- New alliance will crack down on adulterated products touting dietary supplement claims
- Walgreens allies with HHS to launch free flu shot outreach to disadvantaged
- Moving PSE to Rx-only in Mo. lacks fiscal sense
- Report: Sharfstein to leave FDA
- Opening of Intel's on-site medical center officially announced by Take Care
WASHINGTON — Sen. Charles Schumer on Tuesday announced that the Food and Drug Administration has agreed to conduct a full review of the safety and legality of the new caffeine inhaler AeroShot, distributed by Breathable Foods, 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 formulated with 100 mg of caffeine. Schumer first called on the FDA to review the safety and legality of the product in December 2011, before the product started shipping in January, with a particular focus on both how it would affect teens and its use in combination with alcohol. Schumer announced that the FDA has agreed to his request and will conduct a review of the safety and legality of the product.
Schumer also questioned whether or not the product is legally marketed as a dietary supplement. “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,” Schumer stated. “We need to make sure that AeroShot does not become the next Four Loko, [an alcohol/caffeine combination beverage pulled off the market in 2010], by facilitating dangerous levels of drinking among teenagers and college students.”
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. The organization also raised concerns over the impact of the powder in AeroShot being absorbed by the lungs.