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Wednesday, August 24, 2016

FDA Docs: Don't Tell Them Vaping is Winning...

The next item in the FDA NicoPure response is this (see previous post for links to the relevant documents):

"Second, the magnitude of the public health harm caused by tobacco use is “inextricably linked” to nicotine addiction. 75 Fed. Reg. 69,524, 69,528 (Nov. 12, 2010). “The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.” Id. The power of nicotine addiction is perhaps best illustrated by the failure rate of individual cessation efforts. In 2004, for example, “although approximately 40.5 percent of adult smokers reported attempting to quit..., only between 3 and 5 percent were successful.” Id. at 69,529. The tobacco industry has long appreciated the importance of nicotine addiction to their sales. In an internal 1972 memo, one company acknowledged that “a tobacco product is, in essence, a vehicle for the delivery of nicotine”—a “potent drug with a variety of physiologic effects”—and that the “industry is then based upon the design, manufacture, and sale of attractive forms of nicotine.” 146 Cong. Rec. H1849 (Apr. 5, 2000) (statement of Rep. Ganske) (quoting an R.J. Reynolds memo)."

This is really clever.

What is not said is that combustion and tar are the real problems.

Which they are.

After reading the above quote supposes that "nicotine addiction" is the cause real cause of all the problems of smoking.

But its not because Philip Morris now sells the iQUOS - which heats tobacco to below combustion temperature so there is presumably fewer health issues - is new on the market this year.

Hmmm.... Must be no worse than smoking.

Oh wait - Philip Morris's market is currently in decline - 5% a year.  Guess they need vaping to go away (see below).

No burning - no problem!

Third on the FDA list is this:

"Third, the tobacco industry has long depended on recruiting underage users who become addicted before age 18. Congress found that, despite laws prohibiting the sale of tobacco products to minors, the “overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18.” Legislative Finding 31, Pub. L. No. 111-31, § 2, 123 Stat. 1776 (2009). Congress additionally found that “[a]dvertising, marketing, and promotion of tobacco products have been especially directed to attract young persons to use tobacco products, and Case 1:16-cv-00878-ABJ Document 42-2 Filed 08/16/16 Page 19 of 102 these efforts have resulted in increased use of such products by youth.” Legislative Finding 15; see also United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 572 (D.D.C. 2006) (the “central purpose of the tobacco companies’ image advertising is motivating adolescents to smoke”), aff’d in part, 566 F.3d 1095 (D.C. Cir. 2009). "

Again the alternative is left out.

If mom or dad vapes and its "less risk" (according to the FDA itself) why doesn't the FDA want children to also engage in less risky behavior?

Apparently having little Johnny smoking is better than vaping - even though its less risk.

How disingenuous is all this?

No one smokes in my house any more out of six adults.  Four children are no longer exposed to "combustion" smoking.

Yet there's apparently a big problem with this...

The bottom line here is that the FDA knows vaping works better:

In 2011, according to this WSJ article, the NRT (gum, patches, etc.) market was "$835 million market in annual U.S. retail sales of over-the-counter smoking-cessation aids."

The 2014 vaping market according to Wells Fargo?  Two billion ($2,000,000,000) more than twice the size of the NRT market.

Friday, August 19, 2016

FDA Docs: Smoking Beagles and Breast Cancer?

The FDA/nicotine/smoking/tobacco rabbit hole goes very deep.  I have cherry picked away at some of it and left crumbs for you to follow.  The going gets tough for a while so hang in there...

From the FDA Response to NicoPure (bottom of page #10):

"Although the FDA recognized that completely switching to e-cigarettes may reduce the risk of tobacco-related disease for individuals currently smoking conventional cigarettes—one of the deadliest products ever brought to market—it found that e-cigarettes still pose a number of significant health and safety risks. "

Okay, so out of the box the FDA agrees we have "less risk" with e-cigarettes.

Is that a health claim?

