Candy + Calcium = Warning Letter

March 21, 2011

By Riëtte van Laack

On March 4, 2011, FDA issued a warning letter to Goetze’s Candy Co. Inc., because the addition of calcium to Goetze’s Caramel Cream Chocolate goes against FDA’s food fortification policy, 21 C.F.R. § 104.20.   Goetze marketed its product with the (impermissible) nutrient content claim “fortified with calcium.”

Although this is not the first time FDA cited its fortification policy in a warning letter, it is the first time in recent memory that the targeted product is candy.  Previous warning letters citing the fortification policy focused on carbonated beverages.  Candy and carbonated beverages are the snack foods specifically mentioned in FDA’s fortification policy.  Thus, this warning letter does not provide insight into what other types of fortified snack foods might violate FDA’s fortification policy.