Altus Phytrol-Enriched Foods Are GRAS, Cantox Report Finds

Altus Food Company likely will launch a line of functional foods and beverages containing Forbes Medi-Tech's Phytrol tall oil phytosterols in the first quarter of 2001.

The line will consist of cereals, food bars, fruit drinks and smoothies, according to information contained in a "GRAS Report for Expert Review" conducted by Bridgewater, N.J.-based Cantox Health Sciences International.

Three to four Phytrol-based products will launch in North America and overseas by April, with the first product appearing on shelves by January at the latest, according to Forbes. The Vancouver-based firm announced Nov. 29 it already has stepped up its shipments of Phytrol to consumer product manufacturers.

The company is increasing its manufacturing capacity for commercial-scale production of the ingredient, and hopes to finalize negotiations with a third-party manufacturer by January.

The Phytrol-enriched food line will be marketed by Altus, a joint venture of Novartis Consumer Health and the Quaker Oats Company created with the express purpose of introducing functional foods. The companies announced the formation of Altus in February (¹ (Also see "Novartis, Quaker Oats Functional Food Launch Planned For Late 2000" - Pink Sheet, 14 Feb, 2000.)).

Novartis has been in the functional food market for about a year, launching its Aviva line of foods for heart, bone and digestive health in Switzerland and the U.K. in late 1999. Products in the line include muesli, orange juice, hot chocolate drinks, biscuits and cereal snack bars (² ).

The Cantox report, filed with FDA in October, concludes the phytosterols in Phytrol have a "low toxic potential," suggesting products with the ingredient "would not cause any adverse effects in humans."

Altus hopes FDA will grant the Phytrol-enriched foods GRAS status after reviewing the Cantox report since they contain the same ingredient found in Reducol - Novartis' vegetable oil spread - which FDA deemed GRAS in April. The spread will compete with Lipton's Take Control - sterol esters - and McNeil Consumer Healthcare's Benecol - stanol esters (³ (Also see "Free Sterols/Stanols Efficacious For CHD Risk Reduction - Novartis" - Pink Sheet, 11 Dec, 2000.)).

Moreover, the amount of Phytrol consumed in functional foods "would be in an amount equal to or less than the amount from Reducol," the report continues.

Cantox tested the intended use of Phytrol in enriched cereals, food bars, fruit drinks and smoothie beverages at doses of .6 grams per serving. The products' recommended dose is three times per day, amounting to a daily Phytrol intake of 1.8 g.

The 1.8 g/day intake is similar to that of the GRAS vegetable oil spread, as "the proposed products are intended to provide consumers with additional product choices with the goal of maintaining a healthy cholesterol level," the report states.

Cantox studied population groups ranging from infants to adults and based its safety assessment on the body of evidence that already exists for sterol and stanol esters.

Phytrol intake was determined by calculating the percentage of the ingredient by weight in the various food forms. Measurements were then taken on a mg and mg/kg body weight basis. The resulting estimates represent three-day projected averages.

Consumption of "ready to eat cereals and ready to drink fruit-drink mixtures made the most significant contributions to the mean per-user intake of Phytrol by the total population," the report states.

However, Cantox notes its measurements of some population groups' intake may be unreliable since the methodology used provides conservative estimates of product consumption. The report also notes results may vary due to the possibility subjects did not take the recommended serving size or consumed the products infrequently.

Forbes licensed the cholesterol-lowering ingredient to Novartis Consumer Health in April 1999. Forbes is responsible for ingredient research and manufacturing, while Novartis is responsible for clinical trials, regulatory approvals and product marketing.

Forbes recently announced the development of a new "designer oil," which also reduces LDL cholesterol levels. An unpublished study on the oil shows a 14.5% reduction in LDL cholesterol in participants consuming meals containing the oil compared to subjects consuming regular oils in their diet. Forbes expects the study to be published within the month.