What is the Natural Product Number ( NPN )?
Health Canada's regulatory framework
CHFA reminds all consumers that natural health products (NHPs) are regulated by Health Canada under the Natural Health Products Regulations, which set out a rigorous protocol for the licensing of NHPs sold in Canada, to ensure their safety. This pre-market approval process places Canada among the world leaders in NHP regulation.
Natural product licensing process
As part of Health Canada's product licensing process, a company must complete a Product Licence Application (PLA) and submit it to Health Canada's Natural Health Products Directorate for review. This application must demonstrate the safety, efficacy and high quality of the product. Each application must include information about the product, including the medicinal and non-medicinal ingredients it contains, the scientific research supporting the health claims, the product label, and information about the manufacturing facilities. Once the application is approved, Health Canada assigns a natural product (NPN) that will appear on the product label and in the Licensed Natural Health Products Database.
Evaluation and manufacturing criteria
When preparing an PLA, the applicant must also complete a form attesting to the approved test methods used to evaluate the "finished product". The evaluation must comply with a number of criteria, in particular the dose of each ingredient, the dosage form and biochemical performance analyses carried out using standardized laboratory methods. Before a finished product can be licensed and sold in Canada, a report containing the results of the standardized laboratory analyses must be submitted to Health Canada, showing that the product contains the declared medicinal and non-medicinal ingredients.
Good Manufacturing Practices for NPN
In addition, Good Manufacturing Practices (GMP) require any Canadian facility where NHPs are manufactured, imported, labeled, packaged, distributed and stored to hold an operating license. Consequently, all NHPs licensed for sale in Canada must comply with Health Canada's GMPs, which ensure that NHPs are properly packaged, manufactured, stored and monitored, and that high-quality products are made available to Canadians.
Limitations of new analytical techniques
While CHFA fundamentally supports the evolution of new, proven testing techniques to ensure that consistent, high-quality products are available to Canadians, the genetic bar-coding analysis technique for NHP testing has not been validated by Health Canada, or any other regulatory body, nor is it widely available to manufacturers at this time.
Reassuring Canadian consumers
In summary, the CHFA would like to reassure Canadian consumers that they can continue to have confidence in the safety, efficacy and quality of NHPs by shopping at a local health food store and looking for the NPN on their product label.
About CHFA
The Canadian Health Food Association is Canada's largest trade association dedicated to natural health and organic products. Our members are manufacturers, retailers, wholesalers, distributors and importers of natural and organic products, such as foods, vitamin and mineral supplements, herbal products, homeopathic remedies, sports nutrition products, health and beauty products, and more.