Nearing the end of 2010 the natural health products industry was pondering nervously what 2011 would bring, what with the announcement from the Natural Health Products Directorate (NHPD) that starting in March of 2011 a new compliance and enforcement policy would take effect. On Dec. 22, before the end of the year, the NHPD announced that the new policy would be delayed until further notice. A huge sigh of relief followed.
For the first three quarters of 2011 things remained quiet on the regulatory front. Some may now reflect on this period as the quiet before the storm. In August, the regulatory rollercoaster started anew with the NHPD issuing letters to manufacturers of oil of oregano questioning the level and safety of carvacrol in their products.
This was followed by two major announcements in September. The NHPD issued a new monograph for enzymes proposing new labeling requirement for enzymes that would indicate a limit of duration of use to 3 days, while the existing monograph for probiotics was modified to contain only three probiotic strains. And in October it was announced that Health Canada is proposing to move all energy drinks from a classification as a natural health product to a food.
In all cases, the true implications on business are yet to be determined. The real fun will begin when a new date for the compliance and enforcement policy to take effect is announced. 2012 will undoubtedly prove to be another bumpy ride.
Peter Wojewnik is the vice president of business development for Toronto-based scientific and regulatory consultancy Dicentra, Inc.