By: Joanna Chudyk, Regulatory Affairs Specialist, email
On April 22nd, 2022 the Natural and Non-prescription Health Products Directorate (NNHPD) published two more monograph modifications as part of their “What’s New” newsletter, resulting in a total of 4 monographs updated during April 2022. The monographs affected in this update were the Workout Supplement Monograph and Whey Products Monograph. While the changes made to the latter were minor, the former has been updated with significant alterations. The new versions of these monographs can be found on the Natural Health Products Ingredients Database (NNHPID) website.
The modification highlights from the Workout Supplement Monograph include the addition of several new protein ingredients (including Chickpea, Fish protein hydrolysate, and Pea), the relocation of Beta-Alanine, and Citrulline to the non-essential amino acids list, and a new complementary ingredient – Agmatine. There have also been significant changes to the maximum daily dose of select essential amino acids (Isoleucine, Leucine, and Valine) and the introduction of maximum single dose amounts for Beta-Alanine and Citrulline.
As per the Natural Health Products Management of Applications Policy, Product license holders must align all affected products with the recent monograph revisions within a) 3 years of the changes, b) the next label run, or c) a post-licensing change, whichever of these cases come first. These changes should be implemented through the NHP amendment process so a revised Product License can be issued (if applicable).
If you require assistance in determining whether your products with NNHPD monographs may require amendments or if you have specific inquiries on what updates were made, contact us today for a quote.
Contact:
Dell Tech
Joanna Chudyk, M. Sc.
Regulatory Affairs Specialist
joanna@delltech.com
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