FDA WARNING_LETTER - Dual Health Body and Mind - March 01, 2018

The FDA issued a Warning Letter to Dual Health Body and Mind in May 2018, following a January 2018 review of their 8-ounce Caffeine Anhydrous Powder product label and a March 2018 website review. The product, labeled as a dietary supplement, was found to be adulterated under section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act because it presents a significant or unreasonable risk of illness or injury under recommended conditions of use.

The product's label recommends a "1/16 teaspoon (200mg)" serving, 1-3 times daily. The FDA determined that a 200mg serving cannot be accurately measured with common household tools, including a 1/16 teaspoon, due to factors like powder packing and "heaping" scoops. A simple measurement error could lead to dangerous or toxic doses. A single teaspoon of pure powdered caffeine is equivalent to approximately 28 cups of coffee (2.7 grams), and consuming even one teaspoon can cause severe symptoms, while a tablespoon (8.1 grams) has been associated with chest pain, irregular heartbeat, and death.

The 8-ounce package contains approximately 227 grams, or over a thousand recommended servings, with larger packages up to 5.5 pounds (approximately 12,500 servings) also sold. The FDA concluded that the