FDA Understanding the Commenting Process for FDA's Proposed Regulations (a little better, at least)

[Fitzie]

As I'm trying to better understand what we're up against in terms of the proposed FDA regs, while surfing the web I ran across 2 blog posts that:

1. Shed some light on what the commenting process is and does.

2. Narrow the focus of the 241 page proposed regs to highlight the questions and requests for comments on specific proposed rules which apply to e-cigarettes.

While we're all waiting for direction from CASAA prior to submitting any comments to FDA (something the author acknowledges), I thought these might be helpful for others as well. I've never commented on a proposed regulation, so I can use all the assistance I can get to better understand the process.

If this is in the wrong place, moderators, please move it. I wasn't sure if anyone would see it in "media and general news." And if it's inappropriate for any reason, please delete it (I'm still new here so I hope it's not an inappropriate thread).

Here are the blog posts:

Brick by Brick: First Glance at Deeming Regs | diehealthy.org

Brick by Brick: the Questions | diehealthy.org

 

[Steelgirl]

I really appreciate you posting these links. Definitely food for thought. Good work on the authors part for sure. A lot of thought went into his writing. I'm sure I will revisit his blogs again.

 

[Alexander Mundy]

Thank you. This shows the length of questions regarding just e-cigs. I am also awaiting CASAA analysis for this extensive list.

 

[Fitzie]

Here's a publication by the federal government - Tips for Submitting Effective Comments

http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf

 

[AgentAnia]

Good finds, Fitzie, thanks for posting these links. I found the Questions post especially helpful. (If the FDA is actually asking for info relating to these questions, then I find their current level of ignorance on the subject is appalling! If they need answers to these questions, they shouldn't be proposing any rule at all yet. Just saying...)

 

[Roger_Lafayette]

As I'm trying to better understand what we're up against in terms of the proposed FDA regs, while surfing the web I ran across 2 blog posts that:
<snip>
Here are the blog posts:

Brick by Brick: First Glance at Deeming Regs | diehealthy.org
<snip>

Adam (the author) is clearly trying to do his best to assist. However he does seem to have a point of view about the FDA which not everyone shares:

[...] you [may have] heard that every whit of vaping kit you’ve ever imagined using will now be required to be anointed in blood as part of an elaborate sacrifice ritual taking place on the third day of the harvest in the moonlight.
Maybe. But that’s what the comment period is about. If the FDA receives high quality comments that convince them to put away the dagger, they will do so. It’s really that simple. Government agencies are not Brazil-esque bureaucracies, torturous serial killers, or fanatical cultists. What they are, like any other large organization, is risk averse.

They do not want egg or mud on their face. They do not want to be responsible for pissing off major corporations, but they don’t want to piss off the public either (nor aid the death of millions who might stay on cigarettes if ham-fisted regulations stifle the vaping market). They are open to sane compromises that protect the public health (their primary goal, by statute), and that protect them from undue scrutiny and lots of litigation.

One has to ask whether Adam is familiar with the history of FDA regulation in the smokeless tobacco context. His posts also suggest to me that he perhaps might've worked a tad harder to familiarize himself with the Proposed Rule's context, namely the requirements of the FSPTCA (tobacco act), as well as what appeared to be Congress' purpose in passing it.

The tobacco act was specifically designed to make very difficult for the big tobacco companies to introduce new tobacco products, and the standards that it contains do not do a very good job of distinguishing between various types of tobacco products (nor which firms are introducing them). This is because the primary products it was intended to regulate were tobacco cigarettes.

It seems that Adam has a certain attitude towards the FDA, which is understandable. Some posters here who are also unfamiliar with the statute, and/or the FDA's own history in the tobacco regulation context, also share his attitude. In both cases, this perspective may originate from attempting to read the FDA's PDF "from first principles."

As with reports about poison control call center frequences, context is essential here.

***

So I'd like to humbly recommend that we all apply a little caution and perhaps a bit more skepticism regarding both the FDA and the nature of the regulatory process than Adam's blogs reflect. This is not to in any way question his excellent intentions, nor minimize his sedulous efforts.

Personally, I plan to wait to comment on matters other than the extension request, as CASAA suggests. This is because I believe CASAA is well-advised by folks who much in the way of expertise, familiarity, and background relevant to the FDA's CTP, the tobacco act (FSPTCA) and the inner workings of Federal regulatory processes.

