The Food and Drug Administration (FDA) is taking action against companies that manufacture products with highly concentrated and pure caffeine in an effort to prevent consumers from accidentally consuming excessive or potentially dangerous doses.
In 2015 and 2016, the FDA had issued warning letters to 7 distributors of pure powdered caffeine as their products presented a significant or unreasonable risk of illness or injury to consumers. Since then, there has been a growth of similar products being marketed online.
“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,” said FDA Commissioner, Scott Gottlieb, MD.
As a result, a new guidance has been released to clarify that powder or liquid dietary supplements containing pure or highly concentrated caffeine are considered illegal when sold in bulk quantities to consumers. These products—at dangerously high levels—are sometimes used by teenagers for a “perceived energy kick” as part of their workout cocktail.
A safe serving of highly concentrated or pure caffeine product is 200mg, which is 1/16 of a teaspoon of pure powder or ~2.5 teaspoons of a liquid. However, consumers are at high risk of overuse and misuse as these highly concentrated products are sold in large bags or bottles. This would require consumers to accurately measure out a very small amount for safe use.
Half a cup of highly concentrated liquid caffeine (~2,000mg caffeine) and 1 teaspoon of a powdered pure caffeine product (~3,200mg caffeine) is equivalent to about 20–28 cups of coffee, which can be potentially toxic. Moreover, taking <2 tablespoons of some powdered formulations can be lethal for most adults while even smaller amounts can be life-threatening to children.
Another area of risk is that these products can look like safe household items (eg, water, distilled vinegar, flour, powdered sugar), which can result in unintentional and dangerous consumption.
To date, the use of highly concentrated and pure caffeine has been tied to at least 2 deaths in otherwise healthy people. “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. We’ll act to remove these dangerous bulk products from the market,” said Gottlieb.
The new guidance does not apply to other caffeine-containing products such as over-the-counter (OTC) or prescription drugs or conventional food items (eg, caffeinated beverages).
For more information call (888) INFO-FDA or visit FDA.gov.