If it Takes an Average of 1 Minutes to read a Comment, then it would take about 165 Hours to Read 9,891 comments.
So a 10 Person Team could read all the Comments in about 2 1/2 working days.
FDA CASAA Blog - copy of letter to OMB/OIRA re PRA & FDA Reg Proposal
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If it Takes an Average of 1 Minutes to read a Comment, then it would take about 165 Hours to Read 9,891 comments.
So a 10 Person Team could read all the Comments in about 2 1/2 working days.
Remember that they only post those comments that are scientifically or legally relevant in their estimation.
So any comment which is basically a rant is not going to get posted.
We learned this from our last foray with commenting on FDA governance.
Around 5,000 comments and less that 50 posted.
This is why people should be waiting for guidance from CASAA to make their voices heard properly.
But hey, a few thousand rants sends it's own message too.
So any comment which is basically a rant is not going to get posted.
We learned this from our last foray with commenting on FDA governance.
Around 5,000 comments and less that 50 posted.
This is why people should be waiting for guidance from CASAA to make their voices heard properly.
But hey, a few thousand rants sends it's own message too.
Remember that they only post those comments that are scientifically or legally relevant in their estimation.
So any comment which is basically a rant is not going to get posted.
We learned this from our last foray with commenting on FDA governance.
Around 5,000 comments and less that 50 posted.
This is why people should be waiting for guidance from CASAA to make their voices heard properly.
But hey, a few thousand rants sends it's own message too.
Since we can send multiple comments I'm tempted to send at least one full on why do you want to increase my chances of dying early from smoking rant just for the slight guilt trip it might put someone on. They do have to read them all.
I consider that tame.Since we can send multiple comments I'm tempted to send at least one full on why do you want to increase my chances of dying early from smoking rant just for the slight guilt trip it might put someone on. They do have to read them all.
I'll go ahead and call them murderers if I go on a rant.
And it's a rant I've used many times over the years to a number of politicians.
I believe in attacking from all angles.
I've said it before, I don't think "They" have a clue how many of us have moved to activists who write emails, letters and make phone calls from one of those who don't pay attention. I personally have sent a few emails on other things that would affect me and my business that I would not have done before being on here and learning how to do it.
They kicked a bigger hornets nest than they thought we were and now they're finding out what it is to live with it.
I really, truly hope so, and that every last one of them loses their job. Time to get some people working in DC that truly answer to the citizens, NOT the corporations.
And as for lying to congress, I truly hope Zeller loses more than his job.
Andria
They are not dumb people. I'm pretty sure they are well aware of how much conversation there is and where it is (as in an OPEN forum). This is not happening in a vaccum. There are some strong squeeky forces opposing vaping also - tobacco free kids, lung assoc, etc and anyone who knows those folks have gotten an earful since 2009. Our foes have a lot of practice making their arguements against vaping (mainly by calling it smoking) and from their previous campaigns against smoking. They are well funded too, just due to their years of experience with this.
I don't mean to be a downer, but I think it's important to remember the context. So far we've done an amazing job but it's NEVER enough, not by the size of our competition. This is the first time many of us in ECF have spoken up to make our voices be heard.
I think the FDA is counting on anything being smoking related to be politically unpopular which is why most of their comments go unquestioned by the public and media. Our best defense is to get as many people as possible involved.
I don't mean to be a downer, but I think it's important to remember the context. So far we've done an amazing job but it's NEVER enough, not by the size of our competition. This is the first time many of us in ECF have spoken up to make our voices be heard.
I think the FDA is counting on anything being smoking related to be politically unpopular which is why most of their comments go unquestioned by the public and media. Our best defense is to get as many people as possible involved.
I consider that tame.
I'll go ahead and call them murderers if I go on a rant.
And it's a rant I've used many times over the years to a number of politicians.
I believe in attacking from all angles.
I was serious when I mentioned taking them to court for the same reasons tobacco companies were taken to court that created the Master Settlement Act. Misleading and fraudulant information that lead to needless illness and death for millions. When they post on their FB page that "PG is in anti-freeze" just a couple of weeks ago, I don't know how else to explain that as anything else.
Only this time, people get paid because it appears states are willing to be used as tools too.
Remember that they only post those comments that are scientifically or legally relevant in their estimation.
So any comment which is basically a rant is not going to get posted.
We learned this from our last foray with commenting on FDA governance.
Around 5,000 comments and less that 50 posted.
This is why people should be waiting for guidance from CASAA to make their voices heard properly.
But hey, a few thousand rants sends it's own message too.
My understanding is they don't post all the comments but do read/review all the ones that are posted.
From the thread I created about comments already submitted, I can assure you rants get posted. I saw one comment that all it said was "no." That was the entire comment. And I've seen enough that were strictly rants with nothing resembling 'reasons.'
