A tale of how FDA bureaucrats over-regulate hand sanitizer (and everything else)

As the Media constantly warn you, because of the virus there's a shortage of "hand sanitizer."

Lots of Americans found this puzzling:  Isn't hand sanitizer mainly alcohol and glycerin or maybe aloe?  Knowledgeable people could even throw in some hydrogen peroxide.  What prevents Americans from making their own?

Ah, glad you asked.  It's the bureaucrats--wannabe-dictators--at the U.S. Food and Drug Administration.


Yes, the small third-party sellers who make up much of the sales volume for Amazon and eBay quickly bought up all the hand sanitizer they could and then began selling to panicked consumers at a huge markup.  After politicians threatened Amazon and eBay, the dot com giants banned price gouging listings.  And gubmint authorities are now confiscating hand sanitizer from hoarders to be redistributed as the government sees fit.

After all, confiscation worked for the Bolsheviks with wheat, so it’s bound to work with hand sanitizer in America.

To meet the upsurge in demand from the virus, president Trump ordered the FDA to suspend the usual rules on making the stuff.  As a result, the FDA  generously announced that it won’t be cracking down on pharmacies that make their own hand sanitizer.  Oh thank you, god-like bureaucrats!  We're so grateful!

But don’t think the FDA is throwing all caution to the winds by letting individual Americans make their own hand sanitizer!  Not at all!  Rather, the FDA order said “compounders, relative to untrained consumers, are more familiar with standards and methods for producing drug products.”  So it refuses to allow individuals or any ordinary business to mix deadly alcohol (that's sarcasm) with mysterious aloe.  Instead, the FDA's supposed generosity in "allowing" unlicensed businesses to make hand sanitizer is limited to "State-licensed pharmacies or Federal facilities."

Seriously, they actually wrote that in their rules.  (And seriously, f**k all these pin-head assholes.  If I wanna mix isopropyl alcohol (costing a buck a bottle) with aloe, I don't give a damn what some asshole in Washington orders.)

And even with this new, supposedly generous rule, the FDA isn't actually giving permission, but simply announcing that it "does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency." How magnanimous of the bureaucracy.

You can get an idea of how totally the FDA's bureaucrats want to run things by noting that the agency's order warned pharmacies not to add aloe or any “other active or inactive ingredients.”  See, that’s what a dictatorial bureaucrat does to maintain control:  Can't trust pharmacists to make hand sanitizer, eh?  What, do they think it's too damn dangerous?
 
This is the same FDA that made the coronavirus crisis worse by refusing to allow a Seattle lab to test people who had the flu because the lab hadn’t been certified under Medicare.

Given the critical need to avoid transmitting the virus, the FDA could have allowed any business to mix water and alcohol.  Instead the bureaucrats protected their authority.

America isn’t facing a hand sanitizer shortage because of capitalism, but because of socialism.
The speculators buying up hand sanitizer and reselling it on the black market were behaving exactly like their counterparts in socialist countries, stockpiling products due to an artificial shortage, and then pricing the inevitable raids by government agencies against hoarders and speculators into the cost.

The reason we don’t have enough hand sanitizer is because bureaucrats insist that something so dirt-simple needs to be regulated.  By them.

The FDA regulates hand sanitizer like a drug.

In 1994 the FDA issued a "tentative final monograph" on hand sanitizer.

Just last year it issued its final hand sanitizer rule. That’s 25 years from "tentative final monograph" to the final rule for alcohol and water in gel form.  That's bureaucracy doing the usual job.

A whole generation passed, millions were born and died, in the time it took the FDA to finalize its very final rule on using alcohol to sterilize your hands--a practice dating back to Rome.
 
According to Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, the final rule "reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers."

After decades of this madness, the FDA demands still more data to determine that alcohol is a safe and effective means of sterilizing things.

The story of the FDA’s investigation of sterilizing hands with alcohol proves that government is not only more insane than you know, it’s more insane than you could ever begin to imagine.
 
The coronavirus crisis has stirred perfume manufacturers and liquor companies to start making and giving away hand sanitizer. LVMH, which owns Louis Vuitton and Dior, will make and give away hand sanitizer in France--which is beyond the reach of the FDA.

A distillery in the U.S. is making hand sanitizer and giving it away. But FDA rules bar them from calling it that, and from selling it.

If the FDA makes people jump thru this many hoops to make something as simple as hand sanitizer,  imagine what it takes to invent and market a new medication in a timely enough manner to save lives.
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H/T Daniel Greenfield at FrontPage.