Posted March 9, 2012

Maker of Inhaled Caffeine Product Gets Warning

The U.S. FDA issued a Warning Letter to Breathable Foods, Inc. (dated March 5, 2012) advising that their product AeroShot, which is promoted for “breathable energy,” is falsely labeled (misbranded). The warning letter also raised questions about the safety of AeroShot, AeroShot directions state to inhale the product while the product website describes that AeroShot is a dietary supplement intended for ingestion. FDA concluded that the labeling is false and misleading because the product cannot be intended for both inhalation and ingestion and that a product intended for inhalation is not a dietary supplement. In the U.S. only products intended for ingestion can be sold as dietary supplements.

In the warning letter, FDA questioned the safety of inhaled caffeine which it noted has not been well studied. FDA also expressed concern that AeroShot is being promoted to children. While the company recommends AeroShot for those 18 years and older, some AeroShot labeling suggests that it is suitable for people 12 years and older and promotes the product to help with studying. The AeroShot website also provides information about, and links to other sites which discuss, combining caffeine and alcohol. The combination is associated with reduced perception of intoxication which can lead to further alcohol ingestion and potentially hazardous activities.

For information about energy shots, see Product Review: B Vitamin Supplements. The Warning Letter is available on the FDA website using the link below: