# FDA response to lawsuits.



## method1 (18/8/16)

http://www.clivebates.com/documents/FDAresponse.pdf

Spoiler: It's not good.

Reactions: Like 1 | Thanks 4


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## Petrus (18/8/16)

Everytime I see FDA......BAN.......MINISTER OF HEALTH...... BIG TOBACCO COMPANIES.... I want to puke. I don't want to read that posts, rather we the vaping community in South Africa try to get something in place, like what to do.

Reactions: Agree 2


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## SAVaper (18/8/16)

At the risk of becoming an outcast I am going to voice my opinion.

Vaping has been the best thing that happened to me in more than 20 years (bar getting married to a wonderful wife and having a fantastic son). I absolutely love vaping and I truly believe that the health benefits are immeasurable in all aspects.

However, I personally welcome as much testing and research as possible to determine any side effects. I was in the pharmaceutical industry for many years and have first hand experience with regard to latent "hidden" side effects of medication after laboratory and other testing.
Thereby I also admit that should any negative side effects be discovered (excluding the known addition to nicotine), I welcome some regulation by the correct authorities and in proper relation / proportion to the established risk. All with the view of making vaping the safe and satisfying utopia that I have experienced so far and believe it will be. A haven from disease causing cigarettes and possibly other drugs.

We all know that the far east will clone anything and always for the best possible profit. This could mean that some ingredients in ejuice may be substandard or even outright harmful. What about the metals used to manufacture atomizers / tank decks etc. The finish of the surfaces etc. Heating of a chromed surface may release some harmful chemical we are not even aware of. Does SS, Ni and Ti release any substances when heated to 400'F? I do not know, but testing will determine this in future and regulation might be required to make sure vaping stays as beneficial as we believe it should be.

Of coarse all of this said, stopping the nicotine addiction is first prize, but I like many others have been unsuccessful with other methods in the past. I am not sure I would be able to quit vaping.

Regulation (and I do not mean filling the pockets of greedy politicians) may not be conducive to growing a small market via small businesses, but it may ultimately mean saving lives.

Forgive me if I am the only vaper that uses vaping firstly for my health and secondly for my enjoyment.

Reactions: Like 2 | Agree 6


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## Petrus (18/8/16)

@SAVaper, I like your post because it is full of facts, but did the FDA done their homework?, or are they speculating. Say for instance Marlboro or Lucky Strike had developed a regulated mod and tank and a variety of juices how would their regulations affect them? In that case I think that then the FDA would have given permission to the supermarket owner to show the customer how to build a decent coil. Why.......because they the FDA would still be the main beneficiary. They the government don't care about the health of the citizens of their country, as long as the cut 'money,bribe' is efficient they will approve, reject ANYTHING.

Reactions: Like 2


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## YeOldeOke (18/8/16)

I agree with @SAVaper to a great extent. Problem I see is that the current regulatory drive threatens to kill the 'white hat' industry in what is still it's infancy really, before sane, properly studied and justified regulation can be developed to the advantage of millions who want to quit smoking. Vaping will not die. It will go 'underground' and a 'black hat' industry will fill the demand, with zero regulation, no accountability and no morals.

We really have to come up with a way forward ourselves. I am not willing to start supporting big tobacco again.

But if push comes to shove and there are only two choices, most won't choose BT, they'll choose the vaping underground.

Reactions: Like 2 | Agree 1


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## RichJB (18/8/16)

There is growing concern among vaping activists in the US that, after donating thousands of dollars to vaping organisations and lawyers, they haven't seen any results. Looking at the document above, that concern seems well founded. I can't really find any flaws in the FDA's defence. But the plaintiff's case does not seem to have been argued very well.

I don't know how the vaping industry can go into a court of law and argue that, because vaping is safer than smoking, there is no need to regulate vaping. As the FDA countered, that is like claiming that because cars are safer than motorbikes, there is no need to regulate cars. It's the sort of argument that is not really going to stretch the FDA's lawyers unduly.

Reactions: Agree 2


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## Jan (18/8/16)

1) Regulation is good.
2) Over regulation is bad.

Reactions: Agree 2


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## SAVaper (18/8/16)

Petrus said:


> @SAVaper, I like your post because it is full of facts, but did the FDA done their homework?, or are they speculating. Say for instance Marlboro or Lucky Strike had developed a regulated mod and tank and a variety of juices how would their regulations affect them? In that case I think that then the FDA would have given permission to the supermarket owner to show the customer how to build a decent coil. Why.......because they the FDA would still be the main beneficiary. They the government don't care about the health of the citizens of their country, as long as the cut 'money,bribe' is efficient they will approve, reject ANYTHING.



I know you are right, but call me an eternal optimist or just plain blind, I would like to believe there are research facilities doing objective research for the public benefit.

Reactions: Agree 1


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## SAVaper (18/8/16)

YeOldeOke said:


> I agree with @SAVaper to a great extent. Problem I see is that the current regulatory drive threatens to kill the 'white hat' industry in what is still it's infancy really, before sane, properly studied and justified regulation can be developed to the advantage of millions who want to quit smoking. Vaping will not die. It will go 'underground' and a 'black hat' industry will fill the demand, with zero regulation, no accountability and no morals.
> 
> We really have to come up with a way forward ourselves. I am not willing to start supporting big tobacco again.
> 
> But if push comes to shove and there are only two choices, most won't choose BT, they'll choose the vaping underground.



Thanks, and you are off coarse right that vaping will go underground. That is why I specifically said "I welcome some regulation by the correct authorities and in proper relation / proportion to the established risk"

Over regulating will do a lot of damage.


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## Jan (18/8/16)

I'm gonna make myself very unpopular but I would like to see some serious regulations on hardware especially mech mods. Before you get your pitch forks ready just think how many dripbox mods with an auto fire problem or some dude with a triple battery mech mod with a 0,0001 ohm coil (Because he know what he is doing) are in planes right know.

I got quite a chill when I saw an air crash investigation episode about a cargo plane that was brought down by non other than incorrectly packaged 18650's


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## RichJB (18/8/16)

As the FDA explain in the document, they can't really do anything differently. The Tobacco Control Act, which lays out and governs what they can and must do, stipulates that all tobacco products must undergo full testing for premarket approval. So it is not within their discretion to simply give vaping gear a pass on the grounds that it's "safer than smoking". They would be ignoring the prescripts that guide them, which would be grounds for the FDA Board to be dismissed. If the US wants to bypass the onerous premarket application rigmarole, Congress would need to amend the Act accordingly. So it goes a lot deeper than just the FDA trying to be difficult.

@Jan, I agree with this. If we had proper regulation, we wouldn't need Mooch to warn us that Chinese companies were rewrapping 10A cells and marketing them as 35A or 40A cells. I'd also like to see full ingredient listings on juice, and ISO "clean facility" standards applied to all juice manufacturers. Along with an international standard which does not allow hybrid top caps to be paired with a tank which doesn't have a protruding positive pin. Regulation can solve all of these issues. As the FDA points out, regulation increases the public health benefits, it doesn't reduce them.

Of course, a de facto ban on vaping equipment due to prohibitively expensive premarket application processes doesn't further that goal. But if the FDA is legally bound to follow that route, it's a problem for Congress to tackle, not the FDA. The FDA also claims that is an exaggeration, and projects that many hundreds of devices, and a couple of thousand juices, will get premarket approval. I don't know, we'll have to see how accurate their projection is.

Reactions: Like 2 | Agree 1


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