FDA WARNING_LETTER - Breathable Foods, Inc. - February 29, 2012

The FDA issued a Warning Letter to Breathable Foods, Inc. regarding their product, AeroShot, following a website review in February 2012. The product is deemed misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

AeroShot's labeling is false or misleading under section 403(a)(1) of the Act because it inconsistently claims to be intended for both inhalation and ingestion. While the label and website promote "BREATHABLE ENERGY" and "inhalable caffeine," they also characterize it as a dietary supplement, which by definition must be ingested. The FDA states that the epiglottis makes inhalation and ingestion mutually exclusive.

Additionally, AeroShot is misbranded under section 403(y) of the Act as its label lacks a domestic address or phone number for serious adverse event reporting. The Supplement Facts panel also fails to comply with 21 CFR 101.36(e)(6) by not separating dietary ingredients with a heavy bar.

The FDA also raised safety concerns. Due to suggestions of inhalation, consumers might inhale the product, which is concerning as caffeine inhalation is not well-studied. The FDA requested research references supporting claims about particle size and evidence for the product's safety for children and adolescents, given contradictory age recommendations (12 vs. 18) and marketing targeting activities common among youth. Furthermore, the FDA noted