Huffpost Food

AeroShot Caffeine Inhaler Gets FDA Warning Letter For 'Misleading Statements'

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A group of wary teens test out Aeroshot's caffeine inhaler, which was just issued a warning letter by the FDA (AP Photo/Rodrique Ngowi)
A group of wary teens test out Aeroshot's caffeine inhaler, which was just issued a warning letter by the FDA (AP Photo/Rodrique Ngowi)

The FDA announced today that it had issued a warning letter to Breathable Foods, the Cambridge, Mass.-based makers of AeroShot caffeine inhalers, for "false or misleading statements" in the promotional material for its controversial new product.

The Agency took issue with several of AeroShot's claims, especially the idea that the caffeine inhalers deliver "breathable energy" but are "intended to be ingested by swallowing." The FDA's press release rather pedantically notes that, "A product cannot be intended for both inhalation and ingestion because the functioning of the epiglottis in the throat keeps the processes of inhaling and swallowing separate."

The FDA was also worried about the possibility that AeroShot was marketing its product to teens and as a fun complement to alcoholic beverages. The 2010 uproar over caffeinated energy drink Four Loko left the agency with little patience for dangerous caffeine-alcohol mashups.

Breathable Foods indicated that it would cooperate with the terms of the FDA's warning letter.

“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 emailed to the Huffington Post. "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 official warning letter comes hot on the heels of the news that the FDA would review the safety of inhalable caffeine and two-and-a-half months after Senator Chuck Schumer, of New York, vowed to oppose AeroShots.

So far, all this controversy seems only to have helped sales of AeroShot, much as similar outrage spurred sales of Four Loko. Breathable Foods says that AeroShots remain available on store shelves in Boston and New York but are completely sold out on the company's website.

If the story continues to follow the Four Loko model, though, the good times won't last forever. Four Loko was stripped of its characteristic caffeine just when it became most popular -- and now faces further restriction.

Breathable Foods has 15 days to address the FDA's complaints. And what if they don't meet the FDA's standards fast enough?

"I can't say specifically what might happen in any particular case, but companies that do not respond could be subject to further enforcement action," FDA spokesperson Siobhan Delancey told HuffPost Food.

Contemplating the demise of such beautiful, dangerous foodstuffs, it's hard not to think of Keats: "in the very temple of Delight,/ Veil'd Melancholy has her sov'reign shrine."

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