February 9th, 2012
The Public Health Advocacy Institute is asking the FDA to investigate and take enforcement action against The Coca-Cola Company’s unlawful use of heart health claims on cans of Diet Coke. In February of 2010, 2011 and 2012, The Coca-Cola Company has released Diet Coke cans labeled with a large red heart symbol, the National Heart Lung and Blood Institute’s “The Heart Truth” Red Dress logo, and references to women’s heart health. Taken together, the large red heart symbol, the Red Dress logo and references to heart health imply a relationship between consuming a specific food, Diet Coke, and reduced risk for heart disease. The cans pictured below represent the cans in circulation in 2012 (left), 2011 (center) and 2010 (right).
The FDA defines health claims to include “any claim made on the label or in labeling of a food…that expressly or by implication, including ‘third party’ references, written statements (e.g., a brand name including a term such as ‘heart’), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition.” 21 CFR § 101.14 (a)(1). In its food labeling guidance the FDA states, “ health claims characterize a relationship between a substance (specific food component or a specific food) and a disease (e.g., lung cancer or heart disease) or health-related condition (e.g., high blood pressure), and are supported by scientific evidence (see 21 CFR 101.1472).” FDA, Guidance for Industry: A Food Labeling Guide (April 2008), http://www.fda.gov. The use of the heart symbol, the phrase “The Heart Truth” and the reference to a national health organization implies that Diet Coke consumption is beneficial to heart health. This claim is not supported by scientific evidence and is not otherwise allowed under FDA regulations.
This type of misbranding is especially damaging to the public because it unequivocally links the product to a desired health outcome through multiple uses of the word “heart” and the use of a heart symbol—expressly the type of symbols, third party references and words the FDA references in its regulations and guidance on health claims for the food industry. The FDA should act immediately to investigate The Coca-Cola Company’s unlawful use of this health claim, issue the appropriate warning letter and take enforcement action as necessary.