FDA sends warning to Breathable Foods, makers of AeroShot caffeine inhaler

The FDA has issued a warning to Breathable Foods, Inc., the makers of AeroShot. This caffeine inhaler product has come under question from the FDA regarding false or misleading statements in the labeling of the product.

In a press statement released today, the FDA elaborated on concerns in the warning letter sent to the company. Some key issues identified relate to AeroShot saying that the product is not recommended for those under 18 years of age on the company web site, the product label saying that it isn't intended for those under 12--yet the website appears to target those age groups by suggesting that it be used while studying.

The FDA continued, noting that the AeroShot website included links to news articles that refer to the product in conjunction with drinking alcohol. Although the items don't advocate taking AeroShot while drinking alcohol, the FDA noted that the presence of the news items on the AeroShot web site publicizes and may encourage use of AeroShot with alcohol. Caffeine may lead consumers to feel "less drunk", but it does not reduce blood alcohol levels.

The FDA warning letter can be found atwww.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm294774.htm. The company has 15 business days to respond to the FDA to bring the product into compliance with FDA regulations.

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