Update 3/7/2012: The FDA issues a warning letter on inhalable caffeine.
Update 2/19/2012: The FDA says it will review the safety and legality of AeroShot inhaled caffeine.
In 2008, Harvard professor David Edwards gave a talk to the AAPS Inhalation and Nasal Technology Focus Group (INTFG) titled “Inhaled Drugs and Vaccines for Infectious Diseases in Low-Income Settings,” a review of work done by his charitable organization Medicine in Need. Four years later, Edwards is speaking up to defend his latest product against charges by a US senator that the inhaled dry powder formulation of caffeine, is “nothing more than a club drug” that “could be a dangerous health hazard,” allowing partiers to “drink until they drop.”
In December 2011, Senator Chuck Schumer of New York issued a press release along with a letter to the FDA requesting an investigation into the safety and legality of the AeroShot dry powder inhaler.
The AeroShot caffeine inhaler
Schumer expressed particular concern about the marketing of the product to children and teens, noting that the Edwards’ company, Breathable Foods, claimed that the product was healthy and safe for children over 12 — a claim that the company has apparently revised since the AeroShot website now advises that the inhaler is not recommended for anyone under age 18.
According to website, the AeroShot formulation includes approximately 100 mg of caffeine, B vitamins, sweeteners, natural flavor, citric acid, and sodium bicarbonate, all of which are considered generally recognized as safe (GRAS) by the FDA. The makers claim that each puff provides about 15-25 mg caffeine “as an estimate” and that “Caffeine has been proven to offer a variety of potential benefits for health to individuals when consumed in moderation, from providing energy to enhancing attention and focus.” One of the promotional slogans on the site is “Puff in. Be on.”
The AeroShot website also categorically denies the possibility of any particles reaching the respiratory tract: “Our powders are of a median size much larger than 10 microns, and therefore, as confirmed by independent laboratory studies, they cannot enter the lung.”
In an Associated Press video, Edwards compares the inhaler to drinking a cup of coffee, “or maybe a Red Bull,” and says that the advantage of the inhaler is “that it’s the act of breathing.” He says, “The fact that you can avoid overdosing; the fact that you can deliver caffeine with no calories; the fact that you have no secondary or tertiary molecules like taurine and so forth that amplify the caffeine effect are all reasons to consider AeroShot as an eminently safe product.”
Watch the AP video below:
