In the complaint, filed by in California last June, plaintiff Robert Reid alleged that Benecol misled consumers because at 0.85g per serving, it did not contain sufficient plant stanol esters to warrant the cardiovascular health claims it made.
He also alleged that the claim ‘proven to reduce cholesterol’ rendered Benecol a drug, not a food
Finally, he alleged that Benecol was misbranded due to its ‘no trans-fat’ claims because it did in fact contain small amounts of artificial trans fatty acids from partially hydrogenated vegetable oil - and 'no trans fat' is not a recognized/regulated claim on food labels.
The defendants, represented by law firm Tucker Ellis LLP, immediately filed a motion to dismiss the case.
Judge: Plaintiff is building his case based on a rule that is out of date
Granting this motion on September 17, US district judge James Lorenz said he was not persuaded by Reid’s arguments, concluding that no reasonable consumer is likely to be deceived by the Benecol labels and that his claims are preempted by federal law.
Reid had also cited rules governing the conditions of use for plant stanol ester-related claims that were out of date, said Lorenz.
Specifically, Reid’s complaint cited a 2000 rule stipulating that firms must include 1.7g of plant stanol esters per serving to make a health claim, despite the fact that this had been superseded by new conditions of use laid out in a 2003 enforcement letter from the FDA (permitting a claim if foods contain 0.4g of phytosterols per RACC), said Lorenz.
Meanwhile, references to a proposed rule published by the FDA in December 2010 that would change the criteria for making such claims again are not pertinent to this case because the final rule has yet to be published, and the FDA has said it will continue to enforce the 2003 letter in the meantime, claimed the judge.
“Plaintiff’s plant sterol esters claim essentially ask the Court to rule on issues that the FDA has not yet finalized and seeks to impose a different, outdated interim rule requirement for Defendants from that set forth in the 2003 FDA letter.
“Because Benecol’s current product labeling is in compliance with the requirement of the 2003 FDA Letter, the Court finds that Plaintiff’s claim that Benecol does not contain the sufficient amount of plant stanol esters per serving is preempted.”
Benecol is not a drug…
Meanwhile, Reid’s claim that Benecol is an improperly-marketed drug is also “contrary to the FDA’s own characterization that Benecol is a food containing phytosterol nutrients” argued Lorenz.
Finally, the fact that Benecol contains small amounts of partially hydrogenated oils does not preclude it from making 'no trans-fat' claims, said Lorenz (federal law permits firms to claim '0g trans fat' if there is less than 0.5g per serving) and does not mislead consumers, he said.
Drawing a distinction between '0 grams of trans fat' and 'no trans fat' is unreasonable as the terms are “functionally equivalent", he added.
He concluded: “The Court finds that Plaintiff’s state law claims are barred by either express or implied preemption and must be dismissed.”
Reid has served notice that he intends to appeal.
FDA conditions of use for CHD-risk reduction claims about phytosterols
In December 2010, the FDA issued a proposed rule amending the regulation authorizing a health claim on the relationship between plant sterol esters and plant stanol esters and reduced risk of coronary heart disease (CHD) for use on food labels and in food labeling.
It said: “the agency is proposing to amend § 101.83(c)(2)(i)(G) to require that a claim that is the subject of this regulation specify that the daily dietary intake of phytosterols that is necessary to justify the CHD risk reduction claim is 2g per day.”
Typically, consumers will spread their intake throughout the day, adds the agency: “A typical food consumption pattern includes three meals and one snack per day.”
Therefore, firms wishing to make claims about phytoeterols and CHD risk reduction should include a minimum of 0.5g of plant sterols per RACC (reference amount customarily consumed), it says.
“Dividing this [2g] daily intake over four servings per day, the minimum eligible phytosterol content of a food would be 0.5g per RACC expressed as the weight of nonesterified phytosterols.”
It has not yet published a final rule.