Of course, there are still a "number of significant health and safety risks."

So the next few posts are going to examine, in as painless a detail as possible, what the FDA says (next paragraph or so in the response):

"First, nicotine is “one of the most addictive substances used by humans,” 81 Fed. Reg. at 28,988, and “a powerful pharmacologic agent that acts in the brain and throughout the body,” Surgeon General’s Report (1988) at 14 (AR 1183). “[N]icotine is psychoactive (‘mood altering’) and can provide pleasurable effects,” and “causes physical dependence characterized by a withdrawal syndrome that usually accompanies nicotine abstinence.” Id. E-cigarettes can deliver as much nicotine as conventional cigarettes—sometimes more. 81 Fed. Reg. at 29,031."

(Gee, seems like Colorado weed falls into the "psychoactive mood altering and pleasurable" category as well... but that's another story I guess.)

Perhaps, but the first reference (81 Fed. Reg. at 28988, is a (Ref. 7) link to page 29095 #7).  This is, of course the FDA's citing the FDA's own deeming regulation.

The referenced document can be found here (the listed link appears to be broken but you can search the title of the document: "Institute of Medicine of the National Academies, ‘‘Ending the Tobacco Problem: A Blueprint for the Nation,’’ 2007").

This document is quite long and on the bottom of page #5 it says "First, nicotine is “one of the most addictive substances used by humans...”

However, this document also says this (underlines my own):

"The number of studies that have assessed the role of specific genes in smoking behavior continues to grow. The work of Malaiyandi and colleagues (2005), for example, suggests that cytochrome P450 (CYP) 2A6, the liver enzyme which mediates the conversion of nicotine to cotinine, may play an important role in smoking (Malaiyandi et al. 2005). 
In a review of recent genetic studies of nicotine dependence, Li (2006) presents evidence that several genes may be implicated in nicotine dependence (Li 2006). 
The results of these studies suggest that specific subgroups of smokers have a significantly higher probability of abstinence when they use nicotine patches, nicotine nasal spray, and bupropion treatment (Lerman et al. 2002, 2004; Swan et al. 2005). .... "

So maybe smoking is genetic?  (See this and this.)  This is a fascinating subject if you delve into it...

Next the 1988 Surgeon General report is here:

This is hundreds of pages in length but there are many interesting gems to be found besides the FDA's ominous quotes:

  • We discover, for example, that on page 106 much can be said about the chronic smoking of male beagles and their testicles.
  • We also discover that smoking in human women results to some degree is earlier menopause and lower incidences of breast cancer.
  • Smokers weigh less.  Wonder if this has anything to do with the current obesity crisis?

How interesting...

Perhaps nicotine is not all so bad after all.  I am certain that vaping to reduce breast cancer might be an attractive alternative to a mastectomy.

All in all the FDA is regurgitating decades of what every vaper already knows: smoking is bad, or, more specifically, smoking (combustion) tobacco is bad.  Decades of federal dollars flooding the coffers (I wonder if those federal dollars are as addicting as nicotine).

And yes, there can be negative effects of nicotine as well be most of what is said relates to animals.  Humans are often only "observed."

But these document often use "smoking" and "tobacco" and "nicotine" in interchangeable ways leading one to suspect that perhaps these three things have been considered the "same thing" until vaping came along.

Clearly this is all cherry picking: both on my part and the FDAs.

There are thousands of pages here and I am certain you can probably get those pages to say just about anything you wanted to regarding nicotine...

Just remember the 

Thursday, August 18, 2016

FDA: Not Telling the Truth in Court...

From the FDA website linked below...
As I have said before not even the FDA thinks nicotine outside the realm of "combustion tobacco" is addictive (from this FDA website):

"Now, the Food and Drug Administration—after reviewing scientific research on the safety of NRT products sold over the counter (OTC)—has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.

The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence. [my underline, NRT=Nicotine Replacement Therapy]"

Since vaping isn't combustion tobacco and its also sold "OTC" how is this different?

