NNHPD Releases New Monographs for Consultation – Implications for Industry

April 6, 2015 By

The NNHPD has released 2 new product monographs Antioxidants and Kelp, for consultation until the end of April.

The Natural and Non-prescription Health Products Directorate is steadily continuing the development of its Pre-Cleared Information (PCI) system, with the release of two new monographs for industry consultation on March 31, 2015. The two new monographs are Antioxidants and Kelp Products. These consultations are open for comment starting March 31, 2015 until April 29, 2015. Any company marketing products in these categories is encouraged to review the monographs and forward their comments directly to NNHPD.

In the case of Antioxidants, it would seem that Health Canada has come a long way. In the early 1990’s, antioxidants were starting to become a household word. In fact the protective effect of antioxidants was on the leading edge of nutrition research, in an attempt to explain the so-called French Paradox.

Interestingly, at that time, Health Canada would not allow the use of the term “antioxidant”. They claimed the general public didn’t understand the term.  You couldn’t put it on your labels, you couldn’t put it in brochures, and you couldn’t use the term in any advertisements. Companies had to resort to clever ways in which to advertise the fact that they had antioxidant products in their line, for example by using phonetic spelling of the word “antioxidant” in their brand names.

Here we are 25 years later and antioxidants are now firmly in the mainstream and officially recognized by Health Canada. Indeed, it seems these days that everything is an antioxidant. Happily, companies no longer have to use such strategies as “alphabet soup” product names in order to get their message across to the consumer.

However, with this news we should also consider as an industry, what have we really gained? True, we can now make claims for antioxidants on product labels, but these are limited to very basic statements like “provides antioxidants”, “an antioxidant for the maintenance of good health”, etc. Statements like these aren’t very meaningful for the average consumer, they certainly aren’t exciting to sales and marketing people, and they really represent the lowest hanging fruit in the health claims tree.

Those of us who have struggled over the years to obtain product licences (NPN Registration) will certainly appreciate the advent of NNHPD’s PCI monograph system. The NNHPD has been steadily pushing industry toward the almost exclusive use of PCI for NPN Registration. Attesting to PCI undeniably results in a company receiving their NPN in a reasonably short time frame. However, there is a significant drawback to the system.

When attesting to PCI, an applicant must attest to the terms of the monograph without variation. This means that companies are all attesting to the same information in their applications. This will ultimately result in the Canadian marketplace consisting of products that have the same health claims, cautions and warnings, and probably the same ingredients. The only difference will be the brand name and graphics on the label. This in effect stifles innovation in industry, which will be a great shame. The NHP industry has always been on the forefront of innovation in the supplement category, but this may become a thing of the past.

So, as an applicant, you can go ahead and leverage these new monographs in your NPN Registration applications. Be happy that you can at last use the word “antioxidant” and make some claims about the ingredients. Please bear in mind that this monograph outlines the specific ingredients, risk information and restrictions of use for these types products. In order to leverage this monograph and reference it in support of your application, you must meet all the parameters of the monograph.

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