How Are Natural Health Products Regulated?

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Natural health products

Are We Safer Now? 

In January 2014 when you walk into a retail outlet selling Natural Health Products (NHPs), make sure you look for the NPN (Natural Product Number) or HM-DIN (Homeopathic Medicine Number) on the label.  No products should carry the EN-NPN which is now phased out.  That means all products have been evaluated for safety and efficacy by Health Canada.  It was not always that way.

Natural health products (NHPs) are regulated under their own specific regulations, the Natural Health Products Regulations (NHPR), which take into account the unique nature and properties of these products.  These regulations came into effect in 2004 and have been in use ever since. They outline the requirements for the legal sale of NHPs in Canada.

When these regulations came into effect, they captured a large number of products that were already on the market and needed to be licensed. This created an immediate large number of unprocessed applications. To address this, in August 2010, the Government introduced a temporary set of regulations called the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR).  NHP-UPLAR provided a short-term way for products to be legally sold when Health Canada had not completed its licensing decision within 180 days. This allowed lower risk products to be legally sold (and labelled with exemption numbers (ENs)) while awaiting full review. The NHP-UPLAR was intended to be a temporary measure.

As planned, NHP-UPLAR will no longer be in effect as of February 2013. These regulations are no longer needed because changes to NHP licensing processes enable the majority of decisions to be made within 180 days or less. This means that no new ENs for NHPs will be issued, and that Health Canada will be shifting toward the requirement that all NHPs sold in Canada have natural product numbers or NPNs, or Homeopathic Medicine Number (DIN-HM) on the label.

Health Canada developed a transition plan–using key input from stakeholders–that provides time for companies to make necessary changes to business practices and/or phase out products that are not in compliance. With the repeal of the natural health products unprocessed product applications regulations (NHP-UPLAR) in February 2013, new Exemption Numbers (ENs) are no longer issued.

So what has changed?

The Government has introduced a new approach to NHPs which provides a stable, predictable regulatory environment.  The new approach introduces new policies and process improvements to speed up application review and focus evaluation efforts on complex applications. These changes are in addition to newly revised guidance on the requirements and pathways for licensing NHPs. The Department is also developing a new approach to site licensing focused on greater quality assurance for products.  These changes and other ongoing process improvements provide a stable, predictable approach for the efficient processing of applications by Health Canada.

In Conclusion

You can identify products that have been licensed for sale in Canada by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.

A NPN or DIN-HM means that the product has been authorized for sale in Canada and is safe and effective when used according the instructions on the label.

 

How Can you get more info?                 

Ray Chepesiuk is a Pharmaceutical Advertising Advisory Board (PAAB) Commissioner, to find out more about the PAAB, please visit their website.