Space porn: These images are (quite literally) out of this world
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
NASA astronaut Mike Hopkins
On December 28, 2013, Expedition 38 crew member Mike Hopkins participating in the second of two space walks to replace a degraded pump module on the International Space Station. (NASA astronaut Rick Mastracchio is reflected in his helmet!)
The Soyuz TMA-10M
The Soyuz TMA-10M headed towards the International Space Station with crew members from Expedition 37 onboard.
40 years ago the Apollo 8 mission flew up to the moon, orbited it ten times and then returned to Earth. This picture was taken from that flight and shows the Earth as it seemingly rises in similar fashion to a sunrise.
Sunrise from Expedition 36
NASA Flight Engineer Karen L. Nyberg of Expedition 36 took this photo of the sun rising -- a sight they saw nearly 16 times per day due to the speed of the International Space Station's orbit around the earth.
A pair of NanoRacks CubeSats -- nanosattelite spacecrafts carrying experiments -- were launched by Expedition 38.