WASHINGTON (AP) — Food and Drug Administration officials have issued a warning letter to the makers of the inhalable caffeine product AeroShot, saying they have questions about its safety and concerns about how children and adolescents may use it.
The lipstick-sized AeroShot went on the market in January in Massachusetts and New York, and it’s also available in France. Consumers put one end of the plastic canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly. The product’s website calls it “a revolutionary new way to get your energy.”
The FDA said the Massachusetts-based company behind AeroShot, Breathable Foods, misled consumers by saying the product can be both inhaled and ingested, which is not possible. The agency said it is concerned consumers may try to inhale it into their lungs, which may not be safe.
The letter also pointed out that the company’s website says it is not recommended for those under the age of 18, while the product label says it is not recommended for those under 12. At the same time, the FDA said, the company targets both age groups by suggesting it be used while studying.
In a statement, Breathable Foods CEO Tom Hadfield said the product is not intended for those under 18. He said the company will work closely with FDA to ensure compliance.
“AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not ‘inhaled’ into the lungs,” he said.
Another problem cited by the FDA was links on the company’s website to articles that mention using the caffeine product with alcohol. The FDA has attempted raise awareness about the dangers of the combination of caffeine and alcohol in recent years, saying it can lead to “a state of wide-awake drunk” and has caused alcohol poisoning, car accidents and assaults. The agency cracked down on the sale of the energy-alcohol drink Four Loko in 2010, forcing the makers of that product to remove the caffeine.
AeroShot didn’t require FDA review before hitting the U.S. market because it’s sold as a dietary supplement, and FDA regulations require supplement manufacturers themselves to be responsible for products’ safety. If the agency decides a product isn’t safe, it can take action, including taking the product off store shelves.
The company has 15 days to respond to the letter, which asked Breathable Foods to correct the violations the FDA cited and to submit its research on the product’s safety to the agency.
Sen. Charles Schumer, D-N.Y., had urged the FDA to crack down on the product, which is being sold in his state, saying children and adolescents may abuse it.
“This stern warning is the clearest indication yet that AeroShot needs to be taken off the market until these concerns can be addressed and the product’s safety can be confirmed,” he said.
Aeroshot corporate site: —http://www.aeroshots.com
FDA warning letter: —http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm294774.htm
Find Mary Clare Jalonick on Twitter at —http://twitter.com/mcjalonick
More Related Stories
- Is the Environmental Defense Fund ruining environmentalism?
- Top 5 investigative videos of the week: "Winning" Afghanistan
- Jester clowns Westboro Baptist Church
- GOP: Party of crybabies
- Developers evict historic women's shelter to build luxury hotel
- Guantánamo prisoner on hunger strike cries for help on Twitter
- 3 possible solutions to international tax avoidance
- “I just want the U.S. to send my father home”
- Army weapons engineer tied to white nationalist organizations
- Ted Cruz against the world
- David Vitter's hypocritical, punitive, horrible new amendment
- Louie Gohmert: Women should be forced to carry nonviable pregnancies to term
- Could hackers destroy the U.S. power grid?
- Democrats may be even worse than Republicans at regulating Wall Street
- Eric Holder versus journalism
- A progressive defense of drones
- There's no substitute for government disaster relief
- Holder signed off on search warrant for reporter
- Mississippi could begin prosecuting women for miscarriages
- Mike Judge: "Bowling for Columbine" made me pro-gun
- Closing Gitmo is not enough
Featured Slide Shows
The week in 10 picsclose X
- 1 of 11
Lisa Montgomery embraces her nephew Thursday after a tornado tore apart her home in Cleburne, Texas. The twister killed six people and destroyed entire swaths of the North Texas town.
Credit: AP/LM Otero
Jack McMahon, the defense attorney for abortion doctor Kermit Gosnell, speaks outside the Criminal Justice Center in Philadelphia Tuesday. His client was convicted of killing three babies in his clinic, and will serve multiple life sentences.
Credit: AP/Matt Rourke
A photo taken Monday captures Vice President Joe Biden's response to a Milwaukee second-grader's innovative proposal to end America's epidemic of gun violence. This guy!
Credit: AP/Jenny Aicher
Sen. Rand Paul, R-Ky., flanked by a grouper-eyed Michele Bachmann, addresses the IRS' admission that it targeted Tea Party groups in advance of the 2012 election. In an op-ed for CNN Thursday, the Kentucky senator slammed the president for his faux outrage.
Credit: AP/Molly Riley
Ousted IRS chief Steven Miller is sworn in on Capitol Hill Friday. Miller testified before the House Ways and Means Committee on the extra scrutiny the agency gave conservative groups applying for tax-exempt status.
Credit: AP/J. Scott Applewhite
Attorney General Eric Holder pauses as he testifies on Capitol Hill before the House Judiciary Committee Wednesday. Holder is under fire, among other things, for the Justice Department's gathering of phone records at the Associated Press.
Credit: AP/Carolyn Kaster
O.J. Simpson sits during an evidentiary hearing at Clark County District Court in Las Vegas, Nev., Thursday. Simpson, who is currently serving a nine-to-33-year sentence in state prison for armed robbery and kidnapping, is using a writ of habeas corpus to seek a new trial.
Credit: AP/Las Vegas Review-Journal/Jeff Scheid
Major Tom to ground control: On Sunday astronaut Chris Hadfield recorded the first music video from space, a cover of David Bowie's "Space Oddity."
Credit: AP/NASA/Chris Hadfield
When it rains it pours. President Barack Obama speaks during a news conference Thursday with Turkish Prime Minister Recep Tayyip Erdogan, inexplicably inspiring an #umbrellagate Twitter meme.
Credit: AP/Jacquelyn Martin
A smoke plume rises high above a road block at the intersection of County A and Ross Road east of Solon Springs, Wis., Tuesday. No injuries were reported, but the the wildfire caused evacuations across northwestern Wisconsin.
Credit: AP/The Duluth News-Tribune/Clint Austin
Recent Slide Shows
- 1 of 11