FDA Permits Cholesterol Health Claim for Foods with Plant Stanol and Sterol Esters 34800

WASHINGTON--Food products containing plant stanol and plant sterol esters can now carry a health claim that they may reduce the risk of coronary heart disease by lowering cholesterol levels. The Food and Drug Administration (FDA) published its interim final rule on the claim in the Sept. 8 Federal Register.

FDA reviewed scientific studies and health claim petitions submitted by McNeil Consumer Healthcare [maker of Benecol spread] and Lipton [maker of Take Control spread] before making the decision. The agency found that the studies indicate that 1.3 g per day of plant sterol esters or 3.4 g per day of plant stanol esters significantly lower cholesterol levels. Plant sterol and stanol esters are present in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes and other plant sources. Foods that carry the FDA health claim must contain at least 0.65 g of plant sterols or 1.7 g of plant stanols per serving; products must also meet low saturated fat and cholesterol requirements.

In its notice, FDA stated that foods that may qualify for a health claim based on plant sterol ester content include spreads and salad dressings, while those basing the claim on plant stanol ester content include spreads, salad dressings, snack bars and dietary supplements in soft gel form.

"We are very excited about this development for Benecol Spread," said Michael Seed, president of McNeil Nutritionals Worldwide. "By gaining the FDA's approval of this claim, we can now talk directly to consumers about how Benecol can have a major positive impact on their lives."

By issuing an "interim" final rule, FDA is allowing products containing plant sterols and stanols to carry a health claim label during the Federal Register's comment period, rather than waiting until after the period closes. However, the final rule may change the wording or other parts of the rule, which in turn would require that manufacturers revise product labels carrying the claim. Written comments on this interim rule will be accepted for 75 days, beginning Sept. 8. For more information about this rule or to learn how to submit a comment, visit www.fda.gov/bbs/topics-/ANSWERS/ANS01033.html.