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The December 10, 2008 FDA letter (“'Warning Letter' Re: CFSAN-OC-09-01") was sent to Muhtar Kent, president and CEO of The Coca-Cola Company.
The warning letter states, “The Food and Drug Administration (FDA) has reviewed the label for your Diet Coke Plus 20 FL OZ (1.25 PT) 591ml. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act).”
It adds, “Your Diet Coke Plus product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC 343(r)(1)(A)] because the product makes a nutrient content claim but does not meet the criteria to make the claim.”
Specifically, the FDA says, “Your 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.’”
FDA officials further state within their letter, “The ingredient list 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)."
And, “Your product Diet Coke Plus is a carbonated beverage. 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."
Page two discusses comments from the FDA, Coke, and a representative from a public-interest organzation.
