FDA to review safety of inhalable caffeine product

BOSTON — U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and whether its manufacturer was right to brand it as a dietary supplement.

AeroShot went on the market late last month in Massachusetts and New York; it also is available in France. Consumers put one end of the canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly.

Each gray-and-yellow plastic canister contains B vitamins, plus 100 milligrams of caffeine powder, about the equivalent of the caffeine in a large cup of coffee.

The AeroShot inventor, Harvard biomedical engineering professor David Edwards, says the product is safe and doesn’t contain taurine and other common additives used to enhance the caffeine effect in energy drinks.

AeroShot didn’t require FDA review before hitting the U.S. market because it is sold as a dietary supplement. But U.S. Sen. Charles Schumer of New York said he met with FDA Commissioner Dr. Margaret Hamburg and she agreed to review the safety and legality of AeroShot.

"I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit after hit, in rapid succession," Schumer said.

Tom Hadfield, chief executive of Breathable Foods, which makes AeroShot in France, said in a statement that the company will cooperate fully with the FDA’s review to address the issues raised by Schumer and is confident the agency will conclude that AeroShot is a safe, effective product that complies with FDA regulations.

The company said that when used according to its label, AeroShot provides a safe amount of caffeine and B vitamins. It said AeroShot is not recommended for those younger than 18 and is not marketed to children.

Meanwhile, an FDA official who was at the meeting confirmed the decision, saying the review will include a study of the law to determine whether AeroShot qualifies as a dietary supplement. The product also will be tested to figure out whether it is safe for consumption, the official said on condition of anonymity.

Schumer pressed the FDA in December to review AeroShot, saying he fears it will be used as a club drug so that young people can keep going until they drop. He cited incidents that occurred last year when students looking for a quick and cheap buzz began consuming caffeine-packed alcoholic drinks they dubbed "blackout in a can" because of their potency.

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