Advisory

2001-106
October 3, 2001

Health Canada advises that Becel™ Pro-activ™ not approved for sale

OTTAWA - Health Canada is advising consumers that Becel™ Pro-activ™, which has been recently introduced onto the market, is not in compliance with the Canadian Food and Drugs Act and Regulations. There is also evidence to suggest the product is not appropriate for consumption by all Canadians. Becel™ Pro-activ™, made by Unilever Canada Limited, is a fat spread manufactured with added plant sterols (phytosterols) for the purpose of reducing blood cholesterol levels.

Prior to introducing Becel™ Pro-activ™ onto the Canadian market, Unilever did not receive the required approval from Health Canada. The department has therefore been unable to properly assess the effects of exposure to this product with added phytosterols. Phytosterols, while being acknowledged for lowering cholesterol, may pose health risks for certain groups, such as: pregnant women, children, people predisposed to hemorrhagic strokes and people on cholesterol-lowering medication.

In the European Union and Australia where Becel™ Pro-activ™ has passed through the necessary premarket review procedures, it is required to carry a label advising that certain consumers may be placed at risk by consuming the product. Health Canada advises anyone who has been using this product and has concerns to consult their physician.

Health Canada continues to monitor the situation carefully and will take appropriate action to bring this product into compliance with Canadian regulations.

Media inquiries:
Ryan Baker
Health Canada
(613) 941-8189