FDA Calls Cocoa Via Bars Adulterated, Misbranded

FDA took MasterFoods USA to task over its line of functional chocolate products, sending the company a warning letter concerning its Cocoa Via functional bars. One of the agency's primary concerns was the use of folic acid in candy, a use not expressly provided for in the food additive regulations (21 CFR 172.345). The use of that food additive for an unapproved use makes the Cocoa Via Original Chocolate Bar, Chocolate Blueberry Crunch Bar and Blueberry & Almond Chocolate Bar adulterated under section 409 of the Food Drug and Cosmetic Act.

In its letter, FDA notes the foods to which folic acid can be added are designed to keep total folic acid intake under the 1 mg/d level. "The consumption of higher levels of folic acid can mask anemia in persons with vitamin B12 deficiency," FDA writes. "Under those circumstances, the consequences of the anemia (i.e., severe and irreversible neurological damage) would go undetected."

FDA also claims the Cocoa Via products are misbranded because their labels make heart health claims, but would deliver around 30% of the daily value for saturated fat if consumed according to the products' nutrition facts labels. "[Cocoa Via bars] do not promote a healthy heart when consumed daily as recommended on the product label, even though the products also contain ingredients, such as plant sterol esters, that have been shown to lower LDL cholesterol when consumed as part of a low fat, low cholesterol diet," the agency writes. "As a matter of fact, the regulation authorizing a health claim for plant sterol/stanol esters and reduced risk of heart disease includes the requirement that the food bearing the claim be low in saturated fat (1 g or less of saturated fat per reference amount and not more than 15% of calories from saturated fatty acid."

Finally, FDA warned the company that the labeling on two of its Cocoa Via products--Original Chocolate Bars and Blueberry & Almond Chocolate Bars--claiming consumption of the items can reduce various cholesterol levels makes the products drugs, not foods.

At press time, MasterFoods USA had not responded to Food Product Design's calls for comment.