FDA to Examine Inhalable Caffeine
Schumer asks for review of new product
Published in CSP Daily News
BOSTON -- U.S. Food & Drug Administration (FDA) 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, reported the Associated Press.
AeroShot went on the market late last month in Massachusetts and New York, and it is 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, said the product is safe and does not contain taurine and other common additives used to enhance the caffeine effect in energy drinks.
AeroShot did not require FDA review before hitting the U.S. market because it is sold as a dietary supplement. But U.S. Senator Charles Schumer (D) 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, CEO of Breathable Foods, which makes AeroShot in France, did not immediately respond to AP requests seeking comment. A publicist for the company also did not respond.
An FDA official told the news agency 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 figure out whether it is safe for consumption, the official said.
The official spoke on the condition of anonymity because that official was not authorized to discuss the matter.
Schumer asked 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 they drop ( click here to read Schumer's letter to the FDA). 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.
Pressure from the senator and others helped persuade the FDA to curtail the marketing, distribution and sale of these beverages.
"We need to make sure that AeroShot does not become the next [caffeinated energy drink] by facilitating dangerous levels of drinking among teenagers and college students," Schumer said.
Breathable Foods said the product is different from those beverages. The company said that it is not targeting anyone under 18 and that AeroShot safely delivers caffeine into the mouth, just like coffee does.
A single unit retails for $2.99. 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 said 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, the flagship product of Cambridge, Mass.-based Breathable Foods, is the product of a conversation that Edwards had with celebrity French chef Thierry Marks over lunch in the summer of 2007.
The first venture Edwards worked on with Harvard students was the breathable chocolate, called Le Whif. Now he's preparing to promote a product called Le Whaf, which involves putting food and drinks in futuristic-looking glass bowls and turning them into low calorie clouds of flavor.
Click here to read the AeroShot press release.