I would recommend that if you are looking to rant or say not submit your best argument at this time, just submit it as anonymous. Many comments that I've reviewed are anonymous.
It's hard to counter that when even VAPERS call it smoking -- I can't tell you the number of posts I've seen here where someone says "oh I'm smoking this awesome juice..." etc...
Andria
I'm curious. Did you see many comments against vaping or requesting more regulations (like banning flavors)? I know there's been press, emails sent out by ANTZ to have people write in against the extension and requesting MORE restrictions but when I looked through the comments briefly once, I didn't see any of them. No comments from official groups either. Just us (pro-vaping). Did I miss them or are they being sent/posted elsewhere?
I tend to think it's a good idea to stay informed about what they are saying and taylor comments accordingly. Ugly job though.
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I have only seen one pro-regulation comment. It's from Webster County Family Resource. Interesting that their attachment was also posted under the supporting documents section of the website, and no one else's attachments, like studies submitted by our crowd have been.
I think they are waiting until the last few days of the comment period to send theirs in, that way we won't have a way to answer/submit comments about what they have to say as they won't be posted until after the comment period is over. They have had 30+ years to organize, we're the new kids on the block.
Definitely not many. I would say of the 300 or so comments I've reviewed, maybe 10 at most were pro regulations, and of those, I honestly can't think of any that contained sound reasoning. They were all written like, "I favor this and that." But didn't say why.
My quick breakdown, off the top of my head, would be something like this:
- 80% of comments are from pro-vapers (with around 3/4ths of those being personal story type comments)
- 12% of comments are pro-cigar people
- 6% of comments are ANTZ
- 2% of comments are hard to put into a category (like the "no" comment I mentioned earlier).
(please take these percentages with a grain of salt as I am just estimating off top of my head)
- Apr 2, 2009
- 5,171
- 13,288
- 68
Comments to OMB/OIRA on Paperwork Reduction Act of 1995 aspects of FDA proposed Tobacco Regulation are due TODAY before midnight.
Smokefree Pennsylvania submitted the following comment to OMB (and to FDA's deeming reg docket). Feel free to copy or paraphrase from our comments. But please note there are too many characters in this comment to post on FDA's docket (but not to send to OMB's e-mail address), so I submitted a Word file to FDA's docket.
To: oira_submission@omb.eop.gov
Subject: Docket No. FDA-2014-N-0189, RIN 0910-AG38, FDA proposed Tobacco Deeming Regulation
Food and Drug Administration
[Docket No. FDA- 2014-N-0189]
RIN 0910-AG38
Title: “The Food and Drug Administration Deems Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements.”
These comments are submitted on behalf of Smokefree Pennsylvania regarding some of the Paperwork Reduction Act of 1995 aspects of the FDA’s proposed Tobacco Deeming Regulation.
Per the FDA’s estimate (see Table 9) that 25 Applications for Premarket Review of New Tobacco Products would be submitted annually to the agency for electronic cigarette (e-cig) products, the agency agrees with our previous estimate that the proposed Deeming Regulation would ban >99% of the ten thousand plus electronic cigarette (e-cig) products currently on the market.
Even worse, since just four Applications for Premarket Review of New Tobacco Products have been submitted in the past three years, and since the FDA refused to accept any of those four applications, the agency is unlikely to approve (or even accept) most of the Applications for Premarket Review of New Tobacco Products that would be submitted for e-cig products under the proposed Deeming Regulation.
By banning >99% of e-cig products, FDA’s proposed Deeming Regulation would effectively ban 99% of the several thousand current e-cig manufacturers from marketing their e-cig products in the U.S. two years following issuance of the Final Rule (per the Tobacco Control Act’s and FDA’s proposed definition of “manufacturer” that includes "any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product" and anyone who "imports a finished tobacco product for sale or distribution in the US").
Even worse for public health, the proposed Deeming Regulation would ban ALL (or virtually ALL) of the rapidly growing e-market segment consisting of ten thousand plus e-liquid products and Premium Vaporizers (AKA mods, tanks, open systems) and other “components” or “parts” of a tobacco product, which have been found to be far more effective for helping smokers quit smoking than the “cigalike” segment of the e-cig market.
And yet, the FDA’s proposal didn’t even propose a definition for “components” or “parts” of tobacco products (but states that they would be regulated as “tobacco products”), nor did FDA’s proposal indicate if a “component” or “part” of an e-cig product would/could be considered to be a “finished tobacco product”, or if the agency has any intention of approving (or even accepting) any Application for Premarket Review of a New Tobacco Product for a “component” or “part” of a tobacco product (e.g. by claiming that it is not a “finished tobacco product”).
Further, the FDA estimate (in Table 9) that it would cost an applicant just 5,000 hours to prepare a successful Application for Premarket Review of a New Tobacco Product is far below the actual cost of doing so.
