BOSTON (AP) - U.S. Food and Drug
Administration 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.
AeroShot went on 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 planned to announce 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.
Meanwhile, an FDA official
who was at the meeting confirmed the decision, telling The Associated
Press 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's 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 pressed 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. 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 stop the marketing, distribution
and sale of these 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
in a statement.
Breathable Foods says the
product is different from the potent beverages. The company says that
it's not targeting anyone under 18 and that AeroShot safely delivers
caffeine into the mouth, just like coffee does.
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."
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.
In this Jan. 23 still file photo taken from video, students try free samples of AeroShot, an inhalable caffeine packed in a lipstick-sized canister, on the campus of Northeastern University in Boston. (AP Photo/Rodrique Ngowi, File)
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