Supplemented Food guidance document has been finalized by the Food Directorate with an extension for Supplemented Food TMAL holders.

In addition to the Caffeinated Energy Drink (CED) guidance document that was finalized in 2013, the Food Directorate has published the long awaited final Temporary Marketing Authorization for Supplemented Food Guidance Document this past February. This guidance document has been long awaited by both companies currently developing new formulations, since it provides guidance on acceptable quantities of vitamins and minerals that may be added to a supplemented food, but also by companies whom currently hold TMALs set to expire August 31, 2016.

A few interesting highlights of this new guide are as follows:

• Definition: Supplemented food has been defined as “a pre-packaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements.” A key point here is that it is now permissible to submit a product through the TMA process that contains only herbal or bioactive ingredients (with no vitamin or mineral fortification) for review. Additionally, the guide provides a subset of novel ingredients that are being permitted in the TMA pathway as per Appendix 2 of this guidance document, see more on this below.
• Extension: TMALs set to expire on August 31, 2016 have received an extension to comply with the new guide until February 22, 2017. Although to maintain market access beyond February 22, 2017 you must be compliant with this guide, as well as any other applicable Food and Drug Regulations provisions and provide an updated copy of the TMA and label with a letter outlining the revisions to the formula by August 31, 2016. Acceptable products will then be extended until December 31, 2021.
• 2 Pathway system: Supplemented foods will now be categorized into a pathway system based on the potential for adverse effects. In short the 2 pathways are as follows:
  • Path 1 – Intended for a general subpopulation (children ≥4 years old) with maximum levels of addition of ingredients based on a per serving
  • Path 2 – Intended for a subpopulation  ≥14 years old with maximum levels of addition of ingredients based on a per day. This pathway will also have a threshold for vitamin and mineral fortification which when exceed will trigger specific cautionary labelling statements.
• Revision to vitamins and minerals not accepted for addition: Consistent with the feedback that Health Canada provided in several regulatory sessions, they have amended the list of ingredients not permitted for addition. Importantly calcium and manganese have been removed from this section and are now permitted in Path 2 (products not intended for children) supplemented food products in quantities specified in this guide.
• Novel Ingredients: Appendix 2 of this guidance document has now been populated with specific novel ingredients that are eligible for consideration in a supplemented food product. Although, it is worth noting that when an ingredient from this Appendix is added, the Food Directorate cannot commit to the timelines outlined in their performance standards guidance document, and it could delay the TMAL significantly.
• Unique Identifier: No definitive guidance has been provided yet, but Health Canada has indicated that they are exploring the possibility of a front-of-pack identifier on the label of supplemented foods so that consumers can easily identify them. Health Canada has currently developed several options, which have not yet been disclosed, and will test them with consumers.
• Market Research Protocol (MRP): For companies that have already received TMALs they may be aware that they are required to provide data in the form of a MRP on their product to address data gaps to aid in the development of specific regulations for supplemented foods. While TMAL holders of Caffeinated Energy Drinks have been advised that they are expected to prepare a MRP and collect data in accordance with this protocol, supplemented food holders had not yet been advised that they must begin this requirement. Once a TMAL holder of a supplemented food receives their final extension, as discussed above, they will be advised of their expected research requirements to fulfil this obligation in their Letter of Agreement.

In summary, the finalized Supplemented Food guidance document is an overdue, appreciated guidance regarding the requirements of a fortified food (outside of foods that are already permitted to be fortified in the Food and Drug Regulations). This guidance should help many companies develop unique and novel products that have a legal path to market without worry of Health Canada reformulation requests.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries. We evaluate, implement, and provide all the necessary support for your products and operations to gain market access and build confidence in your brand.