FDA Re. Potential Flavor Ban

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zoiDman

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Wow, he has amazing self control, he sat there with a straqight face and said...

...

Personally: I really think Mr. Zeller would like to see his Division of the FDA run with Science being the Driving Force.

But he is a Realist. And knows that NOTHING in Government is done on an Unbiased and Purely Scientific Basis. He also knows that where he might be the Face on the Poster for tobacco and e-Cigarettes, that he does not have Complete control of the Decision Making process.

I have said this before. He may be the One that Many People Demonize with regards to e-Cigarettes. But I think we could have Done a Lot worse in choosing someone to head up the CTP. A Lot Worse.

So I'm trying to look at the Glass as being 1/4 Full. Instead of 3/4 Empty.
 

DC2

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Nobody in government wants to ban anything that can be a cash cow for them. Instead they are drooling like a dog waiting for his treat, trying to figure out how to get the most tax revenue out of ecigarettes. They start all this banning propaganda so that you are ok with paying the tax.
I would argue that they would get the most revenue out of it by making sure people don't switch from real cigarettes to electronic ones.
 

DC2

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What about nicotine that is used as a pesticide?
It is widely believed that nicotine is used as a pesticide, but it is not...

I don't know how current this is, but...
http://www.epa.gov/oppsrrd1/REDs/nicotine_red.pdf

This document presents the Environmental Protection Agency’s (EPA’s or the Agency’s) decision regarding the reregistration eligibility of the registered uses of the active ingredient nicotine. The Agency conducted human health and environmental fate and effects risk assessments for nicotine non-food uses. The registrant of the sole remaining nicotine pesticide product requested the cancellation of its registration on February 25, 2008, to be effective on December 31, 2013, with existing stocks permitted to be sold by dealers and distributors for one additional year. The Agency has accepted this request in concept, and it is subject to notice and public comment. If public comment provides no information that causes the Agency to reconsider, the Agency may accept the cancellation request.

The assessment of risks for the pesticidal use of nicotine is unique in that much of the supporting data is drawn from the open literature, as opposed to studies conducted according to Agency guidelines, and the data that are available are not entirely wellmatched to anticipated routes of exposure and use patterns for the nicotine pesticide. The lack of more relevant data adds considerable uncertainty to the risk assessment and would necessitate that the Agency call-in data from a range of guideline studies. Ultimately, the process the Agency undertook to assess risks and formulate reregistration eligibility decisions was overtaken by the registrant’s request for cancellation. The Agency is finalizing this reregistration eligibility decision as a record of the database and methodologies that were used to assess nicotine and the Agency’s preliminary conclusions about the risks associated with its use.

The sole remaining nicotine registration, for which cancellation has been requested, is a Restricted Use Pesticide used on greenhouse ornamentals, including poinsettias, bedding plants, and chrysanthemums to control whiteflies, aphids, and thrips. Nicotine has been known for its pesticidal properties for centuries, and came into common use in the U.S. about sixty years ago. Production and usage are now quite limited.

Using the limited available data, EPA has assessed the human health risks for the remaining nicotine registration and has concluded that risks for workers both during and after application, and for consumers of plants from treated greenhouses and members of the public who might be exposed to nicotine residues in treated greenhouses, are potentially of concern. Nicotine is not used on any food and feed crops so dietary risks have not been assessed. Because nicotine is used in greenhouses only, drinking water and ecological risks were not assessed for this use pattern, although the Agency did assess the ecological risks associated with another nicotine product used outdoors to repel vertebrate pests of ornamentals which has since been cancelled. The ecological risk assessment and an assessment of episodic ingestion of the nicotine repellant product are posted to the nicotine docket, as are the technical documents supporting the human health risk assessment for the nicotine greenhouse use.
 

zoiDman

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I would argue that they would get the most revenue out of it by making sure people don't switch from real cigarettes to electronic ones.

At DIY Prices in a Free Market, I would agree with you. But in a Limited, Regulated Market, I'm not so Sure.

e-Liquids are going to be Much More Expensive per ml in the Future. Some of it is going to be because e-Liquid OEM have to Compile with FDA Regs and Procedures.

But some of it is going to be Just Because the Sellers can Charge More in a Non-Free Market.
 

DeeLeeKay

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It is widely believed that nicotine is used as a pesticide, but it is not...

I don't know how current this is, but...
http://www.epa.gov/oppsrrd1/REDs/nicotine_red.pdf

Nicotine, a toxic chemical most often associated with cigarettes, has been used as an insecticide since colonial times. One excellent benefit of using nicotine in your garden is that its effectiveness is short lived, but potent. You can kill the critters that damage your plants while saving the ones that protect them. Only a few hours after spraying, you can harvest and eat your vegetables.

Read more: How to Make a Nicotine Insecticide | eHow

How to Make a Nicotine Insecticide | eHow
 

stevegmu

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They have consultants that know that killing the refillable market is in the best interest of everyone involved.

But that will never happen. Maybe when all there really was were cigalikes, PRC juice and cartos, but vaping has gotten too big to go back...
BLU, NJOY, VUSE and the others will all have their own e-juice and re-fillable devices in the future. They get the beginners with cigalikes, who move on to their re-fillables...
 

DC2

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Guesstimate that currently shows up to me as incompetence as I cannot understand why more than 100 hours for a flavor (with nicotine) would be needed. I am open to understanding how that guesstimate was reached. Until I hear that information (in detail), I feel assessment of incompetence and gross exaggeration is warranted.
Because you continue to ignore or discount these words...
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

The FDA said:
This information is needed to understand if
any changes in these characteristics are present and, if they are, whether the
new product raises different questions of public health.

