Benecol, Take Control Marketing Highlight Approved CHD Health Claims

McNeil Consumer Healthcare's Benecol spread will soon be carrying labeling stating it can reduce the risk of coronary heart disease, the company said. The new labeling follows FDA's Sept. 8 approval of McNeil's health claim petition.

A sticker, to be affixed to tubs of Benecol, will read: "Proven to reduce cholesterol! 3.4 grams of plant stanol esters daily, added to a diet low in saturated fat and cholesterol may reduce the risk of heart disease. Benecol spread contains 1.7 g of stanol esters per serving."

"See nutrition information for fat content" also will appear on the additional labeling. The changes will be made as soon as possible, McNeil said.

The firm stated it also will modify its professional marketing strategy to reflect the newly-approved claim. Materials provided to physicians will contain information regarding Benecol's ability to reduce the risk of heart disease.

Lipton also has been quick to promote FDA's approval of its health claim petition, linking sterol esters to reduced risk of CHD. The Unilever division initiated a newspaper ad campaign just a few days after the agency released its decision.

A full-page ad running in the Sept. 8 Washington Post declares: "Big news from the FDA on reducing your risk of heart disease. (Oh, we're talking huge)."

The ad features a tub of Take Control and shows new packaging including a red heart icon containing the words "Heart Healthy!" and a banner statement emphasizing the product "Helps lower cholesterol levels" and "May reduce the risk of heart disease."

More detailed references to the FDA decision, as well as to a "recent independent study" indicating sterol esters lower total and LDL cholesterol, appear in small print at the bottom of the ad.

"From a public health perspective, the FDA's decision stresses the importance of promptly informing consumers of new knowledge about the health benefits of foods," Lipton said in response to the agency ruling.

FDA approved the coronary heart disease risk reduction claims for stanol and sterol ester-containing products under an interim final rule published in the Sept. 8 Federal Register.

The decision came in response to health claim petitions filed by McNeil and Unilever's Lipton division.

Lipton filed its petition Feb. 1, requesting that FDA approve a health claim stating 1.6 grams per day of vegetable oil sterol esters may reduce the risk of heart disease (¹ (Also see "Vegetable Oil Sterol Esters Heart Disease Claim Sought By Lipton" - Pink Sheet, 22 May, 2000.)). McNeil filed its petition Feb. 10, proposing that a similar claim be allowed for products providing 3.4 g plant stanol esters daily (² (Also see "Plant Stanol Esters Enhance Rx Cholesterol Drugs - McNeil Petition" - Pink Sheet, 5 Jun, 2000.)).

McNeil also suggested FDA approve a health claim stating 5 g of plant stanol esters per day is "more effective in reducing cholesterol and may further reduce the risk of heart disease." However, the agency found that scientific evidence does not yet support the benefits of higher stanol ester intakes in the diet.

While FDA did not fully adopt the amounts suggested by McNeil, based on the "totality of publicly available evidence," the agency concluded that both ester substances "may reduce the risk of CHD."

In addition, FDA opined that "risk factors for CHD include high total cholesterol levels and high levels of low density lipoprotein (LDL) cholesterol" and specifically concluded "plant sterol esters and plant stanol esters may reduce the risk of CHD by lowering blood cholesterol levels."

The interim final rule could help bolster sales for both McNeil and Unilever's functional food lines. Since their introduction to the U.S. market in the spring of 1999, the Benecol and Take Control brands have not fared well.

For the 52 weeks ending Aug. 13, sales for the Benecol spread were $27.6 mil., representing a miniscule 2.2% dollar share in the margarine/spreads/butter blends category, according to data from Chicago-based Information Resources, Inc. Take Control sales for the period totaled $27 mil., while Take Control Light sales represented less than a .5% dollar share with $5.2 mil. in annual sales.

In response to the slow sales, both companies have scaled back their product offerings. McNeil discontinued its Benecol salad dressings in the spring and recently decided to pull its stanol-ester containing bars (³ (Also see "Benecol" - Pink Sheet, 31 Jul, 2000.)). The firm also has redefined its marketing strategy to focus on physicians rather than consumers.

Unilever also has discontinued its Take Control salad dressings, citing a desire to focus its efforts on promoting its spread (⁴ (Also see "Salad dressings discontinued" - Pink Sheet, 1 May, 2000.)).

One of the approved sterol ester health claims reads: "Foods containing at least 0.65 grams per serving of plant sterol esters, eaten twice daily with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. A serving of [name of the food] supplies ____ grams of vegetable oil sterol esters."

Another version states: "Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 1.3 grams of vegetable oil sterol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ____ grams of vegetable oil sterol esters."

In approving the sterol ester health claims, FDA has agreed with Lipton's position that Take Control should not be required to meet the "low fat" and "low cholesterol" health claim restrictions other products must adhere to, since the spread is meant to replace other dietary sources of fat.

While most foods must contain 13 g of fat or less per 50 g serving guideline, "spreads and salad dressings are not required to meet the limit for total fat per 50 grams if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section of the label for information about fat content," FDA explains in a Sept. 5 "Talk Paper" on the rule.

Comments on the interim final rule will be accepted for 75 days, after which time the agency will issue a final rule.

FDA has issued previous rules on the relationship between certain foods or food components and CHD risk. The agency previously approved health claims relating a reduced risk of coronary heart disease with fiber-containing fruits, vegetables and grain products, soluble fiber from beta-glucan from oat products, soluble fiber from psyllium seed husk and soy protein.