Food and Drug Law Institute conference session on FDA "deeming" regulation, Godshall to speak

[Bill Godshall]

There will be a session on the FDA's potentially forthcoming "deeming" regulation at the Food and Drug Law Institute's annual conference in DC on April 23 from 4-5:30PM.
Agenda

The following panel has been invited to speak, along with njoy's Craig Weiss (who was just added to the panel).

Bryan M. Haynes, Partner, Troutman Sanders LLP
Bill Godshall, Executive Director, Smokefree Pennsylvania
Rebecca Maisel, Vice President and General Councel, FIN Branding Group, LLC
Daniel P. McGee, General Counsel, General Cigar Co., Inc.

​

Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
​

I'm pretty certain that all of the panelists will oppose the FDA deeming regulation (which would ban e-cigarettes unless the FDA specifically exempts the products from some regulations), as Bryan Haynes represents tobacco companies, FIN is an e-cigarette company, and cigar companies all oppose the deeming regulation.

The title and description of the session (below), however, deceptively imply that the deeming regulation will benefit pubic health and won't be challenged in court. I've informed FDLI organizers, and urged them to change the title and description for accuracy.

• tobacco: Implementing Effective and Reasonable Regulations Following the “Deeming” Regulation—From Good Manufacturing Practices to Tobacco Product Standards

Pending FDA’s release of a notice of proposed rulemaking this spring, this session will address issues related to the implementation of effective and reasonable regulations following the “deeming” regulations that could subject other products that meet the definition of “tobacco product” to FDA’s “tobacco product” authorities under the Food, Drug, and Cosmetic Act (FDCA). Panelists will cover a range of topics, including new tobacco product requirements, allocation of user fees to new tobacco categories, appropriate grandfather date for newly-regulated tobacco products, advertising regulations and marketing restrictions, and good manufacturing practices.​

 

[Bill Godshall]

Altria's Jeff Walker will be presenting another interesting session at the FDLI conference on April 23
Agenda
Hopefully, the FDLI will invite some of us tobacco harm reduction advocates who testified at the Dec. 17 FDA hearing, and who submitted written testimony to the FDA, to present at this session. But I suspect the other invited speakers will be from the drug industry.

Harm Reduction and Innovation: Update on FDA’s Regulation of NRTs and Smoking-Cessation Products
This session follows up on issues raised during FDA’s December public hearing on agency actions related to nicotine replacement therapies (NRTs) and smoking-cessation products, including modified risk tobacco products (MRTPs). Panelists will provide regulatory updates and discuss concerning the implementation of section 918 of the FDCA, including approval mechanisms, additional indications, and extended use of NRTs and related products that deliver nicotine. The panel will also consider the report to Congress (pending its delivery in March 2013) on the development of innovative products and treatments for tobacco dependence.

Jeffrey P. Walker, MD, Vice President and Chief Medical Officer, Altria Client Services

Moderated by Carlos Angulo, Partner, Zuckerman Spaeder LLP

 

[Berylanna]

I noticed this on the NEXT day's agenda, Apr 24. Will someone watch this? It bothers me that they get the "last word."

Tobacco: FDA Center Director Presentation
The Center Director will discuss the three most important developments from last year and the three most important goals in 2013.

Mitchell R. Zeller, J.D., Director, Center for Tobacco Products, FDA
Mark Greenwold, Senior Consultant, Campaign for Tobacco Free Kids
Alfred Kevin Altman, Consultant, Council of Independent Tobacco Manufacturers of America
James E. Swauger, Vice President, Regulatory Oversight. R.J. Reynolds Tobacco Company

 

[Bill Godshall]

Kevin Altman and James Swauger can and will counter any false or misleading comments made by Mitch Zeller and/or by CTFK's Greenwold.

 

[Paulette]

To me, the below blurb from the agenda implies that the FDA will in fact issue that "deeming regulation," before this conference. Am I reading this wrong in thinking this???


"Pending FDA’s release of a notice of proposed rulemaking this spring, this session will address issues related to the implementation of effective and reasonable regulations following the “deeming” regulations that could subject other products . . ."

 

[CaSHMeRe]

To me, the below blurb from the agenda implies that the FDA will in fact issue that "deeming regulation," before this conference. Am I reading this wrong in thinking this???

"Pending FDA’s release of a notice of proposed rulemaking this spring, this session will address issues related to the implementation of effective and reasonable regulations following the “deeming” regulations that could subject other products . . ."

This was my take away as well Paulette. As if something will be proposed prior - and far enough beforehand to allow said speakers (the panel) to comment, prepare, argue for/against, etc....

Bill, please correct Paulette and myself if we are indeed reading this wrong.

 

[hoogie76]

To me, the below blurb from the agenda implies that the FDA will in fact issue that "deeming regulation," before this conference. Am I reading this wrong in thinking this???


"Pending FDA’s release of a notice of proposed rulemaking this spring, this session will address issues related to the implementation of effective and reasonable regulations following the “deeming” regulations that could subject other products . . ."

