FDA FDA regulations and the impact on small juice vendors | another side
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I've read that. Here's the part with which I am not enamored:
"The alternative, with the consumer voice being entirely in the form of mass protest and everything that comes with it, makes it difficult to make good regulations and is more costly to the FDA.
We argued that we and most consumers see proper regulation of smoke-free alternatives as more similar to that for foods and cosmetics (which FDA also regulates) than drugs. Consumers appreciate having an invisible regulatory process that ensures universal and accurate labeling of contents, along with the quality control needed to ensure general safety."
"Good" and "proper" gov't regulation isn't in my vocabulary. And I don't want an 'invisible regulatory process' either
I want informed consumers, and I don't want dozens of e.coli and salmonella outbreaks (By 2012 the figures were roughly 130,000 hospitalizations and 3,000 deaths." wiki) ... that are done under an 'invisible regulatory process' and so many cases with other regulatory agencies, whose 'inspectors' are never fired and the blame always goes to the companies anyway and never to the gov't overseers. And even IF some media casts blame, nothing is ever done. No one loses their job and the solution is always 'more money' or the getting the 'right people' in place. Where the 'right people' are the peers of the person saying they want the 'right people' in place. And when the 'right people' are gotten in place and more money is poured into the program, even more screw-ups occur and the answer is the same - we need the 'right people' and 'more money'. 
Do I really need to list examples of this? If I do, then this isn't just a 'difference of opinion', and I wish you well. 
We aren't going to agree on this. I suggest a "good place to start" is "Machinery of Freedom" by David Friedman (Milton's son), if you're in any way curious about how the free market could 'regulate' without government dictating what's 'good for public health', that would be a good resource.
None of us are 100% that anything we do daily is safe. Which can't be said enough as the whole question of "is vaping 100% safe" comes up too much for a sane person to consider. I'd never be able to get into a car again if that was the standard by which to determine whether or not to allow it.
I don't think the flavor thing is all that complicated. Would be a little complicated if all those cherry cola or peach cobbler vapers were showing up routinely harmed. While the cola and peach vapers were seemingly unharmed.
IMO, it is way closer to ruse and simply preposterous to consider idea that it would take intelligent humans 5000 hours to determine relative safety/harm of inhaling flavors. That alone is ridiculous. Then consider the idea that one of these studies could take say 500 hours (I'm being as liberal and reasonable as I can), but truly outlandish part is that each study after that would take another hundred hours as if all that was gained in previous studies must be tossed out the window cause, duh, uh, well you see, we just don't know what we knew from the umpteen other studies we just did, and so need another 500 hours to do the same thing.
Here, let me help you in case you missed it.
Feel free to cite CASAA's game plan going forward that squarely addresses all the negative things we rehash over and over since 4/24/14.
While this can read an awful lot like I'm bashing CASAA, I'm saying that consumers are essentially powerless against what we've determined is plausible end to vaping as we know it.
A position which I do not subscribe to, but which is not worth a debate as differences in interpretations and understanding of what is likely to occur, ultimately comes down to 'wait and see' and reinforcing notion that we are powerless as things stand right now.
What I mean is that if you have a better idea state it clearly and let's talk about it.
As clear as I can make out, you want us all to contact our representatives NOW instead of later.
And you want us to ask them to change the grandfather date.
And I guess you want CASAA to make that Call to Action as soon as possible.
Currently, having an idea makes for better position. Again, feel free to cite CASAA's game plan going forward.
Most recent CTA about communicating numbers and how far off FDA is in its estimation of products available was a decent strategy, yet was met with our side not being all that coherent on total numbers. Though, I'm thinking total number was secondary to point of telling FDA we, consumers, are aware that they are engaged in ruse to curtail the market. A previously issued CTA from CASAA would've made that clear to the consumer, that the ruse is what this is about.
Better position to me means staying confident going forward, aggressive in our reasonable position. I think CASAA (leadership) will deliver on that at some point, as they routinely do on state / local issues. Though as someone that is already there (never left), and deals often with naysayers to any positive step forward on federal regulations, I continue to wonder if the flock will scrutinize CASAA's future ideas, or do a 180 and not question any future actions? Instead, treating it as "yes, we can now speak to these federally proposed regulations with confidence and reason."
Here are options / ideas I see with regards to current national politics:
- I do put contacting Congress at top, and feeling confident that it is high up on CASAA's game plan with what little has been conveyed about game plan. FDA has openly admitted they don't think they can change what they've proposed, legally. So, FDA isn't really needed from consumers perspective in how to address these regulations, that stem from FSPTCA, which FDA did not write, did not vote into law.
- FDA cited alternatives in economic impact analysis (accompanying document to deeming proposal). Consumers ought to be doing everything possible to make those stay on the table as reasonable considerations under a regulatory framework that currently seems inevitable.
- Gathering all scientific data that can be used for anyone wishing to submit comments now, and that speaks directly to points where FDA asked questions or cited position of "we don't know" or "scientific evidence is lacking."
- Disinformation. If concern is that by submitting comments early, we risk our opposition knowing what we are up to, then why not put out disinformation to throw them off, mislead them. IOW, we could come up with say 4 game plans for going forward. 3 of which are intentionally meant to mislead our opposition. One of which is meant to organize consumers in providing reasonable, confident information for all to consider. All 4 game plans contain data that makes ANTZ look out of touch and entirely misguided.
- (Somewhat) openly organizing for a future underground market. There are reasons (that are obvious) for not doing this openly, but reason to do it openly is to counter FDA's ruse that shows up to many consumers as dramatically scaling back the market. Have our (potential) ruse trump their ruse.
- Posting multitude of questions to FDA as comments, noting that after they are answered, reasonable comments will be submitted. And noting that until they are answered, an extension must be granted that matches the time FDA took to respond. 10,000 questions would be in the ballpark of strategy I'd employ with this route.
All good ideas, except that I would like to make a note about the last one.
The FDA is not going to answer any of those 10,000 comments.
They will read them and then dump them in the trash.
Not that I'm saying we shouldn't flood them with comments, like we did last time...
Just that I hope you're not listing this idea with the expectation of getting some kind of reply from them.
They probably won't answer our questions, but posing them certainly will have to make them think twice (or thrice, or 10,000 times). If we can show that their proposal ends up asking more questions than they themselves already have, it may take a while for them to change the proposal to address those concerns, and if the proposal is changed significantly, may open up the possibility of that rare second comment period before the final issuing.
Hard to agree with idea that FDA will trash them. You are entitled to that opinion. Wonder if you brought this up with regards to either of the CTA's already issued by CASAA?
I would consider it unlikely that FDA responds to the questions, but serves as reasonable basis for why a reasonable comment couldn't be submitted, and hence an extension is warranted. FDA asked a whole bunch of questions and seeking clarification on what they are asking for seems within reason for any person submitting comments.
As one who has tracked, reviewed and posted FDA comments on ECF, I would tell you that absolutely most ridiculous comments are being allowed and posted for public review. To think that 10,000 questions submitted as comments would result in zero of them being posted for public review is something that strikes me as uninformed opinion. If some of them were made available for public review, then it would offer insight going forward in what OMB, Congress and possible judicial bodies may wish to consider before implementation of final rule. IOW, it would be a matter of public record that stakeholders used the comment form to gain clarification and would plausibly work against the FDA if they were shown as refusing to answer those genuine questions. From my perspective, it would actually be good (for politics) if FDA ignored them, and thus show up as ignoring legitimate concerns / desires for reasonable clarification.
I already have a list of my own rhetorical questions I plan to submit. For example: "Are you really proposing to make a nicotine toothpick company submit an application that will cost them $334,000 and expect them to submit studies on whether the toothpicks will increase or decrease a users likelihood to quit/reduce/start smoking?"
Yeah, that is very strange indeed.
Last time we commented they received 5,357 comments, and only 103 were ever posted...
Regulations.gov
Anyway, I wasn't talking about comments being posted.
I was talking about the FDA replying to them.
That's what I've been pondering.
Approved non-flavored nicotine in various strengths sold alongside 'water enhancers' or other flavorings.
I think the flavoring would have to be sold separately and not advertised as being used for eLiquid.
At least that's how I read this, from the proposed deeming Executive Summary:
"Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."
At least that's how I read this, from the proposed deeming Executive Summary:
"Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."
Big warning on label: Do Not, under any circumstances, combine the contents of this bottle of 'Pablo's Refried Beans' Flavored Water Enhancer with a 27ml bottle of 7 mg/ml nicotine solution to attempt to create 30ml of 6mg/ml 'Pablo's Refried Beans' eliquid.
Reminds me of buying 'lamp parts' at smoke shops in Texas back in the early 80s...
Reminds me of buying 'lamp parts' at smoke shops in Texas back in the early 80s...
Isn't vaping "Pablo's Refried Beans" eliquid something that is forced upon you in one of Dante's circles of hell?
Thanks for the chuckle, and your point is very valid. Per the "lamp parts" analogy you mention, humans will always figure out creative ways to work around the system.
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