The FDA have issued a warning letter about AeroShots. AeroShots are an inhaled caffeine shots. The product is not suitable for those under 18 years-of-age but it has been marketed at young students.
AeroShot is an inhalable caffeine product. It comes in a lipstick sized plastic container. To use the product it is placed inside the mouth. Users then breathe in a fine powder which dissolves on the tongue and hits the user with a caffeine kick. It is sold as a dietary supplement and delivers around 100 mg of caffeine. The product retails for around $3.
AeroShots are available in some areas of the USA, like New York, as well as in countries outside the USA. The product is manufactured by Breathable Foods, who are based in Massachusetts.
The US Food and Drug Administration (FDA) have issued a sternly worded warning letter to Breathable Foods. The cause of the FDA concern is over the way in which the product is marketed, which could lead to safety issues over the way in which children and adolescents might use the product. The AeroShot website did state that the product was unsuitable for those under 18 years of age. However, the label on the product merely states that the shots are unsuitable for those under 12 years of age. The FDA is concerned that the product has been marketed towards under-18's as something to take when cramming for exams.
The Wall Street Journal notes that the FDA are also concerned that people may attempt to inhale the product into their lungs and that there is no data to indicate if this practice is safe or not.
Breathable Foods have issued a statement, quoted on CBS News, stressing that the shot is not suitable for those under 18, that it is not designed for lung inhalation and that they will co-operate with the FDA.
"AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not 'inhaled' into the lungs".
A further FDA concern is that there are insufficient warnings about using the product with alcohol. The FDA note that there are risks with the people who are both 'wide awake' and 'drunk'.
The FDA state with regard to the caffeine - alcohol mix:
"The AeroShot website also includes links to news articles and videos that refer to use of the product in conjunction with drinking alcohol. Although these news items do not advocate taking AeroShot while drinking alcohol and express health concerns about such use, the presence of the news items on the AeroShot promotional website publicizes and therefore may encourage the use of AeroShot with alcohol. While using caffeine when drinking may lead consumers to feel “less drunk,” it does not reduce blood alcohol levels."
CNN reports that the manufacturer of AeroShots have 15 days to respond to the FDA warning letter.