NETfacts: Natural Health Products, Over The Counter, Self-care
Health Canada Plans to Implement the Self-Care Framework in a Phased-in Approach, Beginning with Facts Table Labelling for Natural Health Products
After two years of ongoing consultations, Health Canada announced plans to begin phasing in the Self-Care Framework, which would introduce a consistent, risk-based regulatory regime for over-the-counter medications, natural health products and cosmetics.
Currently, similar products sit side-by-side on store shelves and the consumer may not know that they may be subject to different levels of oversight. For example, similar products may have different evidence requirements to support claims, and different approaches to inspections of the sites where products are made, or be subject to different authorities with respect to how Health Canada can respond to a safety issue.
With this recent announcement, Health Canada sketched out their phased approach for moving forward with the Framework under their existing legal statutes.
The first Phase will begin in the Fall of 2018 when Health Canada will introduce amendments to the Natural Health Product Regulations that would improve labelling by requiring information to be displayed using plain language in a facts table box. These requirements would be similar to changes that are currently being adapted for non-prescription medications to introduce drug facts tables by June 2021.
With Phase II in early 2019, Health Canada would introduce amendments to the Food and Drug Regulations that would establish a three-category, risk-based approach to pre- and post-market oversight of over-the-counter medicines.
Phase III, which will begin after 2020, would extend that same three-category, risk-based regulatory approach to other self-care products like natural health products and cosmetics.
CHP Canada will continue to work closely with members, stakeholders and Health Canada to help shape the future regulatory landscape of self-care products in order to establish a consistent regulatory regime that encourages market access for evidence-based consumer health products and supports informed self-care. To learn more about becoming a member, see here.
For more information about the framework see here;
For more information about OTC Drug Facts Tables see here;
See here for more information on the regulation of OTCs;
See here for more information on the regulation of NHPs; and,
See here more information on the regulation of cosmetics.