Health Canada Proposes Changes to Caffeine as a Supplemental Ingredient

Health Canada Proposes Changes to Caffeine as a Supplemental Ingredient
Andrew Parshad
President & Founder of Quality Smart Solutions

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Health Canada’s proposed changes to caffeine as a supplemental ingredient.Changes are on the horizon for caffeine as a supplemental ingredient, and they could directly impact your business. Whether you manufacture energy drinks, snack bars, or functional beverages, these updates will determine how you formulate and market your products moving forward. 

At the same time, Health Canada is tightening regulations to ensure consumers stay informed and protected, which means businesses must adapt. In this article, we’ll break down exactly what’s changing, why it matters, and what you need to do to stay compliant.  

Keep reading to make sure your business is ready for these regulatory shifts. 

What are the proposed changes? 

Health Canada is updating the List of Permitted Supplemental Ingredients to include new requirements for caffeine use in certain supplemented foods. A key change is the introduction of a mandatory cautionary statement: “Do not [eat/drink] on the same day as any other source of caffeine” for solid supplemented foods containing more than 56 mg of caffeine per serving.  

This applies to products such as chocolate confectioneries, protein-isolate- and cereal-based bars, chewing gums, and the newly proposed category of gummies. 

Additionally, new labelling requirements will take effect, giving businesses until January 1, 2028 to comply. The goal is to enhance consumer awareness and reduce excessive caffeine consumption. 

Health Canada is revising the conditions under which caffeine as a supplemental ingredient can be added to foods. These changes focus on: 

1. Permitted food categories

Limiting caffeine supplementation to specific food and beverage types. 

2. Maximum allowable levels

Adjusting the amount of caffeine permitted per serving to align with safety assessments. 

3. Labelling requirements

Strengthening disclosure to ensure consumers understand caffeine content and potential health impacts. These changes aim to mitigate risks associated with excessive caffeine consumption, particularly among vulnerable populations such as children and pregnant individuals. 

Who will be affected? 

Manufacturers and distributors of supplemented foods, including energy drinks, snack bars, and functional beverages, must assess their product formulations to ensure compliance. Otherwise, non-compliance could result in reformulation needs, relabelling efforts, or even product removal from the market. 

In particular, if your product includes caffeine as an additive, now is the time to review your ingredients and packaging in alignment with the new guidelines. 

List of Permitted Supplemental Ingredients 

Health Canada maintains a List of Permitted Supplemental Ingredients, detailing ingredients approved for use in supplemented foods, along with their specific conditions. Specifically, if your product contains caffeine, it’s essential to check this list to ensure compliance with the latest regulations.  

By doing so, you can help prevent reformulation delays and ensure your products remain on the market. Below, you’ll find a summary of the permitted uses of caffeine as a supplemental ingredient.

 Ingredient Permitted Food Categories Max. Amounts per Serving Cautionary Statements Other Conditions 

Caffeine 

 

Protein-isolate- and cereal-based bars (excluding those for physical performance) 70 mg “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine.” “Do not [eat/drink] on the same day as any other source of caffeine.” Individually wrapped portions required. Label must state “high caffeine content.” 
Chocolate confectioneries, sweet chocolate confectioneries, and milk chocolate confectioneries 56 mg None specified Individually wrapped portions required. Maximum caffeine content per prepackaged product: 400 mg. Label must state “contains caffeine” with specified type height. 
Chocolate confectioneries (excluding those for physical performance) with added caffeine over 56 mg 100 mg “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine.” “Do not [eat/drink] on the same day as any other source of caffeine.” If over 79 mg per serving: “Do not [eat/drink] more than X serving(s) per day.” Individually wrapped portions required. Maximum caffeine content per prepackaged product: 400 mg. Label must state “high caffeine content.” 
Foods in category 8 of the List of Permitted Supplemented Food Categories 50 mg If total caffeine in a multiple-serving product exceeds 56 mg: “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine.” “Do not [eat/drink] on the same day as any other source of caffeine.” Individually wrapped portions required. Maximum caffeine content per prepackaged product: 400 mg. Label must state “contains caffeine” with specified type height. 
Foods in category 6 of the List of Permitted Supplemented Food Categories 56 mg None specified Individually wrapped portions required. Maximum caffeine content per prepackaged product: 400 mg. Label must state “contains caffeine” with specified type height. 
Foods in category 6 of the List of Permitted Supplemented Food Categories with added caffeine over 56 mg 100 mg “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine.” “Do not [eat/drink] on the same day as any other source of caffeine.” If over 79 mg per serving: “Do not [eat/drink] more than X serving(s) per day.” Individually wrapped portions required. Maximum caffeine content per prepackaged product: 400 mg. Label must state “high caffeine content.” 

 

How to stay compliant 

To prepare for the proposed regulatory changes, businesses should: 

  1. Review product formulations: Assess caffeine levels and ensure they align with the new permitted thresholds. 
  2. Update labelling: Ensure packaging includes required caffeine disclosures and safety warnings. Businesses have until January 1, 2028, to comply with new labelling requirements. 
  3. Monitor regulatory updates: Stakeholders can stay informed by signing up for Health Canada’s Consultation and Stakeholder Information Management System (CSIMS). 
  4. Submit feedback: Industry stakeholders can provide input on the proposed modifications until May 21, 2025, by emailing food.ibr-ipr.aliments@hc-sc.gc.ca with “caffeine (P-SIS-25-01)” in the subject line. 
  5. Consult compliance experts: Work with regulatory specialists to navigate changes efficiently. 

Why this matters for your business 

Regulatory changes can impact product development timelines, marketing strategies, and overall brand reputation. Therefore, staying ahead of compliance updates helps prevent costly disruptions and ensures consumer trust in your products. 

At Quality Smart Solutions, we specialize in helping businesses navigate evolving regulations. If you need assistance ensuring compliance, contact us today or fill out the form below.

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Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.
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