WASHINGTON -- Highly-concentrated caffeine in bulk quantities cannot be sold directly to consumers, the after discovering that containers "with up to thousands of recommended servings" are being marketed as dietary supplements.
Some powdered products contain 3,200 mg of caffeine per teaspoon, or the equivalent of 20 to 28 cups of coffee, the agency noted. Two tablespoons of some formulations would be lethal to most adults.
"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 FDA Commissioner Scott Gottlieb, MD, in a statement.
The warning came in the form of a spelling out the FDA's thinking on the issue. If packaged in solid form, such as tablets or capsules, or in premeasured packets of powder or liquid, concentrated caffeine may still legally be sold to consumers, the document said. Bulk quantities of low-concentration caffeine, which make it physically difficult for individuals to ingest toxic quantities, would also generally be OK.
On the other hand, "in general we consider products containing potentially lethal amounts of pure or highly concentrated powdered caffeine, sold in bulk such that the consumer is required to separate out a safe serving from a potentially lethal amount," to be illegal, according to the document.