FDA Scolds Inhalable Caffeine Manufacturer Over Ad Claims

Food and Drug Administration has warned AeroShot that it could face regulatory action for misleading labeling claims.

March 08, 2012

WASHINGTON - The Food and Drug Administration has warned AeroShot, the maker of an inhalable caffeine product, that it could face regulatory action over "false and misleading" labeling, CNN reports.

AeroShot, the powdery mixture dispensed from a lipstick-shaped container, is available online or in convenience stores in New York or Boston.

AeroShot??s website claims the product "gives you a higher level of freedom and control that you can only get from airborne energy," while it notes elsewhere that "the powder in AeroShot reaches your mouth where it is swallowed and ingested."

FDA took exception with those competing claims in a letter to AeroShot??s manufacturer, Breathable Foods.

"Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion," FDA said. "Consumers may attempt to inhale your product, causing it to enter the lungs. FDA is concerned about the safety of any such use."

While AeroShot packaging says the product is not recommended for those under 18 years of age, FDA said the company??s website refers to "hitting the books" and "studying in the library" as activities that presumably could be enhanced by using the product.

"These activities are commonly performed by children and adolescents," the letter said. "Indeed, your reference to these activities seems to target this population."

Breathable Food was quick to respond to the FDA??s concerns.

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

FDA has provided 15 working days for Breathable Foods to respond to the charges in its warning letter.

"You should take prompt action to correct the violations cited above," the Agency said in the letter. "Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction."

One AeroShot contains 100 milligrams of caffeine dispensed in three to six "puffs."

As reported last month, U.S. Senator Charles Schumer had sent a letter to FDA urging the agency to examine the safety of AeroShot.

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