(AP) BOSTON — 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.
___
Rodrique Ngowi can be reached at www.twitter.com/ngowi.
All content © Copyright 2000-2011 WorldNow and KFDA. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms of Service.
