After Pressure from Schumer, FDA Issues Warning Letter to Makers of AeroShot Over Safety and Marketing Concerns

March 6, 2012 Updated Mar 6, 2012 at 2:33 PM EDT

By WKBW News

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After Pressure from Schumer, FDA Issues Warning Letter to Makers of AeroShot Over Safety and Marketing Concerns

March 6, 2012 Updated Mar 6, 2012 at 2:33 PM EDT

(WKBW release) After major pressure from New York Senator Charles E. Schumer, the Food and Drug Administration sent a strongly worded warning letter to the makers of caffeine-inhaler AeroShot over the safety of the product and its marketing claims.

In their letter, the FDA raises concerns about the safety of the product, expresses concerns that the product targets teens and encourages consumers to use the product in combination with alcohol, and carries “false and misleading advertising” that could be dangerous to consumers. Schumer said that this letter was the clearest evidence yet that AeroShot represents a clear danger and needs a top to bottom review before it is allowed to continue to be sold on store shelves.

“Today the FDA confirmed what we’ve been concerned about all along: that AeroShot represents a serious danger to the health of our kids,” Schumer said in a news release. “The FDA has agreed with our concerns over the safety of the product, including that it targets kids, encourages taking the product while drinking alcohol, and is blatantly false and misleading in its advertising. 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.”

AeroShot delivers an airborne shot of caffeine powder through a small dispenser.  The company’s materials claim that the product is safe and does not enter the lungs, but rather is dissolved in the mouth and swallowed.  There is no evidence on the company’s website to substantiate these broad, health-related claims.  On the contrary, according to the American Academy of Pediatrics (AAP),  while caffeine has been shown to enhance physical performance in adults, these effects are extremely variable, dose dependent, and most importantly, have not been thoroughly studied in children and adolescents. Moreover, because of the potentially harmful developmental and addictive effects of caffeine, the AAP discourages the non-medical use of caffeine by children and adolescents.  The impact of inhaled caffeine on the lungs of children and teens has never been examined.

In December, Schumer urged the FDA to request and review product safety evidence from AeroShot’s manufacturer, including whether the product is harmful to children, adolescents, and the overall public health. Schumer specifically raised concerns over the potential for the product to be abused by adolescents in conjunction with alcohol. In a separate letter sent to AeroShot’s manufacturer, the American Academy of Pediatrics also raised concerns about the inhaled caffeine product and the effects of caffeine on developing neurologic and cardiovascular systems, the potential for the product to exacerbate asthma, and the risk of physical dependence and addiction.  They also raised concerns over the impact of the powder in AeroShot being absorbed by the lungs. AeroShot has a vitamin B additive, and is sold as a dietary supplement, allowing it to get around pre-sale review by the FDA.