FDA Issues Warning Letter to Makers of AeroShot 'Caffeine Inhaler'

FDA Issues Warning Letter to Makers of AeroShot 'Caffeine Inhaler'

March 6, 2012

(FDA news release) 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.”

According to the news release:

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. 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.     
 
FDA is also concerned about AeroShot’s safety because label statements such as “breathable energy” may 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.  While the company claims on its website 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.
 
In addition, the company’s website indicates that AeroShot is “not recommended for those under 18 years of age,” and the product label states that it is “not intended for people under 12.” But the website also appears to target these age groups by suggesting it be used when studying.
 
The AeroShot website also includes links to news articles and videos that refer to use of the product in conjunction with drinking alcohol.  Although these news items do not advocate taking AeroShot while drinking alcohol and express health concerns about such use, the presence of the news items on the AeroShot promotional website publicizes and therefore may encourage the use of AeroShot with alcohol. While using caffeine when drinking may lead consumers to feel “less drunk,” it does not reduce blood alcohol levels.
 
FDA regulations require manufacturers to ensure that a product is safe and properly labeled before being brought to market. FDA has instructed Breathable Foods Inc. to correct the violations cited in the warning letter and provide information on research the company cites so the agency can evaluate the research. The company has 15 business days to respond to the agency with a plan to bring the product into compliance with FDA regulations.
 
The warning letter also charges that the product label does not include contact information for consumers to report any adverse events to the company, as required under federal law. Consumers who believe they have suffered illness or injury from using AeroShot should also report those events to their regional FDA Consumer Complaint Coordinators2. The agency also encourages healthcare providers to report to FDA any adverse events in their patients that are associated with AeroShot. As of March 6, 2012, FDA has not received any adverse event reports associated with the product.

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