Interim policy statement on foods for special dietary use for inherited metabolic disorders

December 23, 2024

UPDATE: Amendment of scope to include infant metabolic products

This interim policy statement has been amended on December 23, 2024, to include certain metabolic products for infants. Specifically, this applies to infant formula products intended for the dietary management of infants with inherited metabolic disorders for which a premarket notification has been submitted to Health Canada and a letter supporting their distribution in Canada has been issued.

On this page:

• Introduction
• Background
• Interim Policy statement
• Scope
• Contact us

Introduction

Health Canada is responsible for setting standards and providing advice and information on the safety and nutritional value of foods, including foods for special dietary use (FSDU). FSDU sold in Canada are subject to the provisions of the Safe Food for Canadians Act and the Safe Food for Canadians Regulations, as well as those of the Food and Drugs Act and the Food and Drug Regulations (FDR). The current requirements for FSDU set out in the FDR pose barriers to the distribution of FSDU for the dietary management of inherited metabolic disorders (IMD) (herein referred to as "metabolic products").

Background

IMD are a group of rare genetic disorders that are present at birth. People with IMD cannot metabolize specific substances. For example, the amino acid phenylalanine in the case of phenylketonuria and the carbohydrate galactose in the case of galactosemia. The substance that cannot be metabolized accumulates in the body and toxic chemicals may build up, or an essential substance may not be produced. Therefore, these disorders pose a risk to health and can be lethal if not treated.

People with IMD are often diagnosed at birth, or shortly thereafter, and require close medical supervision, along with adherence to a strict diet for life. Many common foods that would normally provide a range of essential nutrients to support good health are excluded from the diet. Instead, people with IMD need to consume metabolic products specially formulated to provide the nutrients their body needs, while avoiding the substances that pose a risk to their health. Some of these metabolic products are in conventional food formats, such as pasta, baking mixes and bread; some are specially formulated beverages; and others are meant for enteral use.

Metabolic products are dispensed through a system with robust safeguards such as requiring proof of diagnosis or written communication from a health care provider before purchase. Products available at dispensaries are manufactured in foreign jurisdictions that have high quality and manufacturing standards similar to those in Canada. They provide label information to distinguish them from conventional foods. This includes statements such as: "low protein food"; "food for special medical purpose for (naming the specific IMD)"; "for individuals on protein-restricted diets"; "low (naming the amino acid) food", etc. They also provide information to help ensure their safe preparation and use.

Metabolic products have a long history of safe use around the world, including in Canada. Due to the rare incidence of IMD, the market for metabolic products is very small; therefore, manufacturers often combine orders from several countries into a single production. This means that not only are the products manufactured using a single standard formulation, but that they are packaged with uniform labels for distribution worldwide. As such, while these products meet the applicable regulatory requirements (e.g., composition and labelling) of the exporting country, they may not align with all the applicable FDR requirements.

For example, metabolic products made in the European Union (EU) comply with the applicable EU regulatory requirements for foods for special medical purposes, with respect to both composition and labelling. These requirements may differ slightly from the applicable Canadian requirements. The labels of these products provide detailed nutrient content information, however, the format in which this information is declared on the label is not compliant with the applicable Canadian labelling requirements. For example, the nutrient declaration is not provided as a percentage of the daily value (%DV); and mineral nutrients may be declared using chemical abbreviations such as Fe for iron and P for phosphorus, which is not permitted in Canada as per the FDR.

Interim Policy Statement

Health Canada has determined that the risk of disrupted access to metabolic products for Canadians with inherited metabolic disorders clearly outweighs the risks related to non-compliance with the current regulations. Restricted access could pose a critical risk to the health of medically vulnerable Canadians who rely on these products to manage serious health conditions. Distribution of these products through a system with safeguards, including medical supervision, helps ensure that they reach only those persons for whom they are intended and for whom they are safe and beneficial.

This interim policy statement signals Health Canada's intention that metabolic products with non-compliant formulations and/or labels remain available until regulatory changes can be implemented as part of future regulatory amendments to modernize Divisions 24 and 25 of the Food and Drug Regulations.

While the labels on these metabolic products may not comply fully with the FDR, companies will still be required to provide information in a manner that permits safe preparation and use of these products. This may include a list of ingredients, nutrition information, and expiration date.

Scope

This interim policy statement applies to metabolic products distributed in Canada that meet the following criteria:

• allowed to be sold in foreign jurisdictions that have high quality and manufacturing standards similar to those in Canada
• issued a letter from Health Canada supporting distribution in Canada following a premarket notification submission, when applicable (i.e. for metabolic formula for infants)
• intended for use under medical supervision, and
• dispensed through a system with robust safeguards

Contact Us

Bureau of Nutritional Sciences
Food and Nutrition Directorate
Health Products and Food Branch
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2203E
Tunney's Pasture
Ottawa, Ontario K1A 0K9
E-mail:bns-bsn@hc-sc.gc.ca
Telephone: 613-948-8476
Facsimile: 613-948-8470