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March 09, 2012

Out: Dunkin’ Donuts. In: Breathin’ Beignets?

It’s good to know that despite how busy the federal government must be legally assassinating American citizens, it still has the time and money to tackle other grave threats to our safety:

Such as novelty caffeine dispensers.

Specifically, “AeroShots,” described as “breathable energy,” and which consist of powdered caffeine and a B vitamin complex you shoot into your mouth in a spray-like cloud and swallow.

The problem? 

First, AeroShots contains caffeine.

Second, it is perfectly legal to sell products containing caffeine.

Those are two warning signs right there.

As a result, maker, Breathable Foods, Inc., this week received a warning letter from the U.S. Food and Drug Administration (FDA) outlining a number of problems it saw with AeroShots beginning with the first two obvious ones:

1) You breathe it in.

Consumers may attempt to inhale your product, causing it to enter the lungs. FDA is concerned about the safety of any such use because caffeine is not typically inhaled through the lungs, and the safety of such use has not been well studied.

2) You don’t breathe it in.

Despite these suggestions that your product is intended for inhalation, you indicate in other statements that the product is intended for ingestion. 

In order to satisfy the FDA Breathable Foods apparently needs to come up with an AeroShot that you both do and do not breathe in. 

But that is where it gets really confusing for the FDA.

Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion.

For the record, marijuana can be intended for both inhalation and ingestion IYKWIMAITYD. 

Regardless, the FDA goes into excruciating detail in support of its contention that AeroShots cannot be both inhaled and ingested:

The functioning of the epiglottis in the throat keeps the processes of inhalation and ingestion mutually exclusive. The epiglottis is a cartilaginous structure that prevents choking or coughing during ingestion. The act of ingestion enables the tongue to push down on the larynx, which in turn elevates the hyoid bone, drawing the larynx upwards. This latter action forces the epiglottis to fold back, covering the entrance to the larynx and the airways, preventing food, drink and particulates from entering the airways and respiratory tract. When a person inhales, however, the epiglottis maintains its upright position, enabling air and particulate matter to enter the airways and ultimately the lungs.

If you are like most Planet Moron readers, you started giggling uncontrollably when you got to the word, “epiglottis.” You are also probably thinking that the FDA is taking much too seriously what is obviously little more than marketing puffery.  (We can’t help but believe that AXE body spray is very popular among FDA bureaucrats.)

The FDA concludes it’s anatomical lesson with this stern warning;

 A product intended for inhalation is not a dietary supplement.

Although the makers say you really just spray it in your mouth and swallow it making it a dietary supplement but if you breath it in, it isn’t a dietary supplement but they say you don’t breath it in which means it is a dietary supplement…

If the FDA were an alien computer from the original Star Trek series, right now smoke would be coming out of its ears.

But that isn’t the only problem the FDA has with AeroShots. There are other serious issues as well: 

We also note that the Supplement Facts panel on the label of your AeroShot product does not comply with 21 CFR 101.36(e)(6) in that the dietary ingredients declared under 21 CFR 101.36(b)(2)(i) (ending with vitamin B12) are not separated from the dietary ingredients described in 21 CFR 101.36(b)(3) (starting with caffeine) by a heavy bar.

 You forgot the heavy bar under 21 CFR 101.36(e)(6) separating dietary ingredients? What, are you trying to get caught?

 And just to clarify, yes, you are paying these people’s salaries.

 The FDA also takes issue with the fact that AeroShots posts links to stories that “…express health concerns about taking AeroShot while drinking alcohol,” which is clearly an outrageous and…

Wait, that can’t be right. Oh yeah, the fact that the stories even mention the possibility of combining AeroShots with alcohol, even while suggesting the hazards of doing so, “publicizes such use.”  As the FDA points out:

Any such publicity may have the effect of encouraging the combination of your product with alcohol---a scenario that raises safety concerns, as peer-reviewed studies show that ingesting these two substances together is associated with risky behaviors, such as riding with a driver who is under the influence of alcohol, which can lead to hazardous and life-threatening situations.

Hey, it could happen.

And of course, the FDA is also very concerned about… the children.

As they point out, when the company says that AeroShots might be useful when “[h]itting the books” and “study[ing] in the library” it is clear that they are marketing to kids.

Leaving aside the fact that students no longer use books or libraries but instead cut and paste Wikipedia entries, the fact that FDA bureaucrats don’t even remember college suggests they did A LOT of bong hits.

But never with caffeine. That would be crazy.

Although you have to admit, an AeroShot would make a nice chaser after a babyccino.

Naturally, Senator Chuck Schumer, a tireless crusader against anything that might make his constituents alert enough to realize they’ve repeatedly reelected Senator Chuck Schumer, came out against AeroShots, calling it the “the new Four Loko.”

“Wait,” you are probably saying to yourself, “Chuck Schumer is still a Senator? Wasn't he removed from office after an investigation revealed that he was Chuck Schumer?”

Also, “But AeroShot doesn’t even have any alcohol.”

That’s true, which is why the Senator feels it is so important that the FDA:

“…focus on testing the inhalable caffeine’s effects on teens, and when it is mixed with alcohol.”

While they’re at it, they should focus on it’s effects when mixed with meth, heroin, sarin gas, and plutonium.

Hey, these AeroShots are even more hazardous than we thought!

The real tragedy in all this?  It’s probably too late to combine AeroShots with the AWOL machine (if only to watch Chuck Schumer’s head explode in a paroxysm of outrageously outraged outrage).

Naturally, as responsible citizens concerned about the well being of our nation and having no prior interest whatsoever in purchasing caffeine delivery systems outside of a powerful cup of coffee, we here at Planet Moron did what any law-abiding American would do upon reading the FDA’s letter.

We ordered ourselves a twelve pack.

AeroShots

We’ll let you know how it goes.

Assuming we live.

J.

NOTE: Annoying day-job-induced sporadic blogging continues for now, just hopefully less so.

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March 9, 2012 at 07:24 AM in Current Affairs | Permalink

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