The Food and Drug Administration has warned manufacturers that it will take action against them if they continue to sell powdered pure caffeine in bulk.
“We’re making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law,” FDA Commissioner Scott Gottlieb said in a statement. “We’ll act to remove these dangerous bulk products from the market.”
Products can still sold if they come in capsules or in premeasured packets. They can also be sold in bulk if the caffeine isn’t as concentrated and lethal.
In guidance issued Friday, the FDA noted that retailers, most of whom are online, market the powder or liquid with up to thousands of servings per container. A single teaspoon of powdered pure caffeine is equivalent to drinking 28 cups of coffee, and less than two tablespoons is considered deadly to most adults.
A safe serving is 1/16th of a teaspoon or less, an amount that the FDA said was difficult to measure with standard kitchen tools. The products often have enough servings to last for years past the expiration date unless someone is sharing the caffeine with multiple users.
Because the product is considered a supplement, it isn’t regulated in the same way as other caffeine products, such as instant coffee, that are not allowed to be on the market unless they’re approved by the FDA first. With most supplements it can be difficult for the FDA to take action because sellers can blame a consumer for not taking it the way they directed or for ignoring warning labels.
But the FDA said in its guidance that it will take action even if the products contain these types of labels, or even if they have a measuring spoon included. The agency “considers many of these products to be sufficiently dangerous such that a warning cannot remedy the adulteration,” it wrote in its guidance. It noted, as well, that the product could easily be mistaken for something else, causing consumers to mix lethal doses with their food by accident.
“We know these products are sometimes being used in potentially dangerous ways. For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails,” Gottlieb said. “The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold.”
The FDA has been warning the public about the dangers of powdered pure caffeine since 2014, after two people died from taking it. The agency also has sent letters to distributors asking them not to provide it directly to consumers.
