The Food and Drug Administration recently sent a warning letter to Breathable Foods Inc. regarding concerns with the labeling and safety of its inhalable caffeine product, AeroShot.

AeroShot is a product that promises to give its consumers energy without the calories via a small and portable capsule. The capsule contains a blended powder that consists of caffeine and B vitamins, according to its website.

The warning letter from the FDA said the product was mislabeled because it was described as a product that could be both inhaled and ingested. The letter specifically cited the conflicting word choice of ‘inhalable caffeine’ and ‘caffeine inhaler,’ along with ‘ingestible food.’

The label on the product claimed it was a dietary supplement, which indicates that it is meant to be ingested rather than inhaled, according to the letter.

‘Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion,’ FDA officials said in the letter. ‘The functioning of the epiglottis in the throat keeps the processes of inhalation and ingestion mutually exclusive.’

The language ‘inhalable caffeine,’ and all references to inhalation, have since been removed from the AeroShot website. The product is now only being referred to as an ingestible supplement.

Dessa Bergen-Cico, assistant professor of public health at Syracuse University, said she agreed with the FDA’s concerns regarding inhalation of the product. She said when something is inhaled it goes immediately into the bloodstream, then to the organs and finally to the blood-brain barrier. The metabolizing stage that typical caffeine products like coffee go through is entirely bypassed, she said.

Sarah Short, professor of nutrition science and dietetics, expressed concern that the product is marketed as a dietary supplement, as this means it undergoes less regulation by the FDA than it would if it were marketed as a traditional food or drug item.

‘You don’t have a clue what’s in them because they are all supplements. Under the 1994 Supplement Act, you can sell anything, and nobody is looking for the purity or anything else,’ she said.

Ashley Collman, a senior magazine journalism major, said she shies away from energy products, supplements and items not approved by the FDA because she is uncertain of their safety.

‘Something tells me that if you heard about a product that was inhalable caffeine, there’s something about that that’s already off to begin with. I know I would research it before I used it,’ she said.

In terms of safety, officials were primarily concerned with the lack of studies on the effects of caffeine inhalation through the lungs, as this is not how caffeine is typically consumed.

‘You’re inhaling caffeine, which means it’s going into your lungs, and that scares me,’ Short said.

FDA officials also took issue with contradictions in the appropriate age for the use of AeroShot. In some instances, such as on the company’s website, the product was not recommended for anyone under 18, but on the product’s label, the age was reduced to 12, according to a March 7 Time magazine article.

In response to this point, Tom Hadfield, CEO of Breathable Foods, confirmed the product is not intended for anyone under age 18. He also said the company will work with the FDA to clear the discrepancy, according to the article.

‘Kids already abuse caffeine, so if it’s easy, like you can carry it around in a spray with you, I’m sure (they would),’ said Austin McColough, a senior anthropology and Spanish major. ‘That sounds like it’s being made to be abused because you’re only supposed to have like a cup of coffee a day or something.’

Bergen-Cico said students should look out for the amount of caffeine in energy products like AeroShot to ensure the supplementary product, combined with other traditional caffeine products like soda or coffee, is still within a healthy range. She said too much caffeine can lead to high blood pressure or increased pulse rate.

‘I always think people need to be informed and be cautious about what they’re putting in their bodies,’ Bergen-Cico said. ‘If they are somebody who regularly ingests caffeine in other ways – like if they drink coffee and things like that – I would recommend that they not add this on top of it.’ 

cffabris@syr.edu 

Published on March 20, 2012 at 12:00 pm

Contact Casey: cffabris@syr.edu | @caseyfabris