FDA Reviewing Caffeine Supplement AeroShot

The U.S. Food and Drug Administration is currently reviewing the safety of AeroShot, an inhalable caffeine product manufactured by Breathable Foods, a company founded by a Harvard professor and led by a College graduate.

AeroShot, a thin plastic tube which delivers about 100 milligrams of caffeine—the same amount contained in one large cup of coffee—in six to eight puffs, hit the shelves of Massachusetts and New York stores last month.

The senator who led the charge against the caffeinated alcoholic drink Four Loko, which was popular at Harvard and other colleges before it was banned in Massachusetts and other states, says that Aeroshot may similarly enable young people to consume a dangerous brew of caffeine and alcohol.

The legislator, New York Senator Charles Schumer, has called on the FDA to review AeroShot.

“I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to over-using a product that allows one to take hit after hit after hit, in rapid succession,” Schumer said, according to the Associated Press.

Pointing to advertisements for AeroShot, Schumer said, according to ABC News, “They’re not showing this with a lot of physics books, for late-night studying. They’re showing you at bars and parties, drinking. And that’s the danger.”

Breathable Foods, which is managed by CEO Thomas D. Hadfield ’08, labels AeroShot, which was invented by biomedical engineering professor David A. Edwards, as a dietary supplement. That designation allowed the product to reach the market without undergoing an FDA review.

In an interview with The Crimson, Hadfield said that AeroShot meets FDA rules.

“We think AeroShot is a healthier, safer, and effective way to consume energy and complies with FDA regulations,” Hadfield said. He said that early feedback on AeroShot from buyers has been positive.

“Sales of the product, since it launched in January, have been strong, especially in and around college campuses,” Hadfield said.

Hadfield said that Breathable Foods will work with the FDA as it conducts its inquiry.

“We will cooperate fully with the FDA review and are confident that it will conclude that AeroShot is a safe, effective product that complies with FDA regulation,” Hadfield said.