Yet in their response to NicoPure's lawsuit here is what the FDA says about nicotine (page 4, first paragraph):

"Second, the magnitude of the public health harm caused by tobacco use is “inextricably linked” to nicotine addiction. 75 Fed. Reg. 69,524, 69,528 (Nov. 12, 2010). “The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.” [my underline]"


A somewhat different story.

Yet I can buy these FDA-approved NRT products OTC anywhere - on Amazon, for example.

I don't have to do a single "age check."

Amazon doesn't know if its me behind the screen placing the order or my 13 year old grandson...

And they don't even think nicotine is addictive on their NRT web site.

Do these gums, etc. have actual leaf tobacco in them - nope.

And neither does vape.

The only difference I see is that the FDA has no control over vaping yet hence it cannot be an NRT.

Despite millions around the world no longer smoking "combustion tobacco."

People come into vape shops all the time, I personally have had this experience, and say their doctor told them to start vaping.

Again, where's the truth here FDA?

Wednesday, August 17, 2016

Nicotine Off Market as a Big Pharma "IND?"

This link describes how the FDA is generating new "guidance" (link here) related to supplements and the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Vapers' and vape-related businesses need to be concerned as to what date "nicotine" became available for sale relative to the passage of DSHEA as well as exactly what it is besides now being a "tobacco product" - or, more correctly, what it was...

The link describes various scenarios" "...[a] drug company decides to corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever more. This could very easily be done under this [new] guidance. Remember that it is not always clear what counts as a NDI or what has been grandfathered, so drug companies can use this confusion to claim that supplements which have been around for decades have been sufficiently “altered” that they can be claimed as drugs."

The "NDI" designation indicates when a "supplement" appeared on the market (before DSHEA its grandfathered and after its "NDI").

"IND" means a new drug under these proposed regulations.

If a company attempts to make nicotine an ingredient in a new drug product, in an "IND," nicotine would lose its status as "NDI" and be forced off the market.

Nicotine, though now an "imaginary" tobacco product, it didn't used to be and I do not know what it was relative to this prior to 8/8/2016.

In any case please read and repeat:

If nicotine is an "NDI" and is incorporated into a new "IND" application its no longer salable as a supplement under these proposed regulations.

These proposed regulations provide a neat back door for Big Pharma (or anyone really) to potentially control nicotine and remove public access to it forever.

Can this happen?

Probably, though there would likely be lawsuits from other Big Pharma as no single company would get to control nicotine for vaping, its simply too profitable!

Also nicotine is now sort of an "imaginary" "tobacco product" which DSHEA specifically exempts (does not include, i.e., tobacco is not a supplement).

The proposed regulations place restrictions on nicotine but its unclear, and I have worked with a DSHEA lawyer on this, as to what DSHEA implies relative to "nicotine" which is why this is dangerous and important to vaping.

DSHEA really, I don't believe, thinks nicotine is tobacco.  Hence it must be "something else..."

But what???

I do not think we can fall back to the prior legal cases related to vaping and the FDA from 2007.  The reason for this is the court told the FDA it couldn't make vaping into a medical device.

This is a different animal in that nicotine could be controlled "by inclusion" in a "drug" application to the FDA.  Its not the FDA deciding what it is.

And this has happened already, a variant of vitamin B6 was eliminated from the market both as a drug and supplement because of its inclusion in an "IND."


Tuesday, August 16, 2016

Philip Morris: Free on Facebook

Meet the iQOS from Philip Morris (PM):

I wouldn't know about this save for the "People Also Shared" iQUOS add from none other than Facebook?

And more!  In the third panel about poor, sad PM laying people off to expand their "improved health" product investments.

But wait, aren't such claims disallowed under the new FDA deeming regs?

This just showed up today on my Facebook feed.

Wow!  People must be "talking about it!"

Except the article is from March, 2016...?

