“Breathable Food” Comes Under Scrutiny

By Ricardo Carvajal –

According to press reports, Senator Charles Schumer (D-NY) has prevailed on FDA to examine the regulatory status of Aeroshot, a product labeled as a dietary supplement that claims to contain “a unique blend of caffeine and B vitamins in a fine powder that dissolves quickly in your mouth.”  According to the manufacturer, each Aeroshot provides 100 mg of caffeine (roughly equivalent to a large coffee) and delivers 4 to 6 “puffs,” which users are directed to swallow.  Sen. Schumer first attacked the product last December, describing it as “nothing more than a club drug.”

Although readers might be reminded of FDA and FTC’s joint action against caffeinated malt beverages (see our previous post here), those products raised the question of whether the intended use of caffeine was generally recognized as safe, or GRAS – the standard applicable to the use of an ingredient in conventional foods when that use of the ingredient has not been the subject of a food additive approval.  Because Aeroshot is marketed as a dietary supplement, it will be evaluated under the definitions and safety standards applicable to those products.  That said, it bears watching whether FDA takes account of the manufacturer’s marketing practices, and of whether the product is associated with “adverse behavioral effects” – factors that the agency cited in support of its conclusion that the use of caffeine in caffeinated malt beverages such as Four Lokos is not GRAS.

Given that Aeroshot appears intended to dissolve in the mouth and be swallowed, it’s not clear what makes it “breathable.”  In any case, the concept of “breathable” food has been on the table for at least 10 years, albeit in a more rarified form.  Intriguing, but no substitute for a good bowl of gumbo.