FDA Allows Claims for Sterols/Stanols, Not Just Esters

FDA Allows Claims for Sterols/Stanols, Not Just Esters

BETHESDA, Md.--In a letter to Cargill Health &Food Technologies, the Food and Drug Administration (FDA) reported it "willconsider exercising enforcement discretion" for companies carrying plantsterol/stanol claims pending publication of the final rule regarding plantsterol/stanol esters and a reduced risk of coronary heart disease. According toCargill, the agency said it will allow a broader range of food products anddietary supplements to bear the heart-health claim when formulated with .65 g ofphytosterol esters or .4 g free phytosterols per serving.

"FDA's action gives our customers more latitude in thetypes of products developed with phytosterols so that consumers can enjoy thebenefits in applications that fit their lifestyle and expectations," saidTed Ziemann, president of Cargill Health & Food Technologies. Thisannouncement came just in time for the launch of the company's CaroWisephytosterol line.

Vancouver, B.C.-based Forbes Medi-Tech also announced that FDAapproved the use of the heart-health claim for its phytosterol products,including Reducol.

According to the agency, publication of the rule is an "AList" priority for the Center for Food Safety and Nutrition's (CFSAN)fiscal year (FY03).