A regulatory dustup has shaped up between one of the world’s biggest food companies and Canadian food regulators. just-food.com brings you the inside track on: Unilever verus Health Canada in the case of Becel pro-activ margarine.

The squabble features the Unilever subsidiary, Unilever Canada, against Health Canada on the issue of the company’s Becel pro-activ margarine. The point of contention is the margarine’s content of plant sterols.

pro-activ was made available in August 2001, following launches in 19 other countries, including the USA, EU Member States and Australia. The month before the pro-activ release, Unilever launched a public education campaign on the role of plant sterols in a healthy diet (see www.plantsterols.ca)

Sold in 227g tubs wrapped in a distinctive green and white wrap for C$3.99 (U2.51), Unilever is marketing pro-activ as a “heart-healthier food “. Daily use is said to help manage cholesterol.

However in October Health Canada issued an advisory saying that Becel pro-active is not in compliance with the nearly 50 year old Canadian Food and Drug Act and as such, “is not appropriate for consumption by all Canadians.”

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HC spokesperson Ryan Baker says that under existing regulations, any food that makes a health claim is a drug. “Managing cholesterol” is a health claim.

According to Health Canada, Unilever did not receive the required premarket approval before putting the product on the market and therefore the ministry has been unable to assess the risks of exposure of added phytosterols in margarine.

“The product could very well be safe, and it may lower cholesterol, but its not approved for sale in Canada,” says Baker. “The regulations are there to protect the health and safety of Canadians.”

Health Canada notes that in the EU and Australia, pro-activ passed through the premarket review, but is required to carry a label advising certain consumers they may be placed at risk.

Risk groups include pregnant women, children, people disposed to hemorrhagic strokes and people taking cholesterol-lowering medication.

Put under the spotlight by Health Canada’s advisory, Unilever stated that it will overlabel existing stock and add dietary guidelines to its packaging. It has also distributed a new brochure. Curiously, the brochure was made available in some stores where the product was not seen on the shelves.

However, the company is standing behind the safety of its product and tells a different story.

“Health Canada itself reviewed safety data on becel pro-activ for two years and that process was considered complete,” Unilever stated in response to Health Canada’s charges. “Regarding the advisory’s reference to certain individuals at risk of hemorrhagic stroke, Health Canada advised Unilever that it “does not have evidence” and cannot say that consumption of the product would be a health risk.”

Following the public thrusts made in early October the dispute has moved behind closed doors.

“We are in discussions with Health Canada and at this point we have no further comment to make, ” Unilever Canada’s Jen Mullen said late in the month.

HC maintains that it wants to bring Unilever into compliance. Baker says: “There is a whole range of things we could do, up to pulling the product off the shelf.”

But this is something Health Canada has balked at doing to date. The ministry’s goal is to get Unilever to make a drug submission for pro-activ. The margarine would then be given a Drug Identification Number (DIN) allowing it to be sold over the counter in grocery stores, on the same level as products like aspirin.
The benefits of having the margarine available on the market could benefit both individual consumers and Canada’s national health system, currently facing budgetary pressures. For example, a recent UK National Health Service estimate savings by use of these kind of spreads been estimated as high as US$150m (NHS/Med Econ J. 2000).

‘Womb to tomb approach’

Sectoral observers are critical over HC’s regulatory shortcomings on functional foods and nutraceuticals, calling the ministry’s arch conservative stance, a “womb to tomb” approach to protecting Canadian’s health. Compared to the EU, USA and Japan, Canada is held to have the most restrictive regulatory climate, which impacts on consumer access and curtails investment and competition. Regulators are also criticised with being slow to harmonise with regulations in other jurisdictions as well as the underfunding of dietary surveys. In lacking accurate data on Canada’s nutritional health, is challenged in its ability in making risk assessments of new food products.

Canada’s functional foods initiative has been moving slowly since it began in 1996. Some of the long awaited regulations are scheduled to reach the final consultative period at the end of 2001.

By Arthur Hanks, just-food.com correspondent