AeroShot Caffeine Inhaler Safety Questioned by FDA in Warning Letter

Federal drug regulators have sent a warning letter to the makers of Aeroshot Breathable Energy, an inhalable caffeine product sold as a dietary supplement, expressing concerns about the safety of the product and accusing the company of making false and misleading statements. 

The warning letter was sent by the FDA to Breathable Foods, Inc. on March 5, after the agency reviewed the company’s website, www.aeroshots.com.

Aeroshot is powdered caffeine and Vitamin Bproduct, sold in a lipstick-like tube and promoted as something that can be breathed in for a burst of energy. However, the website claims that the drug is ingested, which allows it to fall under the category of a dietary supplement.

The FDA noted that it has some concerns about the safety of Aeroshot caffeine inhalers as well, coming just two weeks after the FDA announced it was investigating the product.

The FDA warning letter notes that despite claims that it is ingested, it is also referred to as “breathable” and referred to as an inhalable product by its creators, contradicting claims that it is ingested on the website and elsewhere. If it is an inhalable product, it would not fall under the protection of dietary supplements, which do not require FDA approval before being sold to the public, the agency argues.

The FDA says it is concerned about the entire concept of breathable caffeine because the drugs’ effects on the lungs has never been studied. The company claims that the particles used in the drug are too big to enter the lungs, but the FDA says the company does not show research supporting that claim.

Another concern regarding the drug is that the company’s website links to news articles that refer to the use of Aeroshot in conjunction with alcohol. Caffeine makes the user unaware of the effects of alcohol on the body, which can lead to overdrinking and death.

In recent years, a number of companies released alcoholic energy drinks, like Four Loko, which combined caffeine and alcohol in the same beverage.  As a result of problems associated with the combination of alcohol and caffeine, some people have referred to the beverages as “black-out in a can.” The FDA banned alcoholic energy drinks in November 2010 because of the health risks.

Breathable Foods, Inc. has 15 days to respond to the FDA’s charges or the company could face further action.