FDA CASAA's Basic Background for Understanding FDA Regulation of E-Cigarettes

[AgentAnia]

FYI. Just posted on the CASAA blog: CASAA: CASAA's Basic Background for Understanding FDA Regulation of E-Cigarettes

 

[JimSF]

I was going to comment with a response directly on the blog, but it requires Google login or other such login. As an aside, CASAA really should move blog to Wordpress and install modern commenting system like Disqus for better usability and SEO, but that is another discussion.

I agree with much of the content, but my comments here are just trying to help improve the message.

1. It would be quite useful to include links in the blog post to the proposed deeming regulations, the Sottera case, the TCA, etc. when they are first mentioned as makes it much more useful for the reader to track down these topics in detail.

2. Do further proofreading as found some typos:
"It suggested that FDA the option of asserting authority over them as tobacco products." should read as " It suggested that the FDA had the option of asserting authority over them as tobacco products." "CASAA and a few other advocates represent consumers." does not make sense to me in the context used.

3. Besides being hard to understand this sentence "There is no serious doubt that, under the Family Smoking Prevention and Tobacco Control Act (TCA), FDA has the authority to exert such authority." may in fact not be true. I've had a few lawyers review the TCA legislation and some feel that the referenced definition may not in fact cover nicotine in its refined form as it was likely not the legislators intent to do so. In any case, until this is actually decided in a court I see no benefit to actually declaring it to be so even though the judges in the Soterra case stated that the FDA may take this approach.

4. Using so many parenthetical remarks makes the post harder to read.

5. I disagree that online petitions are not useful. Yes, if this is all one does it would be problem. However, petitions, even poorly worded or slightly misguided ones, do shine the light on the subject for some of those politicos that may not follow this issue. This is a going to be a long, drawn out battle so all publicity is good in my opinion.

6. Is there a concerted CASAA effort to attract new members besides just asking folks on ECF to join or on their site?

With all this said, I just want to make it clear that it is with the upmost respect and thanks for all the hard work that the volunteers at CASAA do for this community that I submit these comments.

 

[Roger_Lafayette]

Jim, while I don't speak for CASAA, ECF, or anyone besides myself, I'd like to thank you for your comments! It's always a pleasure to have a never-vaper/never-smoker on this forum, particularly one who has carefully reviewed the evidence regading vaping, and changed their minds in favor of the technology.

I believe in one of your other posts, you said that it could be a tremendous boon to public health, a position which has been taken by a number of well-respected clinicians and scientists.

You also mentioned your personal story, which is a powerful and especially touching one. Millions around the world have lost those close to them as a result of tobacco cigarette smoking. One can only hope that more people like you can keep open minds, and eventually come to the same conclusions that you have.

Please allow me to welcome you warmly to the forum!

I would like to address your point about the "doubts" you suggest may exist concerning the FDA's authority under FSPTCA. First of all, although it wasn't a critical part of the Soterra decision, a three-judge panel in the DC Cicruit unanimously agreed that Congress' use of the language "derived from" clearly indicated an intent to include products that are ... well, how should I put this ... derived from tobacco Recently, the FDA's former Chief Counsel (who now advises clients who are regulated by the FDA) said just at the Smoke-Free Alternatives Trade ...'n conference in Chicago. I have yet to read or hear of any analysis from a legal expert who takes the position you mentioned (this is the first time for me). But then I don't claim to be the best-informed person in the world on the question.

It's sometimes said that where there are three attorneys, there are four opinions. If those to whom you have spoken have referenced nicotine derived from other sources, they're correct. CASAA's statement refers to e-cigarettes as they presently are, which perhaps is fair enough. (We often discuss other possible sources of nicotine on this forum, as a quick site-specific Google search of "synthetic nicotine" will reveal.) In case it helps, here's what the three-judge panel of the DC Circuilt said about the FDA's authority over "tobacco products" in Soterra (which is - as attorneys would say - dictum - since it was not essential to the holding): http://www.cadc.uscourts.gov/internet/opinions.nsf/D02F9D2CA50299F0852577F20070BCC2/$file/10-5032-1281606.pdf So until there's some published reference casting doubt on this interpretation of the phrase "derived from" in the FSPTCA, I think CASAA's on pretty solid ground.

Incidently, I'm not sure if the "Basic Background" document here is in final form, so I think your comments are particularly helpful for that reason. CASAA has already issued a formal press release: CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA

With regards to your question about recruiting, you may be interested to know that CASAA basically runs on a shoestring, with no paid staff. This is in part a result of their desire to represent consumers, instead of industry. (As a CEO and experienced entrepreneur, I'm sure you feel strongly about ROI.) CASAA's reputation for integrity and independence is a big reason why they're supported by so many people involved with the vaping movement on social media, important web sites such as VP Live, and YouTube (which plays a huge role in educating vapers about the rewards as well as the risks of this complex technology). These and other "electronic communities" form the core of the vaping movement - and I use the word movement intentionally. While it's true that there are vapers out there who may only have a strong connection to their local B&M, normally the owners of that store are dedicated vapers who are aware of CASAA. Typically these owners are former smokers, who feel that vaping has saved their lives. They take their "mission" as seriously as their business, because the two are of course inextricably intertwined. To say that this is a "grass roots" rather than a "grass tops" effort is an understated understatement.

