clearly communicated to the industry to ensure that the industry assessment of compliance is using an approach identical to the one used by regulators.

5. The coming into force provision should apply at point of manufacture or import only. While the proposed regulations provide a 180-day coming into force provision, there is no allowance for a sell-through period to clear retail inventory. VITA assumes this is because the enforcement will be monitored and applied at point of manufacture or import and not at point of sale. It would not be technically feasible for a manufacturer to implement the required packaging changes across all vaping products and have these products sold through the entire supply chain within a short 180-day time frame. Vape retailers should be allowed to sell through their existing inventory as they convert to vaping products packaged in compliance with the new requirements.

Child Resistant Vaping Products

VITA advocates for the regulation of vaping products that are based on credible science, evidence and logic. In order to achieve the Federal Government’s goal of reducing smoking prevalence to 5% by 2035, the introduction of comprehensive and balanced regulations for the vaping product industry is essential.

VITA recognizes the potential, yet significantly low risk of intoxication resulting from accidental oral nicotine ingestion by young children. To this end, we support current limits on liquid nicotine concentrations of 66 mg/mL or less, and the requirements for child-resistant closing systems for bottles of e-liquid.

We do not support the view presented in the RIAS that the industry was not aware that the European Union published a directive in 2014 requiring its Member States to set out regulations for vaping products, including a requirement that refillable vaping devices be child resistant.

The European Union and member countries have focused on child resistance (TPD2) as it relates to bottles of e-liquid, and the packaging of pods (like blister packs). When comparing proposed regulations from Health Canada to those in the European Union’s TPD2 regulations, neither TPD2 or National Regulations specify a child-resistant standard like ISO-8317:2015 or equivalent applicable to open vaping systems as proposed in section 54(1)(b). Therefore, open tank devices with a closing system certified to ISO-8317:2015 are not commercialized in those countries nor any other.

Members of VITA have trusted commercial relationships with Chinese and International device manufacturers and conducted a survey of over 20 manufactures to investigate compliance with this standard. Claims are made by some manufacturers about a child-resistant device but in our survey, we did not find a single tank on the global market that is certified to the proposed standard. The investigation we performed with Chinese manufacturers has confirmed that no ISO 8317 certified devices exist.

Art 20, 3 (g) of EU TPD2 states that ‘electronic cigarettes and refill containers are child and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.’

Health Canada’s statement is misleading in that it suggests that the TPD requirements lead to the availability of child-resistant refillable vaping devices, certified under ISO-8317:2015. Any application of this standard would result in a substantial increase in cost, estimated by one of the manufacturers we surveyed to cost $750,000 for product redesign. A substantial amount of time and money would be required to develop a range of open tank systems with an ISO 8317 certified closure system that would be acceptable to consumers.

We also question whether open tank systems are a contributor to significant accidental ingestion of nicotine liquid resulting in an acute response. With respect to determining nicotine poisoning via ingestion, the statistics provided no detail, which begs the question whether these poisonings were as a result of drinking e-liquid from a bottle or from a tank.

E-liquid bottles dispense their contents by compressing the container itself and considering the relative size of an e-liquid bottle versus an e-liquid tank (which cannot be compressed), and the negative pressure needed to extract e-liquid from a tank, it is unlikely that they could represent a significant risk. It is important to understand the source of nicotine poisoning through e-liquid ingestion before imposing technically challenging and costly solutions.

Unintended Consequences of Child Resistant Tank Systems

As previously stated, no refillable tank on the Canadian or global market is ISO 8317 compliant. Should this standard be applied, the only vaping products that would be compliant are closed systems which are prefilled and cannot be opened or refilled without special tools and equipment.

Closed system vaping products are very popular at C-store retailers, with JUUL and Vype representing the majority market share in the sector. Closed system devices do represent a substantial market share, but the majority of Canadian vapers continue to use open/refillable vaping products.

Implementing regulations based on assumptions of TPD2 compliance in relation to child-resistant tanks/devices would be catastrophic to the Canadian vaping product industry for the reasons listed below.

• Specialty vape shops will lose 90-95% of the devices they currently sell.
• Canadian based e-liquid manufacturing could shrink by approx. 70-80%.
• 85-95% of vape shops would close due to an extremely limited product selection.
• The vast majority of new and innovative products would no longer be available.
• The loss of so many products would result in less consumer choice and a massive reduction to conversion rates.
• The vaping industry would be monopolized by closed system companies.
• An illicit home mixing market may take root
• Hundreds of small business owners would lose their livelihoods
• Thousands of Canadians would lose their jobs

The regulations would unfairly advantage closed pod systems as they are the only products that meet section 53(2) requirements. Since open tank systems comprise the majority of products sold at specialty vape shops, the implementation of these requirements would undercut the product offering that vape store consumers have come to rely on-causing them to instead seek the products online from non-Canadian manufacturers or through illicit channels.

