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
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
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
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