AND Facebook doesn't let anyone advertise anything related to vaping...

Or does it?

Maybe if someone shares it? My private post?  Suddenly people I don't know get to find out about things others are "talking about"?

Gee, sounds like advertising to me...

Perhaps someone should be talking to Facebook and Zuckerberg about prison...

Let's imagine that 1,000s of Philip Morris Facebook goons share this amongst each other to build up the interest...

No, regardless of how much vape stuff "I share" or "I see" none of that makes it up to this level of "talking about..."

How interesting.

So no, this iQUOS crap wasn't just shared into popularity.

Its a plant.

Look at the middle panel: E-Cig poisoning on the rise!

Let me guess, the new Philip Morris product resolves the poisoning issue by making a nice, Big Tobacco product that not mixed in someone's garage or basement...

I suppose somehow Philip Morris can have a article written about their uninteresting, tobacco leaf-based non-vaping no-proof-its-healthier crappy product just so it can magically appear on my Facebook feed.

Guess old Zuckerberg is cool with PM pushing their "improved health" investment opportunities...

Zuckerberg needs prison for this...

Sunday, August 14, 2016

FDA: Air Fresheners Meet the ENDS Standard

(NOTE: Though the tone here is "sarcastic" the science is not...)

As if convenience store "manufacturing" of tobacco weren't bad enough there's a second, more serious issue:

Air fresheners.

A few examples include:

"Scent Warmers"

"Essential Oil Diffusers"

These devices contain warmers that heat chemicals or use atomizers to disperse chemicals for you to inhale.

Yes, indeed, if you smell something you are inhaling it.  Molecules that pass through your nasal passages enter into your lungs after you smell them, hence inhalation.

According to this blog twenty or more million Glade plugins are sold each year.  And there are many manufacturers, e.g., Air Wick, besides Glade.

These units are ENDS systems.

Plain and simple and match exactly the words of the FDA regulations (see page #8):

"The following is a nonexhaustive list of examples of components and parts used with electronic nicotine delivery systems (ENDS) (including ecigarettes): e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software."

But, you say, nicotine is not in these products.  Er, well, bear with me...

First off what's in this "Fresh Citrus Blossom" Glade product (remember, designed for inhalation) would be this:

"(e)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one; [(3,7-dimethyl-6-octenyl)oxy]acetaldehyde; [1-methyl-2-[(4,4,5-trimethyl-3-bicyclo[3.1.0]hexanyl)methyl]cyclopropyl]methanol; 1-(2,6,6-trimethylcyclohex-3-en-1-yl)2-buten-1-one; 2,4-dimethyl-3-cyclohexene carboxaldehyde; 2,6,10-trimethylundec-9-enal; 2,6-dimethyl-7-octen-2-ol; 2-phenoxyethyl isobutyrate; 2-t-butylcyclohexyl acetate; 3.alpha.,4,5,6,7,7.alpha.-hexahydro-4,7-methano-1h-indenyl propionate; 3-hexenol; 3-methyl-2-butenyl acetate; 4,4.alpha.,5,9.beta.-tetrahydroindeno(1,2-d)-1,3-dioxin; 4-methylanisole; 5-methyl-2-(2-methylpropyl)-1,3-dioxane; amyl cinnamal; benzaldehyde; benzyl acetate; benzyl butyrate; butyl ester of pvm/ma copolymer; cyclamen aldehyde; decanal; dimethyl heptenal; dipropylene glycol; ethyl 2-methyl-1,3-dioxolane-2-acetate; ethyl 2-methylbutyrate; ethyl 2-methylvalerate; ethyl butyrate; ethyl isovalerate; ethyl linalool; ethyl methylphenylglycidate; ethyl salicylate; ethyl trimethylcyclopentene butenol; ethyl vanillin; gamma-decalactone; gamma-nonalactone; gamma-undecalactone; geranyl acetate; hexenyl acetate; hexyl 2-methylbutyrate; hexyl acetate; hexyl butyrate; hexyl propionate; indole; isoamyl acetate; isoamyl allylglycolate; isobutenyl methyltetrahydropyran; isobutyl methyl tetrahydropyranol; isopropylphenylbutanal; lauraldehyde; linalool; methyl anthranilate; methyl benzodioxepinone; methyl Ionones; methyl n-methylanthranilate; nona-2,6-dien-1-ol; nonadienal; phenethyl alcohol; ppg-2 methyl ether acetate; terpineol; trans-hex-2-en-1-ol; undecylenal"