The FDA’s proposed Deeming Regulation even states (on page 179 of the printed version) “We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.“
Thus, it would almost certainly cost each successful applicant >50,000 hours at >$50/hour for a cost exceeding $2.5 million for each Application for Premarket Review of a New Tobacco Product.
Since there were only several different first generation “cigalike” products on the market prior to February 15, 2007, and since those products were inferior to all cigalike products currently on the market, there is very little chance that any Substantial Equivalence (SE) applications/reports or Requests for Exemption for Substantial Equivalence would be submitted to FDA under the Deeming Regulation. The FDA’s proposed Deeming Regulation even acknowledges that very few, if any, SE reports would be submitted to the agency.
By banning >99% of e-cig products, FDA’s proposed Deeming Regulation also would threaten the lives of most of the several million vapers and tens of millions of smokers, while creating a huge black market for e-cig products that would dwarf the black market FDA created for e-cigs in 2009 (when it unlawfully banned the products by claiming they were being regulated as drug devices).
The FDA Deeming Regulation would be premeditated public health malpractice (and a disaster for 99% of e-cig manufacturers) that would dwarf the US Public Health Service’s infamous Tuskegee syphilis study decades ago.
By banning >99% of e-cig products, FDA’s proposed Deeming Regulation would not only protect lethal cigarettes from market competition by thousands of existing e-cig companies, but also would give the entire e-cig industry to several Big Tobacco companies and perhaps several large cigalike companies (that can afford the huge costs it would take to submit a successful Application for Premarket Review of New Tobacco Products). Thus, the proposed Deeming Regulation is “crony capitalism” because it would benefit several large corporations at the expense all other competitors.
I presented nearly all of the this information in person at a meeting with OMB/OIRA staff on behalf of Smokefree Pennsylvania on December 19, 2013 when urging the OMB to reject FDA’s proposed Deeming Regulation. I also presented most of this information to the FDA officials and staff at various meetings during the past three years.
In sum, please reject the proposed FDA Deeming Regulation because it would ban >99% of e-cigs now on the market, would give the entire and rapidly growing e-cig industry to just several Big Tobacco companies (and perhaps several large cigalike companies), would threaten the lives of millions of vapers and tens of millions of smokers, and would create a much larger (and potentially hazardous) black market for e-cigs than FDA created in 2009.
Smokefree Pennsylvania is a nonprofit organization founded in 1990 by William Godshall, who has since served as its executive director. Smokefree Pennsylvania has advocated local, state and federal policies to ban smoking in workplaces, stop cigarette marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable for smokers. In 2009 Smokefree Pennsylvania urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of NJOY’s lawsuit against FDA’s unlawful e-cigarette import ban.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.
Sincerely,
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
BillGodshall@verizon.net
Smokefree Pennsylvania submitted the following comment to OMB (and to FDA's deeming reg docket). Feel free to copy or paraphrase from our comments. But please note there are too many characters in this comment to post on FDA's docket (but not to send to OMB's e-mail address), so I submitted a Word file to FDA's docket.
To: oira_submission@omb.eop.gov
Subject: Docket No. FDA-2014-N-0189, RIN 0910-AG38, FDA proposed Tobacco Deeming Regulation
Food and Drug Administration
[Docket No. FDA- 2014-N-0189]
RIN 0910-AG38
Title: “The Food and Drug Administration Deems Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements.”
These comments are submitted on behalf of Smokefree Pennsylvania regarding some of the Paperwork Reduction Act of 1995 aspects of the FDA’s proposed Tobacco Deeming Regulation.
Per the FDA’s estimate (see Table 9) that 25 Applications for Premarket Review of New Tobacco Products would be submitted annually to the agency for electronic cigarette (e-cig) products, the agency agrees with our previous estimate that the proposed Deeming Regulation would ban >99% of the ten thousand plus electronic cigarette (e-cig) products currently on the market.
Even worse, since just four Applications for Premarket Review of New Tobacco Products have been submitted in the past three years, and since the FDA refused to accept any of those four applications, the agency is unlikely to approve (or even accept) most of the Applications for Premarket Review of New Tobacco Products that would be submitted for e-cig products under the proposed Deeming Regulation.
By banning >99% of e-cig products, FDA’s proposed Deeming Regulation would effectively ban 99% of the several thousand current e-cig manufacturers from marketing their e-cig products in the U.S. two years following issuance of the Final Rule (per the Tobacco Control Act’s and FDA’s proposed definition of “manufacturer” that includes "any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product" and anyone who "imports a finished tobacco product for sale or distribution in the US").
