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FDA Cracks Down on Caffeine-Loaded Dietary Supplements

Last Updated: April 13, 2018.

The U.S. Food and Drug Administration announced Friday that it has issued tough new restrictions on the sale of dietary supplements that contain dangerously high amounts of caffeine.

FRIDAY, April 13, 2018 (HealthDay News) -- The U.S. Food and Drug Administration announced Friday that it has issued tough new restrictions on the sale of dietary supplements that contain dangerously high amounts of caffeine.

Supplements that contain pure or highly concentrated caffeine in powder or liquid forms are no longer permitted to be sold in bulk quantities directly to consumers. The new restrictions are effective immediately, and the agency added that it is ready to take action to remove illegal products from the market. The new rule does not affect other caffeine-containing products such as prescription or over-the-counter drugs, or products such as traditionally caffeinated beverages, the FDA said

The caffeine-loaded dietary supplements have been linked to at least two deaths in otherwise healthy people, according to the FDA. 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. That's the equivalent of 20 to 28 cups of coffee, a potentially toxic dose of caffeine, the agency noted.

Less than 2 tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, while even smaller amounts can be life-threatening to children. Bulk amounts of highly concentrated caffeine pose a high risk of overuse and misuse because consumers have to measure a very small, precise recommended serving and often do not have the proper tools to do so, the FDA explained. The recommended safe serving of highly concentrated or pure caffeine products is often 200 mg of caffeine -- about 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid, according to the agency.

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