Compliance and enforcement for natural health products – Phase 2

17 December 2013

December 1, 2013 marked the start of Phase 2 in Health Canada’s increased compliance and enforcement activities for Natural Health Products (NHPs). Health Canada’s 3-phase plan to achieve full NHP compliance and enforcement was discussed in Joel Taller's previous article, The post-UPLAR transition: Compliance and enforcement for natural health products.

As of December 1, 2013, manufacturers, importers, packagers, and labellers (“supply chain members”) must have a market authorization (i.e. a natural product number (NPN))  for their products and the products must comply with the terms of that market authorization, including formulation and labelling. Supply chain members cannot sell non-compliant NHPs to distributors or retailers. Distributors and retailers can continue to sell existing inventory of NHPs that have an active submission number or have been approved with minor modifications still to be incorporated on the label, as long as these products do not pose a risk to health and safety.

As Phase 2 is really the beginning of Health Canada compliance and enforcement activity it is difficult at this time to predict just how much activity to expect or where their efforts will be focussed. However, it is likely that there will be increased activity at the border as it is a continuous opportunity for inspection. Canada Border Services Agency will verify that imported NHPs have an active market authorization and will generally refuse entry into Canada for non-compliant products. Where NHPs are imported for re-labelling or modification, notification to Health Canada will be required and the product must be relabelled within 3 months of importation. Health Canada has not published any information with respect to how notification and relabeling verification is to take place.

This Phase of NHP compliance and enforcement will be in effect until August 2014. Starting September 1, 2014, Health Canada will expect full compliance by the supply chain members, as well as distributors and retailers, with respect  to the import, manufacture and sale of NHPs.

Prepared with assistance from Katrina Coughlin.


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