Charles E. Schumer announced today 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.