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Federal regulators have sent a warning letter to the makers of a new caffeine inhaler product called AeroShot with concerns about the product’s safety and the company’s product marketing.

In a letter yesterday, the U.S. Food and Drug Administration (FDA) warned Thomas Hadfield, CEO of Breathable Foods, Inc., Cambridge, MA, that the agency alleges labeling of the company’s AeroShot product does not meet federal labeling requirements, that the company has made unsubstantiated safety claims and is marketing the product to underage kids and as a “party drug.”

AeroShot is a mix of caffeine, B vitamins, sweeteners and other ingredients such as natural lime flavor, citric acid and sodium bicarbonate. Breathable Foods began selling AeroShot in January 2012. It is available over the counter and people of any age, even children, may purchase it.

According to the FDA, Breathable Foods markets AeroShot as a caffeine inhaler with statements on the labeling such as ““BREATHABLE ENERGY Anytime, Anyplace” and instructions telling the user to “Puff in.” A product designed for inhalation is not a dietary supplement, as dietary supplements by definition must be intended for ingestion by mouth. However, Breathable Foods also characterizes the product as a dietary supplement that complies “with all FDA dietary supplement regulations” and instructs users swallow the product. The FDA says the product cannot be intended for both inhalation and ingestion because human anatomy makes these two very different delivery routes.

The FDA also questioned the safety of AeroShot and demanded documentation to substantiate Breathable Foods’ safety claims.

“FDA is concerned about the safety of any such use because caffeine is not typically inhaled through the lungs, and the safety of such use has not been well studied,” the FDA letter to Breathable Foods said.” “Your website addresses this issue in part by stating that ‘decades of research have shown that particles above 10 microns in size, if inhaled, fall out in the mouth and do not penetrate the respiratory tract,’ and also that ‘our powders are of a median size much larger than 10 microns.’ Please provide us with references to the research you cite so that we can evaluate that research. Please also submit the evidence you relied on in stating that the median size of your powders is ‘much larger than 10 microns.’”

Perhaps the most worrying of the FDA allegations is that Breathable Foods is marketing AeroShot to children and for use with alcohol as a “party drug.”

While Breathable Foods has said the product is not recommended for anyone under 18 years of age, some of the product labeling states “not intended for people under 12” which implies it is suitable for use by children twelve years old and older. The FDA also alleges that AeroShot website marketing targets children and adolescents by promoting the product as designed for use when “hitting the books” and “studying at the library.”

“Please provide us with any safety evidence you have relied upon related to the use of your product by children and adolescents so that we can evaluate that evidence,” the FDA told Breathable Foods.

The FDA also feels that despite AeroShot inventor David Edwards stating that he does not encourage the mixing of AeroShot use with drinking alcoholic beverages, by posting on the website clips of news videos and links to news articles about use of AeroShot in combination with alcohol or as a “party drug” the company is encouraging that use.

“Looking to kick your party or event up a notch?” AeroShot posted on its Facebook page promoting that users could invite the company to show up and distribute free complimentary product samples.

“Any such publicity may have the effect of encouraging the combination of your product with alcohol—a scenario that raises safety concerns, as peer-reviewed studies show that ingesting these two substances together is associated with risky behaviors, such as riding with a driver who is under the influence of alcohol, which can lead to hazardous and life-threatening situations,” said the FDA. “Data and expert opinion also indicate that caffeine decreases the perception of intoxication, meaning that individuals who consume caffeine along with alcohol may consume more alcohol than they otherwise would and become more intoxicated than they realize. At the same time, caffeine does not change blood alcohol content levels, and thus does not reduce the risk of harm associated with drinking alcohol.”

The FDA also found AeroShot product labeling does not comply with federal labeling requirements by failing to list the manufacturer’s address and phone number for consumers to report any adverse health effects.

A December 2011 letter written by U.S. Senator Chuck Schumer to Margaret A. Hamburg, M.D., commissioner of the FDA, voicing his concerns about AeroShot before the product was even on the market and asking the FDA to review the safety and legality of the product may have prompted the FDA’s investigation.

“This product is nothing more than a party enhancer, designed to give users the ability to drink until they drop and it promotes dangerously excessive consumption of caffeine among youngsters and teens,” said Schumer said in a December statement.

“Today the FDA confirmed what we’ve been concerned about all along: that AeroShot represents a serious danger to the health of our kids,” said Schumer said today regarding the FDA’s warning letter to Breathable Foods. “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.”

Breathable Foods has fifteen business days to inform the FDA of its specific actions to correct the violations. The FDA warned it could take regulatory action, including seizure or injunction, if the company does not comply.

“We plan to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements,” Hadfield said in a statement. “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.”

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