FOR IMMEDIATE RELEASE: December 22, 2011
SCHUMER REVEALS: NEW ‘AEROSHOT’ CAFFEINE INHALER, DANGEROUS TO TEENS AND YOUNGSTERS, HITTING NEW YORK STORES IN JANUARY; CALLS FOR FDA REVIEW OF SAFETY AND LEGALITY OF PRODUCT BEFORE IT GETS IN THE HANDS OF KIDS
United States Senator Charles E. Schumer revealed today that a new and potentially dangerous product that allows teens and children to excessively ingest caffeine in a disposable inhaler is slated to hit store counters in New York in January. The product, dubbed “AeroShot,” provides the equivalent of one large coffee in 6-8 pumps of a small plastic inhaler, which sends at least 100mg of powdered caffeine into the body of the user. The product is scheduled to be introduced to the New York and Boston markets in January without an age restriction on its purchase. AeroShot, has never been reviewed by the Food and Drug Administration (FDA) and none of the safety claims of the product have ever been independently verified by regulators. Schumer raised concerns about the use of the product among teens and children, particularly in conjunction with alcohol, noting that the advertising campaign AeroShot uses in Europe highlights drinking and partying among users of the product.
“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. “The product has never been tested for safety by the FDA, particularly among children and teens, and there are absolutely no controls on who can purchase it and how much they can ingest.”
According to the company website, the “AeroShot” delivers an airborne shot of caffeine powder. The company’s materials claim that the product does not enter the lungs, but rather is dissolved in the mouth and swallowed. Moreover, the product is described as “healthy” and “safe” for children over the age of 12. 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 a letter to FDA Commissioner Margaret Hamburg today, Schumer urged the agency to immediately review the safety and legality of the product and compel the company to provide adequate evidence to substantiate its health and safety claims, particularly among children and young people aged 12-20.
Schumer also raised concerns in his letter about the potential for the product to be abused by adolescents in conjunction with alcohol. Last year, at Schumer’s urging, the FDA agreed to take action to stop the marketing, distribution and sale of caffeinated alcoholic beverages after concerns were raised about how their increasing popularity coincided with alcohol-related emergencies, hospitalizations and deaths.
In a separate letter sent yesterday 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.
“This product, in the hands of children and teenagers, can have serious and dangerous consequences,” continued Schumer. “The FDA needs to immediately investigate this product and work to block it from being sold on store shelves until we known the health consequences for youth using this device.”
A copy of Schumer’s letter to the FDA can be found below.
December 22, 2011
The Honorable Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Dear Commissioner Hamburg,
It has come to my attention that a new inhalable caffeine product is available on the internet now and scheduled to go on sale in retail outlets in New York City and Boston in just a few weeks. I write today to ask that you review the safety and legality of this product, the “AeroShot Pure Energy,” manufactured by Breathable Foods, Inc. I am particularly concerned about the use of this product by children and adolescents, as well as the potential for the product to be used by adolescents in conjunction with alcohol.
According to the company website, the “AeroShot” delivers an airborne shot of caffeine powder. The company’s materials claim that the product does not enter the lungs, but rather is dissolved in the mouth and swallowed. Moreover, the product is described as “healthy” and “safe” for children over the age of 12. 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.
Given the health concerns associated with use of caffeine in children, I respectfully urge the FDA to request that the company provide adequate evidence to substantiate its health and safety claims. In particular, I urge the FDA to request specific evidence on the effects of inhalable caffeine on children and adolescents ages 12-20. I also urge the FDA to examine the company’s claims that its caffeine powder does not enter and/or cannot be absorbed in the lungs. Aside from the possible health risks, in general, to children and adolescents, concerns have been raised about the potential for triggering an asthma episode in susceptible individuals.
The FDA should also consider the likelihood of the product being used by adolescents in conjunction with alcohol. We know that alcohol mixed with caffeine poses serious health risks, especially for younger and/or inexperienced drinkers. Last year the FDA agreed to take action to stop the marketing, distribution and sale of caffeinated alcoholic beverages after Senate colleagues and I raised concerns about how their increasing popularity coincided with alcohol-related emergencies, hospitalizations and deaths. It is imperative that the FDA move expeditiously to review the safety and legality of inhalable caffeine to avert the possibility of more caffeine-alcohol related tragedies.
The company’s marketing materials also seem to actively encourage use of inhalable caffeine by adolescents and young adults, including in social situations involving alcohol. A marketing video on the company website flashes through a variety of settings, including a dance party, a club scene, and a bar, where users are shown with AeroShot inhalers in their mouths. The website even boasts that because the inhaler is portable and not a liquid it is easy to bring into bars and clubs. Finally, in case there is any doubt about the product’s appeal to adolescents and young adults, the website also suggests stocking up on AeroShots for use “in class or in the library.” This new inhalable caffeine product seems well on its way to being marketed to encourage use by young adults in conjunction with alcohol and will very shortly be available at retail outlets such as convenience stores. I intend to ask the Federal Trade Commission to investigate whether the marketing of this product violates any laws enforced by the FTC. In the meantime, I am asking the FDA to do its part and promptly review whether inhalable caffeine is even safe for consumption.
I am very concerned that the new caffeine inhaler could increase caffeine use in young people, with potentially harmful consequences. Because the inhaler has not been submitted to the FDA for evaluation or approval, the FDA has no way of knowing the levels of caffeine this product delivers to the user, particularly in children and adolescents ages 12-20. In a letter yesterday to Breathable Foods, the AAP raised many of these same concerns and urged the manufacturer to provide additional data on product safety and on the company’s plans to market the AeroShot to children. I respectfully urge the FDA to do the same. Specifically, I urge the FDA to request and review evidence from the company to determine whether what it is selling is harmful to children, adolescents and the overall public health. Consumers deserve to hear from the FDA regarding the safety and legality of inhalable caffeine.
On a final note, I want to raise a systemic concern about manufacturers’ use of the dietary supplement law as a loophole to avoid having to demonstrate that a food additive, like caffeine, is “generally recognized as safe” (GRAS) by qualified experts. As you know, caffeine is generally recognized as safe when used in cola-type beverages up to a certain percent. However, by adding a vitamin(s) to a beverage, or in this case a powder, the beverage or powder is “transformed” into a dietary supplement and no longer subject to GRAS affirmation. So a beverage or powder that serves little, if any, nutritional or dietary function other than to deliver a concentrated dose of caffeine falls outside the framework of food and drug laws intended to ensure that what we ingest is safe. I urge the FDA to not let the addition of incidental ingredients undermine its critical responsibility to protect public health by ensuring the safety of our food and beverage products.
Thank you for your attention to this important public health and safety issue. I look forward to working with you on this matter and ask that you please keep me apprised of developments.
Charles E. Schumer
United States Senator