Do we have a problem with the media? Absolutely. I could analyze this in more detail, but there are complex reasons why major US government organizations such as the FDA, the NIH, the CDC, Tobacco Control Research Institutes, the American Medical Association and others have taken a strong stand against vaping, and advised the meda that the only effective public health approach is to regard vaping as indistinguishable from tobacco cigarette smoking for every purpose. (Including, but not limited to, the animosity that the public feels towards tobacco cigarette smokers as well as the "big tobacco" companies.)

Very few researchers who have chosen to oppose this position exist in the US, despite the stances of credible researchers abroad. As one example, the UK's leading antismoking group, Action against Smoking and Health, recently conceded that vaping is not a "gateway" to tobacco smoking. While the evidence for this proposition is overwhelming, the almost-unanimous view among authoritative American organizations remains streadfast in its embrace of this discredited proposition. As another example, to this day you will still see major national news outlets repeating the results of a 2009 FDA "study" which is no longer embraced by the FDA itself. US MDs refuse to acknowledge vaping as a legitimate cessation tool, largely because it involves the use of an unapproved drug (nicotine). "Junk" scientific studies are churned out regularly by Tobacco Control Research Institutes, and cited by the media as unvarnished and unquestionable gospel. Perhaps you also were once influenced by this disinformation at some earlier point, as some of your other posts seem to imply. On the other side, cessation evidence from other countries, the plumetting rates of tobacco cigarette sales and minor use of all tobacco products get little attention.

Despite our problems with the US media, so far CASAA's existing strategy has worked well on behalf of vapers' efforts to oppose crippling state legislation. (In fairness, we have lost some high-profile struggles in major cities, which tend to pass ordinances with less deliberation than state legislatures.) This year, we haevn't yet lost any major state battles, although perhaps that will change as things move forward. Still, the record thus far speaks to the effectiveness of CASAA and ECF as an organizing platform, in particular because there are many states that might appear to be tough for vapers which have failed to pass proposed restrictions on vaping, such as OR, WA, MD, UT, as well as numerous others. CASAA's effectiveness at organizing vapers could be better understood by comparing the topics on the legislative forum here on ECF to the state legislatures' session schedules: 2014 Legislative Session Calendar

I've droned on long enough, but since we're talking about organizing efforts and legislation, I'd be remiss if I didn't thank you for your efforts in the struggle regarding CA's AB 1500. This is probably one of the most critical battles that vapers are fighting this year at the state level.

In any event, I hope this post has been helpful to you, in terms of getting some background and context about ECF, CASAA (which grew organically out of ECF), and the vaping movement, which is highly influenced by both ECF and CASAA. If I may brag, I'd say that you've come to something akin to the organizational "nerve center" of three million American vapers. Many may be unaware of the issues we discuss here on ECF every day, and none of them may be keeping track of how many tobacco cigarettes that they have avoided smoking (which is why many ECF denizens reference this in their signatures). Yet you can be sure that the hard work done by CASAA has made a difference in the lives of these US vapers.

We need to do everything we can to keep our "cause" alive, until the health statistics and cessation rates become too difficult to deny for the US media and the American Tobacco Control Government-Industrial Complex. Which is why we need all the help we can get, including yours!

Cheers and welcome again,

--Roger

I was going to comment with a response directly on the blog, but it requires Google login or other such login. As an aside, CASAA really should move blog to Wordpress and install modern commenting system like Disqus for better usability and SEO, but that is another discussion.

I agree with much of the content, but my comments here are just trying to help improve the message.

1. It would be quite useful to include links in the blog post to the proposed deeming regulations, the Sottera case, the TCA, etc. when they are first mentioned as makes it much more useful for the reader to track down these topics in detail.

2. Do further proofreading as found some typos:
"It suggested that FDA the option of asserting authority over them as tobacco products." should read as " It suggested that the FDA had the option of asserting authority over them as tobacco products." "CASAA and a few other advocates represent consumers." does not make sense to me in the context used.

3. Besides being hard to understand this sentence "There is no serious doubt that, under the Family Smoking Prevention and Tobacco Control Act (TCA), FDA has the authority to exert such authority." may in fact not be true. I've had a few lawyers review the TCA legislation and some feel that the referenced definition may not in fact cover nicotine in its refined form as it was likely not the legislators intent to do so. In any case, until this is actually decided in a court I see no benefit to actually declaring it to be so even though the judges in the Soterra case stated that the FDA may take this approach.

4. Using so many parenthetical remarks makes the post harder to read.

5. I disagree that online petitions are not useful. Yes, if this is all one does it would be problem. However, petitions, even poorly worded or slightly misguided ones, do shine the light on the subject for some of those politicos that may not follow this issue. This is a going to be a long, drawn out battle so all publicity is good in my opinion.

