FDA Issues Warning Letter to Makers of Muscle Milk for Mislabeling

Aug 02, 2011   

Last week, the U.S. Food and Drug Administration (FDA) issued an official warning letter to CytoSport, Inc., the makers of the popular fortified sports drink, Muscle Milk, for mislabeling their product as “milk.” The FDA has regulatory authority to issue a warning letter, an official notice that one of the establishments products, practices, or processes has violated the Food, Drug, and Cosmetics Act (FDCA). CytoSport continues to defend the name Muscle Milk and is “proactively and openly addressing the FDAs labeling concerns.”      

Federal regulations define milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows,” see 21 C.F.R. § 131.110. A product is mislabeled if it markets itself as “milk” but fails to conform to the standards set forth in the Code of Federal Regulations. According to the FDA, Muscle Milk does not meet this definition of “milk” because it is not derived from a dairy cow and contains ingredients that are not permitted by the standard.

For this reason, the FDA issued a warning letter claiming that the products use of the word “milk” is misleading to consumers. Even though the product label indicates that Muscle Milk “contains no milk,” the product does contain ingredients derived from milk, such as calcium, milk protein isolate, and whey. An allergen warning appears on the products label, but may still be misleading because it is written in smaller, less prominent writing than the word “milk.” In addition, the product poses risks to consumers who may mistakenly believe that the drink is actually free of milk-derived ingredients.

The FDA observed that the products statements of identity, the common or usual name of a food or dietary supplement, were not easily identifiable on the products label. The words “Protein Nutrition Shake” and “Nutritional Shake” appeared in much smaller and in much less prominent type than the word “milk” or the rest of the product label. In its warning letter, the FDA also pointed out that CytoSport, Inc. failed to comport with the requirements for use of the claims “healthy,” “low fat” and “low saturated fat.”

CytoSport, Inc. has 15 days to address the numerous mislabeling issues contained in the warning letter and to develop specific corrective actions. Failure to do so may put CytoSport, Inc. in jeopardy of facing product seizures or formal legal action by the FDA.

Fuerst Ittleman will continue to monitor the developments in the FDAs regulation of food and dietary supplement products. For more information, please contact us at contact@fidjlaw.com.