Pure powdered caffeine labels perk FDA’s interest

Five companies received warning letters from the FDA for producing pure powdered caffeine packaged for sale to consumers in potentially lethal quantities. According to the FDA, the products could be mixed into beverages at “potentially dangerous” levels that could result in “significant or unreasonable risk of illness or injury.” The difference between a safe or toxic amount of caffeine in the pure powdered products is small and precise measurements are necessary. Measuring tools found in the kitchen such as teaspoons are not precise enough, because of variations introduced by the packaging process.

Too much caffeine can lead to dangerous outcomes. Consuming as little as one teaspoon of caffeine has been associated with symptoms including nausea, vomiting, anxiety, and heart palpitations. Consuming as little as one tablespoon (equivalent to 3 teaspoons or approximately 8.1 grams) of caffeine has been associated with symptoms including chest pain, hypokalemia, elevated blood glucose, tachycardia, bigeminy, agitation, respiratory alkalosis, irregular heartbeat, and in some cases, even death. The FDA found that a teaspoon of caffeine powder as sold by some of the companies contained as much caffeine found in 28 cups of coffee. Following the deaths of two young men in good health in 2014, the FDA issued Consumer Advice alerting consumers to the dangers of pure powdered caffeine.

The Center for Science in the Public Interest, a consumer advocacy group, noted that it hoped the warning letters were first steps in banning the sale of pure caffeine and not a substitute for a ban. The group previously petitioned the FDA to ban the retail sale of pure caffeine, stating that the average consumer would not expect something as dangerous as pure powdered caffeine to be packaged in “zip-lock bags” without warning labels.

Pure powdered caffeine is a relatively new product, available in the market in the last decade. In its warning letter to PureBulk, Inc., an Oregon-based company, the FDA cited the company’s offerings of powdered caffeine in package sizes ranging from 25 grams to 25 kilograms. The agency was unclear as to why PureBulk’s Caffeine Powder (Synthetic) product label provided direction describing a 200 milligram serving size as a “rounded 1/32 tsp” amount, as it was unlikely that consumers would have a 1/32 teaspoon measuring tool. Moreover, even if consumers did have a 1/32 teaspoon measuring tool, the agency faulted the manufacturer for using the measuring tool because it could still deliver a different amount depending on how tightly the caffeine powder was packed.

In addition to the warning letter to PureBulk, the FDA sent warning letters to Bridge City LLC (Oregon), Hard Eight Nutrition LLC (Nevada), Kreativ Health Inc. d/b/a Natural Food Supplements (California), and Smartpowders (North Carolina) regarding various products. The companies are required to respond to the warning letters within 15 days, outlining specific steps taken to correct the violations, namely inadequate labeling, including any steps taken with respect to product currently in the marketplace.