FDA WARNING_LETTER - Hard Eight Nutrition LLC - August 31, 2015

The FDA issued a Warning Letter to Hard Eight Nutrition, LLC, following an August 2015 review of their Caffeine Powder product label, sold as a dietary supplement. The FDA determined the product is 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)] because it presents a significant or unreasonable risk of illness or injury. The label's directions for 50-200 mg servings (1/16 tsp) are contradicted by a chart showing larger, potentially lethal measurements (1/8, 1/4 tsp) that consumers might misinterpret. Crucially, the labeling implies common household measuring tools can accurately measure these small, potent doses, which the FDA found impossible. Given caffeine's high potency (one teaspoon equals ~28 cups of coffee) and the product's packaging in potentially lethal quantities (100 grams), the inaccurate measurement guidance poses a severe risk. Hard Eight Nutrition must promptly correct these violations, including addressing product in the marketplace, and respond within fifteen working days, detailing corrective and preventive measures with documentation. Non-compliance could lead to legal action, including seizure or injunction.