FDA warns companies selling pure or highly concentrated caffeine

caffeine powder photo by WILX news 314x210 FDA warns companies selling pure or highly concentrated and Dual Health Body and Mind were slapped with warning letters from the Food and Drug Administration (FDA) for illegally selling highly concentrated caffeine products – supplements the agency says pose a threat to public health.

“Despite being informed of the dangers of highly concentrated pure caffeine, we’re still finding companies that are disregarding consumer safety by illegally selling products with potentially dangerous and lethal amounts of caffeine,” said FDA Commissioner Scott Gottlieb, M.D. “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 shoulden’t be sold.”

At least two deaths have been linked to pure or concentrated caffeine, which prompted the FDA in May to issue guidance that clarified that dietary supplements consisting of pure or highly concentrated caffeine in powder or liquid forms are generally unlawful when sold directly to consumers. The guidance also provided recommendations on how manufacturers can formulate and market dietary supplements containing caffeine that do not present a significant or unreasonable risk of illness or injury.

The recommended safe serving size of highly concentrated or pure caffeine products is about 200 milligrams of caffeine, which equates to 1/16 of a teaspoon of pure powder or about 2 ½ teaspoons of a liquid. But the 16-ounce package of the product contains multiple toxic doses and as a whole represents an amount of caffeine that could be deadly, the FDA warned.

The Dual Health Body and Mind product contains 8 ounces of pure powdered caffeine, which is far more than 1,000 servings. This product is sold in packages as large as 5 ½ pounds – nearly 12,500 servings.

“We’ll continue to take action against companies who sell these risky products despite the agency’s prior warnings,” Gottlieb said.

FDA News Release
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