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FDA Warning Letters Issued to Five Producers of Pure Powdered Caffeine

Sep 3, 2015

On September 1, 2015, the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine, "because these products are dangerous and present a significant or unreasonable risk of illness or injury to consumers," the agency says.

Caffeine in its pure form is powerful: a teaspoon of caffeine powder is roughly equal to 28 cups of coffee, and a tablespoon can be lethal. A 100-gram package (which is about 3.5 ounces) can have as much caffeine as 400 "tall" cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke. Last year, after two otherwise healthy young men died after using too much pure caffeine, the FDA issued a warning of the dangers, the New York Times reports.

Because pure caffeine is so potent, safe amounts of the substance are very small and hard to measure. Ordinary kitchen measuring spoons are not precise enough, the FDA says. "The difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small," according to the FDA web site. Too much caffeine can lead to a rapid or dangerously erratic heartbeat, seizures and even death. Pre-existing conditions can intensify the effects of caffeine and make the product more dangerous for these individuals.

The consumer advocacy group, Center for Science in the Public Interest, has petitioned the FDA to ban the sale of pure caffeine. The center applauded the FDA for the warning letters, but expressed hope that this was the first step toward a ban of the substance, "and not a substitute for one," according to the Times. Laura MacCleery, the center's regulatory affairs director, said, "People assume something this dangerous would not be sold to consumers in this form. They are used to seeing warning labels and childproof caps on aspirin. This is just a zip-lock bag." Consumer groups say the FDA needs to do more to regulate pure caffeine and other energy products. Comparing caffeinated drinks with pure caffeine "is like comparing a table knife and a table saw," MacCleery said.

Bridge City Bulk is one of the companies that received a warning letter. The letter cited two products, in packages ranging from one kilogram to 25 kilograms. The 10-kilogram package of caffeine powder contains about 1,230 tablespoons, equivalent to 50,000 servings. The products "are packaged to contain an amount that would be lethal to many consumers." The FDA told the company to "take prompt action to correct the violations" and warned that if it did not, the agency could seize its product or stop it from producing more. Bridge City Bulk's founder, Jeffrey Stratton, said the company had "immediately stopped selling the material." He said it had received "no product complaints at any time, ever," according to the Times.

FDA warning letters also went to Hard Eight Nutrition, Kreativ Health, PureBulk and SmartPowders. The companies have 15 business days from receipt of the letter to communicate the specific steps they will take to bring their products into compliance with the law. Steps could include enclosing a measuring device with the product or changing the quantity in the packages. The FDA will evaluate the responses on a case-by-case basis, the Times reports.

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