The probe follow calls for a safety review from US Senator Charles E. Schumer, who claims the product encourages under-age drinking and makes unsubstantiated health claims.
The product, manufactured in France by Breathable Foods, was introduced in New York and Boston markets in January after it bypassed GRAS approval since it was marketed as a dietary supplement.
Each AeroShot gives the user 100mgs of caffeine through 4-6 puffs, which is equivalent to around one cup of coffee.
Senator strikes back
In December, Schumer issued a letter to FDA commissioner Margaret Hamburg urging her to conduct a full review into the safety and legality of the of the lipstick-size disposable inhaler.
“AeroShot is another in a long line of dangerous products designed to facilitate under-age and excessive drinking, and the FDA needs to move quickly to get it off store shelves,” he said.
Schumer was previously instrumental in the FDA’s decision remove alcoholic energy drink Four Loko from the market in 2010.
He complains that Breathable Food’s AeroShots hit stores without an age restriction and had been marketed as a “party enhancer”.
“It can facilitate excessive drinking and its effects have never been examined by independent regulators to determine their impact on the human body.”
“We need to make sure that AeroShot does not become the next Four Loko by facilitating dangerous levels of drinking among teenagers and college students,” he continued.
The lung conundrum
According to Schumer, there is no evidence to support the company’s claim that the product is safe because it does not enter the lungs, but rather is dissolved in the mouth and swallowed.
Breathable Foods says on its website: “AeroShot does not enter the lungs. Decades of research have shown that particles above 10 microns in size, if inhaled, fall out of the mouth and do not penetrate the respiratory tract.”
The American Academy of Pediatrics (AAP) sent a separate letter to Breathable Foods citing its concerns. AAP fears caffeine inhalation could exacerbate asthma in children and affect developing neurologic and cardiovascular systems.
Dietary supplement ‘loophole’
Schumer voiced further concerns that the company was able to surpass GRAS approval by marketing its product as a dietary supplement.
“I want to raise a systemic concern about manufacturers’ use of the dietary supplement law as a loophole to avoid having to demonstrate that a food additive, like caffeine, is “generally recognized as safe” (GRAS) by qualified experts.”
“I urge the FDA to not let the addition of incidental ingredients undermine its critical responsibility to protect public health by ensuring the safety of our food and beverage products,” he said.
Following the investigation, the FDA will have the option to issue a warning letter to Breathable Foods, which could see the removal of the product from stores.
Breathable Foods CEO Tom Hadfield said: "We will cooperate fully with the FDA’s review to address the issues raised by Sen. Schumer
and are confident that it will conclude that AeroShot is a safe, effective product that complies with FDA regulations.”