Guide on the Sale of Human Milk Fortifiers

April 14, 2021

Table of Contents

• 1.0 Introduction
• 2.0 Key Terms
• 3.0 Safety Assessment prior to sale
• 4.0 How HMFs are used
• 5.0 Who can write orders
• 6.0 Where HMFs can be sold
• 7.0 Contact Information

1.0 Introduction

In Canada, human milk fortifiers (HMFs) are regulated under the Food and Drug Regulations (FDR). Specifically, the FDR, Part B, Division 25 (B.25.019) sets out the conditions under which HMFs may be sold.

This document is part of a series of Health Canada guidance documents relating to HMFs, and provides additional guidance on sales of HMFs in Canada.

HMFs are infant foods added to human milk to increase its nutritional value in order to meet the particular requirements of an infant with a physical or physiological condition resulting from a disease, disorder or abnormal physical state (e.g., prematurity, small for gestational age, high protein needs).

HMFs are used when a health professional has decided that HMFs are needed to help meet the nutritional needs of certain infants.

The use of HMFs is typically limited to a neonatal intensive care unit (NICU) under medical supervision. While most infants will not require HMFs after discharge from the NICU, certain subpopulations of infants may benefit from its continued use at home. Regardless of where they are used, HMFs should only be used under medical supervision by a qualified medical professional.

As there are potential risks associated with the use of HMFs, restrictions have been placed on their sale to ensure that they are only used when a medical professional has determined that they are required. It is therefore not appropriate for the general public to make decisions about the use of HMFs.

2.0 Key Terms

Human Milk Fortifier as defined in the FDR, is a food whose composition includes at least one added vitamin, mineral nutrient or amino acid that is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state.

Sell as defined in the Food and Drugs Act includes offer for sale, expose for sale, have in possession for sale, and distribute, whether or not the distribution is made for consideration.

Written Order is an order from a physician, nurse practitioner or registered dietitian^{Footnote 1} for a specific product for a specific person.

3.0 Safety Assessment prior to sale

All foods sold in Canada, including infant formulas and human milk fortifiers must be safe and fit for human consumption, as defined under Section 4.1 of the Food and Drugs Act.

All HMFs available in Canada undergo a rigorous assessment for safety and nutritional adequacy prior to sale. HMFs have been used safely in Canadian hospitals for over 30 years.

For HMFs, Division 25 of the FDR requires manufacturers to submit an application for a new HMF, or those that have undergone a major change, and receive an authorization from the Minister of Health before the HMF can be sold in Canada. The regulations also set out the type of information and evidence that must be included in the application to Health Canada. Then, Health Canada conducts a detailed review of the evidence to evaluate the safety and nutritional adequacy of the HMF.

For guidance on how to prepare an HMF application please visit Guide for the Preparation of Infant Formula and Human Milk Fortifier Premarket Notifications.

4.0 How HMFs are used

HMFs are primarily accessed and used in hospitals in Canada. Medical professionals in hospital NICUs select and administer HMFs based on the specific nutritional needs of each infant, monitor the requirements and regularly adjust the amount of HMF based on the health status of the infant.

While the administration of HMFs in a clinical setting is expected to remain the primary way in which infants receive HMFs, there is evidence to suggest that a short period of use post- discharge will be beneficial in some circumstances. Recent studies suggest that the use of HMFs post-discharge could improve the growth trajectory of certain infants with ongoing medical conditions, provided there is sufficient oversight by a medical professional. However, in most cases, infants are transitioned off of HMFs before they are discharged from the hospital.

5.0 Who can write orders for HMFs

The authority to write orders for HMFs falls within the practice of medicine, which is under provincial jurisdiction. However, when HMFs are to be used outside of the hospital, the regulations set conditions on who can write orders. HMFs can only be sold to a member of the general public if the person has a written order from a physician, nurse practitioner or registered dietitian who is authorized to write that order under the laws of a province or territory for an HMF that is approved in Canada.

Further controls on the sale of HMFs to the general public who have obtained a written order includes that the HMF has been ordered from the manufacturer through a hospital or the HMF is obtained directly from a hospital.

It is recommended that the order from the hospital to the manufacturer contains, at a minimum, the following information:

• patient/caregiver name;
• patient/caregiver mailing address;
• type of HMF; and
• quantity of HMF.

6.0 Where HMFs can be sold

To ensure that HMFs are only used under appropriate medical supervision, restrictions have been placed on the sale of HMFs. The sale of approved HMFs are only permitted from:

• a manufacturer to a hospital;
• a manufacturer to the general public, if the person has a written order from a physician, nurse practitioner or registered dietitian and the manufacturer receives the order from a hospital; or
• a hospital to the general public if the person has a written order from a physician, nurse practitioner or registered dietitian.^{Footnote 1}

For example, HMFs could be obtained by the infant's caregiver from a hospital run specialty food store with a written order from a physician, nurse practitioner or registered dietitian. A hospital may also directly provide HMFs to caregivers with a written order, such as providing HMFs when being discharged from the NICU.

Manufacturers are permitted to sell HMFs to hospitals. Manufacturers would also be permitted to sell a HMF to a person with a written order from a physician, nurse practitioner or registered dietitian, if the manufacturer is requested to do so by a hospital (for example through a post- discharge program). In such circumstances, hospitals would remain the point of access for HMFs to be made available to caregivers. HMFs are not available for sale in pharmacies, retail locations, or online, as these venues do not have the requisite knowledge or controls to sell this specialized food product.

The new HMF regulations, which are part of the FDR, do not prevent manufacturers from operating post-discharge programs. These programs involve HMFs being provided from manufacturers to a caregiver, usually delivered directly to their residence. As sale to the general public is allowed when the person has a written order from a physician, nurse practitioner or registered dietitian, and a hospital makes a written request to the manufacturer to provide HMFs to the person, this allows a manufacturer to operate a post-discharge program. This approach allows the flexibility for post-discharge use of HMFs when a physician, nurse practitioner or registered dietitian determines that an infant would benefit from continued use of HMFs after they are discharged from a NICU. Only in certain circumstances will HMFs be used after discharge from a NICU.

7.0 Contact Information

If you have any questions about the sale of HMFs, please contact the Submission Management and Information Unit of the Food Directorate at Health Canada at:

Email: smiu-ugdi@hc-sc.gc.ca