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 <DRUGINFO@fda.hhs.gov>
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.
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