Although sometimes they opt for this wording...

The FDA said:
This information is needed to understand if
any changes in these characteristics are present and, if they are, whether the
new product raises different questions of public health
because initiation may increase and/or cessation may decrease.

These words are the reason that products were denied substantial equivalency based on...
--a change in ventilation
--a change in filter efficiency
--a change in the amount of an ingredient
--an increase in free nicotine
--addition of a new characterizing flavor

You change anything, and you need studies that show how those changes will affect public health...
And that includes what affect they will have on cessation rates or initiation and usage rates...

How many hours do you think THAT takes?
 

DC2

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At DIY Prices in a Free Market, I would agree with you. But in a Limited, Regulated Market, I'm not so Sure.

e-Liquids are going to be Much More Expensive per ml in the Future. Some of it is going to be because e-Liquid OEM have to Compile with FDA Regs and Procedures.

But some of it is going to be Just Because the Sellers can Charge More in a Non-Free Market.
Until I see someone's math that I trust better than my math...
;)
 

zoiDman

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...

--a change in the amount of an ingredient
...
--addition of a new characterizing flavor

These Two are what I saw as a possible Death Sentence to Flavored e-Liquids as we know it.

Because as I read it, my take on it was, I would Have to get Studies/Approval on a Cherry e-Liquid. And then get Studies/Approval on a Cola e-Liquid. But if I wanted to the sell Cherry/Cola e-liquid, using the Same Approved Flavorings, that I would have to do a Study and then get Approval on Cherry/Cola Also.
 

supertrunker

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Im sure i watched the congressional hearing with Zeller and some old doctor whose name i forget - that said that in fact cigarettes had become more deadly as a result of changes made to them over the years. I don't recall any huge studies being done on my cigarettes at the time to prove they were equally as safe as their predecessors.

Which would imply that the regulator is doing a crap job of things they are currently able to regulate.

T
 

DC2

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But that will never happen. Maybe when all there really was were cigalikes, PRC juice and cartos, but vaping has gotten too big to go back...
BLU, NJOY, VUSE and the others will all have their own e-juice and re-fillable devices in the future. They get the beginners with cigalikes, who move on to their re-fillables...
I really hope you're right.

I have seen where some of the Big Vaping people are moving in that direction.
It can be argued that they are just doing it to make as much money as they can before the regulations hit.

On the other hand, seeing people like NJoy coming out with a refillable device could be taken as being VERY encouraging.
 

DC2

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These Two are what I saw as a possible Death Sentence to Flavored e-Liquids as we know it.

Because as I read it, my take on it was, I would Have to get Studies/Approval on a Cherry e-Liquid. And then get Studies/Approval on a Cola e-Liquid. But if I wanted to the sell Cherry/Cola e-liquid, using the Same Approved Flavorings, that I would have to do a Study and then get Approval on Cherry/Cola Also.
Sadly, it's impossible to read it any other way.
 

zoiDman

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Until I see someone's math that I trust better than my math...
;)

I wish I had done a Screen Shot of Blu's website when Lorillard bought Blu.

Because they did a Press Release to Blu Retailers that with Possible FDA Regulations, that Retailers should Expect to see an Increase in the Price of Cartos due to Increased Expenses to be FDA Compliant.

I know that the Actual Dollar Figure to get a Flavored like Cherry/Cola e-Liquid is Debatable. But just so we can use a Number, say it costs 300,000 Bucks.

Over How Long do you think someone like Lorillard/Blu will apply this 300,000 Expense into the Final Cost of their Cherry/Cola Pre-Filled Cartos?

And then Once the One Time Cost of FDA Approval has been Recovered, do you think they will Lower the Unit Cost of Cherry/Cola Pre-Filled Cartos. Or just Keep it where it is?
 

DC2

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JSYK - I'm not putting Likes on your Posts because I Like the Implications of what you are Saying.

I'm liking them because I think you are Looking at this Realistically. Even though it is Painful to do so.
Of course. I don't like the implications of what I'm saying either.
 
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zoiDman

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Kent C

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It is widely believed that nicotine is used as a pesticide, but it is not...
I don't know how current this is, but...
http://www.epa.gov/oppsrrd1/REDs/nicotine_red.pdf

That's because up until Jan. 2014 it was still used. Even Wikipedia is still behind the curve:
"Natural insecticides, such as nicotine, pyrethrum and neem extracts are made by plants as defenses against insects. Nicotine-based insecticides are widely used in the US and Canada, but are barred in the European Union".

And granted, the use of it has declined since the 80's but it was still being used as well as Dee points out as a DIY.

In Africa, using tobacco smoke or spray as an insecticide or just smoking as an individual, may be the difference between reducing your lifespan by 10%, or dying from malaria (since the econazis have prohibited DDT*) or Dengue fever and other insect related diseases.

The doc, while interesting, never actually states anything about the harm involved, only the exposure and the length of dissipation of that exposure. The 'harm' is a given. lol. While it is true that some uses of it as a pesticide involved combustion. The more common use was a spray. Another thing noted in the study - although it wasn't the emphasis, was how they downplayed the 'skin contact' aspect - something that recently has been raised to new heights. :facepalm:


*http://wattsupwiththat.files.wordpress.com/2010/09/malaria_fig1_goklany_2007.png

A few countries have rejected the UN ban on DDT and have reduced deaths from malaria by millions - or to the level it was before the ban.
 
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