BOSTON — U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.
AeroShot went on the market late last month in Massachusetts and New York, and it's also 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 stimulant in a large cup of coffee.
AeroShot inventor, Harvard biomedical engineering professor David Edwards, said 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 reaching the U.S. market because it is sold as a dietary supplement. But Sen. Charles E. Schumer, New York Democrat, said he met with FDA Commissioner 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," Mr. Schumer said.
An FDA official who was at the meeting also confirmed the decision, telling the Associated Press that the review will include a study of the law to determine whether AeroShot qualifies as a dietary supplement. The product will also be tested to determine whether it's safe for consumption, the official said.
The official spoke on the condition of anonymity because of not being authorized to discuss the matter.
Tom Hadfield, chief executive of Breathable Foods, which makes AeroShot in France, said in a statement that the company will cooperate fully with any FDA review to address the issues raised by Mr. Schumer and is confident the review will conclude that AeroShot is a safe, effective product that meets FDA regulations.
Mr. Schumer pressed the FDA in December to review AeroShot, saying he fears that it will be used as a club drug so that young people can keep going until exhausted.
He cited incidents that occurred last year when students looking for a quick and cheap high began consuming caffeine-packed alcoholic drinks such as Four Loko that were dubbed "blackout in a can" because of their potency. The FDA stopped the marketing, distribution and sale of these beverages.
"We need to make sure that AeroShot does not become the next Four Loko by facilitating dangerous levels of drinking among teenagers and college students," Mr. Schumer said in a statement.
Breathable Foods said the product is different from the potent beverages. The company asserted it's not targeting anyone under 18 and that AeroShot safely delivers caffeine into the mouth, just like coffee does.
A single unit costs $2.99 at convenience stores, mom-and-pops, plus liquor and online stores. The product packaging warns people not to consume more than three AeroShots a day.
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