Make the FDA squirm regarding nicotine and addictiveness thereof.

[gbalkam]

Copy of email I sent, the response and my reply to that response. Please excuse formatting, it is a direct copy/paste with only my email removed to avoid farming bots.

Prime example of avoiding the question?

-----Original Message-----

From: Gary Balkam [mailto:removed for antispam]

Sent: Sunday, August 07, 2016 6:59 PM

To: CDER DRUG INFO

Subject: CDER Contact Information



CDER Contact Information



Apparently, nicotine is only addictive when it is in the FDAs best (read

financial) interest to be addictive. Deeming that vaping products are

addictive, yet the exact same drug nicotine, in patches and gum (how

much, exactly is Johnson and Johnson (parent co of nicorette) and Pharma

paying you?



Does the FDA expect to maintain public credibility?



Nicotine either IS or IS NOT and I quote "HIGHLY ADDICTIVE" (per fda on

ecigs and vaping). Pick one and stick to it!

Gary Balkam
From: CDER DRUG INFO <[email protected]>
Sent: August 8, 2016 11:15 AM
To: 'Gary Balkam'
Subject: RE: CDER Contact Information

Dear Gary Balkam,


Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER). We appreciate you taking the time to share your concerns on this important matter. Please allow us to provide you with the following information.


Please note that until recently vaping products were not regulated in the U.S. FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products. This means that a stringent regulatory body had not confirmed any data to support these products were safe for public consumption FDA Warns of Health Risks Posed by E-Cigarettes and Less Risky Tobacco Product? Only if the Science Says So.


However, nicotine gum has under gone clinical trials and shown that it is safe and effective when used in accordance with the labeled directions. You can find some of the review for nicotine gum here Drugs@FDA: FDA Approved Drug Products.


However, if you require more information than what is posted on our www.fda.gov website you may want to consider submitting a Freedom of Information (FOI) Act request for this information. FOI allows for request of information that is not publically available. You can find instructions and the information on fees for this request at Freedom of Information. FDA is only allowed to release information in accordance with the applicable laws and regulations.


Best regards,


ZA

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration


For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter: @FDA_Drug_Info (FDA Drug Information (@FDA_Drug_Info) | Twitter).

This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

***************** My Reply**************

That was NOT the question. The question was... how can nicotine be NON addictive in GUM and products under patent by glaxosmithkline (under johnson&johnson-parent company) and yet "highly addictive" at the same time, where other uses are concerned.

Furthermore, the FDA has no more business regulating vaping products than it does in regulating coffee makers. Your regulatory limits need to be on the purity of product, disclosure of ingredients. Provided that the FDA has already deemed nicotine as being non-addictive, and thereby no more harmful that caffeine.

Furthermore.. has the FDA then deemed cigarettes "safe for public consumption"?

So is it really the safety of nicotine and the delivery method that is the determining factor in the addictiveness of nicotine, or is it the amount of money paid to the fda to deem one safe and sit on the other? Members of the FDA have already been caught with hands in the cookie jar..

Former FDA Commissioner Charged in RICO Lawsuit




Former FDA Commissioner Charged in RICO Lawsuit | AHRP
ahrp.org
A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal ...
and you are really asking me to believe your stringent regulatory body had nothing to do with this? These are the questions people are asking,
Members of the FDA are padding their pockets at the cost of LIVES. That is how I see it, and that is how John Q. Public is seeing it. Is the USA going to be last in line, a follower behind other countries? Coming in with brooms to clean up after the others have done all the fighting?



You really better find an answer to these questions, and stick to it. I am not the only one asking. Just one of many that bother to take the time to write.

End Quotes
This is a copy of question, answer, reply back to fda.
Just an example of keeping them honest (or trying to) Let them know how people see them and what kind of scrutiny they are currently under due to past infractions.

 

[gingerbread]

Copy of email I sent, the response and my reply to that response. Please excuse formatting, it is a direct copy/paste with only my email removed to avoid farming bots.

Prime example of avoiding the question?

-----Original Message-----

From: Gary Balkam [mailto:removed for antispam]

Sent: Sunday, August 07, 2016 6:59 PM

To: CDER DRUG INFO

Subject: CDER Contact Information



CDER Contact Information



Apparently, nicotine is only addictive when it is in the FDAs best (read

financial) interest to be addictive. Deeming that vaping products are

addictive, yet the exact same drug nicotine, in patches and gum (how

much, exactly is Johnson and Johnson (parent co of nicorette) and Pharma

paying you?



Does the FDA expect to maintain public credibility?



Nicotine either IS or IS NOT and I quote "HIGHLY ADDICTIVE" (per fda on

ecigs and vaping). Pick one and stick to it!

Gary Balkam
From: CDER DRUG INFO <[email protected]>
Sent: August 8, 2016 11:15 AM
To: 'Gary Balkam'
Subject: RE: CDER Contact Information

Dear Gary Balkam,


Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER). We appreciate you taking the time to share your concerns on this important matter. Please allow us to provide you with the following information.


Please note that until recently vaping products were not regulated in the U.S. FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products. This means that a stringent regulatory body had not confirmed any data to support these products were safe for public consumption FDA Warns of Health Risks Posed by E-Cigarettes and Less Risky Tobacco Product? Only if the Science Says So.


However, nicotine gum has under gone clinical trials and shown that it is safe and effective when used in accordance with the labeled directions. You can find some of the review for nicotine gum here Drugs@FDA: FDA Approved Drug Products.


However, if you require more information than what is posted on our www.fda.gov website you may want to consider submitting a Freedom of Information (FOI) Act request for this information. FOI allows for request of information that is not publically available. You can find instructions and the information on fees for this request at Freedom of Information. FDA is only allowed to release information in accordance with the applicable laws and regulations.


