Inhalable caffeine that may be used as a “club drug” by teenagers, according to a New York senator, will be reviewed by U.S. regulators after going on sale last month.
The AeroShot Pure Energy caffeine inhaler became available over the counter last month in New York and Boston and delivers 100 milligrams of caffeine, the same amount in a large cup of coffee.
Though the product didn’t require clearance because it’s classified as a dietary supplement, New York Democratic Senator Charles Schumer requested a Food and Drug Administration review, saying it could pose hazards to teens if taken with alcohol. Doctors say it may carry neurological and cardiovascular risks.
The FDA will review information about the product and respond directly to Schumer on the issues he raised, the agency said in a statement.
Last year, at Schumer’s urging, the FDA stopped sales of caffeinated alcoholic beverages after they were linked to hospitalizations and deaths.
AeroShot, which is also sold in France, was created by David Edwards, a professor at Harvard University’s School of Engineering and Applied Sciences, who also invented Le Whif, a calorie-free inhalable chocolate.
The yellow and gray canister resembling a tube of lipstick is priced at $2.99 and not intended for anyone younger than 18, according to the product’s website.
The inhaler is sold online by Cambridge, Massachusetts-based Breathable Foods Inc. and The Lab Store, in Paris. Breathable Foods says it’s a safe product that delivers caffeine and a mix of B vitamins to the mouth without containing chemicals found in other energy products, such as taurine or glucuronic acid.
Breathable Foods will cooperate fully with the FDA review to address the issues Schumer raised, Tom Hadfield, the company’s chief executive officer, said in a statement. The company is confident regulators will conclude AeroShot is a safe, effective product that complies with U.S. regulations, he said.
AeroShot advertising in Europe focuses on drinking and partying, Schumer said in December, when he requested FDA Commissioner Margaret Hamburg review its safety and legality.
“The product is nothing more than a club drug designed to give users the ability to drink until they drop,” Schumer said.
Schumer noted the American Academy of Pediatrics discourages the non-medical use of caffeine by children and adolescents. The Elk Grove Village, Illinois-based doctor’s group wrote AeroShot’s manufacturer in December about concerns over caffeine’s effect on developing neurologic and cardiovascular systems and the potential for the product to exacerbate asthma.