FDA WARNING_LETTER - Trippo International LLC - January 25, 2021
On March 10, 2021, the FDA issued a Warning Letter to Mr. Azhar regarding the 16-ounce Super Caffeine (Anhydrous) product, labeled as a dietary supplement and sold on wholesalecentral.com/trippo/store.cfm.
The FDA's January 2021 review of the product's label determined it to be adulterated under section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(f)(1)(A)(i)]. The product, a powdered form of caffeine anhydrous, presents a significant or unreasonable risk of illness or injury under its recommended conditions of use.
The label states a "Serving Size: 200 milligrams" with "Total Servings Per Container 2267" and "Recommended use 200mg up to 2 times daily." The FDA found that 200 milligrams cannot be accurately measured with common household tools, and a simple measurement error (e.g., grams instead of milligrams) could lead to a dangerous or toxic dose. A single teaspoon of pure powdered caffeine is approximately 2.7 grams, equivalent to 28 cups of coffee, and can cause severe symptoms or even death. The 16-ounce package contains approximately 454 grams, over 2,00
ID · 95be7ef2-c6bf-4e9a-99c1-43f53d0eaf71
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