A warning by the FDA has been released indicating that the inhalable caffeine product called AeroShot may be unsafe. They stated in a letter to the manufacturer that they have serious questions and concerns about how minors may utilize the product and the ramifications of misuse.
AeroShot which is about the size of a tube of lipstick became available in New York, France and Massachusetts back in January. Users place one end of the canister in their mouths and then inhale. This discharges a very fine powder which immediately dissolves. The product’s official website has coined the descriptive phrase as “a revolutionary new way to get your energy.”
The Massachusetts based manufacturer of the product may have misinformed users, according to the FDA, by labeling the product safe for ingestion as well as inhalation. Ingesting the product is not safe or even possible, therefore leading the FDA to its current safety concerns. The Food and Drug Administration is worried that users might attempt to inhale the substance into their lungs which could very possibly be hazardous.
The letter also alluded to the fact that the company’s website reports the product as being unsafe for those under 18, while conversely the label on the product states that it is not suggested for those below 12 years of age, an obvious contradiction. In addition, the company is actively targeting both of those age groups for use during the study phase.
Tom Hadfield, the CEO for Breathable Foods stated that the product is most certainly not appropriate for people below the age of 18 and that the company will work with the Food and Drug Administration to be sure those guidelines are complied with.
He stated that AeroShot administers a mix of caffeine and B vitamins by mouth for ingestion and not inhalation, and also stated it should not be breathed into the lungs. The problem seems to be labeling and therefore a fix is necessary. Additionally, the FDA has taken issue with statements made on the company’s website in regards to alcohol consumption and the use of caffeine.
The Food and Drug Administration has been attempting to provide awareness in relation to the hazards of mixing the two substances over the past several years. The main concern for the FDA is the fact that mixing alcohol and caffeine could result in a user becoming drunk yet wide awake, an undesirable combination for a number of reasons. The first concern is alcohol poisoning as a result of the counteraction that can occur as a result of the caffeine.
The FDA came down on the company that makes Four Loko, an energy beverage, back in 2010, requiring the company to discontinue the use of caffeine. AeroShot was not required to gain approval by the FDA prior to being released in the US market because it was being marketed as a dietary supplement and the FDA only requires makers of these products to take responsibility for the safety of their products. However, the FDA will step in if something is brought to their attention indicating a specific product may have safety issues, enforcing the removal of particular products from store shelves.
The FDA has given Breathable Foods, the makers of AeroShot, fifteen days to respond to the correspondence asking them to make corrections to the FDA violations brought forth, as well as to submit any and all research related to the safety of the product.