By: Joanna Chudyk, Regulatory Affairs Specialist, email
July and August 2022 were busy months filled with numerous updates and changes, including making significant changes to a number of NNHPD Monographs. The Multivitamin and Minerals, and the Antioxidants Monographs have been updated with significant changes that may affect your products. The new versions of these monographs can be found on the Natural Health Products Ingredients Database (NNHPID) website.
The significant changes in the Multivitamin and Mineral Monograph include modifications to the common names and source materials for some ingredients. These changes include, but are not limited to:
- Cholecalciferol is no longer an acceptable common name for Vitamin D, Vitamin K1 source materials are now restricted to “phytonadione” only, and
- bone meal is now an acceptable source of calcium.
The changes implemented will have a significant impact on the Natural Health Product (NHP) labels affected.
The Antioxidant Monograph update also introduced major changes. Most notably is the removal of the list titled “Potency Information” that appeared at the top of the previous version disclosing acceptable constituents of each antioxidant ingredient. The list has been replaced with a new column that discloses acceptable sub-ingredients on a per ingredient basis, limiting the flexibility that existed previously when declaring potencies. If you have attested to the Antioxidant Monograph in the past then these changes may have a significant impact on the acceptability of your product.
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).
Make sure you verify the impacts of these changes on your products before the 2025 deadline. Need assistance determining if your products are affected? Contact us today for a quote.
Contact:
Dell Tech
Joanna Chudyk, M. Sc.
Regulatory Affairs Specialist
joanna@delltech.com
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.
