FDA WARNING_LETTER - kreativ health inc - August 31, 2015

In August 2015, the FDA reviewed Kreativ Health Inc. dba Natural Food Supplements' Sunshine Valley Caffeine Powder, sold as a dietary supplement on www.aonevitamins.com. 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 under its recommended conditions of use. The product's label directs consumers to take 50-200 mg doses up to three times daily, requiring a precise milligram scale. However, these minute amounts are impossible to measure accurately with common household tools, and the product is packaged with a potentially lethal amount (14.15 grams) of highly potent caffeine. Consuming even small, inaccurately measured quantities can lead to severe symptoms, including death. The company must promptly correct these violations and prevent recurrence. A written response detailing corrective actions, including those for products currently in the marketplace, and steps to ensure future compliance, is required within fifteen working days. Failure to comply may result in legal action, such as seizure or injunction.