FDA WARNING_LETTER - Coca-Cola Company (The)

The FDA issued a Warning Letter to The Coca-Cola Company regarding its Diet Coke Plus product, citing misbranding violations under the Federal Food, Drug, and Cosmetic Act. The product's label, specifically the term "Plus" and the phrase "Diet Coke with Vitamins & Minerals," constitutes a nutrient content claim. However, Diet Coke Plus does not meet the regulatory criteria for using the "plus" claim as defined in 21 CFR 101.54(e).

Key violations include: 1. **Inappropriate Fortification:** The FDA's policy on food fortification (21 CFR 104.20(a)) states that it is not appropriate to fortify snack foods like carbonated beverages. 2. **Missing Reference Food Information:** The label fails to identify a reference food and the percentage difference in nutrient content, which is required for relative claims like "plus" under 21 CFR 101.13(j)(2).

The letter emphasizes that this is not an exhaustive list of deficiencies and that the company is responsible for ensuring full compliance. Failure to promptly correct these violations may lead to regulatory actions such as seizure or injunction. The Coca-Cola Company is required to respond within 15 days, detailing corrective actions taken or planned, including supporting documentation, or explaining any delays.