FDA issues guidance on consumer sales of pure or near pure bulk caffeine
The U.S. Food and Drug Administration (FDA) has issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers.
The U.S. Food and Drug Administration (FDA) has issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. Given the significant public health concern, this guidance is immediately in effect. The FDA is prepared to take steps right away to begin removing illegal products from 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,” said Scott Gottlieb, M.D., FDA commissioner. “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. 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.”
A half cup of a highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine, and just a single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine. This is equivalent to about 20 to 28 cups of coffee, a potentially toxic dose of caffeine. In fact, less than two tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, while even smaller amounts can be life threatening to children. Risk of overuse and misuse is high when highly concentrated caffeine is sold in bulk quantities, and consumers are expected to measure a very small, precise recommended serving. Regardless of whether the product contains a warning label, such products present a significant and unreasonable risk of illness or injury to the consumer.
In the guidance, the FDA explains that when formulated and marketed appropriately, caffeine can be an ingredient in a dietary supplement. For example, the guidance describes how dietary supplements containing caffeine in certain forms are less likely to present the same safety risks, including those sold in premeasured packets or containers, or in solid dosage forms such as tablets or capsules, or when sold in formulations that are not highly concentrated.
The guidance does not affect other types of products that might also contain caffeine, such as prescription or over-the-counter drugs or conventional foods, like traditionally caffeinated beverages.