In March, 2012 the U.S. Food and Drug Administration (FDA) issued a warning to Breathable Foods Inc., who is the maker of AeroShot (a caffeine inhaler) for false or misleading information. Additionally, the FDA also told the company that they question the safety of the caffeine inhaler and are concerned about the use of the caffeine inhaler in children and adolescents as well as in combination with alcohol.
Aeroshot is a product that is marketed to provide an air-based boost of energy in the form of a caffeine inhaler. Each canister contains 100mg of caffeine and B vitamins. It is marketed as a zero-calorie energy option with no mystery ingredients that is convenient for whenever you may need an energy boost.
The Warnings About Potential Damage
The FDA requires that products are safe and are properly labeled before making them available to consumers. The first problem that the FDA had with Aeroshot caffeine inhalers was the product labeling was mid-leading. The company’s promotional material described two different ways in which to use the product. The first method was ingesting by swallowing; the second was by inhaling. The FDA stated that a product cannot be both inhaled and ingested because these two processes are separated by the epiglottis which is in the throat.
The second problem that the FDA had with Aeroshot caffeine inhalers was that they were marketed as “breathable energy” which may have led to confusion by consumers resulting in consumers trying to inhale the product into their lungs. Caffeine is not normally inhaled into the lungs and the damage that can be caused, including lung function damage, has not be thoroughly studied. The makers of Aeroshot stated on their website that there were decades of research that showed that the particles in Aeroshot are too big to be inhaled in the lungs (indirectly saying that they will not cause lung function damage). However, they don’t cite any specific research to back up this statement which is another point that the FDA mentioned in their warning to the company.
The Effect on Lung Function
The next problem that the FDA had with Aeroshot was that it recommended that the product not be used by people under the age of 18, but seemed to be targeting this population by saying that it could be used while studying. Furthermore, the FDA also had a problem with the fact that the Aeroshot website posted links to articles and videos that showed Aeroshot being used in conjunction with alcohol. This poses a problem because while the site didn’t expressly say to consume alcohol while using AeroShot, the presence of the links may have encouraged users to combine the two products. Mixing caffeine and alcohol can be a deadly combination resulting in injury/damage and even death because while the caffeine may make users feel “less drunk” it does not decrease their blood alcohol level.
Lastly, the FDA found that Breathable Foods Inc., did not have contact information for users to report adverse reactions to using this product. This regulation is required under federal law.
When all was said and done, Breathable Foods Inc., had 15 business days to respond to the FDA with a plan to make Aeroshot caffeine inhalers comply with FDA regulations.
The Response – What Breathable Foods Inc. Says About Damage
Tom Hadfield, CEO, of Breathable Foods Inc., released a statement following the FDA warning that read: “We plan to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements. AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not ‘inhaled’ into the lungs. AeroShot is not recommended or marketed to persons under 18 or for use with alcohol. ”
A quick look of their website following the FDA warning reveals that most of the issues that the FDA found with their marketing have been corrected. However, they still do not cite their research sources that found that the particles are not inhaled into the lungs because of their size.
Independent research should investigate Aeroshot and other similar caffeine inhalers to determine if they pose any risk to lung function. Additionally, it should determine if damage to other body systems can occur following use of this product. Until future research is conducted, it may be wise to stay away from caffeine inhalers to preserve your lung function and steer clear of other damage that may occur following use of this product.