Regulatory Focus™ > News Articles > Warning Letter Blasts Maker of 'Caffeine Inhaler'

Warning Letter Blasts Maker of 'Caffeine Inhaler'

Posted 06 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration sent a warning letter to Breathable Foods, Inc., manufacturer of the inhalable caffeine product AeroShot, for "false or misleading statements in the labeling of their product."

FDA also said that it had safety concerns about Breathable Foods' product, particularly when it is inhaled by children and adolescents and concurrently with persons consuming alcohol.

FDA took particular offense to the company's marketing claim that their product was "breathable", while maintaining on the AeroShot's label that the product was to be consumed by swallowing.

"Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied," said FDA in the warning letter. "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."

Among FDA's other concerns: inconsistencies between Breathable Foods' marketing strategy and advised minimum age and lack of adverse event reporting information on the product's label.

No response from Breathable Foods Inc. was available at time of publication.

Read more:

FDA issues warning letter to makers of AeroShot "caffeine inhaler"

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