In anticipation of Bill S-5 receiving Royal Assent and to get a head-start on the regulatory process, Health Canada has opened consultation period for their approach on some of the points of regulation.
Regulations for Bill S-5, the Tobacco and Vaping Products Act (TVPA), will likely come into effect in “sections” and it is safe to assume that the items covered in this consultation period will be the first set to come into effect, if and when Bill S-5 receives Royal Assent.
Overview of the Federal Regulatory Process
The process of creating regulations for the TVPA will generally follow these steps for each set of new regulations:
- Public consultation – WE ARE HERE
- Pre-publication of the proposed regulations and comment period of 30 or 75 days
- Adjustment of the proposed regulations where appropriate
- Final approval by the Governor in Council.
- Final publication
- Coming into force
The TVPA will provide two paths to market for vaping products:
- Food and Drugs Act (FDA) – market authorization for prescription vaping products or those that make therapeutic claims
- Canada Consumer Product Safety Act (CCPSA) – general vaping products with no claims
For our purposes, we will fall under the CCPSA path.
Health Canada as provided 10 proposed measures for vaping product regulations under the proposed TVPA, divided into four categories:
Based on review of the documents provided by Health Canada, below is a pointed summary of how we interpret the proposed regulatory approach.
Regulatory proposals on labelling
- Nicotine concentration must be displayed in mg/mL
- Consumer Chemicals and Containers Regulations (CCCR), 2001 will be applied to all vaping products that contain greater than 0.1 mg/mL of nicotine. (Although nicotine strengths between 0.1 mg/mL and 10 mg/mL are not “Toxic”, HC has determined that liquids containing these concentrations that do not adhere to CCCR 2001 “pose a danger to human health”. CCPSA prohibits manufacture, import, advertise or sell consumer products that is a danger to human health or safety.)
- Nicotine strengths greater than 66 mg/mL are prohibited under CCCR 2001. Section 38 states “The manufacturing, importation, advertising or sale of a chemical product that is classified in the sub-category “very toxic” under section 33 is prohibited.“
- Vaping liquid with nicotine requires child-resistant caps
- This phrase must appear on vaping liquids that contain nicotine: “WARNING: This product contains nicotine. Nicotine is an addictive substance. Use of nicotine during pregnancy may harm the fetus.“
- Ingredients must be displayed in descending order by weight. Previously, we had assumed Food and Drug Regulations but they have suggested Cosmetics standards.
- All information must be printed in both English and French.
Proposal No. 1: Labels - Display of Nicotine Concentration
Health Canada proposes that all vaping products which contain nicotine display their nicotine concentration in milligrams/millilitre (mg/ml).
Proposal No. 2: Labels - Any product with Nicotine
To prevent consumers from being misled about the presence or absence of nicotine, Health Canada proposes that any vaping product be considered to contain nicotine if nicotine is present at a concentration of 0.1 mg/ml or higher.
Proposal No. 3: Labels - Pregnancy Warning
Health Canada proposes to require that vaping products that contain nicotine display a warning such as: “WARNING: This product contains nicotine. Nicotine is an addictive substance. Use of nicotine during pregnancy may harm the fetus.”
Proposal No. 4: Labels - Ingredients
Health Canada proposes to require that products that contain a vaping liquid display a complete list of ingredients in descending order by weight.
Regulatory proposals on information reporting
- Retailers that are NOT manufacturers will not need to provide reports
- Reporting will be used for market analysis and comparisons for impact on tobacco use
- Manufacturers will be required to report the following at specified intervals:
| INFORMATION |
FREQUENCY |
| The name of the business and contact person |
Annually |
| Details about each vaping device or liquid, including the product name, model number and nicotine concentration |
Upon introduction of each product, and annually thereafter |
| Details about the design of each vaping device, including engineering drawings and information about the materials and components used |
Upon introduction of each product, and annually thereafter |
| Contents of vaping liquids, including quantities of each ingredient |
Upon introduction of each product, and annually thereafter |
| Information on research and development activities |
Annually |
| Information on promotional activities |
Annually |
| Sales data for each product |
Quarterly |
- Supplemental / additional information (outside of what has been outlined) may be requested
- Manufacturers will be required to resolve any reporting issues within 30 days of notice of deficiencies
- Data used for reporting must be maintained for 6 years and is subject to review or audit by inspectors (format to be dictated by regulations)
Proposal No. 5: Manufacturer Reporting - Frequencies
Health Canada proposes that manufacturers be required to report the information at specific frequencies.
Proposal No. 6: Manufacturer Reporting - Supplementary Information
Health Canada proposes that manufacturers of vaping products be required to provide supplementary information in a form, manner and within the time frame specified, once notified by the Minister. The form, manner and time frame allowed for manufacturers to provide the supplementary information would be specified in the request and could vary according to the nature of the information requested.
