FDA WARNING_LETTER - Bridge City LLC - August 31, 2015

On August 27, 2015, the FDA issued a Warning Letter to Bridge City Bulk LLC following a review of the labeling for their Caffeine Anhydrous Natural Coffee Bean and Caffeine Powder (Synthetic Anhydrous) products, sold as dietary supplements on www.bridgecitybulk.com.

The FDA determined both products are adulterated under section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act because they present a significant or unreasonable risk of illness or injury under recommended conditions of use. The labeling suggests a "Serving Size: 200 milligrams," with directions to "take 50 to 200 mg up to three times daily" using an accurate milligram scale.

The FDA noted that 200 milligrams is approximately 1/14th of a teaspoon, an amount difficult to measure accurately with common household tools. A single teaspoon of pure powdered caffeine is equivalent to about 28 cups of coffee (2.7 grams), and consumption of this amount has been linked to severe symptoms including nausea, vomiting, anxiety, and heart palpitations. A tablespoon (8.1 grams) has been associated with chest pain, irregular heartbeat, and death.

The products are sold in large quantities (e.g., 1 kg contains 5,000 servings, 10 kg contains 50,000 servings), with each package containing a potentially lethal