As for Defendant’s health-related claim that Benecol is “proven to reduce cholesterol,” Defendant acknowledged that the claim did not comply with the terms of FDA’s interim final rule authorizing certain health claims regarding plant stanol esters and the risk of coronary heart disease. 21 C.F.R. § 101.83. Nevertheless, Defendant argued that its claim was authorized by FDA because the claim met the criteria described in FDA’s 2003 letterstating the agency’s intent to exercise enforcement discretion with respect to certain claims not authorized under the interim final rule.

By Riëtte van Laack -As previously reported, on Dec. 8, 2010, FDA published a proposal to amend the interim final rule ("IFR") governing health claims concerning the risk of cardiovascular heart disease and consumption of phytosterols (see 21 C.F.R. § 101.83). FDA stated that, as of February 22, 2011, it intended to discontinue its policy of enforcement discretion that had been in effect since 2003 concerning certain health claims that go beyond the IFR.

By Riëtte van Laack –FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease. In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship between plant sterol/stanol esters and the reduced risk of CHD. In 2003, the Agency issued a letter announcing that it would exercise enforcement discretion concerning certain claims that went beyond the claims permitted by the IFR ("2003 letter").

FDA recently challenged similar claims made for General Mill’s Cheerios based on the allegation that the claims are illegal drug claims. FDA regulations authorize health claims that “describe the relationship between diets that include plant sterol or stanol esters and reduced risk of heart disease,” but only in the labeling of certain types of conventional food and dietary supplements, and only those that contain esterified phytosterols (21 C.F.R. § 101.83). In 2003, FDA issued a letter stating that the agency would consider exercising enforcement with respect to these requirements, thereby opening the door to the use of the claims in the labeling of other types of conventional food and dietary supplements, including those that contain phytosterols in their free forms.