The Natural Health Products Directorate (NHPD) has established some additional quality control requirements regarding Gelatin in Natural Health Products.
The gelatin used in formulating or encapsulating natural health products may be made from a variety of animal materials. Those products that have been licensed for sale by Health Canada are safe, but in order to further enhance the continued safety and quality of those products which contain gelatin made from the bones of the following animals : cattle, sheep, goat, deer, and elk, which are susceptible to Transmissible Spongiform Encephalopathy (TSE) diseases such as Bovine Spongiform Encephalopathy (BSE or Mad Cow Disease), the Natural Health Products Directorate (NHPD) has established some additional quality control requirements.
The NHPD will be sending notices to licensees of approved natural health products as well as applicants of products currently under licensing review asking them either to replace their gelatin with materials that are not susceptible to containing the causative agent of a TSE or to provide documentation demonstrating that appropriate quality control measures have been undertaken. Further details are provided below.
Affected licensees and applicants are advised to carefully read and comply with the instructions and requirements outlined below. Licensees that cannot adequately demonstrate that their gelatin meets these requirements will be subject to compliance action. Those individuals receiving notices from the NHPD are asked to comply with the request within the indicated timeframe.
To view the entire notice, please visit Health Canada’s Natural Health Products Directorate: Important Notice: Revised Policy Regarding Gelatin in Natural Health Products.
Nexreg Compliance