NRT Labelling Transition Extended to Nov 2025

Summary#

The Order Amending the Supplementary Rules Respecting Nicotine Replacement Therapies Order (SOR/2025-9), made by Health Canada, gives companies more time to sell existing stocks of nicotine replacement therapies (NRTs) that do not yet meet new labelling rules. The change lets those products be sold until they expire if they were labelled under the older rules on or before November 28, 2025. The order took effect on publication in the Canada Gazette on February 12, 2025.

What it does#

• Extends the date that allows some NRTs with older labels to keep being sold from August 28, 2024 to November 28, 2025.
• Allows NRTs that were labelled according to the older Natural Health Products rules on or before November 28, 2025 to be sold until their expiry even if they don’t meet certain new label and packaging requirements (those are the rules in sections that cover label text and flavour/advertising limits).
• Removes the previous requirement that an imported product had to have been both imported and labelled before the earlier date; now the key test is whether the product was labelled by November 28, 2025.
• Repeals one earlier clause in the Order (subsection 29(2)) that overlapped with the extended permitted-sale rule.
• Keeps in place the parts of the rules meant to stop product labels and ads that are appealing to young people. The transition that banned labels or ads that could appeal to youth began with the original Order and remains enforced from February 28, 2025 for those youth-appeal elements.

Who's affected#

• NRT manufacturers and importers who make or bring nicotine lozenges, gums, or other oral NRTs into Canada.
• Pharmacies, retailers, and distributors that sell NRTs and run smoking cessation programs.
• Adults using NRTs to quit smoking — they are the main group likely to notice continued availability of familiar brands, flavours or dosages.
• Small businesses that produce or ship NRTs; some have already re-labelled and may be affected competitively if others keep older labels longer.
• Health Canada will continue to oversee compliance and enforcement.
• It is not clear that any other groups (for example Indigenous governments) are affected; the agency reported no modern treaty implications.

Why it matters#

• The change aims to avoid short-term shortages of NRTs. Health Canada collected industry information suggesting limited supplies could appear as early as March 2025 without an extension.
• For people trying to quit smoking, keeping their preferred brand, flavour or dosage available can make cessation attempts more successful.
• The extension reduces waste and cost for companies that would otherwise have to destroy or relabel large inventories quickly. The Department estimated the amendment would cost less than $1 million per year on average over 10 years.
• The trade-off: some labelling upgrades that add clearer warnings or an age statement will be delayed for a time. Health Canada kept stricter bans in place against labels and ads that appeal to young people, to balance supply concerns with youth protection.