The U.S. Food and Drug Administration (FDA) announced Friday new guidance on the sale of supplements containing high amounts of caffeine.
Supplements that contain pure or highly concentrated caffeine in powder or liquid forms "present a significant public health threat,” the FDA said in a statement. These supplements are no longer permitted to be sold in bulk quantities directly to consumers, the agency said.
The FDA said it is ready to take action to remove these dietary supplements from the market after reports of at least two deaths in otherwise healthy individuals.
Dangerous caffeine “cocktails”
Accidental ingestions can occur if a consumer mistakes the liquid form of these products for a safe household liquid, such as water or distilled vinegar. Pure powdered caffeine could easily be confused with flour or powdered sugar.
“The consequences of a consumer mistakenly confusing one of these products could be toxic or even lethal,” the FDA wrote.
The agency is especially concerned about the health effects that can occur when these products are intentionally misused.
“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,” said commissioner Scott Gottlieb.
“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." Gottlieb added.
Equivalent to 20 to 28 cups of coffee
A half cup of a highly concentrated liquid caffeine can contain approximately 2,000 milligrams (mg) of caffeine. A single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine.
That's the equivalent of 20 to 28 cups of coffee -- “a potentially toxic dose of caffeine,” the agency noted. Ingesting just a few tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, and even smaller amounts can be life-threatening to children.
Bulk amounts of these supplements pose a high risk of overuse and misuse because consumers have to measure a very small, precise, recommended serving, and often they do not have the proper tools to do so, the FDA explained. The recommended safe serving is 200 mg, which is about 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid.
Previous measures to curb overuse
In 2015 and 2016, the FDA issued warning letters to five sellers of powdered caffeine in an effort to stop these highly concentrated or pure caffeine supplements from being sold directly to consumers online. However, the supplements remained on the market.
"Despite multiple actions against these products in the past, we've seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container," Gottlieb said.
The FDA is now banning the sale of pure or highly concentrated caffeine in powder or liquid forms in bulk quantities directly to consumers. The new rule is effective immediately.