Xcel Sports Nutrition, LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Xcel Sports Nutrition, LLC's operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Xcel Sports Nutrition, LLC.

Regulatory Context

Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Pineapple Ko-Ko Nut,” “Crackhead Xtreme PreWorkout Sour Cherry Pina Colada”, “Kranked Pre-Workout Busted Black Cherry Limeade,” “Incinerate-X Ice Blue Lemonade Colada”, “Junky Juice Pre Workout Maui Madness”, “Dominatrix Pineapple Mango” and “Xcelerator XTC Pre-Workout Blackberry Limeade” product labels each bear the statement “Percent Daily Values are based on a 2,000 calorie diet.”  This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of those dietary ingredients is present on the label, so the statement is not permitted.

Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Pineapple Ko-Ko Nut,” “Crackhead Xtreme PreWorkout Sour Cherry Pina Colada”, “Kranked Pre-Workout Busted Black Cherry Limeade,” “Incinerate-X Ice Blue Lemonade Colada”, “Junky Juice Pre Workout Maui Madness”, and “Xcelerator XTC Pre-Workout Blackberry Limeade” products incorrectly list several (b)(2)-dietary ingredients (e.g., niacin, Vitamin B6, etc.).  We note that (b)(2)-dietary ingredients may only be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero (e.g., an amount corresponding to less than 2 percent of the RDI for vitamins and minerals), as required by 21 CFR 101.36(b)(2).  Furthermore, an ingredient that

Your “Kranked Pre-Workout Busted Black Cherry Limeade”, “Junky Juice Pre- Workout Maui Madness”, “Crackhead Xtreme Sour Cherry Pina Colada”, “Crackhead Xtreme Pre-Workout Pineapple Ko-Ko Nut”, and “Crackhead Xtreme Pre-Workout Ass Kickin’ Apple Pie” do not list the phrase “% Daily Value” as a header in the supplement facts label.