FDA

FDA tells federal court no need to sift through facts on vaping

The FDA’s lawyers explained to the D.C. federal court e-cigarettes are really horrible and the court has no need to sift through all the boring facts.  Why? Congress made the FDA the experts so trust them.  In their 102 page legal response to lawsuits filed against the FDA lawyers write, “The Court need not sift through this evidence, however, because Congress entrusted the decision whether to supervise tobacco products, including e-cigarettes, to the expert judgment of the FDA.”

Hubris and government agencies are common friends and the FDA hubris is on full display for all to see.  Before telling the courts not to worry about wasting their time sifting through any evidence FDA lawyers first stated some scary things about e-cigarettes or electronic nicotine delivery systems (ENDS), commonly known as vaping products.  Fear is also a friend of bureaucracy and politics, especially when tied to the notion of simply aiming to protect our children.  Fear is an acronym for false evidence appearing real and fear was fully leveraged in the FDA’s introduction to their response.

FDA Stated Vaping Product Problem

Facts the FDA does not want the courts to learn

Used by more than 13% of high school students, eclipsing traditional cigarette use Smoking among the same age group has dramatically decreased, the number vaping has increased.  The 13% figure is skewed by the study group and what was defined as used. In a small group respondents were considered users if they had tried a vaping product in the past 30 days.  Also unknown from the FDA’s reference is if it was an eLiquid with or without nicotine and whether there was regular use beyond once in 30 days.
Marketed as helping smokers quit, SCANT evidence to back such claims An estimated 2.9 million of the 9 million vaping to quit have done so in the U.S.  and dual users are still significantly reducing damage while striving to be smoke-free.  It is estimated 6 million in Europe have quit through vaping and England’s equivalent to the FDA (Public Health England) is urging smokers who have not quit to switch to vaping.  Their research has helped to prove, scientifically, vaping is less than 5% as dangerous with no harm to bystanders.
Ample evidence e-cigarettes present significant risks to public health. The opposite has been the case as former smokers who now vape instead are regaining their health as if they had quit cold turkey.  With millions getting healthier the risk is from banning or significantly limiting today’s devices or discouraging smokers to try vaping instead.  Significant risk sounds scary yet simply is a false narrative, the risk is significant if people keep smoking.
Nicotine is one of the most addictive substances known to man. Mounting scientific evidence shows nicotine, unchained from burning tobacco, is not nearly as addictive with one study showing indications it is very hard to get rats addicted to nicotine through vaping while through smoking it is very addictive.  Also growing is the evidence nicotine has many benefits, especially now that the delivery system, ENDS, is at least 95% safer than cigarettesHealth benefits from nicotine are being scientifically tested even as the FDA threatens the safest generation of ENDS.
Some deliver other toxic and carcinogenic chemicals like formaldehyde and nickel This is from an older study allowing what is termed ‘dry hits’ which is burning cotton when the eLiquid runs out.  Dry hits are terrible and vapers avoid them and do not routinely take dry hits.  Avoiding dry hits has become easier with advanced technology in vaping products, the advanced technology the FDA is taking aim at with its Feb. 15, 2007 grandfather date.  The FDA is setting the safety and improvement back nearly a decade, that’s toxic.
Others have exploded in users’ faces causing burns and lost teeth Cases of exploding devices is centered on older devices and users inappropriately using the wrong battery types.  Although any battery operated device has risks, current 3rd and 4th generation vaping products have become safer while being threatened through the 2007 grandfather date, essentially banning these safety improvements.  Consumer education is also improving by retail stores training consumers on proper use of batteries and devices, training the new FDA deeming rules are targeting as inappropriate for retailers to provide.
Ingredients of e-liquids are largely unknown This is among the most blatant of the misinformation being discussed.  There are four basic ingredients in all quality eLiquids.  PG and VG have been studied and approved as safe since the 1930s by the FDA.  Nicotine, in the small amounts in eLiquids (from 1.8% per milliliter to 0% nicotine most commonly used).  Food flavors, creating a variety of eLiquid tastes.  Manufacturers have improved their testing, reformulated eLiquids to further remove dangerous food flavoring chemicals and making their vaping oils safer while producing them in clean room facilities.  It is far too easy to know exactly what is in the eLiquids today and major producers have batch testing results showing all compounds measured.  The FDA may not know but anyone else can easily find out.
Many contain diacetyl…especially common in candy-flavored varieties that appeal to youth Diacetyl comes from a buttery flavoring common in our foods, from microwave popcorn to butterscotch candy.  The vaping industry is the ONLY industry to voluntarily self-regulate their products in an effort to remove any diacetyl.  Buttery flavor found in microwave popcorn led to the discovery of its danger yet no other food items have stopped using the buttery flavoring except, for the most part, the vaping industry.  It is still used widely in the food industry.
Plaintiffs contend that e-cigarettes should not be regulated at all. Even in their own introduction they defy this statement by stating the industry supports age restriction.  But that is only one aspect the industry supports.  Self-regulating improved lab certifications, manufacturing standards, age restrictions, product safety, improved consumer education, and more has occurred without the government.  The vaping community has long stood in favor of age restriction, quality manufacturing standards for eLiquids and devices, and safety for users.  The great advances made in the past decade are consumer and industry driven, not government driven yet they cannot help but carry on a long used myth by anti-vaping advocates.

