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| | Mon Jun 11, 2001
New Regulations Affecting Phytosterol-based Food Products in Australia
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| | Vancouver, British Columbia - June 11, 2001 - Forbes Medi-Tech Inc. (TSE:FMI and NASDAQ:FMTI) today announced that the Australia New Zealand Food Authority (ANZFA) regulations governing novel foods, including foods containing plant sterols, will come into force on June 16, 2001. As a result, previously unregulated novel foods, including the products test launched in the last year containing Forbes' cholesterol-lowering functional food ingredient Phytrol(tm) (branded as Reducol(tm)), may now only be sold in Australia and New Zealand after June 16 with regulatory approval.
In anticipation of these regulations coming into force, Novartis Consumer Health Australiasia Pty Ltd. filed an application with ANZFA for regulatory approval for products enriched with Reducol(tm). The application is currently being reviewed by ANZFA.
These regulations are the first which govern the sale of novel foods in Australia and New Zealand. According to ANZFA, the regulations have been developed specifically to ensure that the numerous technological developments in the food industry are matched by appropriate safety evaluations.
The first products to receive approval under these new regulations are edible oil spreads (margarines) containing sterol esters. Food manufacturers are voluntarily withdrawing all other sterol-based products from the Australian and New Zealand markets pending regulatory approval.
The new regulations in Australia and New Zealand are in line with regulations in other countries which also require safety assessments. Reducol(tm) is currently under regulatory review in Europe, and has previously undergone safety assessment in the U.S., obtaining GRAS ("Generally Recognized as Safe") status in the U.S. for use in specified foods.
Last month, the National Cholesterol Education Program (NCEP) Expert Panel in the U.S. issued updated clinical guidelines for the treatment and prevention of high cholesterol. One of their specific recommendations for therapeutic lifestyle changes was to encourage increased consumption of plant sterols/stanols as part of a healthy diet. The NCEP recommendations inform and instruct physicians to make their patients aware of phytosterol-enriched foods which may be purchased and consumed as part of lifestyle changes to control high cholesterol.
Unlike other functional food products currently on the market, (phytosterols esterified with fatty acids), Reducol(tm) is comprised of free sterols with no attached fatty acids. The unique physical properties of Reducol(tm) allow it to be incorporated into a variety of food classes, both fat-based and non-fat foods, as part of a healthy diet.
Phytosterols, also known as plant sterols, are a naturally occurring class of compounds found in the cells and membranes of plants. These plant lipids are present in varying concentrations and compositions in all grains, fruits and vegetables. Most people consume 200 - 300 mg per day of phytosterols as part of a normal healthy diet. Numerous research studies have shown that consumption of an additional 1-2 grams of phytosterols on a daily basis can safely and effectively block cholesterol absorption in the intestine and lower blood cholesterol levels significantly.
More than ten clinical studies over several years have been conducted on Reducol(tm) to determine its safety and efficacy. An important study published in 1999 in the American Journal of Clinical Nutrition showed the relative decrease in LDL cholesterol when hypercholesterolemic (higher than normal cholesterol levels) subjects on a low-fat diet consumed 1.8 grams of Reducol(tm) per day in margarine compared to a control margarine. The combined effects of Reducol(tm) and the polyunsaturated fatty acids in the base margarine resulted in an average 24 per cent lowering in LDL over the four-week study, compared to people only on the low-fat diet who experienced a decrease in cholesterol of nine per cent.
At the recommended dose, Reducol(tm) does not disturb the absorption of vital, fat-soluble pro-vitamins such as carotenoids. Reducol(tm) is also calorie-free and contains no genetically-modified plant material.
Forbes Medi-Tech Inc. is a diversified health Sciences Company dedicated to the research, development and commercialization of innovative nutraceutical and pharmaceutical products derived from nature. By extracting plant sterols from wood pulping by-products, Forbes is developing cholesterol-lowering agents to be used both as functional food ingredients and pharmaceutical therapeutics in the battle against heart disease. Forbes is also developing innovative fermentation technology that converts plant sterols into pharmaceutical fine chemicals, essential in the production of various pharmaceutical steroids such as contraceptive agents and anti-inflammatories. Phytrol(tm) is a registered trademark of Forbes Medi-Tech Inc.
For more information, please contact:
Martin Livingston
Director, Investor Relations
Telephone: (604)-681-8976
E-mail: irinfo@forbesmedi.com
Website: www.forbesmedi.com
The NASDAQ National Market and the Toronto Stock Exchange have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. This press release contains certain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934, which statements can be identified by the use of forward looking terminology, such as "may", "will", "expect", "anticipate", "estimate", "predict", "plans" or "continue" or the negative thereof or any other variations thereon or comparable terminology referring to future events or results. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including the risk of technical obsolescence, intellectual property risks, marketing/manufacturing and partnership/strategic alliance risks, any of which could cause actual results to vary materially from current results or the Company's anticipated future results. See the Company's reports filed with the Toronto Stock Exchange and the U.S. Securities and Exchange Commission from time to time for cautionary statements identifying important factors with respect to such forward-looking statements, including certain risks and uncertainties that could cause actual results to differ materially from results referred to in forward-looking statements. The Company assumes no obligation to update the information contained in this press release. |
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