6. Is there a concerted CASAA effort to attract new members besides just asking folks on ECF to join or on their site?

With all this said, I just want to make it clear that it is with the upmost respect and thanks for all the hard work that the volunteers at CASAA do for this community that I submit these comments.

 

[Roger_Lafayette]

Suit Up: FDA Proposed Deeming Regulations - YouTube is a good example of what's going out on Youtube. She keeps on track as far as accuracy goes, even if she rambles a bit.

We live in a social media-driven world, and one in which video messages are far more effective than anything delivered via the written word.

This is why campaigns are increasingly speaking to their supporters via video, whether the focus is on issues or on political candidates.

It's folks like her, Phil Busardo, Grimm Green, Rip Tripper and so forth who are going to be getting the word out from VP Live about what the vaper-on-the-street should be doing to help the cause.

They are the "town criers" of today's digital age. Messaging strategies built around them are more likely to be effective.

 

[DC2]

We live in a social media-driven world, and one in which video messages are far more effective than anything delivered via the written word.

That's really depressing, because watching a video is my very last resort for getting information.
It takes way too long to watch a video, and it's not possible to skim through it.

 

[tombaker]

I was going to comment with a response directly on the blog, but it requires Google login or other such login. As an aside, CASAA really should move blog to Wordpress and install modern commenting system like Disqus for better usability and SEO, but that is another discussion.

I agree with much of the content, but my comments here are just trying to help improve the message.

1. It would be quite useful to include links in the blog post to the proposed deeming regulations, the Sottera case, the TCA, etc. when they are first mentioned as makes it much more useful for the reader to track down these topics in detail.

2. Do further proofreading as found some typos:
"It suggested that FDA the option of asserting authority over them as tobacco products." should read as " It suggested that the FDA had the option of asserting authority over them as tobacco products." "CASAA and a few other advocates represent consumers." does not make sense to me in the context used.

3. Besides being hard to understand this sentence "There is no serious doubt that, under the Family Smoking Prevention and Tobacco Control Act (TCA), FDA has the authority to exert such authority." may in fact not be true. I've had a few lawyers review the TCA legislation and some feel that the referenced definition may not in fact cover nicotine in its refined form as it was likely not the legislators intent to do so. In any case, until this is actually decided in a court I see no benefit to actually declaring it to be so even though the judges in the Soterra case stated that the FDA may take this approach.

4. Using so many parenthetical remarks makes the post harder to read.

5. I disagree that online petitions are not useful. Yes, if this is all one does it would be problem. However, petitions, even poorly worded or slightly misguided ones, do shine the light on the subject for some of those politicos that may not follow this issue. This is a going to be a long, drawn out battle so all publicity is good in my opinion.

6. Is there a concerted CASAA effort to attract new members besides just asking folks on ECF to join or on their site?

With all this said, I just want to make it clear that it is with the upmost respect and thanks for all the hard work that the volunteers at CASAA do for this community that I submit these comments.

Great post. Improvement is good.
Your catches reminds me of this old one

Aoccdrnig to rscheearch at Cmabrigde Uinervtisy, it deosn’t mttaer in waht
oredr the ltteers in a wrod are, the olny iprmoatnt tihng is taht the frist
and lsat ltteer be in the rghit pclae. The rset can be a taotl mses and you
can sitll raed it wouthit porbelms. Tihs is bcuseae the huamn mnid deos not
raed ervey lteter by istlef, but the wrod as a wlohe.

I know it happens to me when I read my own stuff

 

[KODIAK (TM)]

FYI. Just posted on the CASAA blog: CASAA: CASAA's Basic Background for Understanding FDA Regulation of E-Cigarettes

Also, a followup to the above blog entry here

We appreciate that vapers and harm reduction advocates are anxious to make substantive comments sooner rather than later, but CASAA is asking that you continue to wait… For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs.

 

[pamdis]

Also, a followup to the above blog entry here

We appreciate that vapers and harm reduction advocates are anxious to make substantive comments sooner rather than later, but CASAA is asking that you continue to wait… For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs.

So, 75 days is not enough time to compose a well thought out and researched comment. But guidance issued by CASAA will leave only a couple weeks to write one.

I'm not waiting, I'm writing/researching mine now. I will wait to submit it until the last week. I will use CASAA's guidance to review my own comments, tighten it up with references, add points I may have missed, etc.

Wait to submit, yes. But please don't wait to start writing.

 

[JimSF]

Roger,

Thanks for the additional info and insight.

Cheers,
Jim

Jim, while I don't speak for CASAA, ECF, or anyone besides myself, I'd like to thank you for your comments! It's always a pleasure to have a never-vaper/never-smoker on this forum, particularly one who has carefully reviewed the evidence regading vaping, and changed their minds in favor of the technology.
.
.
.
Cheers and welcome again,

--Roger