The U.S. Food and Drug Administration officials will investigate whether 'AeroShot' inhalable caffeine, which is sold in lipstick-sized canisters, is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.
AeroShot was launched in the market late last month in Massachusetts and New York. It is also available in France.
AeroShot did not require FDA review as it was sold as a dietary supplement. But New York's U.S. Senator Charles Schumer said he had a meeting with FDA Commissioner Dr. Margaret Hamburg and that she thinks that the safety and legality of AeroShot should be reviewed, reported Associated Press.
Schumer said: 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.
The consumers of the product put one end of the canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly.
The content of one grey-and-yellow plastic canister has B vitamins, plus 100 milligrams of caffeine powder, about the equivalent of the caffeine in a large cup of coffee.
David Edwards, AeroShot inventor and Harvard biomedical engineering professor, says the product is safe and does not contain taurine and other common additives used to enhance the caffeine effect in energy drinks.
Tom Hadfield, chief executive of Breathable Foods, which makes AeroShot in France, assured in a statement that the company will cooperate fully with the FDA's review, AP reported. He said he was confident the investigation will prove that AeroShot is a safe and effective product.
The company also said that if the product is used according to prescribed label, AeroShot provides a safe amount of caffeine and B vitamins and does not contain common additives used to enhance the effect of caffeine.
But Schumer fears that it can be used as a club drug by youngsters, and cited incidents last year when students consumed caffeine-packed alcoholic drinks dubbing them blackout in a can.
The senator and others persuaded the FDA to stop the marketing, distribution and sale of those beverages, including Four Loko.
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, Schumer said, according to AP.
However, the company insists that its product is different from the potent beverages and that it is not targeting anyone under 18.
The cost of a single unit of AeorShot is $2.99. The product packaging warning says not to consume more than three AeroShots a day.
The manufacturer says on its website: Caffeine has been proven to offer a variety of potential benefits for health to individuals when consumed in moderation, from providing energy to enhancing attention and focus.
AeroShot is the flagship product of Cambridge-based Breathable Foods.