FDA Rep Tom Cole introduces bill (HR 2058) to change SE date from 2007 to 2015 for newly deemed products

[Bill Godshall]

Last week, US Rep. Tom Cole (R-OK) introduced a bill (HR 2058) to move the Feb 15, 2007 SE date to 2015 (i.e. the date FDA issues the Final Rule for its proposed deeming reg/ban) for all e-cigs and other newly tobacco products.
The bill's text isn't available yet at
THOMAS (Library of Congress)

But Tom Cole's comments when he introduced the bill are at:
Congressional Record - 114th Congress - THOMAS (Library of Congress)::

The bill has been referred to the House Energy &Commerce Cmte.

Since its introduction, 4 other Reps have cosponsored the bill.

All vapers should urge their US Rep to oppose FDA's deeming reg (that would ban >99.9% of e-cigs now on the market) and urge them to become a cosponsor of HR 2058.

This bill evolved from the letter sent by DHHS Sec. Burwell by House leaders Boehner, McCarthy and Upton.

 

[nicnik]

The page with Rep Cole's is gone, but now's there's this:
Bill Summary & Status - 114th Congress (2015 - 2016) - H.R.2058 - Cosponsors - THOMAS (Library of Congress)

4 Republican co-sponsors:
Rep Guthrie, Brett [KY-2]
Rep Hunter, Duncan D. [CA-50]
Rep Rooney, Thomas J. [FL-17]
Rep Rouzer, David [NC-7]

 

[Lessifer]

The search times out, so you'd have to search every time you click the link.

For convenience, here are his comments:

INTRODUCING THE FDA DEEMING AUTHORITY CLARIFICATION ACT OF 2015 -- (Extensions of Remarks - April 28, 2015)



[Page: E596]
---

SPEECH OFHON. TOM COLEOF OKLAHOMAIN THE HOUSE OF REPRESENTATIVESTUESDAY, APRIL 28, 2015

• Mr. COLE. Mr. Speaker, today I rise to introduce legislation, the FDA Deeming Authority Clarification Act of 2015, to make a technical change to the Family Smoking Prevention and tobacco Control Act (FSPTCA). The Family Smoking Prevention and Tobacco Control Act provides the framework for the Food and Drug Administration (FDA) to regulate tobacco products and products with nicotine derived from tobacco.

• Under the FSPTCA, the FDA was provided immediate regulatory authority over cigarettes, smokeless tobacco, and roll-your-own tobacco. Further, the FSPTCA allows FDA to regulate other tobacco products through a regulatory process.

• The issue that my legislation seeks to remedy relates to a specific date--the predicate/grandfather date of February 15, 2007. The FSPTCA specifies that any cigarette, smokeless tobacco or roll-your-own tobacco product that was in the market before February 15, 2007 is grandfathered and can stay on the market without manufacturers submitting applications to FDA approval, but FDA is still able to regulate these products.

• Manufacturers making changes to grandfathered tobacco products or introducing new tobacco products after this date are required to file an application with the FDA.

• Further, a manufacturer is able to file a more abbreviated substantial equivalence application if the manufacturer can demonstrate that the modified or new tobacco product is substantially equivalent to a tobacco product that was on the market before this grandfather date. For this reason, this date is doubly important because it serves as both the grandfather date and the predicate date.

• The FSPTCA further lays out that any products that came to market between February 15, 2007 and the date of enactment (June 22, 2009), or during the following 21 months (before March 22, 2011) were permitted to stay on the market, but the manufacturer was required to file a substantial equivalence (SE) for those products before the end of this transition period.

• Finally, no product may be brought to market after this transition period without authorization from FDA.

• Questions may be raised as to why the so-called predicate/grandfather date of February 15, 2007 was picked in the Act. If you look at the legislative history, February 15, 2007 was the date the Act was introduced in the 110th Congress. There was no other specific reason for the date chosen in the Act. Moreover, the 2007 date reflects the predicate/grandfather date for those immediately regulated products--not for products that FDA could choose to regulate at a later time.

• On April 25, 2014, FDA released its proposed deeming regulation, which would grant authority for the agency to regulate cigars, vapor products and other products with nicotine derived from tobacco.

• However, in the proposed rule, the agency stated it would maintain the February 15, 2007 as the predicate/grandfather date for newly deemed products even though the FDA has the regulatory discretion to choose a different date. Notably, the FDA provided for a two-year transition period, similar to the 21-month transition period contained in the Act.

• The FDA claims that it lacks the legal authority to change the February 15, 2007 date even though it has used regulatory authority to make a number of decisions that were not spelled out in the initial Act. The agency should apply that same authority to altering the predicate/grandfather date for newly deemed tobacco products, while maintaining this important transition period.

