FDA Fires a Warning to Aeroshot

A few weeks ago we wrote about the unknowable contents of energy drinks, particularly caffeine, and their potential to cause problems.

Now, the feds are homing in on Aeroshot Breathable Energy, a dietary supplement that promotes its “unique blend of caffeine and B vitamins in a fine powder that dissolves quickly in your mouth.” The FDA is investigating Aeroshot amid concerns that it’s as much a party drug as a legitimate—and safe—energy booster. Using Aeroshot and alcohol simultaneously, the thinking goes, enables people to drink larger amounts of alcohol than normal because its effects are masked until consumers are extremely inebriated.

Inhaled via dispenser, Aeroshot imparts a large coffee cup’s worth of caffeine with every spray; each container yields 4 to 6 puffs.

In 2010, the FDA and the Federal Trade Commission (FTC) warned people that caffeinated malt beverages might not be “generally recognized as safe” (GRAS), the standard used to analyze food with added ingredients that haven’t been subject to approval. As a result, caffeinated malt beverages such as Four Loko effectively were banned.

But because Aeroshot is marketed as a dietary supplement, not as food, it isn’t subject to the regulatory muscle the FDA can flex for food products. “[I]t bears watching,” said the FDA Law Blog, “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 Loko is not GRAS.”

The investigation, then, will focus on whether Aeroshot is safe and legally marketable as a dietary supplement. If such products make no claims about curing medical problems, they may be sold without FDA approval. But they may not contain active pharmaceutical ingredients that are regulated by the agency. Supplements often have been found in violation of this rule, but the FDA generally does nothing until adverse effects become known.

Although Aeroshot is promoted as a “breathable” product, it actually dissolves in the mouth, and is swallowed, which complicates its categorization for regulatory oversight. The almost incomprehensible category of “breathable” food is not unfamiliar to some food scientists, but it’s a concept few other people can wrap their minds around. Really, who wants to inhale, in the literal sense, their Thanksgiving dinner?

So what’s a consumer to do about Aeroshot? Certainly, if you’ve used the product to ill effect, make a report to the FDA by linking here. If you’re only considering using Aeroshot and questioning its value, think about this: If you can’t even define the category under which something you’re contemplating eating, drinking or inhaling falls, if the full nature of its contents are unknown and have the potential to cause or exacerbate a problem, do you really want it in your body?


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Patrick Malone & Associates P.C. | DC Injury Lawyers on:

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