The only surviving businesses would be that of C-stores or tobacco shops who must hide the product and are more restricted in the information they can provide potential consumers (adult smokers). By undercutting the vape store channel, this proposed regulation undermines the potential of vaping products to reduce smoking prevalence. Without support and proper education, it could ultimately force vapers back to smoking simply because they do not have proper access to the products and service on which they rely to stay smoke-free.

It is also important to acknowledge that the application of a common standard on products with significant variety could diminish functionality of these products. Child-resistant closure system on bottles is similar to what is found on many drug bottles with the press and turn opening mechanism. However, if we apply this to a tank where there is no common container it becomes questionable. Tanks come in different shapes, sizes and all function differently, be it a pressure and slide opening, a screw-top opening, or a pressure fit cap. These openings vary due to coil placement and tank type. Requiring the same standard to be applied would render several of these products obsolete.

If the child-resistant tank regulations are passed, VITA hereby requests an interim implementation exemption of at least 2 years (731 days). This exemption will provide the industry with the time required to conduct an industry impact analysis, as well as inform manufacturers, distributors and retailers of the new requirements so that they may conduct the necessary research and development activities, adjust their products to the standards and comply.

To attract smokers to vaping, and to maintain their interest in the category and to prevent relapse, it is critical that specialty shop owners, distributors, importers and manufacturers provide a variety of high-quality products to their consumers. It is of utmost importance that vaping product users have access to systems that work, that they can physically use, and have are familiar with.

If a regulation like the proposed is implemented, vape shop owners and their consumers will need the time to become familiar with new products vapers have, for the most part, tried many methods to be rid of tobacco addiction and vapour products have been their success. To eliminate a product based on presumption is to diminish their hard work and ability to choose. We owe it to the 46,000 Canadians and their families who die annually – a statistic that hasn’t changed in decades – from tobacco death and disease to a product that works. To remove this would be a disservice to the many lives lost.

These proposed regulations on child-resistant tanks will not achieve the national health goals that Health Canada intends to reach. Instead it will stifle consumer choice, all the while closing stores, and ending employment for thousands of Canadian workers be it retail locations, distribution, or manufacturing.

Requirements for Labeling of Device, Device Part and Packaging Classified as Small

VITA supports many of the proposed regulations for product labeling and packaging. However, in some instances, the proposed regulations will require the manufacturer to label twice the product with the same information. These labels will be duplicative and increase consumer waste. It can also be technically challenging to implement such a requirement. For example, inserting a pod in a blister pack is problematic when a tag is attached to the pod.

Ingredient List and Single-Use Statement

In the proposed VPLPR, subsection 51(3) would require displaying a list of ingredients on a tag attached to the immediate container if the immediate container or exterior package has an area of less than 45 cm2. We observed that in subsection 59(3) and (4), the single-use statement would be displayed only on the exterior package and not on the container unless the exterior package is smaller than 45 cm2.

In all cases, we recommend amending the regulations to only request the application of a tag on the immediate container when it is not packaged or when the required information cannot be displayed as required on the external package, independently of the surface area of the main panel of the external packaging.

Requirements for the Ingredient List

The proposed VPLPR is requesting to display a list of ingredients on the immediate container of the vaping substance and on the display surface of any exterior package.
We observed that the definition of flavour in section 50(2) is problematic as stating that any ingredient adding a flavour to a vaping substance should be listed under the generic term of “flavour” instead of its common name.

As all ingredients added are likely to have a flavour that could potentially contribute to the overall flavour, even if not considered flavouring agents, the label of 50(2) could result in having only water and flavour appearing in the list of ingredients. Commonly found vaping liquids like propylene glycol, glycerol and nicotine have a flavour that can contribute to the overall flavour of the vaping substance.

Furthermore, other ingredients, like the pH modifiers used to prepare the nicotine salt formulation are weak acids often used in food preparation. They can potentially also end up under the flavour category as some of them are sometimes used as flavouring agents in food. Due to the prevalence of salt nicotine products in the Canadian market and because the weak acids are used as pH modifiers, they should be disclosed under their common name whether they have a potential of impacting the flavour or not.

We therefore recommend amending section 50(2) to prevent an inappropriate classification of ingredients under the descriptor flavour and favour the disclosure of information relevant to the consumers while protecting proprietary flavour formulations. For that purpose, we suggest adding the following words to subsection 50(2):

If the intended use of any ingredients is to only add a flavour or a combination of flavours to a vaping substance, those ingredients must be denoted in the list of ingredients by the indication “flavour” instead of their common name.

