On Tuesday, the US Food and Drug Administration (FDA) announced it had sent a warning letter to Breathable Foods Inc., makers of AeroShot, questioning the safety of their caffeine “inhaler” and accusing them of using “false or misleading statements in the labeling of their product”.

On their website, Breathable Foods says their product delivers a “unique blend of 100 mg of caffeine and B vitamins in about 4 – 6 puffs”, and is designed to provide “breathable energy, anytime, anyplace”. The product comes in a container about the size of a lipstick which the user inserts and puffs into the mouth.

The FDA says one of the reasons the product labeling is “false or misleading” is because the company’s promotional material describes two contradicting ways to use it: one way says it is intended to be ingested by swallowing, the other says it is designed to be inhaled.

“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,” says the FDA.

Another objection, on safety grounds, is to the use of statements such as “breathable energy”, which may confuse consumers into thinking the product should be inhaled into the lungs.

“Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied,” says the FDA.

And, although the company says on its website that the particles in AeroShot are too large to enter the lungs, and that this is backed by decades of research, it does not actually refer to any, says the FDA.

FDA regulations require manufacturers to ensure their products are safe and properly labeled before making them available to consumers.

The agency has instructed the company to correct the violations detailed in the warning letter and come up with references to the research it has cited so the agency can evaluate it. They have 15 days to respond with a plan of how they will do this.

Another objection the agency raises is that the company website implies AeroShot can be used while studying, which contradicts the warning that it is “not recommended for those under 18 years of age”, and “not intended for people under 12”, both age groups that include people who study.

The website also contains links to news items and footage that refers to use of AeroShot with alcohol. While these don’t promote use of the product with alcohol consumption, and even go so far as to warn of the health dangers of doing so, their presence on the website could be enough to encourage use of the product with alcohol, says the FDA.

An aspect of this implied combination with alcohol that particularly concerns the agency is that while consumers may feel “less drunk” when they have caffeine, it has no effect on blood alcohol.

The FDA has also instructed the company to include information about who consumers should contact if they want to report adverse events from using the product. This is a legal federal requirement.

Written by Catharine Paddock PhD