WASHINGTON — Food and Drug Administration officials have issued a warning letter to the makers of the inhale-to-ingest 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 that consumers may try to inhale it into their lungs, which may not be safe.
The letter also noted that the company’s website says it is not recommended for those under the age of 18, but 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.
AeroShot didn’t require FDA review before hitting the U.S. market because it’s sold as a dietary supplement.
Comments are no longer available on this story