August 29, 2014
To: All Interested Parties
I am pleased to inform you that the document entitled "Natural Health Products Compliance and Enforcement Policy" (POL-0044) (NHP C&E Policy) has been revised and is now available.
This policy describes the compliance and enforcement approach respecting natural health products (NHPs) under the Food and Drugs Act (FDA) and the Natural Health Products Regulations (NHPR) and is to be used in conjunction with the Compliance and Enforcement Policy (POL-0001). This policy replaces the previous NHP C&E Policy last revised in August 2010.
On March 1, 2013 Health Canada initiated an 18 month transition period for NHPs.
The transition period consisted of two phases during which unlicensed products for which steps had been taken to bring them into compliance and licenced products with old formulation and labels were a low priority for compliance and enforcement actions unless a risk or additional non-compliance was identified by Health Canada.
The transition period ends on September 1, 2014. The compliance approach described in the Inspectorate's Natural Health Products Compliance and Enforcement Policy will apply starting September 1, 2014. Health Canada's expectation moving forward is that all NHPs have a product license (NPN or DIN-HM) before coming onto the market.
The Inspectorate's Natural Health Products Compliance and Enforcement Policy was revised to reflect the Inspectorate's move to balance its use of proactive and reactive compliance and enforcement activities. The NHP compliance and enforcement approach continues to be risk based with actions taken in proportion to risk. The policy also continues to clarify Health Canada's expectations of industry as well as clarifying what industry can expect from the Inspectorate in terms of compliance and enforcement actions beyond September 2014.
Since the implementation of the NHPR in 2004, the Inspectorate has relied on a compliance model that was mostly reactive and complaint based. Moving forward, the Inspectorate will gradually increase its use of proactive activities over time where the balanced use of reactive and proactive compliance and enforcement activities will serve to enhance the Inspectorate's ability to identify and target risk, leading to more effective, predictable and consistent compliance and enforcement risk-based decisions.
Inquiries about this document can be addressed to the Drug Compliance Verification and Investigation Unit by fax: 613-946-5636 or by email at DCVIU_UVCEM@hc-sc.gc.ca.