Information document (Standardized template)

Notice to the reader

The following standardized template was developed by Health Canada to assist importers and manufacturers involved in the exceptional importation and/or sale of certain foods for a special dietary purpose (FSDP) to comply with section 7, Part 1 of the Exemption Order in Respect of Foods for a Special Dietary Purpose (the Order).

It is strongly recommended that the bilingual alternative format of this template be used.

Further information is available in the Guide to the exceptional importation and sale of certain foods for a special dietary purpose (FSDP) in response to a shortage or risk of a shortage.

Information document

Notice to the reader

The product described in this document is being exceptionally sold in Canada pursuant to Health Canada's Exemption Order in Respect of Foods for a Special Dietary Purpose (SOR/2025-248).

As the label on the product does not comply with the requirements of the Food and Drug Regulations, the following document provides the information needed for the safe use of the product.

In accordance with section 11 of the Order, a paper copy of this document must be made available to the purchaser or consumer of the product when it is sold.

Questions about the use of this product? Ask your health care provider or pharmacist.

Brand name and product name:

Instructions: provide the brand name and product name in bold and in a 12-point font size. You may also include an image of the product.

The special dietary purpose of the product:

Instructions: provide the special dietary purpose of the food in bold and in a 12-point font size. The description of the special dietary purpose should include an indication of the FSDP category the product belongs to (i.e., infant formula, human milk fortifier, or formulated liquid diet) as well as its indications for use.

Examples:

• "Infant formula with iron (milk-based/ready to serve)"
• "To be added to human milk to increase its nutritional value for premature infants (human milk fortifier) "
• "Nutritionally complete liquid formula (formulated liquid diet) for individuals with renal failure"

For infant formula and human milk fortifiers: guidance on how to present appropriate indications for use is available in section 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions.

Manufacturer's name and contact information:

Instructions:

For products manufactured outside Canada: provide the name and contact information (website, mailing address, telephone number, and/or email address) of the foreign manufacturer. You may also include the name and contact information of the Canadian importer.

For products manufactured in Canada: provide the name and contact information (website, mailing address, telephone number, and/or email address) of the Canadian manufacturer.

Note – per 7(a) of the Order, the information in this section is only required in one official language.

List of ingredients:

Instructions: Include a complete list of the food's ingredients; precede the list with the title 'Ingredients:' in bold; separate the ingredients with either a comma or a bullet point.

Food allergen sources, gluten sources and added sulphites:

Contains:

Instructions: if applicable, indicate the presence of all food allergen sources, gluten sources and added sulphites that are intentionally added ingredients/components of the food (Eggs; Milk; Mustard; Peanuts; Crustaceans and molluscs; Fish; Sesame seeds; Soy; Sulphites; Tree Nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts); Wheat and triticale; and/or Gluten sources (Barley; Oats; Rye; Triticale and Wheat). Note – allergen sources, gluten sources and added sulphites must be noted in this section even if they are highlighted in the List of ingredients. If none, indicate 'n/a'.

May contain:

Instructions: if applicable, indicate all food allergen sources, gluten sources and added sulphites that may be present due to unavoidable cross-contamination. If none, indicate 'n/a'.

Aspartame/phenylalanine statement:

Instructions: if applicable, include a statement to the effect that the food contains phenylalanine or that aspartame contains phenylalanine (e.g., "Persons with phenylketonuria: contains phenylalanine"; "Aspartame contains phenylalanine"). If not applicable, indicate 'n/a'.

Nutritional information:

Instructions: it is highly recommended that the nutritional information be presented in a table format for better readability. Ensure that the units of measure are clear and standardized. The following units of measure are recommended: Calories (Cal) for energy value, International Units (IU), grams (g), milligrams (mg), or micrograms (µg) for the nutrients.

Directions for the preparation, use and storage of the product:

Instructions: ensure that directions are clear and concise. The use of bullet points and numbered steps is recommended for better readability. Diagrams and pictograms are also encouraged to support understanding.

For infant formula: recommendations on appropriate directions of use are provided in sections 4.12 and 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions.

For human milk fortifiers: the directions must include a statement that the food is to be used only under medical supervision; recommendations on appropriate directions of use are provided in sections 4.12 and 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions.

For formulated liquid diets: the directions must include a statement that the food is intended to be consumed orally or by tube feeding.

Expiration date:

Instructions: provide the expiration date or indicate where the expiration date appears on the food's label and the format of the date, e.g., "see the bottom of the container (dd-mm-yyyy)".

Lot number:

Instructions: Provide the lot number or indicate where the lot number appears on the food's label, e.g., "see the bottom of the container".