FDA prepares to remove highly concentrated caffeine in supplements

April 13 (UPI) — The Food and Drug Administration on Friday announced it is taking steps to remove highly concentrated caffeine found in dietary supplements.

The federal agency said in a release that at least two deaths have been linked to the highly concentrated and pure caffeine often sold in bulk packages.

“Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container,” Dr. Scott Gottlieb, the FDA commissioner, said in a statement. “We know these products are sometimes being used in potentially dangerous ways.”

He noted teenagers are sometimes mixing “dangerously high amounts” of super-concentrated caffeine into workout cocktails.

“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,” he said.

Approximately 2,000 mg of caffeine can be present in a half-cup of these products. One teaspoon of powdered pure caffeine can contain approximately 3,200 mg of caffeine — the equivalent of about 20 to 28 cups of coffee.

The recommended safe serving size is often 200 mg of caffeine, which equates to 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid.

The FDA’s action does not include energy drinks or energy products that contain caffeine or supplements. “Moreover, this 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,” the FDA said.

The agency said using the highly concentrated caffeine products can be confusing to consumers.

Using a “heaping scoop” instead of a “level scoop,” can be a harmful misestimation, the FDA cautioned.

It added that products in a clear liquid form could be easily confused with water or distilled vinegar, and pure powdered caffeine could be easily confused with flour or powdered sugar. “The consequences of a consumer mistakenly confusing one of these products could be toxic or even lethal,” the FDA said.

In 2015 and 2016, the FDA sent warning letters to seven distributors of pure powdered caffeine.

“The FDA intends to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form, and the agency will continue to take action when products put consumers at risk,” it said in a release.

The FDA noted that safe products are ones that include the right dosage forms in capsules or pills, ones sold in premeasured packets or containers and bulk powder or liquid diluted to low enough concentrations of caffeine.

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