Canadian regulations breed consumer and industry confusion
Products Directorate does not bode well for nutraceutical food and
drinks seeking the federal stamp of approval that can lead to
better sales.
Health Canada recently put the processing of these food and beverage license submissions on hold while the NHPD and the Foods Directorate grapple over which jurisdiction such products fall under. The grey area arose because in Canada a health claim based on ingredients means a product is a 'natural health' product - even though it may also be marketed as food or drink.
In a recent bulletin, Health Canada warned the industry against labeling products not yet authorized for sale as 'pending', stating that this could seriously mislead consumers to believe that the products would eventually receive the approval and therefore be safe.
Unlike in the US, dietary supplements or nutraceuticals require pre-market review in Canada. They are listed under the category of 'natural health products' and are governed by Food and Drugs Act and Regulations.
A product that has been reviewed by Health Canada and received a license has a natural product number, or NPN, on its label.
South of the border there is no such labeling system for dietary supplements. In the US, manufacturers are responsible for ensuring the safety of their product before marketing it. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is only approves new dietary ingredients introduced since 1994 before products containing them can be brought to market.
In Canada, the NHDP regulations came into effect in January 2004, applying to all products in the category as of that date. Products made or packaged before that date were given two years (until January 2006) to comply with regulations and be given an NPN.
But in its short existence the NHDP has already been hampered and unable to cope with the influx of product licensing applications. Even before the current hold on nutraceutical food and beverages, the office admitted to being burdened.
In short, "the Directorate, under present conditions, cannot effectively manage the flow of incoming vs outgoing" submissions, stated the NHPD in its quarterly report (fall 2005/winter 2006).
The Natural Health Products Directorate has received a total of 12,129 licence applications since January 1, 2004 and since then it has issued 602 licences. Although some of the applications have been rejected, a great many are still pending.
No spokesperson from Health Canada was available to comment prior to publication on when the hold on applications might be removed.
