WASHINGTON, DC ( release ) United States Senator Charles E. Schumer announced Sunday that the Food and Drug Administration (FDA) has agreed to conduct a full review of the safety and legality of the new caffeine inhaler, AeroShot, which hit stores in New York and Boston this past month. The product, a lipstick sized disposable inhaler, allows the user to inhale a powder that sends 100mgs of caffeine into the body. The product was introduced into New York and Boston markets in January without an age restriction on its purchase, without ever having been reviewed by the FDA, and without having its safety claims independently verified by regulators.
In December, Schumer called on the FDA to review the safety and legality of the product – with a particular focus on both how it would affect teens and its use in combination with alcohol. Today, Schumer announced that the FDA has agreed to his request and will conduct a review of the safety and legality of the product.
“A new product like AeroShot raises questions that need to be answered before allowing consumers, especially teens and kids, to use and abuse it. The AeroShot caffeine-inhaler is being marketed as a party enhancer; it can facilitate excessive drinking and its effects have never been examined by independent regulators to determine their impact on the human body and in combination with alcohol, especially for adolescents,” said Schumer. “We need to make sure that AeroShot does not become the next Four Loko by facilitating dangerous levels of drinking among teenagers and college students.”
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. AeroShow has a vitamin B additive, and is sold as a dietary supplement, allowing it to get around pre-sale review by the FDA.
“I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to over-using a product that allows one to take hit-after-hit-after-hit, in rapid succession,” said Schumer. “Scientists, pediatricians and public health professionals should do a top-to-bottom review of its impacts before we let our youth serve as guinea pigs for a questionable product.”
Since that time, Aeroshot has claimed that it changed its advertising materials to indicate the product’s safety for those 18 years and over. However, while that information appears to have been updated on its website, the packaging on AeroShot products sold in New York and around college campuses like Columbia University, still claim that the product is safe for those 12 years and older.
Schumer announced today that the FDA had agreed to conduct a review of the safety and legality of AeroShot, which could involve compelling the company to provide adequate evidence to substantiate its health and safety claims, particularly among children and young people aged 12-20. After reviewing the safety and legality of the product, the FDA could issue a warning letter to AeroShot identifying possible violations of the Food, Drug, and Cosmetic Act or other laws under FDA's jurisdiction. Possible actions as a result of the review include those similar to FDA actions taken against Four Loko, including requiring the manufacturer to make changes to the product, its marketing, and compelling it to be removed from the market entirely. Last year, at Schumer’s urging, the FDA agreed to take action to stop the marketing, distribution and sale of caffeinated alcoholic beverages, including Four Loko, after concerns were raised about how their increasing popularity coincided with alcohol-related emergencies, hospitalizations and deaths.
A copy of Schumer’s December 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.