FOR IMMEDIATE RELEASE
Health Canada Announces Proposed New Approach to
Regulating Caffeinated Energy Drinks
Toronto, Canada, October 11, 2011 – On October 6, Canadian Health Minister Leona Aglukkaq announced a new approach to regulating Energy Drinks that would classify them as food products rather than Natural Health Products (NHPs). Up until now Energy Drinks have been regulated as NHPs and are not required to state nutrition information (e.g. Nutrition Facts Panel). Energy ‘shots’ which are dose-based will remain classified as NHPs.
This change in policy goes against the advice of her expert panel, formed nearly a year ago, which recommended they be classified as drugs and sold only in pharmacies. In response, Minister Aglukkaq commented, “I firmly believe that it’s up to individuals and parents to make their own decisions when it comes to what they eat and drink. Today’s announcement will ensure that parents have the information to make the best choice for themselves and their families.”
Health Canada says it intends to initiate the new food requirements as of November 1, 2011 with the assurance that “industry will be given time to adjust to these requirements (e.g. change the labelling practices).” However, it is important to note that this is currently a proposed approach and Health Canada is accepting comments from stakeholders until 12:00am EDT, November 15, 2011
A transition is expected to take 18 – 24 months once the products are deemed eligible to be sold as foods under a Temporary Marketing Authorization (TMA). To meet the requirements for a TMA companies will be subject to data collection related to the product consumption, market share and consumer complaints (incident reporting etc). The TMA is proposed to be valid for 5 years during which time Health Canada will evaluate collected data to determine if its approach for Energy Drinks needs to be modified. Companies may need to reformulate and/or relabel to meet the new requirements.
– General implications of the proposed approach include:
– No requirements for product or site licensing
– Most likely fewer warnings and contraindications needed on the label
– Limited health claims
– Tighter regulations around nutrient and caffeine addition and permitted ingredients (e.g. herbal extracts)
– Requirement for Nutrition Facts Panel on products and full compliance with Food Labelling requirements
Implications of the Composition Requirements:
– Specific requirements will be established to control the types and levels of ingredients added to Energy Drinks; for example, setting minimum and maximum limits for caffeine from all sources (natural and synthetic sources), vitamins and minerals as well as other ingredients e.g. herbal extracts. Currently under the Food Regulations, you cannot add any vitamins, minerals or amino acids to products classified as “Energy Drinks /beverages”. Health Canada will need to provide guidelines as to what will be allowed.
– A maximum concentration of 100 mg of caffeine per 250 ml in all products, not to exceed 180 mg for any single serve product (single serve containers are any containers that can’t be resealed such as a can, or any resealable container that is 591 ml or less)
– Health Canada has determined that any Energy Drink container that cannot be resealed will be treated as a single-serve container. Health Canada has determined that re-sealable containers equal to or less than 591 mL will be treated as single-serve containers.
Implications of the Labelling Requirements:
– Caffeinated Energy Drinks will be subject to all food labelling provisions such as ingredient labelling, nutrition facts panel, allergen labelling etc.
– Health Canada proposes the following additional labelling information requirements:
– The amount of caffeine from all sources in mg per container or serving size.
– A statement on the label identifying the product as a “high source of caffeine” given that an Energy Drink will be required to contain a minimum amount of caffeine that is deemed to be sufficiently high.
– A statement indicating that the product is “Not recommended for children, pregnant or breastfeeding women, and individuals sensitive to caffeine”
– The statement “Do not mix with alcohol”
– Depending on the formulation of the product, additional labelling requirements may be required.
In addition, Health Canada would prohibit the use of caffeinated Energy Drink beverages as an ingredient in pre-mixed alcoholic beverages. They would also require that industry collect data on any consumption incident associated with their products that they receive through consumer complaints. These data would be reported to Health Canada every six months.
Comments on this proposed approach may be submitted in writing, either electronically or by regular mail. If you are submitting your comments electronically, please use the term “Energy Drinks” in the subject box of your e-mail. Comments must be received by 12:00 a.m. EDT, November 15, 2011.
Bureau of Policy, Regulatory and Governmental Affairs
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2202E
Ottawa, Ontario K1A 0L2
Dicentra will continue to monitor the situation and work on behalf of its clients and industry to develop optimal regulatory strategies moving forward.
Dicentra is a leading international scientific and regulatory consulting firm with specialized expertise in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs. For years, we have been helping clients resolve complex scientific issues, develop safe and effective market-leading products, and facilitate timely regulatory global approvals. Dicentra provides regulatory and scientific solutions for accelerated business growth. We can be reached at 1-866-647-3279 or at dicentra.com
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Lydia Hunziker at 416 361 3400 x 229 or email at email@example.com