Best regards,


ZA

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration


For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter: @FDA_Drug_Info (FDA Drug Information (@FDA_Drug_Info) | Twitter).

This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

***************** My Reply**************

That was NOT the question. The question was... how can nicotine be NON addictive in GUM and products under patent by glaxosmithkline (under johnson&johnson-parent company) and yet "highly addictive" at the same time, where other uses are concerned.

Furthermore, the FDA has no more business regulating vaping products than it does in regulating coffee makers. Your regulatory limits need to be on the purity of product, disclosure of ingredients. Provided that the FDA has already deemed nicotine as being non-addictive, and thereby no more harmful that caffeine.

Furthermore.. has the FDA then deemed cigarettes "safe for public consumption"?

So is it really the safety of nicotine and the delivery method that is the determining factor in the addictiveness of nicotine, or is it the amount of money paid to the fda to deem one safe and sit on the other? Members of the FDA have already been caught with hands in the cookie jar..

Former FDA Commissioner Charged in RICO Lawsuit




Former FDA Commissioner Charged in RICO Lawsuit | AHRP
ahrp.org
A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal ...
and you are really asking me to believe your stringent regulatory body had nothing to do with this? These are the questions people are asking,
Members of the FDA are padding their pockets at the cost of LIVES. That is how I see it, and that is how John Q. Public is seeing it. Is the USA going to be last in line, a follower behind other countries? Coming in with brooms to clean up after the others have done all the fighting?



You really better find an answer to these questions, and stick to it. I am not the only one asking. Just one of many that bother to take the time to write.

End Quotes
This is a copy of question, answer, reply back to fda.
Just an example of keeping them honest (or trying to) Let them know how people see them and what kind of scrutiny they are currently under due to past infractions.

The same way as you do. I am new here and live in the UK. I am a member on a US vaping forum also and this is the only view one can reasonably conclude regarding the actions and language comming out of the FDA. It is unbelievable and indefensible.

 

[vapinshith0use]

I agree entirely. Fair play mate. But you pissing into the wind. How many hundreds of thousands people signed the menigitus jabs for all childen petition to get to parliment for a discussion. And how many emails amd letters did local mps get on this subject. Not sure but alot im sure. What happened. Nothing. Why? Money.

 

[vapinshith0use]

Also what they are saying doesnt make sense in this way..... tightening regs on a substance as its not been tested, i.e. eliquid. So what about the equipment they looking to ruin?? Thats not nic based. Its hardware. Thats like banning smoking pipes, ashtrays and roll up makers.

 

[nikki from mars]

@gingerbread yep I am afraid the only conclusion we can draw based on the FDA's stance is that they have succumbed to heavy lobbying by both the Tobacco and Pharmaceutical companies to ban a progressive technology that will lose both industries revenue at the expense of human lives... we have some similar issues in the UK and the rest of Europe although thankfully current legislation while heading down the same route is less regressive... just be thankful you are not in Australia or elsewhere where they have taken a completely backwards stance and outright banned things... my understanding of the FDA rules are that new products will require ridiculous certification etc.. but that already marketed products can still be sold... bear in mind that both big Pharma and big Tobacco are developing their own ecig products (although technologically less good /advanced to those already on the market) and that they will have the financial/procedural ability to get through the new licensing measures where smaller companies just couldnt afford to do so and I think we all know what the only reasonable conclusion is to this... shonky less good overpriced products that will also be able to capture return sales as they will be back to a situation like we had with early cigalikes where each product only worked with its own cartos and chargers as they all had different connectors.. whereas most vape gear now has the capacity for customisation as most tanks and mods can be swapped around with others.. ok we still have it with tank coils (except rebuildable types) but the market is generally pretty open... this will lead to less consumer choice and less good options...

 

[eyeball kid]

@gingerbread yep I am afraid the only conclusion we can draw based on the FDA's stance is that they have succumbed to heavy lobbying by both the Tobacco and Pharmaceutical companies to ban a progressive technology that will lose both industries revenue at the expense of human lives... we have some similar issues in the UK and the rest of Europe although thankfully current legislation while heading down the same route is less regressive... just be thankful you are not in Australia or elsewhere where they have taken a completely backwards stance and outright banned things... my understanding of the FDA rules are that new products will require ridiculous certification etc.. but that already marketed products can still be sold... bear in mind that both big Pharma and big Tobacco are developing their own ecig products (although technologically less good /advanced to those already on the market) and that they will have the financial/procedural ability to get through the new licensing measures where smaller companies just couldnt afford to do so and I think we all know what the only reasonable conclusion is to this... shonky less good overpriced products that will also be able to capture return sales as they will be back to a situation like we had with early cigalikes where each product only worked with its own cartos and chargers as they all had different connectors.. whereas most vape gear now has the capacity for customisation as most tanks and mods can be swapped around with others.. ok we still have it with tank coils (except rebuildable types) but the market is generally pretty open... this will lead to less consumer choice and less good options...

The same overall aim of the UK directive. Place a law ready to shut down every vaping product except the patents owned by big pharma and tobacco. Make no mistake the ambiguity of the rules are placed as a strategic trap door when big pharma and tobacco are ready to tell us that vaping is the future. This will happen when they have their own products at the ready. It's only a matter of time and the big pharma tobacco companies will push aggressive takeovers of the top vaping names.

 

[Arctic_Wolf]

If current US proposals actually take place, hardware and liquids produced after 2007 will essentially be banned, so called grandfather laws.

As such, this means the only ecig designs permitted will basically be the small and crappy cigalikes that were available at the time and were patented by and made by guess who?? Big pharma!!

They're trying to at least get the grandfather laws adjusted to 2016, so at least hardware produced up until now can still be produced and sold. Liquids is going to be an absolute minefield .