Vegetable Oil Sterol Esters Heart Disease Claim Sought By Lipton

Spreads and salad dressings bearing a proposed health claim for vegetable oil sterol esters (VOSE) and a reduced risk of heart disease should be exempted from "total fat" and "low fat" disqualifying levels, Lipton urges FDA in a citizen petition recently made available by the agency. Certain levels of fat and cholesterol can prevent an otherwise qualified product from being able to use a health claim.

In a Feb. 1 filing, the Unilever division, which markets the cholesterol-lowering spread Take Control with plant sterol esters, requests FDA authorize a health claim for spreads and salad dressings containing a minimum of 1.6 g VOSE per reference amount customarily consumed. Take Control spread contains 1.65 g sterol esters per serving.

"For a health claim, the disqualifying level for fat is 13 g per reference amount, per serving, and for foods with reference amounts of 30 g or two tablespoons or less, per 50 g," Lipton says.

Since spreads and salad dressings both have reference amounts </=30 g and two tablespoons, "the disqualifying level is calculated on a 50 g basis. Spread products typically contain fat levels above the disqualifying level," the petition states.

"Consumption of vegetable oil sterol ester-containing spreads and salad dressings is intended to substitute for pre-existing consumption of similar foods," Lipton notes. "Therefore, consumers would not be expected to experience a net increase in fat consumption."

The minimum effective level of VOSE - 1.6 g/d - would be provided in a single serving of food, the company states. "Since the average consumption of spreads and dressings is 11.4 g/d and 40 g/day respectively, substitution of VOSE-containing spread and dressings would not result in a significant change in levels of fat consumption," Lipton maintains.

Lipton says no increases in fat intake were observed in large clinical trials conducted in 1998 and 1999, where subjects were asked to replace their usual intake of spreads with spreads containing sterol esters.

However, Lipton asserts spreads and dressings must meet the nutrient content requirements for "low cholesterol" and "low saturated fat" to carry the proposed health claim.

The company also requests salad dressings be exempted from the requirement that a food is ineligible to carry a health claim unless it contains 10% or more of the Reference Daily Intake or Daily Reference Value of vitamin A, C, iron, calcium, protein or fiber per reference amount prior to any nutrient addition.

Dressings provide various nutrients, including vitamins E and K, although not at the 10% level, and are consumed with other nutritious foods, making nutrient-rich salad ingredients more appealing, the firm argues.

Lipton hopes VOSE will become the fourth food component authorized to carry a health claim regarding coronary heart disease. Oat foods, psyllium fiber and, most recently, soy protein have received FDA-approved health claims based upon their ability to lower cholesterol levels as part of a diet low in saturated fat and cholesterol (¹ (Also see "Soy Protein Health Claim For Reduced Heart Disease Clears FDA" - Pink Sheet, 25 Oct, 1999.)).

Lipton presented FDA with summaries of 15 studies describing the effects of plant sterols and sterol esters on cholesterol metabolism in humans, as well as 18 animal studies.

"From the data presented, it can be concluded that consumption of 1.6 g/d VOSE (equivalent to 1.0 g/d sterol) will significantly reduce total- and LDL-cholesterol by about 5% and 7%, respectively. These reductions are clinically significant; accomplished in the U.S. population, a 10%-15% reduction in CHD risk could be expected," the company says.

"Consumption of higher levels of VOSE, about 3 g/d (which appears to be optimum), has been reported to decrease total cholesterol about 10% and LDL-cholesterol by 13%. This could lead to a 20%-25% reduction in CHD risk," Lipton reports.

In further support of its petition, Lipton submitted statements from various experts in the field of lipids and health who concur "there is significant scientific agreement that 1.6 g/d VOSE will significantly reduce total- and LDL-cholesterol levels."

In asserting the safety of VOSE in up to 1.6 g/serving in spreads and dressings, the firm notes "extensive human safety information from published clinical studies on plant sterols is pertinent in establishing safe exposure limits."

"There are a number of these studies, including studies of high doses (up to 25 g/d), over a long term (up to three years). Over 1,800 people have participated in these trials, and some studies involved children and adolescents," the firm says, adding, "no adverse health effects have been reported." Furthermore, extensive animal and in vitro safety testing has been conducted on VOSE, "with no evidence of any adverse effects."

In giving Lipton the go ahead in April 1999 to market Take Control, FDA said it had no questions regarding the company's conclusion that plant sterol esters are generally recognized as safe. Nevertheless, FDA directed Lipton to "continue to monitor, through scientific studies or otherwise, consumers' dietary exposure" to the product's active ingredient (² (Also see ""Functional" Margarine Long-Term Effects Monitoring Advised By FDA" - Pink Sheet, 31 May, 1999.)).

The agency issued similar findings in allowing McNeil Consumer Healthcare to market Benecol, a spread containing plant stanol esters.

One FDA consideration in the approval of an official health claim is the effect the claim might have on dietary habits, including possible increased consumption of the food substance bearing the claim.

Lipton launched Take Control spreads in May 1999, extending the line in September with three flavors of cholesterol-lowering salad dressings. However, both Lipton and McNeil recently discontinued shipments of their respective dressings (³ (Also see "Salad dressings discontinued" - Pink Sheet, 1 May, 2000.)).

The requested health claim is limited to spreads and salad dressings because the GRAS determination for VOSE covers only those foods, according to Lipton. Lipton recommends two servings of Take Control daily "to help lower your bad cholesterol levels up to 10%."

Lipton proposes several model health claims, including "1.6 g of vegetable oil sterol esters a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ g of vegetable oil sterol esters."

Other proposed claims include: "Diets low in saturated fat and cholesterol that include 1.6 g of vegetable oil sterol esters may reduce the risk of heart disease. One serving of [name of food] provides __ g of vegetable oil sterol esters" and "[Name of food], containing vegetable oil sterol esters, may lower LDL-cholesterol levels and reduce the risk of heart disease. The minimum recommended level of vegetable oil sterol esters in the diet is 1.6 g; this food contains __ g."