FDA Sends Warning Letters to Powdered Caffeine Distributors Following Teen Deaths

FDA Sends Warning Letters to Powdered Caffeine Distributors Following Teen Deaths
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September 02, 2015

The Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine following the deaths of two teenagers. According to the warning letters, the product labels include confusing information that could lead a person to use a toxic amount.

Powdered caffeine has come under heavy scrutiny after two healthy teenagers died in 2014. One teaspoon of pure powdered caffeine is equal to the amount in nearly 30 cups of regular coffee. None of the companies that received warning letters recommended using more than 200mg, which is less than a teaspoon, but confusing language could lead to accidental overdose, says the FDA. all the labels include measuring information that is well in excess of the maximum serving size the company recommends.

For example, in its warning letter to Hard Eight Nutrition, the FDA wrote, "Although your directions say to take 50 milligrams to 200 milligrams of the product at a time, it is possible that a consumer would understand your label as a whole as suggesting a serving size of one-eighth of a teaspoon or one-quarter of a teaspoon."

The agency says that the difference between a safe amount and a toxic dose is very small and common kitchen measuring tools are not precise enough to calculate how many milligrams of caffeine are in the serving size.

Small amounts of caffeine, like those in coffee, tea and soda, have less serious effects such as nervousness and tremors. The effects of powdered caffeine, however, are much more serious, especially for those who have certain pre-existing medical conditions. Symptoms of caffeine toxicity include rapid or dangerously erratic heartbeat, seizures, vomiting, diarrhea, stupor, and disorientation.

Because powdered caffeine is marketed as a diet supplement, it is not regulated by the FDA. The FDA can, however, pursue legal action. If violations persist, the FDA can seize the products or issue an injunction to prevent the company from continuing to make or market the product.