The FDA has issued a warning letter to Breathable Foods, the manufacturer of AeroShot inhalable caffeine for “false or misleading statements in the labeling of their product.” The agency is also questioning the safety of the inhaler, including the possibility that users may inhale the formulation into their lungs, that children will use the product, and that AeroShot may be used in combination with alcohol. Although Breathalbe Foods claims that the particle size is too large for inspiration into the lungs, the FDA says, the company has provided no data to support that claim.
According to the FDA, the product labeling is false or misleading because it calls AeroShot “breathable energy” but claims that the ingredients are swallowed, and “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.” Also, despite the fact that the AeroShot website now says that the product is not recommended for “those under 18 years of age,” the product label says “not intended for people under 12,” and the website promotes use of the product as a study enhancement, suggesting that it is targeting children.
Breathable Foods will have 15 days to respond to the FDA with a plan for correction of violations and for submission of data on the product. As of March 6, 2012, the agency says, it has received no reports of adverse events but is encouraging consumers and clinicians to report any problems and says that it “will consider regulatory action if a violation of the Federal Food, Drug and Cosmetic Act has occurred.”
Read the FDA press release.
