Back in 2017, some five years ago now, I wrote "Deeming Regs: A War on Science and Common Sense" (see http://lwgat.blogspot.com/2017/12/deeming-regs-war-on-science-and-common.html).
The premise: only a fool or an idiot could possibly believe software or electronics were tobacco products.
About four months later in April of 2018 (see https://lwgat.blogspot.com/2018/04/science-backs-fda-down-vaping-is-free.html) I described how the FDA published guidance at that time saying software and wires, among other things, fall into a category under 904(a)(1) which the FDA “does not intend to enforce…”
Hmmm...
My blog, which never had huge traffic, was suddenly more popular by orders of magnitude over those intervening four months after I wrote that first post.
Why? Because I shamed the FDA. And they knew it.
Even the FDA could imagine a lawyer standing in a court room holding up a fist full of wires or a USB drive and asking the judge if he really believed they were “tobacco products.” Even the FDA could imagine losing that case, in fact, it probably gave them indigestion.
Nobody at the time took my posts or comments seriously yet, reviewing the FDA’s initial stand and where they ended up on this, they were put in their place.
(I am sure it didn’t help their cause that I also published the wildly popular “Your Childs iPhone is a Tobacco Product” (see: https://lwgat.blogspot.com/2016/09/your-childs-iphone-is-tobacco-product.html) showing how, under their reasoning, software I had written for both iPhones and Android phones to control vaping devices made those cellphones “tobacco products”.)
Which brings us to where we are today.
A guy I know, Greg, wrote this: “FDA is filing notices in the pending MDO appeals to alert the courts of the recent synthetic bill. It is implying that synthetic product manufactures should have done testing in advance in claiming they’ve had plenty of time to do so." Greg’s a lawyer for vaping companies fighting the FDA on a variety of issues.
This quote caught my eye because here is yet another example of the worst sort of “science denying” (just like wires and software are tobacco products) by the FDA.
Though in some sense this is actually worse.
The issue is that along with the recent omnibus spending bill the Congress called out “synthetic nicotine” as something the FDA must regulate.
Prior to this bill “synthetic nicotine” was not regulated by the FDA because it was not a “tobacco product.”
Now, back in May of 2014 I wrote “USP Nicotine” (see https://lwgat.blogspot.com/2014/05/usp-nicotine.html).
This clearly lays out how nicotine (or water or any other molecule known to science) cannot be a “tobacco product.”
Why?
The answer is simple: If you mix “synthetic nicotine” and “tobacco product nicotine” together you cannot separate them because the molecules cannot be differentiated as to their sources or how they were created.
Sure, tobacco plants make nicotine, but so do potatoes.
Nicotine is a chemical substance, a molecule. It's not specific to tobacco or any other plant.
“Synthetic nicotine,” on the other hand, is anti-science nonsense made up by the FDA to account for their regulatory short comings.
So Greg is writing how now “FDA now seems to expect regulated parties [vaping companies] to anticipate in advance when and to what extent they will be regulated and begin compliance efforts even before those regulations are made.”
So though the FDA drove the creation of “synthetic nicotine” via over regulation and drove vaping companies to use it under their draconian deeming regulations and somehow the FDA now expects that, when out of the blue Congress gives them authority over it, those vaping companies using it “should have known” it was going to be regulated and therefore should have gone through the PMTA (or whatever) process in advance of Congress taking action.
So let’s take a look at this new “law” - something to the following amending Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.” 21 U.S.C. 321(rr).
I submitted a letter to the FDA in 2014 that indicated, among many other things, that science had discovered naturally occurring nicotine in a variety of sources: egg plant, potatoes, and tomatoes among many others (see: https://lwgat.blogspot.com/2014/08/so-its-time-to-write-comments-for-us.html).
So not only is nicotine a chemical compound, but it's also a naturally occurring chemical compound common to nearly all plants.
But now, through the magic of scientific ignorance and denial, we have a new “category” of chemistry: “intended for human consumption.”
The first question would be: intended by whom?
Believing in the Bible I would have to say that God created all the edible plants for humans to consume so now the FDA reigns supreme over God's vegetables I guess.
Or is it the "manufacturer" who somehow extracts or makes nicitine?
Does it depend on marketing, on what the plant manager was thinking? Who knows? (But this is very scientific of course...)
Nicotine is used as an insecticide world wide (outside the US). This means, according to the FDA, like ivermectin of “horse dewormer” Covid fame, it's perfectly safe to vape this insecticide as it was never intended for human consumption. (Meanwhile ivermectin got it's inventors a Noble prize and billions of doses are taken world wide - by humans no less).
If the FDA stood for science they would understand that USP nicotine has nothing to do with tobacco. Nicotine is a compound found in a plant, along with vitamin B12 and water. Hence water and B12 are “tobacco products” by their definition, not.
But they don’t stand for science. They deny it. And they keep creating "science denying" nonsensical categories of “nicotine” to further twist common sense around to their point of view.
The FDA and CDC are the same people that cooked up Covid mRNA “vaccine” injectable product policy, which, according the CDC’s own VAERS database has killed thousands of children (no, no the fact checkers say otherwise... ha ha - but little Suzy and Johnny will need EKG's this year for high school sports).
I wonder how that number of vaccine deaths compares to the number of people (children or otherwise) killed by commercial vaping products (even including those killed those selling bogus liquid vitamin-E vaping products)?
The FDA has probably “authorized” orders of magnitudes more Covid vaccine deaths than any amount of vaping or vapes ever killed.
FDA, save the children! Haha - right. Kill them for profit the sake of science ought to be your motto.
FDA, you ought to be ashamed of yourselves.
You are science deniers.
Myocarditis - can’t be from the vaccines we approved, oh no… but don't forget that EKG.
Nor are hundreds of thousands of Covid vaccine injectable product VAERS (see: https://vaers.hhs.gov/) “adverse events” real, no, no just nonsense according to “fact checkers.”
(Yes, I have an SQL version of this data on my very laptop - so stop pretending it's "meaningless" data in the context of Covid injectable products.)
FDA - you denied science to call wires tobacco products.
FDA - you denied science to call software tobacco products.
FDA - now you’ve invented “intended for human consumption” nicotine.
How many kiddies world wide will start vaping insecticide because of your bogus, science denying declarations?
FDA - you can release a vaccine with one bogus, self interested corporate study on the ENTIRE WORLD, generate hundreds of thousands of “adverse events” in the US alone, yet you pretend nicotine is a “tobacco product" and vaping will kill everybody.
FDA - You are full of shit.
FDA - You deny science, facts, and common sense.
You are science deniers.
Five years ago I wrote “Vaping: Safer than a Vaccine” (see: https://lwgat.blogspot.com/2017/01/vaping-safer-than-vaccine.html). For those of you one the VAERS list, how's that working out for you?
(To be clear I am not anti-vax - I am vaccinated, my kids are vaccinated, my dogs are vaccinated. I accept science and the questioning of science and scientific results. I do not accept the whining of science deniers like you or their handmaidens in the “media.”)
As for vaping being safer than vaccinations, looks like I was right…
So, vaperatti, time to call out the FDA for what they are: science deniers.
The FDA will respond to shame.
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