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The U.S. Food and Drug Administration on Tuesday issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the "caffeine inhaler."
The FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol.
The company claims AeroShot is designed to provide "breathable energy, anytime, anyplace." The company also claims on its website that its product is intended to be ingested by swallowing.
The company's labeling is false or misleading because these two claims contradict each other, the FDA said, adding that 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.
Published: March 08, 2012 - Volume 10 - Issue 47