Pharmaceutical

FDA bans bulk sales of highly concentrated, pure caffeine

caffeine powder photo by WILX news 314x210 FDA bans bulk sales of highly concentrated, pure caffeineBulk sales of dietary supplements that contain highly concentrated or pure caffeine to consumers have been banned because they pose a public health risk, the Food and Drug Administration (FDA) announced in a News Release. These potent caffeine products pose a high risk of use at excessive levels, which can be dangerous and even deadly. At least two deaths have been linked to the concentrated or pure caffeine, the agency said.

“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. We know these products are sometimes being used in potentially dangerous ways,” said FDA Commissioner Scott Gottlieb, M.D. “For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails. The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold.”

Gottlieb said the agency is making it clear to the industry that the highly concentrated forms of caffeine sold in bulk packages are generally illegal. “We’ll act to remove these dangerous bulk products from the market.”

The recommended safe serving of highly concentrated or pure caffeine products is generally 200 mg of caffeine, which equates to about 1/16 of a teaspoon of pure powder or 2.5 teaspoons of liquid. Correctly measuring these dosages is difficult for consumers because they do not have the right tools to properly measure such small amounts, the agency said. But even if they did have the tools, the agency said, errors can easily happen.

For example, a half-cup of concentrated liquid caffeine can contain about 2,000 mg of caffeine and a single teaspoon of a powdered pure caffeine can contain about 3,200 mg of caffeine. That is the equivalent of about 20 to 28 cups of coffee – a potentially deadly dose.

In 2015 and 2016, the FDA warned seven distributors of pure powdered caffeine citing that the products were dangerous and presented a significant or unreasonable risk of illness or injury to consumers. Since then, the FDA has continued to see a “proliferation” of similar products being sold online.

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

Source: FDA