October 21, 2018

FDA Warns Companies to Stop Selling Highly Concentrated Caffeine Products

The FDA is warning companies that make two highly concentrated caffeine products to stop making them, because the government considers them a threat to public health. The companies are Liquidcaffeine and Dual Health Body and Mind.

FDA Commissioner Scott Gottlieb said, “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. 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. These letters build on our efforts to stop the illegal sale of highly concentrated forms of caffeine that are being sold in bulk packages.”

The recommended serving size of “highly concentrated caffeine products” is 200 mg, which equals 1/6 teaspoon of pure powder or about 2-1/2 teaspoons of a liquid product. The label on the liquid caffeine product contains “multiple toxic doses” according to the press release, and represents an amount of caffeine that could “be potentially lethal to certain populations.” The Dual Health Body and Mind product contains 8 ounces of pure powdered caffeine, which is more than 1,000 servings. And the 200 mg serving size cannot be accurately measured using the tools an average household would have.

The FDA issued guidance in May that said dietary supplements that consist of pure or highly concerned caffeine in powder or liquid forms are “generally unlawful when sold directly to consumers in bulk packaging.”

Highly Concentrated Caffeine Products

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