Or it could be read as this session is pending based on whether the FDA releases deeming regulation to discuss

hoog

 

[Bill Godshall]

The person who wrote the FDLI title and description of our session didn't understand the legal ramifications of the deeming regulation.

After I pointed out the inaccuracies, she told me that she agrees with my concerns, was willing to making corrections, and wanted to set up a conference call for panelists in our session.

Regardless, all speakers at that session will be pointing out the actual legal ramifications of the deeming regulation.

Nothing like a nonlawyer (me) pointing out the details of laws to lots of well paid lawyers.

 

[kelli]

Nothing like a nonlawyer (me) pointing out the details of laws to lots of well paid lawyers.

oh how they hate that! ♥

 

[Paulette]

Regardless, all speakers at that session will be pointing out the actual legal ramifications of the deeming regulation.

So what are you going to talk about if the FDA does not issue the deeming regulation by the time of this conference?

 

[orson]

To me, the below blurb from the agenda implies that the FDA will in fact issue that "deeming regulation," before this conference. Am I reading this wrong in thinking this???


"Pending FDA’s release of a notice of proposed rulemaking this spring, this session will address issues related to the implementation of effective and reasonable regulations following the “deeming” regulations that could subject other products . . ."

This is a horribly constructed sentence!

"Pending" is a prepositional or adjective and could have several nuanced meanings, basically in this case it's meaning could be "in the period before" or it could mean "awaiting release"

"of a notice...." of is being used to show what the pending release pertains to: "propsed rulemaking".

So in a nutshell this is what it says:

"Meeting to discuss implementation of regulations that will be based on deeming regulations before the deeming regulations are released."

Which sounds like a ridiculous proposition, so now I understand why they constructed the sentence that way in the first place.

 

[Berylanna]

The person who wrote the FDLI title and description of our session didn't understand the legal ramifications of the deeming regulation.

After I pointed out the inaccuracies, she told me that she agrees with my concerns, was willing to making corrections, and wanted to set up a conference call for panelists in our session.

Regardless, all speakers at that session will be pointing out the actual legal ramifications of the deeming regulation.

Nothing like a nonlawyer (me) pointing out the details of laws to lots of well paid lawyers.

And here I was so concerned that the FDA medical decisions appeared to be decided by J.D.'s. Did they have the M.D.'s do the legal stuff?

 

[Bill Godshall]

Per my request, the FDLI changed its title and description of the April 23rd session on the deeming regulation.
The new title, description and panel list is below.


Tobacco Product Deeming Regulations – Are They Appropriate and What Should They Look Like?”

FDA has indicated that it will publish proposed deeming regulations this spring to expand its tobacco product jurisdiction to additional tobacco products, such as cigars, pipe tobacco and electronic cigarettes. This session will address issues related to the implementation of such regulations. Panelists will cover a range of topics, including new tobacco product requirements, allocation of user fees to new tobacco categories, an appropriate grandfather date for newly-regulated tobacco products, advertising regulations and marketing restrictions, and good manufacturing practices.

Bryan M. Haynes, Partner, Troutman Sanders LLP
Bill Godshall, Executive Director, Smokefree Pennsylvania
Rebecca Maisel, Vice President and General Councel, FIN Branding Group, LLC
Daniel P. McGee, General Counsel, General Cigar Co., Inc.
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP

 

[DC2]

Based on the new title, it sounds like the FDA isn't really very close to issuing any deeming regulations yet.

 

[2coils]

Based on the new title, it sounds like the FDA isn't really very close to issuing any deeming regulations yet.

Maybe they have to rethink things a bit. The evidence and support for the industry is growing by the day. They are going to get hammered if they go in the wrong direction and they know it!

 

[brooke2775]

Maybe they have to rethink things a bit. The evidence and support for the industry is growing by the day. They are going to get hammered if they go in the wrong direction and they know it!

from your lips to God's ears.

 

[DC2]

from your lips to God's ears.

Check out this thread and you'll see why 2coils might be on to something...
http://www.e-cigarette-forum.com/fo...red-do-you-want-feel-better-about-things.html

 

[Berylanna]

I'm still worried about my e-liquid vendors.

I'm tempted to put up a thread on the e-liquid subforms that says "URGENT!!!! Make it clear if you are selling CRAFT e-liquid!!!"

Craft beers do NOT require massive $$$ in order to be able to sell them, not on the order needed to sell meds anyway. But they are not allowed to be poison either.

I want to insinuate the idea into the minds of the media and legislators that my vendors are CRAFT ELIQUID vendors, not furtive bathtub chemists, and I should be allowed to buy from them without criminalizing them. I realize this is early wrt the FDA but if the idea isn't floating around out there, I'm afraid it could get to be too late.

What do all y'all experts think?

 

[2coils]

DC thanks for the above post !! Vapers should really listen to this if they want to get current on whats going on! Really good stuff!!!

 

[Paulette]

Check out this thread and you'll see why 2coils might be on to something...
http://www.e-cigarette-forum.com/fo...red-do-you-want-feel-better-about-things.html

LOVED that tape and I tried very hard to get everyone I know to listen to it -- very enlightening!