FDA Warns Against Adding Folic Acid to Candy Products

FDA Warns Against Adding Folic Acid to Candy Products

WASHINGTON

The Food and Drug Administration (FDA) lashed out against functional candy products, sending a warning letter to MasterFoods USA about the folic acid content in its Cocoa Via functional candy bars. The agency advised the regulation on folic acid as an additive regulation (21 CFR 172.345) does not expressly provide for the use of folic acid in candy; thus, FDA noted Cocoa Via Original Chocolate Bars are adulterated under section 409 of the Food Drug and Cosmetic Act.

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

FDA (www.fda.gov) also claimed the Cocoa Via products (www.cocoavia.com) are misbranded because their labels make heart health claims, but would deliver around 30 percent of the daily value for saturated fat if consumed according to the productsnutrition 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 wrote. 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 percent of calories from saturated fatty acid. Further, label claims promoting consumption of the bars to reduce cholesterol levels positions those products as drugs.