• Should the agency choose not to alter the date, the February 15, 2007 predicate/grandfather date will make it costly and create significant barriers for the industry and the FDA to bring innovative new products that may significantly reduce the harms associated with tobacco to market, and could force the withdrawal of many products that have come to market since February 2007.

• The end result will be that newly deemed tobacco products would be treated much more harshly than immediately regulated products. Specifically, the ``look back'' period for cigarettes, smokeless tobacco and roll-your-own tobacco products was two years (June 2009 to February 2007) while the period for newly deemed products would be eight years (June 2015 to February 2007) if FDA meets its June 2015 target to publish a final deeming rule, and perhaps longer if FDA does not publish its final rule in time.

• It makes no sense that immediately regulated products--which Congress decided were most in need of FDA regulation--get such an advantage over later regulated products.

• In addition, applying the February 2007 predicate/grandfather date to newly deemed products or failure to provide for a transition period will immediately and dramatically add to FDA's enormous backlog of SE applications, which stands at thousands to date.

• Even though the FDA already has this authority, the legislation I introduce today will underscore that FDA should choose a new grandfather/predicate date each time the agency deems new tobacco products. Specifically, the bill would make the grandfather/predicate date for newly deemed tobacco products the effective date of the final rule and mimic the 21-month transition period provided for cigarettes, smokeless tobacco and roll-your-own tobacco.

• Accordingly, on the crucial issue of path to market, later regulated products would be treated no better and no worse than immediately regulated products.

 

[Lessifer]

Common sense legislation, imagine that. I still don't agree with deeming vaping products as tobacco, but at least this wouldn't kill the industry, not immediately anyway.

 

[DC2]

I am blessed to be represented by folks like Darrell Issa and Rocky Chavez.
They have told me they will support our cause.

One of the co-sponsors of this bill (Duncan Hunter) is the representative next door to me.
God bless him as well.

 

[Luisa]

The page with Rep Cole's is gone, but now's there's this:
Bill Summary & Status - 114th Congress (2015 - 2016) - H.R.2058 - Cosponsors - THOMAS (Library of Congress)

4 Republican co-sponsors:
Rep Guthrie, Brett [KY-2]
Rep Hunter, Duncan D. [CA-50]
Rep Rooney, Thomas J. [FL-17]
Rep Rouzer, David [NC-7]

I wish I could vote for these honest Reps!

 

[nicnik]

I am blessed to be represented by folks like Darrell Issa and Rocky Chavez.
They have told me they will support our cause.

One of the co-sponsors of this bill (Duncan Hunter) is the representative next door to me.
God bless him as well.

OK, six Republicans and zero Democrats so far. Thanks for communicating with representatives!

 

[Luisa]

Send them love from Texas--and come to Texas to help us.

 

[Bob Chill]

Nice to see this type of legislation getting put on the table at least. The SE date has by far the most serious implications on the world as we know it today. We know the tax man is coming. We know the free flowing bottled nic juice internet era is probably coming to an end. But both of those issues would come with a much softer blow is the SE date is changed to 2015.

 

[Endor]

I am blessed to be represented by folks like Darrell Issa and Rocky Chavez.
They have told me they will support our cause.

One of the co-sponsors of this bill (Duncan Hunter) is the representative next door to me.
God bless him as well.

You are blessed. I've always held a lot of respect for Issa.

 

[Bill Godshall]

Everyone who opposes FDA's proposed e-cig ban should contact their US Rep urging them to oppose FDA's deeming reg (because it would ban >99.9% of e-cigs now on the market) and urge them to become a cosponsor of HR 2058.

 

[AndriaD]

Here's the email I just sent:

Dear Rep. Woodall,

I'm writing to urge you in the strongest possible terms to support HR 2058, to move the Feb 15, 2007 "Substantial Equivalence" date from 2007 (when e-cigarette technology had barely even arrived) to 2015 (i.e. the date FDA issues the Final Rule for its proposed "deeming" regulation/ban) for all e-cigs and other new "tobacco products."

If this date is not moved, then greater than 99% of all existing e-cigarette products will be effectively BANNED -- which will result in millions of smokers never having the opportunity to quit smoking via the only means of cessation that has ever worked: e-cigarettes -- as well as actively encouraging the formation of a black market for these products. Please don't play into the hands of the corrupt and already-obscenely-rich pharmaceutical industry by failing to support this crucial Bill.

Thank you very much for your attention,

Andria Duncan

 

[Alexander Mundy]

Everyone who opposes FDA's proposed e-cig ban should contact their US Rep urging them to oppose FDA's deeming reg (because it would ban >99.9% of e-cigs now on the market) and urge them to become a cosponsor of HR 2058.

