VANCOUVER, British Columbia--Feb. 27, 2003-- Forbes Medi-Tech Inc. today announced it has received a letter from the US Food and Drug Administration (FDA) which will allow the use of the phytosterol heart-health claim to be applied to Forbes' range of phytosterol products, including Reducol(TM). The FDA's action provides an immediate opportunity for the food industry to include statements about the health benefits of Forbes' cholesterol-lowering phytosterol ingredients in a variety of food products and dietary supplements.
"The ruling should have a significant impact on our ability to sell our clinically proven product, Reducol(TM)," said Charles Butt, President and CEO of Forbes Medi-Tech Inc. "We provided a substantial amount of scientific evidence to the FDA regarding the application of Reducol(TM) towards the prevention of coronary heart disease (CHD). I am encouraged by the FDA's action and the opportunity this represents to advertise the efficacy of our phytosterol products," said Butt.
Previously, the interim final ruling authorized a heart health claim for only plant sterol esters and plant stanol esters, the substances that were the subjects of the two health claim petitions. However, the FDA now recognizes that there is "substantial additional scientific evidence regarding the cholesterol-lowering efficacy of phytosterols." As a result, pending completion of the final rule, the FDA has stated "it would be appropriate to consider the exercise of enforcement discretion with regard to use of the health claim on a wider range of foods."
Forbes is in a unique position to capitalize on this opportunity. Forbes' manufacturing joint venture, Phyto-Source LP, currently operates the world's largest wood phytosterol manufacturing plant. With an annual production capacity of 1000 metric tonnes, this state of the art facility is dedicated to manufacturing phytosterols of consistently high purity and quality. The plant capacity can be doubled or tripled should product demand warrant expansion. Unlike vegetable sterols, wood phytosterols hold a competitive advantage coming from non-genetically modified organism (GMO) sourced materials. In many international markets, both consumers and food manufacturers have demonstrated a preference for non-GMO based products.
About Forbes Medi-Tech Inc.
Forbes Medi-Tech Inc. is a biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceuticals and nutraceutical products for the prevention and treatment of cardiovascular and related diseases. By extracting plant sterols from wood pulping by-products, Forbes has developed cholesterol-lowering agents to be used as pharmaceutical therapeutics, dietary supplements and functional food ingredients.
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