FDA to review inhaled caffeine device - AeroShot

By Dr. Ananya Mandal, MDFeb 20 2012

The U.S. Food and Drug Administration (FDA) has announced its intentions of investigating whether inhalable caffeine sold in lipstick-sized canisters called AeroShot is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.

AeroShot appeared in 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 grey-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. 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's sold as a dietary supplement. But New York's U.S. Sen. Charles Schumer 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. He announced the AeroShot review Sunday.

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 are confident it 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 and does not contain common additives used to enhance the effect of caffeine in energy drinks. It said each AeroShot contains B vitamins and 100 milligrams of caffeine, about the equivalent of caffeine in a large cup of coffee, and that AeroShot is not recommended for those under 18 and is not marketed to children.

A single unit costs $2.99 at convenience stores, mom-and-pops, and liquor and online stores. The product packaging warns people not to consume more than three AeroShots a day. “When used in accordance with its label, AeroShot provides a safe shot of caffeine and B vitamins for ingestion,” 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.”