FDA Not Happy With Diet Coke Plus Label
Seattle – On Dec. 10, 2008 Roberta Wagner of the FDA issued a warning letter to Muhtar Kent, President and CEO of Coca-Cola. This letter states that Diet Coke Plus is misbraneded because it does not meet the criteria to make a nutrient content claim. The letter further states that “FDA does not consider it appropriate to fortify snack foods such as carbonated beverages.” Wagner gave Coca-Cola fifteen working days to take corrective action.
Diet Coke Plus was launched by Coca-Cola in March, 2007 as “a sparkling, calorie-free beverage with vitamins and minerals.” The nutritional information provided on the label of Diet Coke Plus shows that an eight-ounce serving provides 15% Daily Value (DV) of Niacin (vitamin B3), vitamins B6 and B12, and 10% DV of zinc and magnesium. But, this is not quite right according to the FDA. The FDA says the product is misbranded because, in order to meet the “Plus” criteria the label would have to list an “appropriate reference food” and show that the nutrients referred to are at a level at least 10% more than the reference.
In addition to this concern over labeling the FDA is not happy with Coca-Cola fortifying a carbonated beverage, invoking the long standing 21CFR 104.20(a), or so-called “Jellybean Rule”. However, Coca-Cola is not the first company to do this. Pepsico currently sells a soft drink fortified with gensing as Diet Pepsi Max, and Cadbury has previously marketed a fortified 7-UP with calcium and vitamin C. The FDA seems to be reasserting these long standing rules as soft drink companies like Coca-Cola work to re-make themselves in the face of a more health conscious customer base.
Coca-Cola North America spokesman Scott Williamson issued a statement via email stating that even though Coca-Cola takes the issues raised by the FDA seriously “this does not involve any health or safety issues, and we believe the label on Diet Coke Plus complies with FDA policies and regulations.” According to Williamson, Coca-Cola will be issuing a detailed response to the FDA in early January.
The FDA says it is Coca-Cola’s responsibility to promptly bring the product and the label into compliance with these regulations. Coca-Cola is expected to document that steps are being taken to correct the violation within the given fifteen-day timeline or explain why it cannot be completed. Failure to do so, the letter states, could expose Coca-Cola to regulatory actions such as seizure and injunction.
It does not appear that Coca-Cola intends to remove Diet Coke Plus from store shelves any time soon. The soft drink giant seems to be taking this opportunity to test the mettle of the FDA and its policies regarding its products. It wouldn’t be the first time that Coca-Cola has done so. Coca-Cola undertook research along withCargill to prove the safety of a sweetener based on an extract from the stevia leaf to use in their products under the brand name TRUVIA. Earlier this December Coca-Cola released a low calorie version of its Odwalla brand sweetened with TRUVIA. They have done this even though the FDA has so far refused to approve stevia based sweeteners. Despite this, the FDA issued a “letter of no objection”, after the fact of Coca-Cola announcing the release of products containing the sweetener.
Too bad the FDA is so concerned about insignificant items.
They should be concentrating on serious drug effects that can cause real damage and danger.
Who cares if there are a few vitamins in Coke Plus.
This is legal ridiculousness and a waste of taxpayer dollars.
From a Registered Pharmacist
Why is FDA wasting its time and resources on this? I happen to like Diet Coke Plus and do not consider it a “snack food” but rather a refreshing beverage. If one is trying to control their sugar intake (which includes no or little fruit juice which causes havoc with diabetes) then this is a friendly alternative with some nutritional value.
I say “KEEP this product.”
This feels like an advertisement, like the VNR’s [video news release]
FDA? Go figure