A company named Breathable Foods Inc, which makes an ‘breathable’ caffeine energy product called AeroShot Pure Energy, received a warning from the US Food and Drug Administration (FDA) yesterday.
According to a statement posted through the FDA’s website, the company is being warned about false or misleading labeling on their product and inconsistent statements regarding using their product with alcohol.
The FDA points out that:
“The company claims AeroShot is designed to provide “breathable energy, anytime, anyplace.” The company also claims on its website that its product is intended to be ingested by swallowing. The company’s labeling is false or misleading because these two claims contradict each other. 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.”
The FDA also noted that the company’s website, http://www.aeroshots.com, also says the product is meant for users 18 years and older, but the actual product labeling says it’s for users 12 and older.
The AeroShot does look much like an inhaler. According to their site, one tube can be used 4 to 6 times. When it comes to dosage, the text on their site says “Take only the energy you need. Save the rest for later.” On another page of the site, it says the Aeroshot delivers a blend of 100mg of caffeine and B vitamins. It does not say if that is the entire amount in the tube, or if that is what one ‘shot’ of the tube delivers.
The FDA states in their letter that there is also an issue concerning the consumption of alcohol together with use of the Aeroshot. They report that there are several links from the Aeroshot website to news sites and videos showing the product used in conjunction with alcohol consumption. The FDA writes that they are concerned that the links connecting the sites will encourage the use of Aeroshot with alcohol, and says “While using caffeine when drinking may lead consumers to feel ‘less drunk,’ it does not reduce blood alcohol levels.”
In addition to the above, the FDA also says the product labeling does not include the company’s contact information for reporting any adverse events related to the use of the product, and that such contact information is required by law.
Breathable Foods Inc. has 15 days to respond back to the FDA with plans to bring Aeroshot into compliance with FDA regulations.