Unilever urges FDA loosen phytosterol health claim

Among many other products, Unilever is a worldwide manufacturer of margarine and says an estimated 13 million households worldwide use its Becel/Flora pro-activ products containing plant sterols. The US Food & Drug Administration (FDA) heart disease health claim for phytosterols has been in effect since 2003. "FDA regulations should be amended to permit the use of the phytosterol health claim for a food that provides the full daily intake of phytosterols in a single serving,"​ said the Unilever in the letter dated May 5, 2006, made public this week. The current FDA health claim for phytosterols says, as part of a diet low in saturated fat and cholesterol, vegetable oil sterol esters "may reduce the risk of heart disease"​. The claim calls for a serving of at least 0.65g of the sterol esters twice daily with meals. Unilever's letter to FDA's Center for Food Safety and Applied Nutrition, indicates it finds the agency's claim too constraining for products it has in the pipeline. "There are now adequate data upon which to base a conclusion that phytosterols will significantly reduce cholesterol levels, and therefore may reduce the risk of coronary heart disease, when consumed once a day,"​ wrote Unilever deputy general counsel Nancy Schnell in the letter. "For this reason, FDA's prior rationale for requiring at least twice-a-day use is no longer applicable."​ Unilever's request that the FDA "promptly implement the claim requested by this petition"​ echoes the nutraceutical industry's frustration with the agency over perceived rigourous and time-consuming policies with regards to health claims and subsequent delays for payoffs in sales. To date, the FDA has issued scant numbers of health claims - veritable stamps of approval from the agency that can generate greater sales if they inspire consumer confidence. However, the road to getting a health claim is lengthy and not guaranteed to work or even to be useful. Not only does the FDA require an overwhelming body of evidence in favor of a healthy ingredient, but it can issue heavily worded health claims that manufacturers may not end up using for fear of confusing consumers. Unilever could likely use the boost from the health claim amendment, if it is approved. The Anglo-Dutch group reported a 14.8 percent margin decline in this year's second quarter. However, globally, Unilever's Becel/Flora pro-activ spreads and dairy drinks have grown over 25 percent in each of the last three years. The 2003 health claim decision may have contributed to the catapulting sales of its products containing phytosterol ingredients. In a recent report, Frost & Sullivan valued the US phytosterol market at $103.9m in 2005 and estimated it double to $196.7m in 2012. The growth potential is at least in part driven by heart diseases, which are blamed for approximately 50 per cent of all mortalities in the industrialized world.