Canada's Natural Health Products Directorate, currently facing a backlog of over 10,000 product license applications, has placed all those products in a food or drink format on hold pending branch level review between the Natural Health Products Directorate and the Foods Directorate to determine under which category these products should be evaluated.
The move comes after comments made by NHPD officials in late February implying that they had been asked to not proceed any further on any food or beverage product license submissions.
"Food and NHP Directorates are currently in discussion to re-evaluate how to look at them", confirmed an NHPD spokesperson. "By making a claim and based on the ingredients, the products meet the definition of an NHP, but the way they are marketed and perceived is as foods. We recognize that something needs to be done; we're not sure what we're going to do."
Asked what a likely resolution could look like, the spokesperson could not say, but noted that a tentative date for a decision might be by the end of the summer. Asked whether there was a possibility of a collaborative solution whereby both NHPD and Foods would be involved in assessing the merits and science of the product license applications, the spokesperson pointed out that already the directorates were working in collaboration.
The outcome of the decision affects all food or drink format products including energy drinks, other beverages, jams, cakes, yoghurts, butter, chocolate products and bars.
When asked whether there would be industry or consumer input at this stage, NHPD pointed out that such input had been provided by both in the original consultations before the regulations were introduced, but this issue over jurisdiction was not foreseen. No stakeholder consultation is therefore currently planned on this issue. If it turns out the regulation needs to be changed, one would presume that at some stage in the future, consultation will be solicited.
In the meantime, the status of hundreds of products involving millions of dollars of research and investment remains unclear, providing certain competitive advantage to Red Bull Energy Drink, granted Natural Product Number 80000012 shortly after the new regulations came into effect and well before the hold on competitive submissions was introduced.
List of Approved Natural Health Products (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lists/listapprnhp-listeapprpsn_e.html)
Natural Health Product Regulations (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index_e.html)