Requirements for the Nicotine Concentration Statement and the Suitability of the Nicotine Measurement Method C57.1

The proposed VPLPR and the associated RIAS indicate that the statement of nicotine concentration and health warning are required on the main display panel of the product or package. For products containing no nicotine, it would be possible to use specific statements indicating that fact on the packaging. Child-resistant containers and specific toxicity information would also be mandatory when a product contains at least 0.1 mg/mL of nicotine.

It is important to observe that the demonstration of compliance to the requirements listed above relies heavily on the capacity to accurately measure nicotine in the vaping substance and to establish if a product contains nicotine or not. A close examination of the requirements has raised three areas of concern that should be addressed in the final regulations:

1. The technical definition of what is a product not containing nicotine is not explicit;
2. No tolerance limit is indicated for the accuracy of the statement of the nicotine concentration
3. The current Health Canada method C57.1 is not fit for the purpose of regulatory enforcement or assessment of compliance.

The following sections detail the various issues and suggest how these points could be readdressed in the final regulations.

Definition of Vaping Products not Containing Nicotine

While vaping products containing less than 0.1 mg/mL are exempt from health warning and child-resistant containers, it is not obvious that these containers are without nicotine for the purpose of regulation. For example, method C57.1 that could be used by inspectors for enforcement purpose can detect traces of nicotine even if it is with poor accuracy. In quantities as low as 0.03 mg/mL, would that measurement disqualify a product as being considered for regulatory purpose as without nicotine?

We propose that all vaping substances containing less than 0.1 mg/mL are considered de facto as products without nicotine. As per the proposed regulations, they would be exempted from displaying the Nicotine Concentration Statement and could carry one of the expressions indicating that the product is without nicotine. This move would be further supported by the fact that such a nicotine level is very low and insignificant in practice.

To put things into perspective, such a low-nicotine level can be found naturally in food used by consumers such as; eggplant which has been reported to contain 0.1 mg/g of nicotine.1 Such a low level of nicotine in a vaping product is likely to simply result from a residual contamination whether from the manufacturing process or the measurement methodology.

Accuracy of the Nicotine Concentration Statement

The requirement for displaying the nicotine concentration is not associated to an accuracy tolerance level. In many consumer products, such a tolerance accounts for the unavoidable production variability and ingredient concentration instability during the expected life of the product. This provides guidance to the manufacturers and importers about what is considered acceptable. For example, the Federal Government has established tolerances for nutrient content on nutrition labels2 or for the declaration of the net quantity of various consumer goods.3

Nicotine concentration in nicotine products is not an exception and is known to show variability as it is driven by nicotine measurement uncertainties, process variability and the variable product stability during its shelf life. This has been acknowledged by the industry and the regulators. For example, the British Standard Institute published a voluntary standard (PAS 54115:2015) for vaping products indicating in section 4.9.4. that the quantitative analyses for finished products should demonstrate that nicotine concentrations are accurate to within +/- 10% of label claim for nicotine concentration for liquid products (sold in bottles), and within +/- 20% of label claim for pre-filled products (pods, cartridges) for the duration of their respective shelf lives.4 In their Finished Product Specifications Form User Guide, Health Canada allows for a tolerance of +/-20% for label claim of most ingredients in natural health products which includes nicotine in a licensed nicotine product.5

Based on the tolerance set for Natural Health Products ingredients and the Canadian vaping industry experience, we recommend having an accuracy tolerance of +/- 20% around the stated nicotine concentration. This tolerance would be limited by section 52 of the proposed regulation which prohibits nicotine concentration of 66 mg/mL or more in vaping products. This recommendation is applicable to all liquids and pre-filled products.

In addition, it would be advisable to propose a method to measure the nicotine level displayed in the nicotine concentration statement of a vaping liquid should it be measured. As for the 0.1 mg/mL threshold, the use of a common standard method by manufacturers and regulators facilitates compliance and enforcement. The use of ISO 20714:2019, an international standard method, could be a good choice to measure nicotine in the range of 1 to 66 mg/mL, as likely to be used worldwide and therefore suitable for manufacturers importing or exporting vaping liquids. The Health Canada method C57, Determination of Nicotine, Propylene Glycol and Glycerol in Liquids used in Electronic Nicotine Devices by GC-MSD/FID, is not recommended as not sufficiently validated.

For that purpose, Section 11 should be amended by indicating that the measured nicotine concentration should be within 20% of the nicotine concentration statement while not reaching the value specified in section 52 (66 mg/mL) and specify with which international standard method the nicotine concentration should be measured.

