There is a lot of buzz in the industry over what will happen come January 1, 2010, as if hordes of inspectors and customs agents are just waiting to pounce at the stroke of midnight. Some are under the impression that this is the deadline for all natural health products to obtain an NPN in order to be legally sold. In reality, all NHPs must currently hold an NPN or DIN to be sold legally in Canada. So what is this January 1, 2010 deadline all about? This is the deadline, as established in the Natural Health Product Regulations, by which NHPs that currently hold a DIN must be transferred to the NHPD and licenced accordingly. So when the NHPD states in their Overview of the NHP Regulations Guidance Document that “All natural health products must comply with all the Regulations by January 1, 2010”, this is referring specifically to DIN products.
“But,” you may ask, “can’t I legally sell my product if I have a submission number?” The answer is no. However, in recognition of the ongoing backlog, the NHPD has stated that they will not focus their enforcement action on those products that do not pose an undue risk and that were issued submission numbers before the applicable category deadline1. The site license deadline for manufacturing packaging, labelling, and importing NHPs (December 31, 2005) has, of course, come and gone and is currently being enforced. But it appears that the NHPD will continue to apply their current compliance approach to product licensing so long as the backlog persists (the January 1, 2010 deadline notwithstanding).
Like the Y2K bug, January 1, 2010 will likely dawn on the industry not with a bang but with a whimper.
1For details of the NHPD’s approach to enforcement refer to the Natural Health Products Compliance Guide, January 2007 – Version 2.1, available on the NHPD’s website.