The product is also sold as a similar-appearing product containing two gallons of liquid caffeine, or approximately 128 grams of caffeine, which is the equivalent of several lethal doses. A consumer is required to measure a safe serving from a potentially toxic amount, but the product labeling incorrectly implies that the process of separating out a safe serving from a potentially toxic amount can be done with a pump that is not sold with the product. The 16-ounce package of the product contains multiple toxic doses and as a whole it represents an amount of caffeine that could be potentially lethal to certain populations. The recommended safe serving size of highly concentrated or pure caffeine products is often 200 milligrams of caffeine, which equates to 1/16 of a teaspoon of pure powder or about 2 1/2 teaspoons of a liquid product. We’ll continue to take action against companies who sell these risky products despite the agency’s prior warnings.” These letters build on our efforts to stop the illegal sale of highly concentrated forms of caffeine that are being sold in bulk packages. “We’ve let consumers know that they should avoid pure caffeine sold in bulk, and we’ve issued guidance to help firms understand when these kinds of products are considered adulterated and shouldn’t be sold. Today’s action is part of these efforts,” said FDA Commissioner Scott Gottlieb M.D. We’ve already seen at least two deaths linked to pure or concentrated caffeine, and we’ll be enforcing the law to protect consumers from these products. The FDA recently took action to explain which pure and highly concentrated caffeine products cannot be lawfully marketed because they pose an unacceptable risk to consumers. “Despite being informed of the dangers of highly concentrated and pure caffeine, we’re still finding companies that are disregarding consumer safety by illegally selling products with potentially dangerous and lethal amounts of caffeine. The FDA considers these products to be a threat to public health. Food and Drug Administration has issued warning letters to the parties responsible for and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.
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