Even worse for public health, the proposed Deeming Regulation would ban ALL (or virtually ALL) of the rapidly growing e-market segment consisting of ten thousand plus e-liquid products and Premium Vaporizers (AKA mods, tanks, open systems) and other “components” or “parts” of a tobacco product, which have been found to be far more effective for helping smokers quit smoking than the “cigalike” segment of the e-cig market.
And yet, the FDA’s proposal didn’t even propose a definition for “components” or “parts” of tobacco products (but states that they would be regulated as “tobacco products”), nor did FDA’s proposal indicate if a “component” or “part” of an e-cig product would/could be considered to be a “finished tobacco product”, or if the agency has any intention of approving (or even accepting) any Application for Premarket Review of a New Tobacco Product for a “component” or “part” of a tobacco product (e.g. by claiming that it is not a “finished tobacco product”).
Further, the FDA estimate (in Table 9) that it would cost an applicant just 5,000 hours to prepare a successful Application for Premarket Review of a New Tobacco Product is far below the actual cost of doing so.
The FDA’s proposed Deeming Regulation even states (on page 179 of the printed version) “We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.“
Thus, it would almost certainly cost each successful applicant >50,000 hours at >$50/hour for a cost exceeding $2.5 million for each Application for Premarket Review of a New Tobacco Product.
Since there were only several different first generation “cigalike” products on the market prior to February 15, 2007, and since those products were inferior to all cigalike products currently on the market, there is very little chance that any Substantial Equivalence (SE) applications/reports or Requests for Exemption for Substantial Equivalence would be submitted to FDA under the Deeming Regulation. The FDA’s proposed Deeming Regulation even acknowledges that very few, if any, SE reports would be submitted to the agency.
By banning >99% of e-cig products, FDA’s proposed Deeming Regulation also would threaten the lives of most of the several million vapers and tens of millions of smokers, while creating a huge black market for e-cig products that would dwarf the black market FDA created for e-cigs in 2009 (when it unlawfully banned the products by claiming they were being regulated as drug devices).
The FDA Deeming Regulation would be premeditated public health malpractice (and a disaster for 99% of e-cig manufacturers) that would dwarf the US Public Health Service’s infamous Tuskegee syphilis study decades ago.
By banning >99% of e-cig products, FDA’s proposed Deeming Regulation would not only protect lethal cigarettes from market competition by thousands of existing e-cig companies, but also would give the entire e-cig industry to several Big Tobacco companies and perhaps several large cigalike companies (that can afford the huge costs it would take to submit a successful Application for Premarket Review of New Tobacco Products). Thus, the proposed Deeming Regulation is “crony capitalism” because it would benefit several large corporations at the expense all other competitors.
I presented nearly all of the this information in person at a meeting with OMB/OIRA staff on behalf of Smokefree Pennsylvania on December 19, 2013 when urging the OMB to reject FDA’s proposed Deeming Regulation. I also presented most of this information to the FDA officials and staff at various meetings during the past three years.
In sum, please reject the proposed FDA Deeming Regulation because it would ban >99% of e-cigs now on the market, would give the entire and rapidly growing e-cig industry to just several Big Tobacco companies (and perhaps several large cigalike companies), would threaten the lives of millions of vapers and tens of millions of smokers, and would create a much larger (and potentially hazardous) black market for e-cigs than FDA created in 2009.
Smokefree Pennsylvania is a nonprofit organization founded in 1990 by William Godshall, who has since served as its executive director. Smokefree Pennsylvania has advocated local, state and federal policies to ban smoking in workplaces, stop cigarette marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable for smokers. In 2009 Smokefree Pennsylvania urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of NJOY’s lawsuit against FDA’s unlawful e-cigarette import ban.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.
Sincerely,
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
BillGodshall@verizon.net
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Zeller mentioned in the hearings that there were 115 people to handle the 'applications'. Whether they have that many on 'comments', I don't know. ....
Well said, Bill. I especially liked the Tuskegee reference, since it puts the harm that would be done in real terms. I've quit using 'crony capitalism' since nothing that occurs in that relationship bears any resemblance to capitalism. It does resemble another 'ism' though, where the company gets to retain it's name and title but where virtually all control of the actions of the company comes from the government. Something the tobacco companies have lived with rather comfortably for years now. But so did Volkswagen at one time.
At this Point, I am More Concerned with things going to the Right Place.
Than how long it will take them to read them.
Slightly OT:
If you emailed a comment to OMB please read the last paragraph in rolygates post here http://www.e-cigarette-forum.com/forum/advocates-updates-usa/567740-action-alert-omb-oira-today.html , you may need to resend it by 12pm tonight.
If you emailed a comment to OMB please read the last paragraph in rolygates post here http://www.e-cigarette-forum.com/forum/advocates-updates-usa/567740-action-alert-omb-oira-today.html , you may need to resend it by 12pm tonight.
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