FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

The U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.

The agency 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. 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," said Scott Gottlieb, M.D., FDA commissioner. "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."

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.

The recommended safe serving of highly concentrated or pure caffeine products is often 200 mg of caffeine, which equates to 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid. Yet, despite these small serving sizes, powdered forms of caffeine are sold in large bags and liquid forms are sold online in bottles that can contain a gallon or more. Often, consumers do not have the right tools to correctly measure such a small amount. Even if they do, simple and common errors, such as packing the powder too tightly or using a "heaping scoop" instead of a "level scoop," can increase the amount of caffeine in a single dose, with harmful results. Consumers could also make similar errors with highly concentrated liquid caffeine products. For comparison, a can of caffeinated soda contains about 35 mg of caffeine, which would equate to less than half a teaspoon of highly concentrated liquid caffeine.

Additionally, these products often closely resemble safe household items, potentially leading to accidental and dangerous ingestions. Highly concentrated caffeine in a clear liquid form could be easily confused with commonly available liquids, such as water or distilled vinegar, and pure powdered caffeine could be easily confused with flour or powdered sugar. The consequences of a consumer mistakenly confusing one of these products could be toxic or even lethal.

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.

Moreover, this 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.

In 2015 and 2016, the FDA issued warning letters to seven distributors of pure powdered caffeine, with several of the letters citing that the products were dangerous and presented a significant or unreasonable risk of illness or injury to consumers. Since that time, the FDA has continued to see a proliferation of similar products being sold online. The FDA intends to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form, and the agency will continue to take action when products put consumers at risk.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.