PureBulk Inc – FDA Warning Letter, Aug 31, 2015

On August 27, 2015, the FDA issued a Warning Letter to Purebulk, Inc. following a review of the label for their Caffeine Powder (Synthetic) product, sold as a dietary supplement on www.purebulk.com. The FDA 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 recommended or suggested conditions of use.

The 25-gram product label states a serving size of 200 milligrams, described as a "rounded 1/32 tsp," and advises using a digital gram weight scale precise to 0.01 grams or better. The FDA found that a 1/32 teaspoon is not generally available in consumer measuring sets, and common household tools like 1/4 or 1/8 teaspoons cannot accurately measure 200 mg. Even a 1/32 teaspoon is inadequate due to packing variability, and many consumers lack a sufficiently precise scale.

The FDA highlighted that a single teaspoon of pure powdered caffeine is approximately 2.7 grams (equivalent to 28 cups of coffee), and consuming this amount is associated with severe symptoms including nausea, vomiting, anxiety, and heart palpitations. A tablespoon (8.1 grams) has been linked to chest pain, irregular heartbeat, and death. The 25-gram