Thursday, August 26, 2010

What is an NPN and what does it mean?

In Canada, natural health products (NHPs) are regulated by a government agency called the Natural Health Products Directorate (NHPD). For a company to legally sell or distribute a product that is classified as an NHP in Canada, it must apply to the NHPD for a product license, also called an NPN.

First, what is the Canadian definition of an NHP?

From the regulations:
"natural health product" means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(b) restoring or correcting organic functions in humans; or
(c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Schedule 1 is a listing which sets out what products/ ingredients qualify as NHPs.

So there is a very well defined set of regulations and definitions which allow the general public and manufacturers to understand what qualifies as an NHP. Also whether a product is a food or an NHP is defined on the basis of how it is to be used. NHPs are typically sold in a format that allows them to be consumed in measured or controlled amounts (doses). If a product is sold in a particular food format (for example, a beverage) that lends itself to dosing (for example if it is sold in single dosage units or it is sold with a measure that indicates it to be consumed in controlled amounts) this is one indication that the product is an NHP. Also the product must make some form of claim as how it would affect the person’s well being as stated above.

Once a company determines the product is an NHP and what it is that they want to claim the product can do, they are now ready to start the license process. There are 3 options (assuming this discussion is limited to typical NHPs and excludes homeopathic medicines):
1. Follow a monograph as set out by NHPD. Monographs are technical documents that define what the ingredient(s) are, what they can be claimed to do, the permitted dosages, and any cautions etc that should be on the label. These are formulated based upon an expert advisory committee and always contain a bibliography of the research used to come to their conclusions. Monographed products will be licensed rapidly by NHPD and must comply 100% with the monograph.
2. Another is termed precleared information. In this situation one may be combining ingredients which are all monographed but they are in a new or novel combination. Assuming the dosages etc meet the requirements set out in the evaluation guidance, then these as well should be licensed in a short time period of less than 60 days.
3. Finally are products where all medicinal ingredients are not found in the compendium of monographs and the safety and efficacy (effectiveness) are supported by research submitted by the company. In this case, the product will be evaluated by experts within NHPD and this may take a significant amount of time to be licensed depending upon how well the company has formulated its argument and the information provided to support the argument. The time to receive a license may be up to a year or possibly more.

So as you can see in Canada NHPs are well governed by regulation and if all products are assessed in this manner then you the public should be able to have confidence that the products that you take should produce outcomes as expected and advertised.

As of August 27, 2010 the NHPD has entered the final stage of the development of the licensing program. This final stage will be expected to clear all back logged products and to start the actual enforcement of licensing. There is a 6 month transition period, meaning that after February 2011 the NHPD will be in a position to start to put pressure on manufacturers and distributors to remove products from the market that do not have a license number.

Also as an interim measure, the NHPD will allow companies to market products that have been submitted for a license but are still in the assessment phase. To get this permission a product application must have been in the assessment process for 180 days, it must also only be marketed to an adult population. If it meets these basic properties it will be given what is called an exemption number. All exempt products will be listed on the NHPD website. So if you are uncertain if a product that does not contain an NPN is legal for sale you can check this listing. If it is not on this list, it is not a product that is permitted for sale in Canada. We would expect this list to start in February 2011.

This evaluation and licensing regime is one that many other countries in the world are looking at closely and is the first of its kind. Based upon this process, it does mean that product innovation may be somewhat hindered but at the same time you the consumer can feel assured that any product that has an NPN license has met the basic quality requirements, has been produced in a licensed GMP facility, is backed by credible research findings, should be effective and is safe to use.

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