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Posted April 14, 2018

Highly Concentrated, Bulk Caffeine Products Dangerous and Illegal, Says FDA

On April 13, 2018, the FDA announced a new industry guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. The agency stated that when highly concentrated and pure caffeine is sold in bulk, often as a powder in large bags or as a liquid in bottle containing a gallon or more, consumers can too easily, and accidentally, consume more caffeine than they realize -- and more than is safe. Consumption of such highly concentrated and pure caffeine at least two deaths in otherwise healthy individuals.

"We're making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law. We'll act to remove these dangerous bulk products from the market," FDA commissioner Scott Gottlieb, M.D., stated in the news release.

According to the FDA, a half cup of a highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine and a single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine. These amounts are equivalent to about 20 to 28 cups of coffee, which is a potentially toxic dose of caffeine.

Additionally, the agency noted that bulk caffeine products often closely resemble and could be easily confused with safe household items such as flour or powdered sugar, or water or distilled vinegar, allowing for accidental ingestion.

Although the FDA issued warning letters to seven distributors of pure powdered caffeine in 2015 and 2016 citing that the products were dangerous and presented a significant or unreasonable risk of illness or injury to consumers, the agency stated it has "continued to see a proliferation of similar products being sold online."

The guidance does not affect other types of products that might also contain caffeine, such as prescription or over-the-counter drugs or conventional foods, like traditionally caffeinated beverages.

See related warnings and recalls:

Powdered Caffeine Risky, FDA Warns

Powdered Caffeine Can Be Lethal, FDA Warns

To read the FDA's news release, use the link below.