Department of Health and Human Services
Public Health Service
College Park, MD 20740
Dec 10, 2008
RETURN RECEIPT REQUESTED
Mr. Muhtar Kent
President and Chief Executive Officer
The Coca-Cola Company
1 Coca Cola Place, NW
Atlanta, GA 30313-2424
Dear Mr. Kent:
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). 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.
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." 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).
Your product is misbranded within the meaning of section 403(r)(1)(A) of the Act because it bears the nutrient content claim "plus" but does not comply with the regulations governing the use of this claim. The term "plus" in "Diet Coke Plus," read in conjunction with the language "Diet Coke with Vitamins & Minerals," meets the definition of a nutrient content claim because it characterizes the product's level of vitamins and minerals, which are nutrients of the type required to be in nutrition labeling (21 CFR 101.13(b)). The term "plus" is defined in 21 CFR 101.54(e). This term may be used on the label or in labeling of foods to describe the level of nutrients (such as vitamins and minerals) in the food, provided that (1) the food contains at least 10 percent more of the Reference Daily Intake or Daily Reference Value for the nutrient per reference amount customarily consumed than an appropriate reference food, (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20, and (3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii).
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. 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).
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.
You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Felicia B. Williams, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.
Roberta F. Wagner
Office of Compliance
Center for Food Safety
And Applied Nutrition
cc: FDA Atlanta District Office
This page was posted on January 7, 2009.