FDA WARNING_LETTER - Cytosport Inc

The FDA issued a Warning Letter to CytoSport, Inc. on June 29, 2011, following a review of labels for their "Chocolate Muscle Milk Protein Nutrition Shake," "Vanilla Crème Muscle Milk Light Nutritional Shake," and "Chocolate Peanut Caramel Muscle Milk" products. The FDA concluded these products are misbranded under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

Key violations include:

1. **False or Misleading Labels (403(a)(1)):** Products prominently feature "MILK" but contain no actual milk, despite containing milk-derived ingredients (caseinate, milk protein isolate, whey) and an allergen statement indicating milk-derived ingredients. The "Contains No Milk" statement is misleading. 2. **Failure to Conform to Standard of Identity (403(g)(1)):** Products purport to be "milk" but do not meet the standard of identity for milk (21 CFR 131.110), which defines milk as lacteal secretion from cows. The products contain no milk and numerous unpermitted ingredients. 3. **Unauthorized Nutrient Content Claims (403(r)(1)(A)):** * "Healthy" claims are used on products ("Chocolate Muscle Milk Protein Nutrition Shake," "Chocolate Peanut Caramel Muscle Milk") that exceed fat and saturated fat limits for "low fat"