Health Canada has recently released a revised Category Specific Guidance for Temporary Marketing Authorization – Caffeinated Energy Drinks. The initial guidance was developed during the transition of caffeinated energy drinks (CEDs) from the natural health product regulatory framework to the food regulatory framework. Now that the transition process is complete, the guidance document has been updated to reflect this fact, as well as provide additional guidance and revised requirements for CED products.
The guidance document includes additional clarification on the types of products that do not qualify as CEDs, including drinks dispensed by fountain machines where the necessary labelling requirements cannot be met and there is a greater possibility of overconsumption. CEDs also do not include “energy shots,” defined as pre-packaged, ready- to-consume products containing 90 mL or less, and meant to be consumed in a single dose. CEDs with a volume of 125 mL or greater will be regulated as a food, while caffeinated products that are between 90 mL and 125 mL will be classified on a product-by-product basis taking into account product representation.
In addition, the guidance specifies that CEDs are predominantly water-based but cannot be represented as flavoured or sweetened water. CEDs cannot be dairy-based beverages, soy beverages, rice beverages, almond beverages, or similar plant beverages and they cannot contain, singly or in combination, 25% or more fruit and/or vegetable juice, puree or pulp, as consumed or include the words “juice”, “puree” or “pulp” outside of the ingredient statement.
There are also changes in the guidance affecting product composition. The maximum permitted amounts of some vitamins, minerals and amino acids have been revised: niacinamide maximum is 126 mg per day (down from 450 mg); pantothenic acid maximum is 100 mg per day (up from 60 mg); and L-Arginine, L-Isoleucine L-Leucine, L-Lysine, L-Theanine and L-Valine maximum is 300 mg per amino acid per day (versus 300 mg per day combined). The guidance specifies that the addition of nicotinc acid is not recommended in light of flushing that arises from consumption, and reiterates that all food ingredients and food additives (other than caffeine) must be compliant with the Food and Drug Regulations.
With respect to labelling and advertising, the revised guidance has a new section with information on including “caffeinated energy drink” as the statement of identity on the principle display panel when this is not clear from the product name. There is also a new recommendation to include statements to the effect of “this product may not be suitable for everyone” and “always read the label and follow directions for use” in product advertisements. Lastly, the guidance now specifies that children are 12 years of age and under, consistent with the definition of children that has been used in previously issued Temporary Marketing Authorization Letters (TMALs).
The above highlights only some of the key changes in the new CED guidance. Health Canada has recognized that some CEDs with TMALs may not be compliant with the revised CED category criteria and has committed to working with affected companies to bring the products into compliance over the next several months. As more information becomes available from the research TMAL holders are required to complete and provide to Health Canada, and the regulatory amendment process moves forward, there may be additional revisions to the CED category requirements resulting in product re-formulation or re-labelling.