By Sara ZborovskiRegulation Research & Development Health & Wellness Ingredients & Additives NHPs sweeteners
Why are Canadians missing out on the latest in low-sugar foods?
Stevia, the controversial sugar substitute, once again made headlines when it was recently approved for use as a sweetener in a range of foods and beverages in the EU. The EU agency’s recent decision approving stevia means that, as of Dec. 2, 2011, food and beverage manufacturers in the EU can use this zero calorie, sweetening powerhouse in foods and beverages. This is something they’ve been able to do in the U.S. since 2008 when the FDA first determined that stevia was GRAS (“generally recognized as safe”) for use as a sweetener in foods and beverages.
This decision adds to food and drink manufacturers’ arsenal in the war against sugar, sweetening the pot of options for use in the preparation of sugar-free foods and beverages. The approval comes at a time when companies are being pushed to develop great-tasting, sugar-free foods for increasing numbers of the population on sugar-restricted diet.
Canadian approval still missing
Despite approval by the FDA, and most recently the EU, Health Canada has yet to approve the use of stevia in foods or beverages. In Canada, stevia leaves (fresh, dried or powdered) can be sold for personal use, and stevia and its extracts has been approved by Health Canada for use as a sweetener and a medicinal ingredient in natural health products (NHPs). However, foods or beverages containing stevia leaves or stevia extracts are still a no-no.
So what gives? In Canada, foods and NHPs are subject to different regulatory standards. In the context of a food or beverage, Health Canada classifies stevia as a food additive, which makes it subject to a full safety evaluation before it can be used.
More specifically, Health Canada requires, among other things, data establishing that the food additive will have the intended physical or other technical effect, and detailed reports of tests done to establish the safety of the food additive for use under the proposed conditions. According to Health Canada’s website, it has yet to be provided with sufficient safety information to support approval of stevia extracts as a food additive, however it is open to receiving submissions.
Proven safety and efficacy
In contrast, approval of a NHP requires information that supports the safety and efficacy of the NHP when used in accordance with the recommended conditions of use. Stevia also meets the definition of a NHP (for example it is an extract of a plant), and it appears as though companies have leveraged this different – and arguably lower – regulatory standard to obtain approval of products via the Natural Health Products Regulations rather than the Food and Drug Regulations as they pertain to food additives. For instance, Pepsi Co. markets a vitamin-infused Aquafina water beverage sweetened with PureVia, its own brand of stevia, and Tropicana markets Trop50. Both of these low-sugar juices are making headlines and are widely advertised on television featuring actress Jane Krakowski and a varying cast of buff men.
To date, it does not appear that any company has convinced Health Canada that stevia is safe for use as a food additive. In the end, among other things, what we Canadians are missing out on is access to the newest (and possibly tastiest) in low-sugar foods, including chewing gum, dairy products, candies and canned foods.
Stay tuned though – certainly someone will provide Health Canada with evidence similar to that which was provided to the U.S. and EU regulatory authorities to support its approval for use as a food additive, right?
Sara Zborovski is a partner at Gilbert’s LLP in Toronto, practicing food, beverage and drug law. Read her blog at www.thefoodlawyer.ca
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