Home Health AeroShot “caffeine inhaler” producer receives a warning letter from FDA

AeroShot “caffeine inhaler” producer receives a warning letter from FDA


AeroShot producer, Breathable Foods Inc., has received a warning letter for false or misleading statements in the labeling of its product, the U.S. Food and Drug Administration announced on March 6.

There are concerns about the safety of the “caffeine inhaler” and about children and adolescents using it combined with alcohol, said the FDA.

AeroShot gives “breathable energy, anytime, anyplace,” and it is intended to be ingested by swallowing, it is written on the product website, but the FDA said these statements were in contradiction.

The company’s labeling is false or misleading because these two claims contradict each other. 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,” said the FDA.

Also, labeling a product as “breathable energy” may lead to an improper usage.

Consumers may tend to inhale it, but inhaling caffeine into the lungs is not safe as long this process has not been well studied. The particles in AeroShot are too big to enter the lungs, says the company on its website, but it shows no specific research in support of this claim.

 

AeroShot

On March 6, 2012, the FDA issued a warning letter to the makers of AeroShot “caffeine inhaler.”

 

In the same time the FDA is worried about the use of the AeroShot by the children.

AeroShot is “not recommended for those under 18 years of age,” says the website and it is “not intended for people under 12,” says the label.

But the website also appears to target these age groups by suggesting it be used when studying,” said the Agency.

The product is not intended for persons under 18, said Tom Hadfield, Breathable Foods CEO.

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,” he told the Huffington Post.

The FDA has another concern regarding the utilization of AeroShot while drinking alcohol.

The product website has links to news articles and videos about using AeroShot in combination with alcohol. Those news items express health concerns about this kind of usage, but their presence publicizes and may encourage the use of AeroShot with alcohol, said the FDA.

Taking caffeine while drinking may make consumers to feel “less drunk,” but it does not lower blood alcohol levels, and it does not remove the side effects of drinking too much alcohol. Mixing caffeine with alcohol can be dangerous, especially for very young people, old people, or persons with health problems.

The product label does not include contact information for consumers to report adverse events, as required under federal law.

Consumers who believe they have suffered illness or injury from using AeroShot should also report those events to their regional FDA Consumer Complaint Coordinators. The agency also encourages healthcare providers to report to FDA any adverse events in their patients that are associated with AeroShot. As of March 6, 2012, FDA has not received any adverse event reports associated with the product.

In 2010 there was another issue over caffeinated energy drink Four Loko. The media coverage at that time led to increased sales and the drink became more popular. However, the caffeine was eliminated from Four Loko and now further restriction may be added.

AeroShot is sold out on the company’s website, but remains available on store shelves in Boston and New York, according to Breathable Foods.

Senator Chuck Schumer, of New York, promised to oppose AeroShot, over two months ago. The FDA has to take measures concerning the product, because the children and adolescents may abuse it, he said.

Massachusetts-based company, Breathable Foods Inc. has 15 business days to respond to the agency with a plan to bring the AeroShot into compliance with FDA regulations.