US FDA issues warnings to companies illegally selling concentrated caffeine products


07 Jun 2018 --- The US Food and Drug Administration (FDA) has issued warning letters to the parties responsible for and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products. The FDA considers these products to be a threat to public health. The recipients of the warning letters have 15 days to notify the agency about how they have addressed the violations and will prevent them from recurring. If the companies fail to promptly correct these violations, the FDA announced it may take additional action, such as seizure and/or injunction.

“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 recently took action to explain which pure and highly concentrated caffeine products cannot be lawfully marketed because they pose an unacceptable risk to consumers. 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. Today’s action is part of these efforts,” says FDA Commissioner Scott Gottlieb M.D. 

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.

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. 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 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 life-threatening dose of caffeine is typically estimated at between 10 and 14 grams, though a smaller amount can be life-threatening in children and sensitive populations.

The Dual Health Body and Mind product contains 8 ounces of pure powdered caffeine, which is well over 1,000 servings of the product. The product is also sold in packages as large as 5 1/2 pounds, which is almost 12,500 servings of the product.

The 200 milligram serving size recommended on the labeling of the Dual Health Body and Mind caffeine powder cannot be accurately measured using common household measuring tools. 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 agency notes.

Last month, the FDA issued 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 in bulk packaging. 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.

Linked to at least two deaths in otherwise healthy US individuals, highly concentrated and pure caffeine products “present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses,” according to the agency.

Importantly, the bulk quantities and concentrated forms of these products make it far too easy for consumers to ingest “deceptively high” amounts of caffeine, as they may not have the correct measuring tools or knowledge to ensure the use of safe amounts.

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