A complaint filed in the southern district of California on July 27 against Smart Balance and operating subsidiary GFA Brands on behalf of plaintiff Maria Aguilar acknowledges that plant sterols can help lower cholesterol, which in turn can help reduce the risk of coronary heart disease.
But it adds: “Smart Balance Spreadable Butter, however, does not have sufficient levels of plant sterols to block the absorption and thus reduce cholesterol in the body.”
Clinical studies suggested that ”consumers require a minimum of 0.8g of plant sterols daily and preferably 2g (almost the entire container of Smart Balance Spreadable Butter) to lower LDL cholesterol levels”, says the complaint.
False misleading and deceptive advertising message
However, Smart Balance Spreadable Butter contains only 0.1g (100mg) of plant sterols per serving (a 14g tablespoon), which meant consumers eating an entire 7.5oz pack of the butter (just over 15 tbsps) would still fall short of the 2g/day recommendation, said the complaint.
“Plaintiff brings this action on behalf of herself and other similarly situated consumers who have purchased Smart Balance Spreadable Butter to halt the dissemination of this false misleading and deceptive advertising message, correct the false and misleading perception it has created in the minds of consumers and obtain redress for those who have purchased the products.”
FDA conditions of use for CHD-risk reduction claims about phytosterols
In December 2010, the Food and Drug Administration (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 [coronary heart disease] 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 plant sterols 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.”
A Smart Balance spokeswoman said: "As a matter of policy, Smart Balance does not comment on pending litigation."