FDA Godshall meets with White House OMB/OIRA again urging rejection of FDA deeming ban on vapor products

[MacTechVpr]

Pretty sure that was part of the 'problem' - those vendors that didn't have an 'undercounter stash' suffered in sales. Soon everyone was defying the law. Which is when the tax was reduced.

A good "lesson" for vaping perhaps Vendors take note....

Luck is what happens when preparation meets opportunity—Seneca the Younger

 

[Lessifer]

Isn't today 90 days since the rule was sent to OMB? Are they still reviewing and having meetings? Any movement at all?

 

[roxynoodle]

Isn't today 90 days since the rule was sent to OMB? Are they still reviewing and having meetings? Any movement at all?

That is the big question.

 

[Lessifer]

That is the big question.

I remember seeing a link to the schedule of meetings, but I don't remember where.

 

[roxynoodle]

I remember seeing a link to the schedule of meetings, but I don't remember where.

I don't remember either. But, I also don't remember seeing any scheduled after Christmas.

 

[Endor]

Meeting calendar link:

EO 12866 Meetings Search Results

It looks like some of the meetings now have documents/artifacts from the meeting attached. I didn't see any attachments the last time I checked a few weeks ago. I'm not sure if that means anything or not....

EDIT: Check out 12/11/15 1:30pm... called by PETA?? I guess everybody's in the bash e-cig game now.

 

[WorksForMe]

I remember seeing a link to the schedule of meetings, but I don't remember where.

No meetings listed after Dec. 18th.
http://www.reginfo.gov/public/do/eom12866SearchResults?pubId=201510&rin=0910-AG38&viewRule=true
EO 12866 Meetings Search Results

 

[nicnik]

Meeting calendar link:

EO 12866 Meetings Search Results

It looks like some of the meetings now have documents/artifacts from the meeting attached. I didn't see any attachments the last time I checked a few weeks ago. I'm not sure if that means anything or not....

EDIT: Check out 12/11/15 1:30pm... called by PETA?? I guess everybody's in the bash e-cig game now.

They're concerned that vaping will cause smokers to become extinct, so they're lobbying to have smokers declared a protected species.

 

[navigator2011]

Meeting calendar link:

EO 12866 Meetings Search Results

It looks like some of the meetings now have documents/artifacts from the meeting attached. I didn't see any attachments the last time I checked a few weeks ago. I'm not sure if that means anything or not....

EDIT: Check out 12/11/15 1:30pm... called by PETA?? I guess everybody's in the bash e-cig game now.

They concerned that the FDA's deeming is going to lead to yet more animal testing as companies are forced to determine toxicity levels of all products developed beyond the predicate product.

 

[gmoney$]

They concerned that the FDA's deeming is going to lead to yet more animal testing as companies are forced to determine toxicity levels of all products developed beyond the predicate product.

Right. PETA is a animal welfare group rather than a wildlife conservation group. Will CASAA or someone notify us prominently of any action on deeming when it occurs?

 

[nicnik]

Right. PETA is a animal welfare group rather than a wildlife conservation group.

oops...please disregard my ill-informed speculation. Thanks for the correction.

 

[MacTechVpr]

Greatly appreciate this summary position from AEMSA Dec 18th meeting handouts…

"The e-vapor device is a revolutionary technology that has the ability to greatly benefit the public health, as it provides the first viable recreational alternative to tobacco for cigarette smokers. As detailed in AEMSA’s comments to the NPRM for the Deeming Regulation (FDA Docket No. FDA-2014-N-0189) available online8, our position is that e-vapor products are technology products, not tobacco products, and that Congress never intended the Tobacco Control Act to apply to novel, tobacco-free products. Rather, the legislative history of the Tobacco Control Act makes clear that the law was only intended to apply to agricultural-based products that actually contain tobacco-leaf. In particular, the onerous PMTA process was designed to make it nearly impossible for tobacco companies to introduce new, more harmful tobacco-leaf products, particularly combusted products, to the market – not to effectively ban an entirely novel category of products that has the potential to greatly reduce tobacco-related disease and death."

If only most were capable of considering such good reason.

Good luck all.

 

[Endor]

They concerned that the FDA's deeming is going to lead to yet more animal testing as companies are forced to determine toxicity levels of all products developed beyond the predicate product.

Yep, and it will result in more animal testing, so their argument is actually valid. I guess I was misguided too in believing PETA was out to get us too.

 

[Lessifer]

Well, according to the Review page, there is no "legal deadline" so I guess they can take as long as they need to.

 

[navigator2011]

Yep, and it will result in more animal testing, so their argument is actually valid. I guess I was misguided too in believing PETA was out to get us too.

I read part of the PETA handout, and it seemed that PETA's position sort of helps us--not because vaping a wonderful, but because they argue the FDA has not considered all the unintended consequences, some of which may be undue.

 

[nicnik]

I read part of the PETA handout, and it seemed that PETA's position sort of helps us--not because vaping a wonderful, but because they argue the FDA has not considered all the unintended consequences, some of which may be undue.

http://www.reginfo.gov/public/do/eoDownloadDocument?pubId=&eodoc=true&documentID=1743

In its proposed rule, FDA states that it does not have the authority to amend the
February 15, 2007, reference date for predicate products with respect to e-cigarettes
or other products. If this is the case, we are very concerned that manufacturers of
newer proposed deemed tobacco products that are ineligible to enter the market
through the substantial equivalence pathway will instead submit premarket tobacco
applications (PMTAs). In its draft guidance for industry on PMTAs, FDA directs
applicants to evaluate the toxicity, abuse liability, and carcinogenicity of their
products using some combination of in vitro, in vivo, or ex vivo studies to
demonstrate that they are appropriate for the protection of the public health. While
we appreciate FDA’s efforts to hold tobacco product manufacturers to this high
standard, it is unconscionable that more animals be made to suffer and die in order to
bring new tobacco products to market. We are also concerned by recent media
reports that FDA is funding inhalation toxicity experiments on mice with e-cigarette
vapor.

 

[Endor]

Greatly appreciate this summary position from AEMSA Dec 18th meeting handouts…

If only most were capable of considering such good reason.

I'm about half-way through the document to OIRA from AEMSA (second attachment I think). Very well done and quite compelling, especially the economic impact and how the FDA so dramatically underestimated it (which, I understand, is a key metric that OIRA needs to consider).

It is also interesting that AEMSA brings up problems with the way the FDA proposed their rulemaking, specifically that the FDA did not go through the Advanced Notice method, but instead went straight to the Proposed Rulemaking process and then asked a lot of questions in the proposed rule... which is supposed to be done via Advanced Rulemaking notice (gather details and scientific information in order to formulate a rule based on that data and move to Proposed Rulemaking). The example used was how the FDA managed the menthol cigarette issue, which is quite different and utilized the Advanced Rulemaking route. My take: the deeming was rushed to Proposed Rulemaking due to intense political pressure to do something and do it quickly, but provides further evidence that the FDA regulatory proposal isn't fully baked and that the FDA doesn't quite have enough facts to actually propose a Rule in good faith.

 

[navigator2011]

It is interesting to see arguments/evidence for future litigation beginning to take shape right now.

 

[nicnik]

It is interesting to see arguments/evidence for future litigation beginning to take shape right now.

And there's priceless support for probably every issue in nearly every upcoming lawsuit, in Bill G.'s massive document collection submitted to the FDA.

 

[navigator2011]

And there's priceless support for probably every issue in nearly every upcoming lawsuit, in Bill G.'s massive document collection submitted to the FDA.

Yeah, true that.