Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order)
. This order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the minister on March 30.
The Interim Order permits the minister to allow the exceptional importation and sale of certain drugs, medical devices and foods for a special dietary purpose (FSDP) that do not fully comply with Canadian requirements but are approved by a foreign regulatory authority or are allowed to be sold in foreign jurisdictions that have high quality assurance and manufacturing standards similar to Canada. If the minister approves such products for importation, they will be exempt from certain Canadian regulatory requirements (e.g., compliant labelling).
The Interim Order defines a “food for a special dietary purpose
” as a food that has been specially processed or formulated
(a) to meet the particular requirements of an individual in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; or
(b) to be the sole or primary source of nutrition for an individual
Canadian FSDP manufacturers are responsible for contacting Health Canada if they are expecting shortages as a result of COVID-19.
Importers requesting to import FSDP in short supply may apply to have foreign products designated and listed on List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale (designated FSDP).
Foods that may be eligible to become a designated FSDP include:
- Food for special dietary use, as defined in the Food and Drug Regulations B.24.001;
- Human milk substitutes (infant formula), as defined in the Food and Drug Regulations B.25.001; and
- Human milk fortifiers, which are foods labelled and advertised as intended to be added to human milk to increase its nutritional value, and are used by infants for whom they are medically required.
The process for applying for such designation is outlined in Health Canada’s Guidance on the implementation of the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 with respect to foods for a special dietary purpose (the Guidance).
Designated FSDP are exempt from the Food and Drugs Act’s prohibition on the use or presence of any of the following substances or materials:
(a) food additives;
(b) any nutritive material that is used as an ingredient of the food;
(c) vitamins, mineral nutrients and amino acids;
(d) agricultural chemicals;
(e) food packaging materials and components of those materials;
(f) drugs recommended for administration to animals that may be consumed as food; and
(g) any other substance specified in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale in respect of the food.
Certain labeling requirements, including the requirement for a nutrition facts table and the prescribed labeling for vitamins, minerals and amino acids, also do not apply to designated FSDP.
Manufacturers wishing to add certain FSDP as to the designated list of products may contact the Bureau of Nutritional Sciences, Food Directorate via phone at (613 948-8476) or email at email@example.com.
Importers who wish to import designated FSDP must apply to the minister at least five calendar days before the date of import. Contact firstname.lastname@example.org to obtain a copy of the notification form.
Upon selling of the imported product, the importer must ensure the following information is available, in both English and French:
- The special dietary purpose for which the food is represented;
- The warnings, if applicable;
- The directions for the preparation, use and storage of the food;
- The expiration date;
- The lot number of the food; and
- The list of food ingredients, including priority allergens
Similar processes and lists of designated products are in place for drugs and medical devices. Interested readers can review Norton Rose Fulbright’s summary published on the Pharma in Brief blog.