Done:

Dear Rep. Long,

I write today to ask you to support H.R.2058 - FDA Deeming Authority Clarification Act of 2015 dealing with the "grandfather date" that is hard coded into the FSPTCA. This date, February 15, 2007, is the date the FSPTCA was enacted into law by Congress. The date is important since it is the date which beyond no new tobacco product could be marketed without going through extremely expensive (on the order of a million dollars per very specific product) new product approval or substantial equivalence. (This does not guarantee a product approval, it is the research and fees to submit for approval)

H.R. 2058 would make the "grandfather" date for any newly deemed tobacco products (deeming puts a product under FDA authority to regulate) the date the deeming becomes final, just as the hard coded date did with cigarettes. The FDA is in the process of deeming ecigarettes as a tobacco product. As it stands this hard coded date would make all ecigaretee products not on the market before the date subject to the expensive approval.

Congresses intent was to leave products on the market before the date of deeming available, however the hard coded date has (unforeseen at the time) dire impact on the ecigarette market. If the hard coded date is kept, then greater than 99% of all existing e-cigarette products will be effectively banned and the whole industry will be turned over to big tobacco since they are the only ones that can afford to put their products through the process.

Further exacerbating the issue is that big tobacco "cigalikes" are less effective at keeping people off cigarettes than the products that will be effectively banned. I myself smoked cigarettes for over 20 years and although I tried gums, lozenges, cold turkey, hypnosis, and Chantix (which I wouldn't wish on my worst enemy) I was unable to stop. I had resigned myself to smoking for whatever lifespan I had left. One day I tried a big tobacco "cigalike" but over the course of several weeks was back to smoking. I ran across someone using what is referred to as a "mod" which is a second generation ecigarette that has no resemblance to a cigarette and he conveyed to me that he had tried cigalikes with similar results but the mod had worked for him. I ordered one (there were no brick and mortar shops in Springfield at the time) and have not touched a cigarette in over over 2 years and have no urge to. I feel better, can breath better, taste food, and no longer smell like an ashtray. Am I less likely to die from the effects of ecigarettes than from combustible cigarettes? Research is pointing that direction, but that is not what this bill is concerned with. It is concerned with my personal liberty to choose to use second and third generation ecigarettes (which will be effectively banned) instead of smoking combustible cigarettes.

Please consider supporting H.R. 2058 and even co-sponsoring it. Do not let big tobacco win and take over the industry with their inferior cigalikes.

 

[Bill Godshall]

The text of HR 2058 has been posted on Thomas
THOMAS (Library of Congress)

I've cut and pasted it below (as weblinks on Thomas expire after 30 minutes)



H.R.2058 -- FDA Deeming Authority Clarification Act of 2015 (Introduced in House - IH)

HR 2058 IH

114th CONGRESS

1st Session

H. R. 2058
To amend the Federal Food, Drug, and Cosmetic Act to provide for a certain effective date with respect to deemed tobacco products, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

April 28, 2015
Mr. COLE introduced the following bill; which was referred to the Committee on Energy and Commerce


A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for a certain effective date with respect to deemed tobacco products, and for other purposes.

• 
  Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

• 
  This Act may be cited as the `FDA Deeming Authority Clarification Act of 2015'.

SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT TO DEEMED TOBACCO PRODUCTS.

• 
  Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is amended--

• • 
    (1) by striking `This chapter shall apply' and inserting the following:

• • 
    `(1) IN GENERAL- This chapter shall apply'; and

• • 
    (2) by adding at the end the following new paragraph:

• • 
    `(2) DEEMED TOBACCO PRODUCTS- For each tobacco product deemed subject to the requirements of the Act pursuant to paragraph (1), each reference in sections 905(j) and 910(a)--

• • 
    `(A) to `February 15, 2007', shall be considered to be a reference to `the effective date of the regulation under which a tobacco product is deemed subject to the requirements of this Act pursuant to section 901(b)(1)'; and

• • 
    `(B) to `21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act', shall be considered to be a reference to `21 months after such effective date'.'.

 

[nicnik]

"(B) to `21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act', shall be considered to be a reference to `21 months after such effective date'."

But doesn't the 21 months only change the SE date to the end of 2008? Must be something I don't understand, here.

 

[Bill Godshall]

Please note that "effective date" refers to the date the Final Rule for the Deeming Regulation takes effect.

 

[nicnik]

Please note that "effective date" refers to the date the Final Rule for the Deeming Regulation takes effect.

Thanks! Confusing to read, for me, but I believe you.

 

[caramel]

I'll pray.

 

[Cool_Breeze]

Is an endorsement of a change to a Deeming Regulation an endorsement of the Deeming Regulation with the change..?

 

[DC2]

Is an endorsement of a change to a Deeming Regulation an endorsement of the Deeming Regulation with the change..?

Not if you qualify your endorsement.