ALAMEDA, Calif.—CytoSport Inc.’s nutritional shakes are misbranded, according to FDA, because their labels prominently feature the word “MILK," however these products contain no milk. FDA also noted the company did not follow guidelines regarding the terms “healthy" and “0 g of trans fats" on product labels or on the company website.
In an FDA warning letter sent to Michael Pickett, chief executive officer and president of the company, the agency said the labels for “Chocolate Muscle Milk Protein Nutrition Shake" (14 fl. oz.), “Vanilla Crème Muscle Milk Light Nutritional Shake" (4-8.25 oz. servings) and “Chocolate Peanut Caramel Muscle Milk" (5.57 oz.) are in violation of section 403(a)(1) of the Federal Food, Drug, and Cosmetic Ac [21 U.S.C. § 343(a)(1)].
FDA added the actual statements of identity on the “Protein Nutrition Shake" and “Nutritional Shake" products are in significantly smaller and less prominent type than the words “MUSCLE MILK" on these product labels. Further, while the product labels include the statement "Contains No Milk" on the principal display panel, the ingredient statements say these products contain milk-derived ingredients, such as calcium and sodium caseinate, milk protein isolate and whey. The allergen statement printed on both of these products states, ''This product contains ingredients derived from milk . . . ." The “Contains No Milk" statement could give consumers the impression that these products are free of milk-derived ingredients, according to FDA.
The “Chocolate Muscle Milk Protein Nutrition Shake" and “Vanilla Crème Muscle Milk Light Nutritional Shake" products are also misbranded, according to FDA because they purport to be milk (by prominently featuring the word “MILK" on the labels), but do not follow federal regulation of the definition and standard of identity for milk. The standard of identity for milk (21 CFR 131.110) describes milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows," and it lists the vitamins and other ingredients that may be added. According to the ingredient list on product labels, CytoSport’s products contain no milk and contain numerous ingredients not permitted by the standard.
FDA said the “Chocolate Muscle Milk Protein Nutrition Shake" and “Chocolate Peanut Caramel Muscle Milk" products are misbranded because they bear the nutrient content claim "healthy," but do not follow the legal definition of healthy. Specifically, the products are not "low fat" as defined in 21 CFR 101.62(b)(2) (total fat content of 3 g or less per Reference Amount Customarily Consumed (RACC)); not "low saturated fat" (saturated fat content of 1 g or less per RACC and no more than 15 percent of calories from saturated fat); exceed the disclosure level for cholesterol set forth in 21 CFR 101.13(h) (60 mg cholesterol per RACC); do not contain at least 10 percent of the Daily Value per RACC of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein or fiber; and contain no more than 480 mg sodium per RACC and per labeled serving.
Further, FDA said the “Chocolate Peanut Caramel Muscle Milk" product label bears the nutrient content claim “0g Trans Fat," but fails to bear the “See nutrition information for saturated fat content" claim required by 21 CFR 101.13(h).
On the company’s website, CytoSport, FDA also noted the company makes unauthorized nutrient content claims for “trans-fat free," “healthy fats," “good carbohydrates" and “good fats."
FDA gave CytoSport 15 working days from the receipt of the warning letter to outline the specific actions it is taking to correct the violations.