Wednesday 1 May 2024

Budget Bill gives Minister new powers to address nicotine pouches (and other therapeutic products)

In late March, Health Minister Mark Holland cautioned Imperial Tobacco to "stay the hell away from our kids" while marketing their Zonnic brand nicotine pouches.  Yesterday, Parliament was notified about the specific changes to the law the Minister is seeing which will provide the power to make this happen. 

This post provides an update on this important development in thee nine-month saga of Canada's experience with nicotine pouches. 

The proposed power

Among the measures contained in the 650-plus pages of the Notice of Ways and Means Motion to introduce an Act to implement certain provisions of the budget tabled in Parliament on April 16, 2024  were three paragraphs of legislative text that expand the power of the Minister to issue Interim Orders. In cases where the Minister perceived a risk to health - even if it was not proven - he or she would be authorized to lay down the rules by which therapeutic products could be sold or promoted: 

Supplementary rules — therapeutic product
30.01. Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health.

(2) For greater certainty, the Minister may, in the order, establish rules for the purpose of preventing the therapeutic product from being promoted for a use, other than the intended use, of a therapeutic product or preventing a use, other than the intended use, of a therapeutic product from being appealing.

(3) The Minister may make the order despite any uncertainty respecting the risk of injury to health that the use of the therapeutic product, other than the intended use, may present.

The potential scope 

It seems clear from the budget document that this section was introduced to address nicotine pouches, but the powers given to the Minister would extend to other therapeutic products regulated by the Food and Drugs Act. Nicotine pouches and other NRT are the only nicotine products regulated under this act. 

The potential speed

Unlike regulations, Interim Orders can be issued without pre-notification and without the administrative burden of developing regulatory impact assessments, cost-benefit analyses and other time-consuming background. The Interim Order mechanism is designed to provide an urgent response, and such orders are time-limited, as these new "Supplementary Rules" may be.  The Minister cannot make these orders without the support of cabinet colleagues through the Order in Council process.

There is no authority for Interim Orders in the Tobacco and Vaping Products Act. Regulations under that Act generally take more than two years to put in place. 

The Budget Bill is one of the government's highest priorities and  -- despite its enormous size and complex set of laws being adjusted - is usually passed more quickly than other government legislation. It is possible that with the Budget Bill passed by the beginning of summer, new rules for marketing pouches could be in place this summer. 

The Tobacco Industry

BAT-Imperial Tobacco has launched an aggressive campaign against the Health Minister. Its public-facing PR initiatives include newspaper advertisements and a website. History suggests they will only ramp-up these efforts with intensive behind-the-scenes lobbying.  Health Canada's failure to implement guidance for politicians and public servants on respecting FCTC Article 5.3 (on tobacco industry interference) makes this important legislative step more vulnerable than it should be.

Notably, similar industry advertorials were recently identified as illegal promotions in the United Kingdom.

The hanging threads

Although Zonnic is the only nicotine pouch currently authorized for sale in Canada, other companies are known to have submitted their products for approval. New rules on the nicotine pouch market are likely to be followed with expanded competition in this new market. 

The Hon. Mark Holland has authority over the Food and Drugs Act, but is not the Minister responsible for the Tobacco and Vaping Products Act.  Tobacco legislation is the responsibility of his colleague, the Hon. Ya'ara Saks, who is the Minister of Mental Health and Addictions. In the 9 months since she was appointed to this position, she has been largely silent on questions related to tobacco control. 

This silence may be broken later this month -- on May 23rd -- when she faces a deadline to present Parliament with her review of the Tobacco and Vaping Products Act.  (The law requires the Minister to file such a report every two years, but her predecessor, Dr. Carolyn Bennett, ignored the deadline on this statutory duty ). 

This review is an opportunity for the two Ministers to move forward in developing an integrated regulatory framework for nicotine, as we and others have recommended.