The Food and Drug Administration is clamping down on the distribution of pure powdered caffeine, a product already linked to the deaths of two teenagers.
The agency said Tuesday it issued warning letters to five distributors of powdered caffeine. The problem is these pure powdered products have a small margin of error between a safe dose and a toxic dose, the FDA said in a press release.
Powdered caffeine is meant to be added to water or other types of liquids such as workout shakes. But it’s difficult for people to calculate the right dose, and using a teaspoon is not precise enough to calculate how many milligrams are needed in a serving size, the agency added.
Regulators have been on alert regarding pure powdered caffeine following the deaths of two young men last year. The agency has said that one teaspoon of the powder is equivalent to about 28 cups of regular coffee.
A caffeinated product has some mild side effects like nervousness or tremors. Since these powdered products are far more potent, they can cause serious problems such as a rapid or erratic heartbeat, seizures and even death, the agency said.
The distributors warned were Smartpowders, Purebulk, Kreativ Health, Hard Eight Nutrition and Bridge City. The FDA told each of these distributors that they appear to be recommending dosage levels that may not be safe. In the case of Smartpowders, for example, the FDA noted that this company recommends 200 mg as a serving, and then notes on the label that one-quarter of a teaspoon is 574 mg.
“Although your product’s serving size is listed as 200 milligrams, it is possible that a consumer would understand your label as a whole as suggesting a serving size of one-quarter teaspoon,” the FDA said.
The FDA said that amount puts consumers at risk, and asked the company to explain within 15 days “the specific steps you have taken to correct these violations.” Similar letters were sent to the other companies.
“The FDA will continue to aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate,” the agency said. “If violations exist, the FDA can pursue enforcement action, such as seizure of the product or an injunction to prevent the firm from continuing to manufacture or market the product.”
Dietary supplements are not heavily regulated by the FDA. The agency does not review and approve each supplement before it hits the market.
