FDA Widens Scope Of Sterol Health Claim

Concerned that a loss of product innovation is at stake, the Food and Drug Administration (FDA) has agreed that a wider range of foods can include a health claim linking phytosterol-containing foods and a reduced risk of coronary heart disease.

In a letter to Cargill Health & Food Technologies that effectively opened the category, the FDA said it would exercise 'enforcement discretion' and not go after companies marketing health claims on foods and supplements containing plant sterol/stanol esters before a final health claim is published, probably later this year.

"We were saying that by the FDA's inaction, they are eliminating innovation in the marketplace," said Barbara Benson, director of regulatory safety and quality for Cargill. "Helping innovation seemed most receptive to them."

FDA in September 2000 had allowed an interim health claim for only the two companies that filed the original petition—Lipton for plant sterol esters and McNeil Consumer Healthcare for plant stanol esters—and only for spreads and salad dressings.

"Clearly more than two companies should have access to this claim," said Phil Harvey, PhD, chief science officer for the National Nutritional Foods Association. "The challenge for companies is to get the education out."

To qualify for the health claim, a food must, among other things, contain at least 400mg phytosterols per serving as well as at least 80 per cent combined weight of beta-sitosterol, campesterol, stigmasterol, sitostanol and campestanol.

Publication of the final phytosterol health claim is expected to be a high priority.

"The agency cautions manufacturers that the final rule may differ from the broadened criteria listed above," said Christine L Taylor, director of the Office of Nutritional Products, Labeling and Dietary Supplements, in discussing FDA's decision. "Manufacturers would then be required to change their labels to conform to the final rule."

The traditional food delivery systems for sterols are spreads and salad dressings. Like all ingredients that are granted a health claim, plant sterols and stanols will undoubtedly see growth.

This may be more of a challenge in the US market than in Europe, which has embraced more healthy spreads, such as the cholesterol-lowering Benecol. Such new functional products have largely flopped in the US, probably because of the counter-intuitive message that butters can actually be good for one's heart.

"The foods that were eligible, spreads and salad dressings, are incompatible with how Americans think about heart and healthy eating," said Benson. "In Europe that model worked because those spreads are used more commonly, but in our American diet we typically say that's off-limits."

This is where Benson says product innovation will come into play. Cargill, she said, will be looking to get sterols and stanols in a greater range of foods besides only spreads and salad dressings.

"It very much opens up the product category," said Benson. "We've been limited to using only the esterified form of plant sterols. Now, we will be manufacturing free sterols, which are not esterified and can be more easily incorporated into different food matrixes such as beverages."

To view the entire record, go to www.cfsan.fda.gov/label.html.

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