FDA Renews Warnings of the Dangers of Pure Powdered Caffeine

Because pure powdered caffeine products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine and the agency has renewed warnings to consumers about this substance.

A teaspoon of pure caffeine is roughly equal to 28 cups of coffee. A tablespoon of pure caffeine 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, the New York Times reports. In 2014, two otherwise healthy young men died after using too much pure caffeine, prompting the FDA to issue a safety warning. Too much caffeine can cause a rapid or dangerously erratic heartbeat, seizures and even death. Some pre-existing medical conditions can intensify the effects of caffeine, making the product more dangerous for these individuals. Safe amounts of pure caffeine are hard to measure and kitchen measuring spoons are often 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.

The Center for Science in the Public Interest, a consumer advocacy group, has petitioned the FDA to ban the sale of pure caffeine and hopes the warning letters are the first step toward a ban of the substance, “and not a substitute for one,” according to the Times. “People assume something this dangerous would not be sold to consumers in this form,” said Laura MacCleery, the center’s director of regulatory affairs. Consumers are used to seeing warning labels and childproof caps on dangerous products, MacCleery said, but caffeine powder is sold in a zip-lock bag. Consumer groups say the FDA needs to do more to regulate pure caffeine and other energy products. MacCleery rejects comparisons between pure caffeine powder and caffeinated beverages. She said this “is like comparing a table knife and a table saw.”

The FDA sent warning letters to Bridge City Bulk, Hard Eight Nutrition, Kreativ Health, PureBulk, and SmartPowders. In the letter to Bridge City Bulk, the FDA cited 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 Bridge City Bulk that if it did not, the agency could seize its product or stop the company from producing more. Jeffrey Stratton, Bridge City Bulk’s founder, said the company had “immediately stopped selling the material,” though it had received “no product complaints at any time, ever,” according to the Times.

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. The companies could stop selling pure caffeine, as Bridge City Bulk did, or they could include a measuring device in the package or change the quantity in the packages. The FDA said will evaluate the responses on a case-by-case basis, the Times reports.

This entry was posted in Health Concerns. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.