The US Food and Drug Administration has warned Mars/Masterfoods that its CocoaVia chocolate bar is in breach of FDA regulations on several grounds and given the company 15 days to respond.
In its warning letter, FDA questioned the level of folic acid in several CocoaVia products as well as the heart health claims they were employing due to their plant sterol content. FDA also stated the products' health claims meant they should be classified as drugs.
In regard to folic acid, FDA stated foods to which folic acid can be added are designed to keep total folic acid intake under 1mg. "The consumption of higher levels of folic acid can mask anaemia in persons with vitamin B12 deficiency. Under those circumstances, the consequences of the anaemia (i.e., severe and irreversible neurological damage) would go undetected," it said.
The FDA warning went on to say the CocoaVia products contained too much saturated fat to carry a heart health claim. "The labels of these products bear the claims 'Promotes a healthy heart' and 'Now you can have real chocolate pleasure with real heart health benefits,'" FDA said. "These claims are false or misleading because of the high levels of saturated fat in the products."
The letter added: "The regulation authorizing a health claim for plant stero/stanol esters and reduced risk of heart disease includes the requirement that the food bearing the claim be low in saturated fat (1g or less of saturated fat per reference amount and not more than 15 per cent of calories from saturated fatty acids)."
Moreover, FDA said the claims promote the bars as being able to "prevent, mitigate, and treat hypercholesterolemia" and should therefore be classified as drugs.
"Overall, this warning letter is troubling," said Loren Israelsen of Utah-based industry consultancy LDI Group. "I do not yet know why FDA decided to challenge this product in this way, but I do know this warning letter is reminiscent of the kind of arguments FDA made prior to passage of [the Dietary Supplement Health and Education Act of 1994] in challenging a wide range of dietary supplements."