Breathable Food Draws FDA Warning Letter

March 7, 2012

By Ricardo Carvajal

In a letter that includes fun facts about the function of the epiglottis, FDA has warned Breathable Foods, Inc. that its AeroShot product is misbranded.  The product’s labeling is alleged to be false and misleading because it contains contradictory statements regarding whether the product is intended for inhalation or ingestion.  The labeling also declares the product to be a dietary supplement, which – by definition – must be ingested.  The product is alleged to be further misbranded because the labeling fails to bear contact information that would enable third parties to notify the company of a serious adverse event.  In an accompanying press release,  FDA “encourages healthcare providers to report to FDA any adverse events in their patients that are associated with AeroShot,” but notes that no such reports have been received to date.

With respect to safety, the letter raises concerns with respect to the potential inhalation of caffeine, and questions whether the product is intended for use by adolescents.  In a prior posting, we noted the possibility that FDA might show interest in the manufacturer’s marketing practices, and in the product’s potential effects on consumer behavior.  Sure enough, the letter notes that the product’s website includes news videos and articles that reference the use of the product with alcohol.  The letter contends that such “publicity may have the effect of encouraging the combination of your product with alcohol – a scenario that raises safety concerns, as peer-reviewed studies show that ingesting these two substances together is associated with risky behaviors, such as riding with a driver who is under the influence of alcohol, which can lead to hazardous and life-threatening situations.”