 

The links above are simply a very small portion of the vast, growing scientific data proving vaping is a much safer, improved method for those using nicotine.  The millions finally able to quit smoking and their returning health stands as a strong witness outside the labs that vaping is better and does help many quit.  Even if there are long term challenges science is showing it will not exceed 5% of the known health problems, including death, cigarette smoking causes.  Why is the FDA and other government entities across the country coming down so hard on a product that finally is helping smoking rates plummet while people regain their health?  Some say follow the money while others simply believe it is further proof our bureaucracies are out-of-control and far from being experts in areas they were hired to be.

Strangely, vaping products do not contain tobacco but the FDA insists they’re a tobacco product.  The FDA goes as far, in their deeming rules, to classify the circuit boards, software, tips, and batteries used in vaping products to be a tobacco product under their control.  But federal courts and citizens in the United States need not bother sifting through the facts because, after all, congress made the FDA the experts.

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  • EJLEE072006

    they key word here is
    FEAR
    FALSE EVIDENCE APPEARING REAL
    FDA
    FALSE
    DATE
    ASSHOLES😂

  • loony2nz

    There are 3 superpowers at hand that are puppeteering the FDA. 1) Big Tobacco 2) Big Pharma 3) Individual states.

    States need the money promised by the MSA to keep their pockets lined. They need to keep people smoking.

    Big Tobacco needs to keep sales high to fulfill their obligation to the states from the MSA.

    Big Pharma is here to help rescue you from yourself by providing drugs to make you better from smoking.

    It’s a huge game they’re playing, and the end result is the public loses and they win.

    “Fight the Power” – Public Enemy

  • marcedward

    People used to tell me how the government lied to us all the time, I didn’t believe them.
    Boy was I wrong!

    • Wrong yes, but understandably. We have ‘representatives’ that are supposed to…well…represent us. Trusting our government is something we should be able to do but as we all now know very clearly, we cannot. That has me more sad than mad.

  • Red Saul

    Don’t forget about state governments loosing money. Does anyone thing that $14 pack of cigarettes close the vendor $14??

  • philnolan3d

    It’s funny that they’re putting the same regs on vaping with 0% nicotine.

    • Due to them classifying the devices as tobacco products and the 0% nicotine is going in a device…yep, these are the experts congress granted authority to.

    • Rich Valone

      don’t buy your batteries from a vase shop, and order your own pg/vg online, and buy flavorings online, any flavoring suspended in propylene glycol will work, also used to make candy, so once u have your device, u can avoid all the taxes, if you buy a 4oz bottle of nicotine, it will last year’s, keep in fridge razor, fyi

  • Michael O’Neil

    Big Pharma is losing their shirts. They are the real enemy here. Without smokers the industry goes under. No more drugs designed to keep you hooked, no more lawsuit money for states, no more research dollars from that money. There’s no money in a cure. Cancer is a cash cow. The government doesn’t want smoking stopped. They just want their cut of the death benefit.

    • Juliery

      Not just that, the entire healthcare industry. Manufacturers of everything from diagnostic machinery to devices used due treatment, countless supplies used in large quantities from syringes to IV tubing all the way diem to millions of bandages and cotton swabs. Think about the amount of lost revenue if millions of people suddenly aren’t using all these products. Then the orgs that thrive as a direct result of smoking induced illness and disease. The orgs may be non profit but they still employ many thousands of people. What happens over time if those illnesses/diseases declined by millions? Then don’t forget the overall cost to society of millions of people living years and decades longer but still aging. Our entire societal system is set up based on a fairly predictable birth vs death rate and average life expectancy…. What is the cost when you suddenly upset that? On the surface it sounds great to say millions of lives will be saved, millions of lives substantially lengthened…..but there’s a huge cost to that. There’s a lot more to this, and many more entities against it, than I think most people consider.