Health Canada and JUUL Labs Canada, Ltd. meeting: Vaping products – November 9, 2018

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Subject:

Vaping Products

Date:

November 9, 2018

Participants:

Health Canada (HC)

JUUL Labs Canada, Ltd. (JUUL)

Introduction:

A meeting was held at the request of JUUL Labs, Inc. (JUUL) to discuss JUUL’s action in response to the Food and Drug Administration’s (FDA) request in the United States, Health Canada’s Document Request, and JUUL’s product launch in Canada.

The Chair opened the meeting by doing round table introductions.

The Chair reminded participants that this meeting is subject to disclosure as per HC’s Openness and Transparency policies. In the interest of transparency, the department stated that it would be making a record of the meeting publicly available. The handling of information and privacy notice was mentioned and acknowledged.

Subjects:

1. Letter to HC:
JUUL presented a letter addressed to the DG, TCD, regarding its planned introduction of JUULpods containing 3% nicotine on the market, as of November 19, 2018.

2. Letter from FDA:
JUUL indicated that a response was provided to the US FDA’s letter and that a public release of its action plan is imminent. JUUL recognized that the US FDA was focused on the presence of flavoured vaping products in the market, and informed HC that its action would include pulling flavoured products from retail sectors showing poor sales to youth prevention records, making them only available through JUUL (online web store). JUUL also informed HC that authorized distributors are not permitted to resell in bulk (where bulk sale is greater than 4 units), and that JUUL uses track and trace methods in the US supply chain to ensure full traceability to end consumer.

JUUL representatives indicated that they were committed to taking measures to keep vaping products out of the hands of youth in Canada.  JUUL’s point-of-sale displays will include a “18+” or “19+” sticker. HC asked whether JUUL would consider including a statement such as “not intended for non-smokers” on their point-of-sale display.

3. Secret shopper program:
JUUL asked if HC had interest in a secret shopper program to monitor sales to youth. HC responded that an upcoming retailer behaviour survey would include secret shoppers. HC invited JUUL to put in place a corporate secret shopper program and offered to provide contact information for a contractor who conducts retailer behaviour surveys.

4. Vaping products as cessation tool:
JUUL stated that it has approached a leading provider of human resources consulting and outsourcing services and insurance companies about offering vaping products as part of cessation programming. According to JUUL, these companies have expressed interest in this initiative, but would like to see more evidence in the form of clinical data and support from regulators, demonstrating that these products could be recommended as a harm reduction tool.

5. Nicotine-free products:
HC asked whether JUUL intends to release a nicotine-free vaping product as a means to taper down nicotine consumption. JUUL responded that there is a worry that nicotine-free vaping products could be a gateway to using nicotine.

6. Next generation vaping products:
JUUL indicated that work is underway to develop Bluetooth-connected vaping devices that could be used to track nicotine consumption goals/prompt use and also collect data about users’ consumption patters. JUUL recognized that there are privacy concerns to consider with respect to collecting data from users. JUUL also expressed that the possibility of releasing JUUL pods containing 1.7% nicotine on the market.

7. Letter from HC:
JUUL acknowledged receipt of the letter sent by HC requesting that JUUL disclose information shared with the FDA in response to the FDA letters dated April 24, 2018 and September 12, 2018 respectively. JUUL indicated that it intended to cooperate with HC.

8. Sales channels:
HC asked JUUL whether they had been made aware of competitors in the vaping market attempting to sign exclusivity agreements with retailers. JUUL representatives confirmed that they have no exclusivity agreements of their own.

9. Flavours:
JUUL indicated that in the US, it is removing all flavours from brick-and-mortar retail locations, except tobacco and mint flavours. All flavour options will be maintained on the JUUL website, where there are controls in place. JUUL stated that there are better protections in place for flavours in Canada and that it believes that retailers in Canada are better at respecting the sales to youth prohibition.

10. Sales volume in Canada:
HC indicated that it would be interested in sales data being shared voluntarily until such time that it becomes required by regulations.

11. Complaints and concerns:
HC asked JUUL whether it has received complaints or concerns from Canadians since its product launch. JUUL representatives responded that they have no data on significant complaints, and do have a one-year warranty that is fulfilled if the product is registered. HC asked whether the warranty covered returns; JUUL could not confirm the current return policy during the meeting.

Conclusion:

The meeting was then concluded.

Documents:

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