Canada Proposes to Modernize the Regulations for Foods for Special Dietary Use and Infant Foods

On November 28, 2023, Health Canada announced to seek public comments on a proposal to modernize the regulations for foods for special dietary use (FSDU) and infant foods, which are currently regulated by the Divisions 24 and 25 of the Food and Drug Regulations. Any comments can be sent to bns-bsn@hc-sc.gc.ca until February 6, 2024.

1. Background and purpose

The current regulatory framework for FSDU and infant foods were established decades ago and has undergone few changes. With the development of the food industry, many problems of the current regulatory framework begin to expose, such as the narrow application scope, the inflexible and outdated compositional and labelling requirements, as well as the misalignment with international legislations. These issues pose challenges for innovative products to enter the Canadian market, leading the country with a less diversified supply layout where may be more severely affected by the possible shortage.

This proposal aims to get rid of these limits, while supporting increased innovation, improving alignment with international jurisdictions, and reducing barriers to the entry of these foods into Canada.

2. Product classification

Under the current framework, both FDSU and infant foods are comprised of three categories. After reintegrating these categories, the newly proposed framework sets two new divisions, namely, foods for a special dietary purpose (FSDP), and other foods. The term "FSMP" will be used to cover several key products used to fall under FSDU and infant foods, including infant formula, prepackaged human milk, medical foods for infants (including HMF), medical foods for ages one and more, and total diet replacements for weight reduction.

Besides, "foods containing infant formula as an ingredient" are eliminated from the regulatory framework, since there are no such products on the market.

Comparison of food classifications between the two regulatory frameworks Source: Health CanadaComparison of FSDU and FSDP Source: Health Canada

3. New regulatory requirements

The draft establishes new requirements for each category under FSDP and other foods within the proposed regulatory framework. These requirements cover product definition, composition, labeling, claims, premarket authorization, advertising restrictions, etc. Take infant formula for example:

Item	Description/Requirements
Definition	Any food that is labelled or advertised for use as a partial or total replacement for human milk and is intended for consumption by infants.
Composition	The draft compositional requirements for infant formula will be presented in future consultation. For products containing new infant formula ingredients (NIFI), premarket authorization of the NIFI will be required for NIFI manufacturers instead of infant formula manufacturers.
Labeling	Nutrition information: current provisions will continue to apply, with minor changes, such as the removal of the requirement to declare the ash content. Mandatory label statements: a) Information on the principal display panel, such as the age range of the intended product user; b) Directions for use, including the preparation, storage and disposal; c) Lot numbers; d) Information on protecting and promoting breastfeeding; e) Cautionary statements; f) Prohibition on cross branding; g) Labeling exemptions; h) Changes to labeled text or images.
Claims	In all infant formula, existing prohibitions for disease risk reduction claims and therapeutic claims will be maintained. So do nutrient content claims for foods intended solely for children under 4 years of age. Health claims and/or use indications for all infant formula require substantiation with acceptable evidence from clinical research. However, certain use indications are exempted. Font size restrictions for any claims on the label will be added.
Premarket authorization	A written premarket authorization will be required from Health Canada prior to the sale of a new product or a product with a major change. The information required for the premarket authorization submission will not change significantly from the current practice.
Advertising restrictions	Certain advertisements will be prohibited, such as any images, text or videos that may idealize the use of infant formula, as well as terms including "humanized", "maternalized", "human milk oligosaccharide", "human milk identical oligosaccharide" or similar terms, words, and abbreviations.

In addition to the proposed category-specific regulatory requirements, the draft specifies some other regulatory requirements applicable to all FSDP, including shortage provisions, stop-sale provisions, clinical trial and remarket review requirements.