Supplemented Foods Proposed Regulatory Framework

Supplemented Foods Proposed Regulatory Framework

Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent Health Canada webinar indicated new proposals/consultation could be on the horizon. Health Canada anticipates publishing a new draft regarding the Supplemented Foods Regulations shortly (June 2021) in Canada Gazette Part I. Until now, supplemented foods have been regulated under a Temporary Market Authorization Licence (TMAL) in Canada.

What They Heard

Industry indicated that new regulations and guidelines must/should be able to capture the following: allow for innovation, limit pre-market burden, consider existing TMAL formulas and their ingredients, and allow health claims. 

Limiting Innovation: 12 categories of supplemented foods would be available to start. Additional categories could/would be added/considered upon safe review. 

Pre-Market Burden: Majority of existing TMALs could go straight to market under this new framework. Required information to proceed would be published in regulations or guidance. 

Permitted ingredients: Majority of TMALs would be able to remain the same/unchanged under the new framework. Some changes would be required based on upper limits to specific ingredients. Approximately 6.5% would require reformulation.  

Health Claims: Limiting claims that contradict required risk statements is a priority. Such as liver benefits when a liver caution is required. Some claims would not require notification. Some higher risk claims would require review prior to marketing.

Canada Gazette Part I, Prepublication:

Upon publication, the documentation will include Regulatory Impact Analysis Statement, List of Permitted Supplemented Food Categories, List of permitted supplemental ingredients, Directory of Supplemented Food Facts Table Formats, Directory of Supplemented food caution identifier specifications, Supplemented food guidance document. 

Established 12 Categories Proposed Upfront:

  1. Carbonated and non-carbonated water-based beverages including concentrates and mixes 
  2. Caffeinated energy drinks including mixes
  3. Fruit and vegetable drinks from fruit and vegetable concentrates
  4. Fruit and vegetable based smoothies
  5. Juices
  6. Protein beverages including mixes other than workout supplements
  7. Single serving prepackaged tea, coffee, and herbal infusions
  8. Bars
  9. Hard, soft and semi-soft candies
  10. Chocolate confectionery
  11. Chewing gums
  12. Ice pops

Supplemental Ingredients:

Charts are being proposed for each ingredient allowable in Supplemented foods, based on the category of product to be used. 

For example: Vitamin A: limit of 745 mcg per serving size.

For example: Magnesium as a List 1 category up to 175 mg, and up to 23 mg for a List 2 category product allowed per serving size.

Amounts/limits for amino acids will be published for supplementation in specific categories as well. 

For example: up to 1537 mg Leucine per serving size. 

Cautionary statements may be required per category, should an ingredient surpass a certain threshold. 

Caffeine:

150 ppm would be regulated under the food additive framework, not as a supplemented food.

Over 150 ppm would be considered a caffeinated energy drink. Where any new uses would require a pre-market review. 

Other ingredients would have set limits when formulated with caffeine as well. 

Not recommended for those under 14 years old, would be a required risk statement. 

List Modification:

Modifications will be able to be made to the List of Permitted Food Categories and List of Permitted Supplemental Ingredients by request. (Additions, removals, changes, etc.)

Changes would require sound rationale and support, The process to make updates will be explained in the regulations and guidance documents. 

Supplemented Food Facts Table:

The table Would include various formats such as: standard, narrow, horizontal, simplified, linear, aggregate, dual, etc. Like the Nutrition Facts Tables. 

They are also proposing a front of package text box to signify this is a supplemented food.

The size of the SFCI would be dependent on the label and principal display surface size. There also would be an additional smaller/boxier version available. 

Post Market Monitoring:

Based on TMAL data reviewed by Health Canada, Supplemented Foods were generally found to be safe. However, Incident reporting and post market requirements still showed some gaps to be addressed.  Health Canada is recommending the CFIA be a single window for post market monitoring for follow ups and recalls. Collaboration between HC, CFIA and Poison Control are important to ensure these products are properly overseen. 

Proposed Transition:

There is a 3-year proposed transition once the regulations are published. Current TMAL products would still be exempt from the Food and Drug Regulations during this period until the coming into force date. These products can remain on market with an existing and compliant Nutrition Facts Table and ingredient listing. Anything submitted prior to the coming into force would also qualify for the transition up until the deadline.  After the label coordinator policy is finalized a compliance date would be set that likely aligns with the transition period.  

Proposed Timelines:

April – May 2021: Stakeholder engagement sessions

June 2021: Canada Gazette Part 1 Publication. (Target)

Summer 2021: 60-day consultation period, technical briefings for stakeholders

*All current TMALS will be extended until the regulations come into force. *

How Quality Smart Solutions can help:

If you would like to be involved in the consultation period (Summer 2021) or have any questions once the draft regulations are released, reach out to our team!

Please also contact our team for more information on food safety, food classification, formula review, labelling projects or for your importing needs. Our specialists are here to help!

Resources:

Health Canada Webinar 2021

How We Can Help

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