FDA issues warning to inhalable caffeine maker

WASHINGTON — 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.

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Online:

Aeroshot corporate site: —http://www.aeroshots.com

FDA warning letter: —http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm294774.htm

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Find Mary Clare Jalonick on Twitter at —http://twitter.com/mcjalonick

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