FDA warns firms to stop selling highly concentrated caffeine

Allen Cone

June 5 (UPI) -- The U.S. Food and Drug Administration has sent warning letters to two websites the agency said are selling illegal highly concentrated caffeine products.

The FDA on Tuesday warned and Dual Health Body and Mind to find ways to make their products more safe, based on previous warnings of potential dangers to consumers.


In April, the FDA announced it was taking steps to remove highly concentrated caffeine found in dietary supplements.

The FDA has given the two companies 15 days to notify the agency about specific ways it will address the violations -- that is, make it easier for consumers of their products to avoid ingesting dangerous or toxic amounts of caffeine -- and prove that the violations will not occur again.

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The agency said it may take additional action, such as seizure and/or injunction, if the companies fail to promptly correct these violations.

"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," said FDA commissioner Dr. Scott Gottlieb. "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."


Gottlieb noted there has been at least two deaths linked to pure or concentrated caffeine.

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"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," he said. "We'll continue to take action against companies who sell these risky products despite the agency's prior warnings."

The FDA's recommended safe serving size of highly concentrated or pure caffeine products is 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.

A life-threatening dose of caffeine is typically estimated at between 10 and 14 grams, though in children and others a smaller amount can be life-threatening, according to the agency.

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In the case of, a 16-ounce package of the product contains multiple toxic doses.

Although consumers are required to measure safe servings, rather than a potentially toxic amount, the product labeling said separating out a safe serving from a potentially toxic amount can be done with a pump sold with the product.

In addition, also makes available two-gallon containers of liquid caffeine, or approximately 128 grams of caffeine, which is the equivalent of several lethal doses.

The Dual Health Body and Mind product contains 8 ounces of pure powdered caffeine, which is more than 1,000 servings. The product is also sold in containers as large as 5 1/2 pounds.

The FDA noted the 200 milligram serving size recommended on the labeling of the Dual Health Body and Mind caffeine powder needs a special scale. Even if consumers were to have a tool that measures one-sixteenth of a teaspoon, the FDA said it would still not be adequate to accurately measure a 200 milligram dose.


The tools can scoop out different amounts depending on factors such as how tightly the powder is packed and whether a "heaping" scoop is used, the agency said.

"A simple mistake, such as measuring a serving in grams or fractions of a tablespoon, rather than milligrams or fractions of a teaspoon, could result in a toxic or even life-threatening dose," the FDA said in a release.

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