Health Canada guidance on Nicotine Replacement Therapies, a call for evidence-based reforms

Imperial Tobacco Canada (ITCAN) is calling on Health Canada to adopt science-backed measures for Nicotine Replacement Therapy (NRT), saying restrictive rules could harm public health by limiting access to effective products.

Last week, ITCAN submitted its response to Health Canada’s Draft Guidance on Additions to the List of Nicotine Replacement Therapy Dosage Forms. 

The guidance outlines steps for approving new NRT products that can be sold in all retail outlets where cigarettes are sold, but ITCAN says the criteria are flawed. 

According to the company, the guidance demands that new NRTs prove they will not be misused by non-smokers, a nearly impossible standard that could stifle innovation and drive consumers toward illicit markets.

Eric Gagnon, ITCAN’s vice-president of corporate and regulatory affairs, said the guidance lacks real measures to protect youth. 

“Both the ministerial order and the draft guidance fail to provide genuine youth protection,” said Gagnon. 

“A better approach would be to prohibit sales to minors across all channels, rather than creating an arbitrary division of NRT dosage forms.”

In October 2023, ITCAN released ZONNIC, the first Health Canada-approved nicotine pouch aimed at helping smokers quit. 

But a Ministerial Order from then-health minister Mark Holland on August 28 undermined its potential by imposing restrictions without clear evidence, according to ITCAN. 

The company says that while the order was intended to shield young people, it lacks specific rules to achieve this goal and instead jeopardizes Canada’s broader public health strategy to cut smoking rates.

ITCAN argues these rules need to be balanced.

They need to be tough enough to keep youth safe, yet flexible enough to support adult smokers who want to quit. 

The company points out that all smoking cessation products should be judged with the same evidence-based lens. 

“Nicotine pouches do not pose a greater risk than any other NRT when used as intended,” said Gagnon. 

“This is not how good public health policy is made.”

ITCAN argues that by limiting legitimate products, the order has fueled the sale of illegal nicotine pouches and made it harder for smokers to access the tools they need. 

ITCAN’s submission calls for the current ministerial order to be replaced by rules that ban underage sales across all product forms, without discriminating between different NRTs.

A significant drop in cigarette sales tied to ZONNIC’s availability supports the efficacy of nicotine pouches, according to ITCAN. 

The company says ignoring such results may deny smokers the chance to use proven smoking cessation aids while trying to quit harmful cigarettes. 

It wants the government to broaden the criteria for NRT approval so that any product meeting the same flavour restrictions is accessible in all retail locations.

ITCAN is urging Health Canada to adopt reforms built on scientific proof, fairness, and a shared goal of reducing smoking rates. 

If policy-makers listen to evidence, ITCAN believes, more Canadians will have the best possible chance to leave cigarettes behind.