FDA Warns Of ‘Caffeine Inhaler’
March 8, 2012 by UPI - United Press International, Inc.
WASHINGTON (UPI) — Officials of the U.S. Food and Drug Administration said they have concerns about children and teens using a “caffeine inhaler” with alcohol.
The FDA said in a warning letter to Breathable Foods Inc., the makers of AeroShot, that it has questions about the safety of the caffeine inhaler for false or misleading statements in the labeling of their product as well as questions about the safety of the caffeine inhaler.
Breathable Foods says AeroShot is designed to provide “breathable energy, anytime, anyplace,” but that it also says the product is intended to be ingested by swallowing.
The FDA said the company’s labeling is false or misleading because these two claims contradict. A product cannot be intended for both inhalation and ingestion because the functioning of the epiglottis in the throat keeps the processes of inhaling and swallowing separate, the FDA said.
FDA officials also said it was concerned about AeroShot’s safety because labels that say “breathable energy” might confuse consumers about the proper use of AeroShot and encourage them to try to inhale it into their lungs.
Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied, the FDA said.
“The company claims on its Web site that decades of research have established that the particles in AeroShot are too big to enter the lungs, the company does not point to any specific research in support of this claim,” the FDA said in a statement.