FDA AEMSA urges FDA to reject Deeming Regulation for e-liquid products

[Bill Godshall]

AEMSA submits 117 pages of comments to FDA on Deeming Regulation urging agency to reject proposed Deeming Regulation for e-liquid, urges agency to make many other changes in proposal that would allow some/many/most e-liquid products to remain on market
http://www.aemsa.org/wp-content/upl...ents-to-Proposed-Deeming-Regulation-Final.pdf


Although I'm only halfway through, this is another excellent comment to FDA, which (like comments by CASAA and me) appear primarily intended for e-cig company lawyers, Judge Richard Leon and the DC Court of Appeals (if/when FDA issues the Final Rule for the Deeming Regulation and subsequently bans e-liquid products from the market).

Looks like Azim Chowdhury's finger prints (and of course Lou Ritter's) are all over AEMSA's comments.

 

[ClippinWings]

AEMSA submits 117 pages of comments to FDA on Deeming Regulation urging agency to reject proposed Deeming Regulation for e-liquid, urges agency to make many other changes in proposal that would allow some/many/most e-liquid products to remain on market
http://www.aemsa.org/wp-content/upl...ents-to-Proposed-Deeming-Regulation-Final.pdf


Although I'm only halfway through, this is another excellent comment to FDA, which (like comments by CASAA and me) appear primarily intended for e-cig company lawyers, Judge Richard Leon and the DC Court of Appeals (if/when FDA issues the Final Rule for the Deeming Regulation and subsequently bans e-liquid products from the market).

Looks like Azim Chowdury's finger prints (and of course Lou Ritter's) are all over AEMSA's comments.

Bill,

AEMSA, Like Lorilard, pushes for the FDA to regulate Misbranding and set GMPs...

How is THIS one an "Excellent comment to FDA", but Lorilard's is not?

I'm not trying to be antagonistic, just trying to understand the distinction, as on it's face it looks like a bit of bias.
I suspect that's not the case and there is a good explanation I'm just missing. But, I'm having a hard time distinguishing a good comment from a bad comment because of this.



Can you explain for those of us who are not as familiar with these terms when used in a regulatory setting?

 

[UncloudedThinking]

I am also trying to understand the distinction.

When are GMP's and missbranding/adulteration a problem and when are they standards we should be promoting? It is my understanding that the SFATA comments and subsequent guidance for vendors (which included both), was basically written by regulatory and corporate attorneys who see the big picture and deal with agencies like the FDA every day.

Like, ClippinWings I am definitely not trying to be antagonistic. Just trying to understand your perspective on this.

 

[DC2]

I am also trying to understand the distinction.

And you are the one that wrote this, aren't you?
Reconsidering Electronic Cigarettes: A Story | Unclouded Thinking

If so, thank you.
Thank you so much.

 

[DrMA]

And you are the one that wrote this, aren't you?
Reconsidering Electronic Cigarettes: A Story | Unclouded Thinking

If so, thank you.
Thank you so much.

Really powerful story. Thanks for posting the link.

 

[DC2]

Really powerful story. Thanks for posting the link.

I've sent it to everyone I know.
It's that good.


Don't forget to read the comments!

 

[UncloudedThinking]

Thanks, guys. I am glad my story has resonated with so many people. If more people on the outside could see what have seen (and not base their perceptions on Blu adds) maybe things would start to change.

 

[Bill Godshall]

While AEMSA's comments urge FDA to reject deeming and regulating all e-liquid and all e-cig components as tobacco products (under Chapter IX of the FDCA), Lorillard's comments urged FDA to approve its proposed deeming regulation.

That's a huge difference.

SFATA encouraged its members to simultaneously urge FDA to reject the deeming regulation for e-cigs, while simultaneously urging FDA to propose new regs that included "adultered" and "misbranded" tobacco product bans, GMP, sales ban to minors, etc.). That confused many e-cig companies, and many vapers.

Somewhat similarly, AEMSA urged FDA to reject the deeming regulation for e-liquid and for e-cig components, while also urging the agency to propose a new less burdensome regulatory scheme for these products.

Since the our key goal is to reject its proposed Deeming Regulation, those who also recommended that FDA propose alternative regulatory provisions for e-cigs were trying to be nice to the agency (by trying to appear supportive of FDA regulations for e-cigs).

The reality is that if FDA abandons their proposed deeming regulation (as they should), the agency is unlikely to propose new regulations for awhile (and an entirely different regime will be at FDA by then).

 

[ClippinWings]

Oh OK...

Thanks.

I guess I need to re-read Lorilard's comments... I thought they opposed the regulations as proposed and asked for a bunch of changes.

 

[aubergine]

UncloudedThinking, I hadn't come across your article before. It's so very strong, accessible, clear and moving! I'm also going to make copies and add it to my little stack of references to hand out.
Thanks for that!

 

[Kent C]

I know that it's been mentioned that ecigs weren't even around when the legislation leading to the proposed deeming, was made, but AEMSA makes the point a bit more striking. I would have used this in my comment....

"It is quite apparent from reading the statute that Congress only contemplated tobacco
leaf-containing products would be subject to the requirements as enacted.

ii. There is No Mention of E-Cigarettes or E-Liquid in the Tobacco Control Act or its Legislative History

This is further supported by the fact that neither e-cigarettes nor e-liquid are mentioned
anywhere in the Tobacco Control Act or its legislative history. As noted above, FDA exercised
its discretion to not deem premium cigars as covered tobacco products in its proposed “Option2”
of the NPRM. In a recent draft report by the House Appropriations Committee on the FDA
funding bill, the Committee noted that exempting premium cigars from the scope of the Deeming
Regulation made sense because there was “little mention of cigars” in the legislation.

While there maybe “little mention” of cigars in the Tobacco Control Act, there is no
mention at all of e-cigarettes or e-liquids in either the text of the legislation or in the
Congressional record. These products, which are clearly distinct from the currently regulated
tobacco leaf-containing products, were not on the U.S. market or were just entering the market
when the Tobacco Control Act was being debated, and Congress was clearly unaware of their
existence. This further suggests that Congress could not have intended FDA to strictly apply the
Tobacco Control Act requirements to these novel, tobacco leaf-free products."

 

[Kent C]

I was hoping to see Azim's 'baseline predicate product' argument, but it doesn't seem to be there. Instead, they push for a new grandfather date at final rule. The focus of AEMSA is on eliquids, - although they did get into some hardware issues - so perhaps that is the reason. I think the same 'baseline' argument could be made for eliquids as well and while they do delineate what they think that would be, I would have like to have seen the same 'baseline' argument instead of a final rule gf date.

I'd also add that while all of these group comments have been good, this one, in particular, has some of the best fodder for taking it to court - on 'Congressional Intent' and whether or not the FDA had any legitimate reason to add e-cigs and eliquid into the deeming other than Zeller's whim and some Senators' urging, but that was after the fact of the TCA.