The 9th Circuit Court of Appeals reversed a district court’s dismissal of a lawsuit targeting certain allegedly false and misleading nutrient and health-related claims for Benecol, a vegetable oil-based spread. As noted in our prior posting on this case, the district court had held that Plaintiff’s state law claims were preempted.
Defendant contended that its “No Trans Fat” claim was authorized under FDA’s regulations because an amount of trans fat below 0.5 g per serving must be declared as 0 g. The appellate court disagreed, citing to FDA’s lack of authorization for nutrient content claims for trans fat, as well as agency warning letters stating that “No Trans Fat” is an unauthorized nutrient content claim. Thus, the appellate court held that Plaintiff’s state law claims targeting the “No Trans Fat” claim were not preempted.
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 letter stating the agency’s intent to exercise enforcement discretion with respect to certain claims not authorized under the interim final rule. Specifically, the 2003 letter stated that “[t]he scientific evidence establishes that including plant sterol/stanol esters in the diet helps lower blood total and LDL cholesterol levels,” and that FDA would “consider exercising enforcement discretion with regard to the use of a claim about reduced risk of [heart disease] in the labeling of phytosterol containing food,” provided that certain conditions were met.
The appellate court declined to give preemptive effect to FDA’s 2003 letter because it did not “carry the force of law.” The appellate court noted that the letter was “couched in tentative and non-committal terms,” and that “FDA’s equivocal language regarding its intention to foreclose its own ability to enforce noncompliance with existing rules is a good indication that it did not intend to foreclose state law challenges to health claims that do not comply with existing rules.” The fact that FDA did not authorize the claims in the 2003 letter through rulemaking indicated to the appellate court that the agency did not intend to create a standard with the force of law that would foreclose state-law claims.
The appellate court also held that the doctrine of primary jurisdiction did not bar the claims because there were no issues of first impression, and more than a decade had passed since FDA had stated that it would issue a final plant stanol esters rule. Curiously, although the briefs mentioned FDA’s 2010 proposal to amend the interim final rule and FDA’s renewed affirmation that it would continue to exercise enforcement discretion as detailed in the 2003 letter, the appellate court did not address those more recent developments in its primary jurisdiction analysis.