Proposal No. 7: Manufacturer Reporting - Time Limits for Response
Health Canada proposes that manufacturers of vaping products be given a period of no more than 30 calendar days to address any deficiency in the reporting of information prescribed by the regulations, once they are notified of the deficiency by Health Canada. Should the manufacturer fail to address the deficiency, or should the information provided continue to be deficient, the sale of the product in question would be suspended until the missing information is submitted to Health Canada, and the manufacturer would be informed accordingly.
Proposal No. 8: Manufacturer Reporting - Records Retention
Health Canada proposes that manufacturers of vaping products be required to maintain all records and documents used to prepare their information reports for a period of six (6) years after the end of the year to which the document relates. This documentation would have to be kept in a form and manner prescribed by the regulations, so that it could be readily accessed and viewed in Canada during audits.
Regulatory proposal on relative risk statements
- No unauthorized statements of relative risk compared to tobacco use
- HC will provide a “list” of approved relative risk statements and references that can be made and will regulate how they can be used
- Changes to the list will be done through public consultation
Proposal No. 9: Authorized Statements
Health Canada proposes to establish regulations that would specify the conditions upon which manufacturers, retailers and others could use authorized relative risk statements in vaping product promotions. The regulations would incorporate by reference a selection of authorized statements regarding the relative health risks of using vaping products or comparing the potential health effects arising from the use of a vaping product relative to that of a tobacco product. As the authorized statements may need to be amended from time to time to keep up with scientific knowledge, these regulations would also set out the requirement for public consultations on such amendments.
Regulatory proposal on advertising restrictions
- Regulation is intended to protect youth
- Lifestyle advertising will not be permitted (some exceptions for targeted, adult only venues, such as bars)
- Testimonials, endorsements and sponsorship will not be permitted
- Types of media, locations and content of advertising will be restricted (i.e. time of day, near a school)
- Restricted to platforms where the audience if predominantly adult smokers
Proposal No. 10: Advertising
Health Canada proposes to establish regulations to help limit youth exposure to information and brand-preference advertising of vaping products. These regulations would include restrictions on the type, medium and content of advertising of vaping products. In line with the objectives of the proposed TVPA, the restrictions would be based on limiting advertising that has a high likelihood of being viewed by youth, while still allowing vaping product manufacturers to advertise their products and brands to adult smokers. Restrictions would therefore seek to limit advertising in or near locations that are attended predominantly by youth, such as schools, parks, recreational and sporting facilities. Restrictions would also be placed on advertising in certain media, for example by either prohibiting advertisements on television and radio or restricting the times of the day when such ads may appear or be heard to limit youth exposure to them.
Send your feedback…
Consultation responses can be sent by:
Email (in PDF or MS Word format) – hc.pregs.sc@canada.ca
Mail
Manager, Regulations Division
Tobacco Products Regulatory Office
Tobacco Control Directorate
Health Canada
AL 0301A Tunney’s Pasture Drwy
Ottawa, ON K1A 0K9
Bill S-5 is currently in the House of Commons and has completed First Reading. Second Reading is anticipated to follow shortly after the members return on September 18, 2017.
How does this Bill move through the Government?
Since this is a bill that has been initiated by the Senate, the bill first move through these stages within the Senate (See Passing Bills in the Senate):
- First reading – Completed Nov 22, 2016
- Second reading – Completed Mar 9, 2017
- Committee stage – Completed May 2, 2017
- Report stage – Completed May 9, 2017
- Third reading – Completed June 1, 2017
*Debates on the Senate floor may or may not be held at different points through the process.
After Third Reading in the Senate, the Bill will be sent to the House of Commons for a similar process (See Process of Passing a Bill):
- First reading – Completed June 15, 2017
- Second reading – WE ARE HERE
- Committee stage
- Report stage
- Third reading
- Royal Assent
*Debates on the House floor may or may not be held at different points through the process.
The deadline to submit your response is October 27, 2017 and we encourage everyone to review the Document for consultation and provide your input. The ECTA will be doing ours as will many others, including those that would see even tighter regulation. This IS your opportunity to be heard on these topics.
Silence is consent…
La cigarette électronique sauve des vie
Proposal 9 does not belong in a democratic country
It does seem a bit over reaching but we do understand what they are trying to accomplish though.
A simplistic (but stupid) example could be something like this… An article by Dr. Xyz is published that says: “Vaping products are not a cure for cancer.”
Some fool posts a billboard with, “Dr. Xyz says, ‘cure for cancer.’” But the industry in Canada has done a relatively good job at keeping the facts as facts.
The challenge is going to be when vaping product opposition posts some meta-analysis that says “vaping causes cancer”. That’s what people will hear without regard to the credibility of the meta-analysis that was performed.
Until Health Canada “approves” a response, the industry is stuck with former smokers that go back to smoking because “vaping causes cancer” and we can’t refute the argument, even if a credible source publishes an article with facts discounting the meta-analysis as having been performed in a mechanic’s workshop.