AeroShot Caffeine Inhaler Scrutinized By FDA

The U.S. Food and Drug Administration sent a warning letter Monday to the makers of the controversial AeroShot caffeine inhaler, saying the product is mislabeled and could be dangerous to users' health.

AeroShot, which is made by Breathable Foods Inc. and allows users to inhale 100 milligrams of caffeine and B vitamins, has been described by U.S. Sen. Charles Schumer, D-N.Y., as nothing more than a "club drug." The FDA expressed concerns in Monday's letter about Breathable Foods' publicizing the use of AeroShot with alcohol and the potential dangers of consuming caffeine through the lungs.

The FDA also said the labeling for AeroShot is false or misleading because it is intended for both inhalation as "breathable energy" and ingestion as a dietary supplement. A product that is inhaled cannot by definition be called a dietary supplement, the agency said.
Breathable Foods should "take prompt action to correct the violations" or risk facing seizure or injunction, the FDA said, giving the company 15 working days to respond to the letter and outline the actions it plans to take to address the violations.

"We plan to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements," Breathable Foods CEO Tom Hadfield said in a statement Tuesday. "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."

The Breathable Foods website includes an interview in which the product's inventor said he is not encouraging the mixing of AeroShots and alcohol, but also features videos and links to news articles that refer to AeroShots and alcohol being used together as a "party drug," according to the letter. Posting the items on the website publicizes the use of the two in combination, the FDA said.  "Any such publicity may have the effect of encouraging the combination of your product with alcohol - a scenario that raises safety concerns, as peer-reviewed studies show that ingesting these two substances together is associated with risky behaviors, such as riding with a driver who is under the influence of alcohol, which can lead to hazardous and life-threatening situations," the letter said.

The FDA said it is also concerned about the use of inhaling caffeine because the safety of consuming caffeine that way has not been well studied. Breathable Foods claims on its website that "decades of research" have shown that particles above a certain size "do not penetrate the respiratory track" when inhaled, but the FDA is asking for references to that research so it can evaluate it independently.

Although Breathable Foods released a statement saying AeroShot was not recommended for people under 18 years of age, the FDA criticized the product's labeling, which states the product is "not intended for people under 12," implying it is safe for those 12 and over, the letter said. The FDA asked Breathable Foods to provide the agency with safety evidence it has relied on to make that claim.

The issue of AeroShot use among adolescents was one of the main concerns raised by Sen. Schumer in a December letter requesting the FDA review the product. Schumer also expressed dismay about AeroShot's being used with alcohol.

"This product is nothing more than a party enhancer, designed to give users the ability to drink until they drop, and it promotes dangerously excessive consumption of caffeine among youngsters and teens," Schumer said in December. "The product has never been tested for safety by the FDA, particularly among children and teens, and there are absolutely no controls on who can purchase it and how much they can ingest."

The FDA launched a review of AeroShot in February, and Hadfield issued a statement saying the company "will cooperate fully with the FDA's review to address the issues raised by Sen. Schumer and [is] confident that it will conclude that AeroShot is a safe, effective product that complies with FDA regulations."