Sean Moloughney01.05.09
FDA issued a warning letter to Coca-Cola on Dec. 10 regarding its Diet Coke Plus beverage after concluding the product is misbranded since it makes an unsubstantiated nutrient content claim.
The agency said foods labeled "plus" must have at least 10% more nutrients than comparable products. FDA also claims it is inappropriate to add extra nutrients to snack foods such as carbonated beverages.
The ingredient list in Diet Coke Plus includes the following added vitamins and minerals: magnesium sulfate (declared at 10% of the Daily Value (DV) for magnesium in the Nutrition Facts panel), zinc gluconate (declared at 10% of the DV for zinc), niacinamide (declared at 15% of the DV for niacin), pyridoxine hydrochloride (declared at 15% of the DV for vitamin B6), and cyanocobalamine (declared at 15% of the DV for vitamin B12).
The product bears the term "Plus" as part of its name, and the principal display panel of the product label also includes the language, "Diet Coke with Vitamins & Minerals."
According to the agency’s letter: “The policy on fortification in 21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods such as carbonated beverages. Additionally, the label of your product does not state the identity of a reference food and the percentage (or fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs, as is required for relative claims such as ‘plus’ under 101.13(j)(2). Therefore, the ‘plus’ claim on the label of this product does not meet the requirements of 21 CFR 101.54(e)(1).”
FDA called on Coca-Cola to revise the drink's labeling and inform the agency of its plans within 15 days of receiving the message. Coca-Cola said it will respond to FDA in early January but has no plans to change the label. The company launched Diet Coke Plus in March 2007.
The agency said foods labeled "plus" must have at least 10% more nutrients than comparable products. FDA also claims it is inappropriate to add extra nutrients to snack foods such as carbonated beverages.
The ingredient list in Diet Coke Plus includes the following added vitamins and minerals: magnesium sulfate (declared at 10% of the Daily Value (DV) for magnesium in the Nutrition Facts panel), zinc gluconate (declared at 10% of the DV for zinc), niacinamide (declared at 15% of the DV for niacin), pyridoxine hydrochloride (declared at 15% of the DV for vitamin B6), and cyanocobalamine (declared at 15% of the DV for vitamin B12).
The product bears the term "Plus" as part of its name, and the principal display panel of the product label also includes the language, "Diet Coke with Vitamins & Minerals."
According to the agency’s letter: “The policy on fortification in 21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods such as carbonated beverages. Additionally, the label of your product does not state the identity of a reference food and the percentage (or fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs, as is required for relative claims such as ‘plus’ under 101.13(j)(2). Therefore, the ‘plus’ claim on the label of this product does not meet the requirements of 21 CFR 101.54(e)(1).”
FDA called on Coca-Cola to revise the drink's labeling and inform the agency of its plans within 15 days of receiving the message. Coca-Cola said it will respond to FDA in early January but has no plans to change the label. The company launched Diet Coke Plus in March 2007.