By Manushvi Chadha, BPharm, RA Cert
NHP, Cosmetic and Drug Regulatory Affairs Associate

All water-based, ready-to-consume caffeinated energy drink products containing caffeine are now deemed foods, though it is to be noted that energy shots are still NHPs.

These drinks are subject to all applicable food product requirements as per the Food and Drug Act and additional requirements are detailed in the guidance document released recently, entitled “Category Specific Guidance for Temporary Marketing Authorization: Caffeinated Energy Drinks”

As per the guidance document;

• The caffeine content must be 200 – 400 ppm (mg / L) from all sources.
• It must be clearly declared on the label per container, or per serving.
• Max allowable amount of caffeine is 180 mg per container or per serving.
• Alcohol is NOT allowed to be mixed in caffeinated energy drinks
• Folic acid and Vitamin A cannot be added to caffeinated energy drinks
• Proposed food must contain no novel ingredient

The guidance document has outlined the minimum and maximum levels of vitamins, minerals and amino acids that may be present in caffeinated energy drinks. Based on these levels, labels must state the number of servings that are not to be exceeded daily.

TMA applications will need to be filed and products that meet all requirements will be issued a TMAL (Temporary Marketing Authorization letter). For most products, it is to be noted that TMALs are temporary and are being issued by Health Canada with the purpose of gathering data related to the product. Health Canada reserves the right to revoke the TMALs, and they have an expiry date of 5 years.

All products with TMAs will be posted on Health Canada’s website. See below for a summary of the transitional process:

https://dicentra.com/wp-content/uploads/2012/04/TMA_Flowchart_UPDATED.pdf

The reference amount for caffeinated energy drinks has been set at 500 ml by Health Canada and may be sold in single or multi-serving containers.

Until a TMAL is issued for a product, it remains under jurisdiction of the Inspectorate, and once it has a TMAL, it will be deemed a food and be under the jurisdiction of the CFIA.

After the TMAL is received, the products cannot to be advertised to or sold to children. Their labels have to have the statement, or equivalent of the statement “High Caffeine content”. Specific cautions related to the restrictions outlined must also be on the label.

The level of bioactive ingredients must be declared on labels if there is a limit specified for the ingredient by the Food Directorate or if there is a monograph for it published by the NHPD or an authoritative source. Specifics regarding label and text placement are detailed in the guidance.

Caffeinated Energy Drinks must be compliant with current allergen labelling requirements for foods, including the enhanced requirements that will be effective Aug 4, 2012. NHPs that are being transitioned will have additional time to comply – until Dec 2013.

Voluntary statements with regards to the nutrient content and health claims may be made as long as they are supported by the Food and Drugs Act though the use of caffeinated energy drinks for sport performance is not supported. Also, “Energy” will not be allowed as part of drink name.

As a condition of their TMAs, manufacturers or distributers will have to undertake consumption incident reporting. A standard form for the reports will be released soon, and these reports will be submitted to Health Canada annually.

Some products that are being transitioned from NHPs will have in them certain additives, such as steviol glycosides, that are not normally permitted in foods. During the transition process, such additives will be allowed to continue to be a part of the formulation under a TMAL. However, a food additive submission will need to be filed to request the approval of new food additives before the TMA expires.

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