FDA WARNING_LETTER - Smartpowders - August 31, 2015

On August 27, 2015, the FDA issued a Warning Letter to SPN, LLC dba Smartpowders, regarding their Caffeine Anhydrous 400 Grams product, labeled and sold as a dietary supplement on www.smartpowders.com. The FDA's review of the product label in August 2015 determined the product is 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 the recommended or suggested conditions of use.

The product label lists "Serving Size: 200mg" and "Servings per container: 2000," but also states "Teaspoon: 574mg." The FDA found it unclear why the label provides the 574mg per quarter teaspoon information, as this amount exceeds the recommended serving size. The FDA determined that the label's suggestion that a one-quarter teaspoon can be used to measure a 200mg serving is inaccurate, as 200mg is only 34.8% of a one-quarter teaspoon (574mg), making accurate measurement with a common household tool impossible.

The FDA highlighted that caffeine is a powerful stimulant, noting that one teaspoon of pure powdered caffeine is roughly equivalent to 28 cups of coffee (approximately 2.7 grams