FDA Action on Pure and Highly Concentrated Caffeine

If violations exist, the FDA can pursue enforcement action, such as seizure of the product or an injunction to prevent the firm from continuing to manufacture or market the product. The FDA aggressively monitors the marketplace for dangerous products, including dietary supplements consisting of pure and highly concentrated caffeine, and will continue to take action as appropriate. Pre-existing conditions can intensify the effects of caffeine and make these products even more dangerous for some individuals. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. While consumers of commonly available caffeinated products such as coffee, tea, and soda may be aware of caffeine’s less serious effects – such as nervousness and tremors – they may not be aware that these pure and highly concentrated caffeine products are much more potent and can cause serious health effects, including rapid or dangerously erratic heartbeat, seizures and death. These are toxic amounts that can have serious health consequences. Just one teaspoon of pure powdered caffeine can contain the same amount of caffeine as 28 cups of coffee, and a half cup of a liquid highly concentrated caffeine product contains the equivalent of more than 20 cups of coffee. These products are also often sold in ways that increase the likelihood of accidental measurement error.

For many of these products, volume measures such as teaspoons are not precise enough to calculate how many milligrams of caffeine are in the recommended serving size. Safe quantities of these products can be difficult or nearly impossible to measure accurately with common kitchen measuring tools. The difference between a safe amount and a toxic or life-threatening amount of caffeine in these highly concentrated products is very small. These products are often marketed in bulk packaging with up to thousands of servings per container, requiring the consumer to measure out a safe serving from what can be a toxic or even lethal amount of bulk product. In recent years, dietary supplement products consisting of pure or highly concentrated caffeine in powder and liquid forms have emerged on the market. Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States.

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