Phytosterol-based foods: Still seeking a foothold
Phytosterols, also known as plant sterols, are the key ingredient in cholesterol-lowering foodstuffs such as Benecol and Take Control margarine. The health benefits of phytosterols have been recognised since the early 1950s. On the most basic level, the premise is that phytosterols have a similar molecular structure to cholesterol and will compete with cholesterol for absorption in the body.
In 1989, Finland's Raisio Group developed a method for converting plant sterols into a fat-soluble form that was usable in food, which led to the development of Benecol margarine - marketed in Finland in 1995 with great success.
A study published in November 1995 in the New England Journal of Medicine documented a 10% reduction in total serum cholesterol levels and a 14% drop in low-density lipoprotein (LDL) levels among Finnish consumers who used Benecol margarine regularly.
In 1997 Raisio Group granted McNeil Consumer Healthcare, a Johnson & Johnson company, the North American marketing rights to Benecol's dietary ingredient, stanol ester. At about the same time, Lipton (now a unit of Unilever Plc) announced the launch of its cholesterol-lowering spread, Take Control. Key to the success of both products was the FDA's stamp of approval.
A functional food?
McNeil hit a snag in February 1999 however when the FDA denied the company permission to sell Benecol as a functional food product. Lipton, in the meantime, had taken a different route by applying for and receiving FDA's GRAS ("generally recognized as safe") status for its ingredients.
By mid-1999, McNeil had done the same and the race was on - with both companies expecting millions of Americans with high cholesterol to beat a path to their product. But that didn't happen.
At about the same time, a new player entered the market - the Vancouver-based biotechnology company, Forbes Medi-Tech. In 1997 Forbes announced that it had developed a plant sterol ingredient, which it dubbed Phytrol (brand name Reducol), that it planned to sell to licensed food processors to be developed into a myriad of cholesterol-lowering foods. The company touted a proprietary processing technique that produced a phytosterol ingredient that could be used in foodstuffs beyond margarine. Reducol received FDA GRAS status in May 2000.
Convincing the consumers
Despite promises of unlimited new cholesterol-lowering foods - from cookies to salad dressing to drink mixes - consumers were still not buying. Blaming their apparent reluctance on lack of knowledge about the benefits, both McNeil and Lipton/Unilever petitioned the FDA for permission to include a heart-health claim on its packages.
In September 2000 FDA issued an interim final rule which allowed the companies to state that their products had been proven to lower cholesterol and lower the risk of heart disease when part of a diet low in saturated fat and cholesterol. Previously, the FDA allowed labels for the products to say they helped "promote healthy cholesterol".
However, even with the new heart-health label, neither Take Control nor Benecol took off. And plans for new phytosterol-based foods were put on hold or scrapped. In addition, both McNeil and Unilever faced regulatory hurdles in the US and elsewhere.
In October, FDA reopened the comment period for a final rule on the health claims of foods containing phytosterols - noting that both the European Commission (EC) and the Australian New Zealand Food Standards Council (ANZFSC) had taken regulatory actions limiting food use of plant sterol esters and requiring advisory labeling statements on foods to which plant sterol esters have been added. Also, a recent publication from the American Heart Association (AHA) raised a concern about daily ingestion of plant sterol/stanol ester-containing foods among certain individuals who have abnormally high absorption of plant sterols.
Keeping the faith
Nevertheless, the companies continue to press forward, unwilling to give up on this functional food category that some predict will reach US$83bn by 2005. Forbes Medi-Tech continues to make deals with food companies. Currently, the newly formed Altus Food Co., created by Novartis Consumer Health, Inc. and The Quaker Oats Company, is test marketing a handful of food products containing Reducol in upstate New York. And Pacific Foods of Oregon, a manufacturer of non-dairy nutritional products, recently launched a line of Reducol-enriched soy beverages.
Forbes is meanwhile working with dairy and food producers in Australia to market new cholesterol-lowering products and lobbying food agencies in countries like Canada, where phytosterols have yet to be approved, to change their regulations. Raisio, as well, is trying to create new food company partnerships. In February it signed an agreement with Finish meat and food processing company Atria under which the two companies will develop cholesterol-reducing products that are expected to reach the market this autumn.
Also noteworthy is that companies like Cargill, Monsanto and Archer Daniels Midland are also eyeing this market, looking to patent their own plant sterol technologies. In February, Archer Daniels Midland and biotech company Lifeline Technologies announced a licensing agreement for phytosterol technology for applications in foods and beverages, in particular, non-fat and low-fat foods.
Despite some serious bumps in the road, most still expect the market for stanol ester-based foods to grow - granted, not as quickly as first anticipated, but nevertheless to grow just the same - figuring that, sooner or later, consumers struggling with high cholesterol will welcome this grocery store source for better health.
By Pam Ahlberg, just-food.com correspondent
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