FDA ruling boosts Forbes marketing power
given Canadian company Forbes Medi-Tech a major boost for its
cholesterol-lowering ingredient Reducol.
Forbes Medi-Tech has gained US Food and Drug Administration (FDA) approval for the use of the phytosterol heart-health claim to be applied to its range of phytosterol products, including the cholesterol-lowering ingredient Reducol.
The FDA's action means that the food industry can include statements about the health benefits of Forbes' 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," said Charles Butt, president and CEO of Vancouver-based Forbes Medi-Tech.
"We provided a substantial amount of scientific evidence to the FDA regarding the application of Reducol towards the prevention of coronary heart disease (CHD). I am encouraged bythe FDA's action and the opportunity this represents to advertise the efficacy of our phytosterol products," said Butt.
An interim ruling had authorized a heart health claim for only plant sterol esters and plant stanol esters. 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' manufacturing joint venture Phyto-Source is said to operate the world's largest wood phytosterol manufacturing plant. Earlier this year the company said it has begun shipments under a new agreement with Phyto-Source, and a large unnamed company. Unlike vegetable sterols, wood phytosterols hold acompetitive advantage coming from non-genetically modified organism (GMO) sourced materials.
Forbes is still awaiting approval for the benefits of phytosterol from the European Union.