The FDA has issued a warning letter to Breathable Foods, Inc. regarding AeroShot, a breathable shot of caffeine and vitamin B. The company has responded and agreed to comply. Please see our reporting about this update.
The product is packaged in a lipstick-shaped dispenser. A white powder mixture comes out of the product when you pull one end, insert it between your lips, and puff into your mouth.
Senator Charles Schumer (D-NY) asked the FDA to examine this product in December 2011. On March 2, 2012 he said, “The bottom line is this product asks more questions than we have answers, and to have it on our shelves before these questions are answered is a serious, serious, serious mistake.”
The government has several concerns with this product. It’s intended for inhalation since the instructions tell the consumer to “Puff in” and the label says, “BREATHABLE ENERGY Anytime, Anyplace”. But the label also states that it’s a dietary supplement; the company’s website says AeroShot is an “ingestible food” and tells users to swallow it.
Dietary supplements must be intended for ingestion. Those products cannot be both inhaled and eaten, since those biological functions are mutually exclusive.
The FDA also has concerns about the safety of this product. Caffeine is not typically inhaled, and the safety of this practice hasn’t been studied. The company’s website says that “particles above 10 microns in size, if inhaled, fall out in the mouth and do not penetrate the respiratory tract” and “our powders are of a median size much larger than 10 microns” without supporting evidence.
And while the company has said the product isn’t recommended for those under the age of 18, the label says it’s not intended for people under 12.
Each “dose” of AeroShot has 100 milligrams of caffeine. But more than 500 milligrams of caffeine taken daily by healthy adults can cause elevated heart rate, stomach upset, muscle tremors, and insomnia. Teenagers may easily ingest more than that amount using AeroShot.
And finally, labeling contradicts other statements on the website about mixing the product with alcohol. The inventor of the product says he doesn’t encourage mixing AeroShot with alcohol.
But news items, including videos on the company’s website, claim the the product is taken in combination with alcohol or as a “party drug”, while at the same time discouraging that use. Combining alcohol and caffeine can decrease the perception of intoxication.
The company has fifteen working days to respond to this letter.
If you have used this product and believe you have been injured by it, visit your healthcare provider. And please call your region’s FDA Consumer Complaint Coordinator to file a report, or tell your doctor to file. As of March 6, 2012, the FDA hasn’t received any reports about illness or injury associated with the consumption of this product.
