FDA Cites Inhalable Caffeine Maker for Misleading Statements

Caffeine dispensed from lipstick- size canisters is mislabeled because the manufacturer encourages consumers to breathe the mist into their lungs instead of spraying it on their tongues to be swallowed.

The Food and Drug Administration cited Breathable Foods Inc. for describing its AeroShot Pure Energy inhaler as “breathable energy” that may confuse users, according to a warning letter sent yesterday from the agency.

“Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied,” the FDA said in a statement.

Democratic Senator Charles Schumer, of New York, wrote FDA Commissioner Margaret Hamburg in December, saying the inhaler could be used as a “club drug” by teenagers. AeroShot, which is sold over the counter with no age restrictions, is touted for its convenience and zero calories.

The agency also warned the Cambridge, Massachusetts-based company for videos on a website promoting AeroShot that the agency said may encourage people to use the product with alcohol, the letter said.

FDA Instructions

“FDA has instructed Breathable Foods Inc. to correct the violations cited in the warning letter and provide information on research the company cites so the agency can evaluate the research,” according to the agency statement.

Breathable Foods has 15 business days to respond to the agency and comply with FDA regulations.

“We plan to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements,” Tom Hadfield, chief executive officer of Breathable Foods, said in an e-mail. “AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not ‘inhaled’ into the lungs.”

Last year, at Schumer’s urging, the FDA stopped sales of caffeinated alcoholic beverages after they were linked to hospitalizations and deaths.

“This stern warning is the clearest indication yet that AeroShot needs to be taken off the market until these concerns can be addressed and the product’s safety can be confirmed,” Schumer said in a statement.

The inhaler 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.

AeroShot delivers 100 milligrams of caffeine, the same amount in a large cup of coffee. The caffeine is absorbed in the mouth and digestive tract, not through the lungs, according to a fact sheet from Breathable Foods. AeroShot is priced at $2.99 and is not intended for anyone younger than 18, according to the product’s website.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net