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  1. Dietary Supplement Products & Ingredients

Pure and Highly Concentrated Caffeine

Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States.

In recent years, dietary supplement products consisting of pure or highly concentrated caffeine in powder and liquid forms have emerged on the market. 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.

The difference between a safe amount and a toxic or life-threatening amount of caffeine in these highly concentrated products is very small. Safe quantities of these products can be difficult or nearly impossible to measure accurately with common kitchen measuring tools. 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. These products are also often sold in ways that increase the likelihood of accidental measurement error.

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 are toxic amounts that can have serious health consequences.

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. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. Pre-existing conditions can intensify the effects of caffeine and make these products even more dangerous for some individuals.

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. 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.

FDA Action on Pure and Highly Concentrated Caffeine

On September 1, 2015, the FDA issued warning letters to five distributors of pure powdered caffeine products. The Agency issued two additional warning letters in March 2016 and then issued two more in June 2018.

On April 13, 2018, the FDA released a guidance for industry on highly concentrated caffeine in dietary supplements. This document provides guidance for companies who manufacture, market, or distribute dietary supplements containing pure or highly concentrated caffeine, or are considering doing so, in order to help them determine when a product is considered adulterated and illegal by the FDA.

The agency will continue to update this page in the event additional actions are taken related to pure and highly concentrated caffeine products.

For more information:

Links to Warning Letters:

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