Supplemented Food Regulations & Supplemented Foods Facts Table (SFFT)

Are you worried because your products are not meeting the FDR regulations? Fret not. Our regulatory affairs specialists will help you navigate the complex Supplemented Foods Regulations.

Supplemented foods are prepackaged foods with added vitamins, minerals, amino acids, and/or other ingredients such as caffeine. These foods must meet certain requirements to be eligible for sale in Canada. The Supplemented foods regulations and the documents incorporated by reference into the Food and Drug Regulations outline the requirements for supplemented foods including compositional and labelling requirements.

What are supplemented foods?

Supplemented foods are those that have been fortified with additional vitamins and minerals, amino acids, and/or other ingredients such as caffeine. These products can be purchased in grocery stores or at pharmacies and may be identified by their marketing name or a statement on the product packaging.

When it comes to supplemented foods, Health Canada has established the following:

List of permitted supplemented food categories – which lists all the food categories that are permitted to be supplemented
List of permitted supplemental ingredients – which list of all the supplemental ingredients that are permitted in supplemented foods, along with conditions of their use

Food and Drug Regulations: Amendments Limitations

Health Canada recently announced Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) published in the Canada Gazette, Part II on July 20, 2022. Before these regulations came into force, Health Canada let certain supplemented foods be sold through an interim measure known as the Temporary Marketing Authorization (TMA). Although the TMA process is no longer required, Health Canada is giving those who held a valid TMA a transition period (ending on December 31, 2025) for their supplemented foods to become compliant with the new regulations.

Products eligible for the transition include supplemented foods that had a valid TMAL at the time of coming into force, as well as products that applied for a TMAL before the coming into force of the regulations and subsequently received a Health Canada notification. Any new supplemented food, other than those previously mentioned as eligible for the transition period, coming onto the market after the coming into force of the food regulations (conventional vs. supplemented foods), will be required to immediately comply with the new regulations.

Supplemented Food Facts Table (SFFT) Requirements

The Supplemented Food Facts Table (SFFt) is similar to the Nutrition Facts Table (NFT) which is required for prepackaged food products. The SFFt requires the name and absolute amount of each supplemental ingredient under the “Supplemented with” heading. When vitamins, minerals, amino acids, or other supplemental ingredients are added to a product, they will also be included under this heading. A statement to interpret this requirement will be mandatory on supplemented foods to clarify that the amounts of supplemental ingredients declared by the SFFT include both supplemental and naturally occurring quantities. Sample SFFt formats are available on the Health Canada website.

Cautionary Statements & Identifier List

There are certain ingredients or levels of ingredients that may trigger a requirement for a supplemented food product to include cautionary statements on the label. Warnings must be separated from other information on the label and appear in a way that you can understand them easily. Supplemented food products must also display an “SFCI” (Supplemented Food Caution Identifier) on the principal display panel. The SFCI will show the word “Supplemented” and also have an exclamation mark to prevent any confusion.

Supplemented Foods Regulations Transition Timeline

As of July 21, 2022, all TMA approvals for existing supplemented foods on the market will expire. Health Canada will continue to process TMA license applications that have already been submitted, but existing supplemented foods on the market approved under the TMA framework will have until Jan 1, 2026, to become compliant with the new regulations

Permitted Supplemented Food Categories and Ingredients by Health Canada

List of Permitted Supplemental Ingredients: This list will capture substances that might be added to a specific food as a supplemental ingredient grouped as; mineral nutrients, amino acids, vitamins, etc. The conditions of use for each supplemental ingredient are also very detailed. Some examples of this could include the maximum levels of use in a product and ingredients that trigger an SFCI or cautionary statement.

List of Permitted Supplemented Food Categories: This list captures the various categories of food for which supplemental ingredients can be added. Various categories of food are exempt from the category like alcohol and fortified foods.

Health Canada can update these lists, and stakeholders can request changes (including additions, removals, or modifications) through a premarket submission process. This submission must be accompanied by supporting information demonstrating that the proposed change would be safe for Canadians.

Regulatory Experts help to prevent pitfalls/refusals

Regulatory Precision: Regulatory experts possess an in-depth understanding of the complex and ever-evolving regulations governing supplemented foods. They ensure your Supplemented Foods Facts Tables adhere to all relevant standards, avoiding costly compliance issues.
Comprehensive Knowledge: These experts stay updated on the latest regulatory changes and requirements, guaranteeing that your product labels reflect current guidelines, thereby reducing the risk of non-compliance.
Risk Mitigation: Regulatory experts are adept at identifying potential compliance pitfalls and addressing them preemptively. This proactive approach minimizes the risk of regulatory fines, product recalls, or legal actions.
Consumer Trust: Accurate and compliant Supplemented Foods Facts Tables enhance consumer trust. When customers perceive your products as transparent and trustworthy, they are more likely to make informed purchasing decisions.
Competitive Advantage: Compliance can set you apart in a crowded marketplace. Regulatory experts ensure that your products stand out for their adherence to quality and regulatory standards, giving you a competitive edge.
Resource Optimization: By outsourcing regulatory tasks to experts, you free up your internal teams to concentrate on core business activities like product development and marketing, improving overall efficiency.
Time Efficiency: Regulatory experts streamline the compliance process, expediting the time it takes to get your products to market. This can be a game-changer in the fast-paced world of supplemented foods.
Global Expansion: If you have ambitions for international markets, regulatory experts can navigate the complexities of various regulatory frameworks, enabling smooth global expansion.
Cost Savings: While it may seem like an additional expense, utilizing regulatory experts often results in cost savings. Their proficiency minimizes the risk of costly compliance errors or delays, optimizing your budget.
Legal Compliance: Non-compliance can lead to legal repercussions. Regulatory experts ensure your business operates within the bounds of the law, shielding you from legal complications.
Product Integrity: Accurate labeling reinforces the integrity of your products. Regulatory experts help maintain product consistency and quality, which is essential for long-term success.

Frequently Asked Questions

What criteria do I need to qualify for a TMA license?

All supplemented foods and beverages must meet the following general criteria to be eligible for a TMA License:

The supplemented food must be safe for use under TMA conditions
The food must be pre-packaged
They must contain a non-compliant vitamin, mineral
Must have amino acid and an unapproved novel food
They shall neither contain alcohol nor be represented as water

What is a Temporary Market Authorization (TMA License)?

A Temporary Market Authorization (TMA) is issued for foods that fail to meet the Canadian Food and Drug Regulations (FDR). The purpose of TMA is to allow marketing of food so that specific data can be gathered and evaluated by Health Canada with the ultimate goal of finalizing an amendment to the FDR.

What foods & beverages require a TMA License?

Products that may require a TMA are foods and beverages supplemented with minerals, vitamins or other bioactive ingredients (for example, the addition of Omega-3 in orange juice). On a successful TMA submission, a Temporary Marketing Authorization License (TMAL) is issued by Health Canada, signifying official approval.