FDA to Investigate Safety of Inhalable Caffeine

ABC News' Mark Greenblatt reports:

The Food and Drug Administration will launch a safety investigation of a new product that allows consumers to inhale caffeine through a lipstick-sized portable device,  rather than drinking it.

AeroShot delivers 100 milligrams of caffeine per use, and comes in bright colored packages that describe it as "pure energy," and "breathable energy anytime, anyplace."

The manufacturer, Breathable Foods Inc., put it on the market in New York, Massachusetts, and in France late last month.

"You could easily overdose or succumb to toxicity associated with the caffeine ingestion," Dr. Bruce Goldberger told ABC News. "You could mix it with alcohol in a social setting and also I'm troubled by its availability, potentially at home where young children can get a hold of it."

Sen. Charles Schumer of New York said he shares those concerns.

"A new product like AeroShot raises questions that need to be answered before allowing consumers, especially teens and kids, to use and abuse it," he said. "The AeroShot caffeine-inhaler is being marketed as a party enhancer; it can facilitate excessive drinking and its effects have never been examined by independent regulators to determine their impact on the human body and in combination with alcohol, especially for adolescents."

The  inventor of AeroShot, Harvard biomedical professor David Edwards, says his product is as safe as a cup of coffee, which provides roughly the equivalent dose of caffeine.

"I think that we are absolutely welcoming a dialogue with the FDA," he said. "As I say, this is a new way of delivering food in your mouth, and we're confident that as they look at the product that they will confirm what we hold, that the product is both safe and follows FDA regulations."

Edwards was able to bring Aeroshot to the market without an FDA review being required because it is sold as a dietary supplement.   ABC News asked Edwards if he or his company had done any studies of the health effects of AeroShot on children or teenagers.

"The answer is no, we did not do tests on children," he said, explaining that children and teenagers are not part of his target market. "We need to be really clear what a company responsibly does to test the safety of their product, and we've followed those safety regulations."

Edwards says his product delivers a lower dose of caffeine than many energy drinks or caffeine pills currently on the market, and says it comes in a controlled, smaller dose of caffeine.

Edwards says demand for the product is eclipsing anything he could have ever anticipated, and increasing.

ABC News found the product on store shelves throughout New York and around college campuses.  We visited three delis near Columbia University - two sold us their shelf stock, while the third store was already sold out.

"I would try it during something like finals week," said Thalia Dergham, a Columbia University student.  Dergham said, though, that she would likely not be a regular consumer of the product outside of high stress times.

Other students were not so willing.

"It looks intense," said Kristin Simmons, a Columbia University art history and visual arts major. "It looks like one of those monster Red Bull drinks."

After announcing its review, the FDA is now likely to examine the health effects of inhaling the caffeine on at-risk populations, along with looking into the potential health effects of use when combined with alcohol.

"FDA will review information brought to the agency's attention about this product," the agency said in a statement.  "As with any complaint or concern we receive about FDA-regulated products, we will consider whether a violation of the Federal Food, Drug, and Cosmetic Act has occurred and, if so, whether regulatory action is warranted in light of FDA's enforcement priorities and resources."

The product's manufacturer has come under fire for a round of advertisements that seem to show its use by younger men and women who are out at nightclubs, where alcohol may be present.

ABC News asked the inventor of the product about those ads.  Edwards said the product itself is safe and fundamentally sound, but there is ongoing discussion within his company about how to market it and where to sell it.

"Speaking as an innovator, you're not developing a product thinking of targeting people that it's going to hurt. And so on the contrary,  the motivation of this product was to actually create a healthier and more accessible way of having caffeine, when you need it, as opposed to overdoing yourself often when you don't need it."