March 7, 2012
AeroShot Maker Warned By FDA
The makers of Aeroshot, Breathable Foods Inc has come under fire from the US Food and Drug Administration (FDA). The company labeled the product as both breathable and ingestible, a contradictory combination.
The FDA said, “Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied.”The problem comes about because of inconsistency in the labeling of the product.
According to the company each shot delivers caffeine and B vitamins in a fine powder that instantly dissolves in the mouth. The agency complained that the company´s website notes the product is not for use for consumers under 18 years of age, while the product label says it is not recommended for people under 12. The FDA complains that the company is targeting both age groups by saying it can be used for studying.
Tom Hadfield, Breathable Foods CEO says the product is unintended for people under 18 and they would work with the FDA to come into compliance.
The FDA also brings into question Aeroshot´s use as a party enhancer by being mixed with alcohol. Links on the company´s website show articles about using the caffeine product with alcohol.
Recently the FDA has been raising awareness about mixing alcohol and caffeine together. It causes people to be in a state of “wide awake drunk” that can lead to alcohol poisoning, car accidents and assaults. In 2010 the company cracked down on Four Loko telling the company to remove the caffeine from their beverage.
Aeroshot is not a medication so it did not require FDA approval before being marketed. It is classified as a dietary supplement and requires the manufacturer to be responsible for the products safety. The FDA can only take action against a product if it is deemed unsafe, removing the product from store shelves if it does not fall into safety compliance.
Breathable Foods has 15 days to respond to the FDA´s letter and to prove the products safety to the agency.
On the Net: