FDA Interesting new docket opened and withdrawn

[pamdis]

I was perusing the FDA docket on the proposed rule, and I noticed something new added in the docket details secion.

Related Dockets:FDA-2015-N-1514. So I clicked on it.

The title of the new docket is "Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing e-liquid(s), and Other tobacco Products".

All documents have been "withdrawn at the request of the Food and Drug Administration and the Department of Health and Human Services."

I imagine this is propably one of the new proposed rules that they are going to put out once the deeming is final. Someone jumped the gun.

But, wouldn't it be nice to imagine that this is the replacement for the deeming and that this is all they are going to do?

Regulations.gov

 

[KattMamma]

it would be nice... but I'll add that to my "dream on" list... :/

 

[skoony]

more than likely a deliberate slip to throw the competition
off.
mike

 

[Bill Godshall]

If you click on View More Docket Details, you will see

"Keyword(s): 2015-196, Nicotine Exposure Warnings, Child-Resistant Packaging, Liquid Nicotine, Nicotine-Containing E-Liquid(s), Other Tobacco Products, Request for Comments, open, Advance notice of proposed rulemaking, FD&C Act
Type: Rulemaking"

How did you find out about this new docket (as I'm on FDA's e-mail list, and I didn't receive any notice)?

It appears that some folks at FDA got ahead of themselves (by proposing new e-cig product regulations before the agency has the legal authority to propose e-cig regulations), as the FDA needs to issue a Final Rule for its proposed Deeming Regulation before it can propose new regulations for e-cigarettes (or other products that would be deemed to comply with Chapter IX provisions).

 

[pamdis]

Bill, I found it by accident when I was looking at the deeming docket. Click on View More Docket Details on that one and there is a field on the left side for "Related Dockets" after the little date block where this new one had been added.

 

[Hype]

Checked with some connections on the Hill and it looks like someone made a big oops. But its apparant they've got their ducks in a row to shoot them down one after the other once Deeming goes final

 

[pamdis]

Assigned a RIN number and sent to OMB in pre-rule stage.

AGENCY: HHS-FDA RIN: 0910-AH24
TITLE: Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments
STAGE: Prerule ECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 06/05/2015 LEGAL DEADLINE: None

 

[C0NPAQ]

I am in Germany and EU regulations will limit *all* containers for liquids that have nicotine inside no matter the purpose (so not just vaping liquid containers, or ready-to-use containers) to 10ml and 20mg/ml max concentration by mid 2016. This means no more bulk purchases for consumers and thus enormous ramping of prices. Say goodbye to $50 for 1L of 100mg/ml. In the future you will only be able to pay $5 for 10ml of 20mg/ml. This is a 50 fold price increase.

I am mentioning this here, because this makes enormous sense economically for government taxes and vendors, to get the bucks that they lose from lack of advertizement plus the more pricey child-proof-approved containers etc., back on the fixed $1-$2 profit margin per consumer product.

In the EU directive, they made the effort to hide this restriction mid-document in ambiguousness and the phrasing of the the paragraph was rather unusual. It was sold as making the liquid more safe to the consumer. I very much suspect the US will suffer just the same fate.

 

[SeniorBoy]

Checked with some connections on the Hill and it looks like someone made a big oops. But its apparant they've got their ducks in a row to shoot them down one after the other once Deeming goes final

Yep and I also agree with Bill's post in this thread. Of course, I could also argue that this was planned to mitigate any pushback the FDA/HHS may receive under the CRA. By this I mean they can tell Congress that we are ready to implement and we have already written our rules to protect the kiddies. Here it is. Read it and then don't pushback so the final rule becomes the law of the land my beloved Congress person.

 

[philoshop]

Independent law-making by bureaucrats.
I honestly don't know why we even bother with the ruse of having elections any more.

 

[pamdis]

Independent law-making by bureaucrats.
I honestly don't know why we even bother with the ruse of having elections any more.

This is exactly the purpose of 'Agencies'. Lawmakers don't want to deal with many things they might get pushback from or outrage over. So they pass a general law creating agencies to hash out the details, and the lawmakers insulate themselves from the consequences.

 

[DrMA]

wow! Clearly they will not stop until vaping is completely destroyed. We must stop this lunacy before the [HASHTAG]#deskMurderers[/HASHTAG] kill us all.