But hey, that's just me

Thanks for digging that stuff up, Fitzie - I wasn't intending to detract from your efforts, which I much appreciate.

Just throwing in my for what it may be worth.

 

[Fitzie]

Roger, I wasn't suggesting that anyone should jump the gun and submit their comments prior to CASAA issuing guidance on this matter. You can see my cautionary statement regarding this above.

What I do see in many threads is a lack of knowledge regarding the regulatory process. Most folks aren't lawyers (I am, for whatever that's worth, as my specialty was federal personnel law - wanna know how to fire a federal employee and make it stick? I could write a book).

Perhaps I'm being too thin-skinned, but I found your post to be extremely patronizing. I'll concede I'm not as articulate as you, but I'm no dummy either.

I think knowledge is power and if I can help anyone to better understand the legal gobbledegook, I feel i'm doing my small part in this fight. And, as one who worked for the feds for over 30 years, there are few who could match my level of skepticism when it comes to the machinations of the FDA or any other federal agency.

"Rant" over. I'll leave it to the moderators to monitor my posts.

 

[Roger_Lafayette]

Roger, I wasn't suggesting that anyone should jump the gun and submit their comments prior to CASAA issuing guidance on this matter. You can see my cautionary statement regarding this above.

What I do see in many threads is a lack of knowledge regarding the regulatory process. Most folks aren't lawyers (I am, for whatever that's worth, as my specialty was federal personnel law - wanna know how to fire a federal employee and make it stick? I could write a book).

Perhaps I'm being too thin-skinned, but I found your post to be extremely patronizing. I'll concede I'm not as articulate as you, but I'm no dummy either.

I think knowledge is power and if I can help anyone to better understand the legal gobbledegook, I feel i'm doing my small part in this fight. And, as one who worked for the feds for over 30 years, there are few who could match my level of skepticism when it comes to the machinations of the FDA or any other federal agency.

"Rant" over. I'll leave it to the moderators to monitor my posts.

Fitze, I wasn't trying to "mod" you.

The part that I quoted was intended to address the very level of ignorance that you cited. Or more precisely, a certain attitude towards the FDA that the author of those blogs (Adam) seemed to have. I think we're on the same page as far as regarding them in a certain light. He seems to be inviting readers to make certain sorts of comments, based on his perspective.

I apologize if you found it patronizing, that wasn't my intent. I probably would've said nothing, had it not been for the point I just raised about Adam's attitude.

 

[DrMA]

Good finds, Fitzie, thanks for posting these links. I found the Questions post especially helpful. (If the FDA is actually asking for info relating to these questions, then I find their current level of ignorance on the subject is appalling! If they need answers to these questions, they shouldn't be proposing any rule at all yet. Just saying...)

^^^This^^^ +1

The most useful links I've seen so far on the FDA regs. Thanks for posting, Fitzie.

 

[aikanae1]

As I'm trying to better understand what we're up against in terms of the proposed FDA regs, while surfing the web I ran across 2 blog posts that:

1. Shed some light on what the commenting process is and does.

2. Narrow the focus of the 241 page proposed regs to highlight the questions and requests for comments on specific proposed rules which apply to e-cigarettes.

While we're all waiting for direction from CASAA prior to submitting any comments to FDA (something the author acknowledges), I thought these might be helpful for others as well. I've never commented on a proposed regulation, so I can use all the assistance I can get to better understand the process.

If this is in the wrong place, moderators, please move it. I wasn't sure if anyone would see it in "media and general news." And if it's inappropriate for any reason, please delete it (I'm still new here so I hope it's not an inappropriate thread).

Here are the blog posts:

Brick by Brick: First Glance at Deeming Regs | diehealthy.org

Brick by Brick: the Questions | diehealthy.org

I love the layout of both those blog posts and personally, wouldn't mind seeing them as a sticky / thread topic where each question outlined (I didn't count them) could be posted with documentation addressing the issue. Just

Another thought I read recently was a guess that the regulations were rushed due to pressure from other stakeholders to get this done because the FDA left so many big issues unanswered and ill-defined. It certainly seems like a lot IMO, and overwhelming for people (like me) who don't live in a regulatory world. I don't know how true that is, but some of the other regulations I've seen seem to take on a much narrower scope; i.e. menthol for example and I believe those regulations were several extentions just on that one topic.

Sometimes its hard to believe a "safer alternative" to smoking can cause this much fury.