Limitation of Method C57.1

A review of the proposed Method C57.1 provided by Health Canada by expert analytical chemists consulted by VITA has led to the following observations:

• The method is essentially based on ISO/FDIS 20714 with respect to the nicotine determination; sample to solvent ratio and solvents used.
• It differs from ISO/FDIS 20714 for the narrower and lower nicotine calibration range (0.084 – 0.673 mg/g for C57.1, vs 0.5 to 150 mg/g for ISO).
• Method C57.1 uses a much larger sample size (3 g) to solvent volume (10 mL) ratio.
• There is no chromatography shown in the document which makes difficult to assess the potential complications that could result from a high sample (propylene glycol, glycerol)
• to solvent ratio like carry-over and peak tailing.
• The repeatability of the FID method has been established with a sample having a concentration higher than the LOQ which would mean that the repeatability of the method
• would be higher when measuring liquids containing less than 0.1 mg/mL.
• The method repeatability is poor (19% for GC-FID and 15% GC-MSD).
• The reproducibility of the method is not provided but based on the inter-laboratory variability of more than 10 laboratories reported in ISO/FDIS 20714, we could expect the value to be more than 3 times the repeatability value. This means that it is reasonable to assume a measurement uncertainty in the order of 50% and probably more at a lower nicotine concentration.
•  The method variability will be slightly higher if we account for the correction for density that should be measured according to method C52. A method mentioned in C57.1 but not mentioned in the regulations and with reported repeatability of about 1% (no reproducibility available).

Based on the above limitations, a liquid sample having a nicotine concentration not quantifiable by the more sensitive GC-FID method, which means inferior to 0.07 mg/mL, could still be confirmed as being under the regulatory threshold value with a good level of confidence.

However, for samples containing measurable nicotine concentration in the range of 0.07 to 0.099 mg/mL, it could be wrongly concluded that they reach or exceed the threshold value of 0.1 mg/mL (false positive) unless a wide tolerance is applied. For example, it would be necessary to have a nicotine concentration exceeding 0.15 mg/mL to conclude with a 95% confidence level that a non-nicotine product is at or above the threshold of 0.1 mg/mL when measured by different laboratories. This could be considered an excessive regulatory tolerance by the regulator.

In our view a method with lower limits of quantification and tighter repeatability limits is needed for regulatory monitoring purpose of vaping liquids. This would limit the number of false positive results in a way that is compatible with the industry requirements and the regulatory enforcement needs.

We, therefore, suggest amending section 11(2) by referring to a nicotine measurement method that is demonstrated fit for purpose after a full validation of the measurement method. In absence of such a possibility, a more complete validation of method C57.1 should be performed, including estimation of the reproducibility using multiple labs. A wide tolerance factor based on the validation results, probably in excess of 50%, should be used for regulatory enforcement and clearly communicated to the industry to ensure that the industry assessment of compliance is using an approach identical to the one used by the regulators.

To conclude, as highlighted above and described throughout this submission, we have made five key recommendations for Health Canada’s consideration:

1. Currently no refillable tank on the Canadian or global market is ISO 8317 compliant. Caution should be exercised in applying this standard as it would significantly distort the market and seriously undermine the specialty vape shop channel, offering less choice to the vaper. If such a standard is to be applied, a period of two years should be introduced to allow for market adjustments to maintain consumer satisfaction and to provide enough time for the research and development activities required to permit industry compliance.
2. Section 50(2) should be amended to prevent inappropriate classification of ingredients under the descriptor flavour and favour the disclosure of information relevant to the consumers while protecting proprietary flavour formulations. The Association has recommended amendments to the wording of the document which can be found in the body of the document.
3. All vaping substance containing less than 0.1 mg/mL of nicotine should be classified in practice as not containing nicotine.
4.  Section 11(2) should be amended to refer to a nicotine measurement method that is fit for purpose. In absence of such a possibility, a more complete validation of method C57.1 should be performed, including estimation of the reproducibility using multiple labs. A wide tolerance factor based on the validation results, probably in excess of 50%, should be used for regulatory enforcement and clearly communicated to the industry to ensure that the industry assessment of compliance is using an approach identical to the one used by the regulators.
5. The coming into force provision should apply at point of manufacture or import only. While the proposed regulations provide a 180-day coming into force provision, there is no allowance for a sell-through period to clear retail inventory. VITA assumes this is because the enforcement will be monitored and applied at point of manufacture or import and not at point of sale. It would not be technically feasible for a manufacturer to implement the required packaging changes across all vaping products and have these products sold through the entire supply chain within a short 180-day time frame. Vape retailers should be allowed to sell through their existing inventory as they convert to vaping products packaged in compliance with the new requirements.

Thank you in advance for your consideration of VITA’s response to Health Canada’s Draft Vaping Products Labelling and Packaging Regulations, Published in Canada Gazette, Part I, on June 22, 2019.

We would be pleased to provide additional details on details included herein, or meet at your convenience.

Sincerely,
Daniel David
Executive Director
Vaping Industry Trade Association/ Association des Représentants de l’Industrie du Vapotage