Health Canada Consultation Summary

Health Canada Consultation Summary

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 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
Proposal No. 2: Labels - Any product with Nicotine
Proposal No. 3: Labels - Pregnancy Warning
Proposal No. 4: Labels - Ingredients

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
Proposal No. 6: Manufacturer Reporting - Supplementary Information
Proposal No. 7: Manufacturer Reporting - Time Limits for Response
Proposal No. 8: Manufacturer Reporting - Records Retention

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

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

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?

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…

3 Responses to Health Canada Consultation Summary

    • 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.