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FDA Questions AeroShot Caffeine ‘Inhaler’

The U.S. Food and Drug Administration sent a warning letter to Breathable Foods for “false and misleading” statements about AeroShot, a product the company claims is “inhalable caffeine” but the FDA says is a actually a dietary supplement intended to be swallowed.

“Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion,” Michael Roosevelt, FDA’s acting director in the office of compliance, wrote in the March 5 letter.

The Breathable Foods website describes AeroShot, which is about 100 milligrams of caffeine powder in a lipstick-sized tube, as “breathable energy” that delivers a blend of caffeine and B vitamins “in about 4-6 puffs.”

But the website also instructs users to swallow the product, saying AeroShot provides a “safe shot of caffeine and B vitamins for ingestion.”

Given this contradictory information, the FDA says consumers may attempt to inhale the caffeine powder and questions its safety, because “caffeine is not typically inhaled through the lungs.” The agency asks Breathable Foods to provide research references so that it can evaluate the safety data the company cites in its marketing.

AeroShot, which retails for $2.99, is sold online and in France, Massachusetts and New York. Last year, U.S. Sen. Charles Schumer (D-NY) asked the FDA to take a look at the product, expressing concerns that it had the potential to be misused, much as caffeinated malt-alcohol drinks were. In 2010, after several states banned the sale of such beverages, the FDA forced four companies to remove caffeine and other stimulants from their products.

The FDA warning letter criticized Breathable Foods for mixed messages about combining AeroShot with alcohol. While the product’s inventor says he doesn’t encourage mixing AeroShot with alcohol, the company website includes news items the FDA says seem to promote it as a “party drug.”

Although Breathable Foods says AeroShot is not marketed to those under 18, the FDA asked why the company’s website states that the product is designed to be used when “hitting the books” or “studying in the library,” adding  “these activities are commonly performed by children and adolescents.  Indeed, your reference to these activities seems to target this population.”

Breathable Foods has 15 days to respond officially to the FDA and outline steps it will take to address the agency’s concerns.

Meanwhile, Breathable Foods has posted a response on its website promising “to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements.”

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