After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for these types of products, Health Canada has released new Directives/Guidance Documents and Publications in Canada Gazette part II. These articles pave the way for new regulatory requirements and now list Human Milk Fortifiers (HMFs) within the Food and Drugs Regulations.
This framework will enhance the ability of industry to add vitamins, minerals, and amino acids to human milk, in turn, providing infants with these important nutrients. These types of products are commonly administered to premature and low birthweight infants, bolstering the benefits of human milk to aid in growth and development.
A clear pathway to market will increase efficiency and accessibility for these products in medical and prescribed home care settings, thus benefiting medical practice and the individual infants. There are currently 10 approved HMFs. Many more are expected to be approved with the implementation of this programme.
Safety of infants is of utmost priority. This framework lays out clear guidance for the regulation and oversight of safe and innovative products. A risk-based approach will be taken to implement and enforce these products.
Quick Definitions:
Human milk fortifier means a food that: (a) includes at least one added vitamin, mineral nutrient or amino acid, and (b) 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.
Infant means an individual who is under the age of one year.
New (Draft) Guidance Documents:
Health Canada is currently drafting 8 new guidance documents regarding HMFs. If you would like access to any specific draft guidance document such as: Guide on the Sale of Human Milk Fortifiers please reach out to our team.
Premarket Submission:
HMFs were previously marketed under the Temporary Market Authorization Framework, like caffeinated energy drinks and supplemented foods. Now, HMFs are required to be submitted to the regulator and reviewed prior to sale on their own. Applications are to be submitted to allow sufficient time for review prior to April 30, 2022. Applications shall include the following components:
- Brand name
- Manufacturer’s name and address
- Name and address of other manufacturing establishments
- Quantitative list of ingredients
- Formulation rationale
- Product specifications, Including nutrients, microbiological and physical quality
- QC details for product and ingredient testing
- Details of manufacturing process and QC procedures
- Stability results, to determine expiry
- Nutritional adequacy support, when consumed under the proposed directions
- Description of packaging
- Directions for use
- Copy of all labels to be used
- Name and time of applicant who signed and dated the application
Authorization and Application Review:
Should the application be deemed complete and sufficient the product would be authorized. The regulator may also request changes or conditions prior to approval. Additional information or confirmations may be requested during the submission process. Resubmissions and new approval would be required if your formula undergoes a major change, unless otherwise authorized by the regulator. If any information submitted is missing, considered false, misleading, or deceptive the application may be refused.
Legal Sale:
HMFs will only be sold to hospitals directly or to individuals for home use with a written order (prescription) from an authorized physician, nurse practitioner, or dietitian (Health Care Practitioner). Industry will not be able to sell these products direct to consumer.
Label Requirements:
Labels of HMFs are required to carry the following information on the outer label:
- List by quantity the amount of protein, fat, carbs, and fibre (in grams)
- Statement of energy value/calories
- Statement of quantity (in mg or mcg) of all vitamins, minerals, or amino acids
- Statement of quantity (in mg or mcg) of any other nutritive substance
- Storage instructions for both opened and unopened containers
- Directions of use including preparation and storage instructions
- Statement to only use this product under medical supervision
- Expiration date
- Lot number
- Any other statements or content required to be added during review.
Information can be displayed on outer label, inner label, or on an affixed leaflet.
You are not permitted to list the following on any labelling or any advertising materials to percent daily value amounts.
Health Claims:
It is suggested to remove/limit all health claims regarding these products, as it would be the health care practitioner’s discretion when and why they are dispensing the product. Marketing verbiage and imagery should also be minimal.
Formulation:
Ingredients used in HMFs may include Amino acids, Minerals and Vitamins.
Also, based on recent safety assessments, several new food additives will be permitted for use in Human Milk Fortifiers. These include carrageenan, gellan gum, lecithin, monoglycerides, potassium citrate, potassium hydroxide and sodium citrate. Please keep in mind each of these may have specifically approved purposes and required cautionary statements. Otherwise, Infant foods are currently prohibited from containing food additives, but some can be granted. There currently are no limits set for these ingredients for HMFs the responsibility will be on the applicant to prove each ingredient is safe and effective.
Safe Foods for Canadians Regulations Note:
All foods in Canada will be regulated by the Safe Foods for Canadians Regulations. Conventional and supplemented foods now have additional requirements such as: Licensing, Traceability and Preventative Controls. Reach out to our team for assistance complying and importing within this new framework.
References:
Canada Gazette Part II Listing
List of Human Milk Fortifiers
List of Guidance Documents
Food and Drug Regulations
