FDA issues guidance on pure powdered caffeine

Maricruz Casares
Abril 17, 2018

The U.S. Food and Drug Administration (FDA) announced Friday new guidance on the sale of supplements containing high amounts of caffeine.

Previous FDA actions including warning letters have failed to stop the flow of these highly concentrated or pure caffeine supplements being sold directly to consumers online. This is equal to about 20 to 28 cups of coffee.

"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.

FDA said in the guidance that the use of bulk caffeine has been associated with two deaths. 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. 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.

The Food and Drug Administration (FDA) said it's prepared to remove these dietary supplements from the market after reports of at least two deaths in otherwise healthy individuals.The products "present a significant public health threat" because of the high risk consumers will mistakenly use them at unsafe doses, FDA said.

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"Extremely concentrated or pure caffeine has no place in the consumer marketplace, and CRN fully supports FDA's commitment to taking immediate steps to remove products from the marketplace that present public health concerns", said Steve Mister, CEO of the Council for Responsible Nutrition.

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 risky and presented a significant or unreasonable risk of illness or injury to consumers. Further, a teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg 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 in children. 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. "When sold in bulk, it is almost impossible for consumers to tell the difference between a safe dose of pure powdered caffeine and a lethal one", said Durbin.

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. "Consumers have access to a whole host of dietary supplements and other over-the-counter products that are manufactured with safe amounts of caffeine".

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