Considerably more ingredients than an e-cigarette.

And remember, these are in the rooms of your small children and family.

So what if I had, say a Walmart, where I sold both Vuse and Glade products?

Certainly a Glade product that atomizes fragrance for inhalation with heat would be considered an "atomizer" in the FDA regulations sense (the Glade site says its an atomizer).

And Walmart is, in fact, a "vape shop" by any stretch of the imagination because it sells a variety of e-cigarettes right at the "tobacco" checkout.

And these Glade things contain ingredients like "ethyl vanillin."  This is a "fragrance" sold as such to giant companies like SC Johnson (who make Glade) and is also exactly what you might find in a "big tobacco" vape...

SO it must be safe to inhale, right?

What about "ethyl trimethyl cyclopentene butenol" (see this - its a synonym for "(E)-2-ethyl-4-(2,2,3-trimethyl-1-cyclopent-3-enyl)but-2-en-1-ol").  Why, its a perfume agent, just like you might by from, say, a standard vape flavor source.  (I can't seem to find it under the FDA GRAS list for food much less for "inhalation..."

(You and your kids are inhaling it right now - day in and day out - probably for years or decades...)

And certainly the FDA requires any ENDS-based products for inhalation, whether they contain nicotine or not in a "vape shop," to be properly marked as "tobacco products."

But I see that air fresheners are not...

So what's going on here?

Bullshit is what's going on...

Regulatory fraud is what's going on...

Vape shops have been singled out for targeted enforcement.

Trust me, no FDA inspector is going to Walmart and start seizing the Glade plugins or Vuse.

But if you should mix a simple nicotine-free e-liquid and not charge someone to sample it its prison for you....

So here's the plan:

1) Go out and buy a Glade (or AirWick or whatever) plugin system (make sure it has an atomizer or "heats" the fragrance).

2) Hook it up so that it runs and then buy a pack or two of refills and add them to your shop's inventory (and yes, in Pennsylvania at least, add 40% of the retail price to your tobacco tax form).

3) Now sell one to someone.

So now several things are true:

A) You and your vape shop are just like Walmart (or Target or K-Mart) - same products for sale, same ingredients, etc.

B) Your Glade product, because you also sell nicotine, must be marked as such because anyone who walks into your shop is now "vaping," i.e., "inhaling" a chemical mix of non-nicotine vape (this would include the FDA inspector).

C) You must therefore demand payment before the inhalation of the "vaping" compounds in your shop.

(If you are interested check out the Youtube videos for refilling air freshener cartridges... Put some e-liquid in one ... er, wait - you probably wouldn't want to inhale what's in an air freshener...)

WARNING (Adults only past this point...)

These FUCKING IDIOTS are putting Fabuloso into their Glade plugins...

There are many, many youtube videos of this.

(I assume a bottle of Fabuloso is far cheaper than a Glade plugin hence this mania...)

Gee, I wonder what inhaling C9-11 Pareth-8 does (here's the MSDS if you've got a strong stomach...)  More here.  Irritates mucous membranes...  No wonder little Johnny has asthma.

Better yet, at least one video had some kid sitting in the room no doubt enjoying the "fresh smelling" house.

Where's the FDA?

Fabuloso as an inhalant.

No outrage...

Not nicotine so no problem...

Where's the outrage?