FDA Altria, Reynolds & Lorillard sue FDA to block Substantial Equivalence (SE) Guidance

[Bill Godshall]

Altria, Reynolds and Lorillard sue FDA to block recently issued SE Guidance, claim agency ignored ACA law requiring public comment and review, and agency exceeded authority of FSPTCA by claiming product changes also include package label changes.
Big Three sue over packaging labels - Local Business - WS Journal


The FDA's SE Guidance that is being challenged was posted and discussed at
http://www.e-cigarette-forum.com/fo...sible-obtain-fda-se-approval-2006-e-cigs.html

 

[Bill Godshall]

More news articles
Tobacco Companies File Suit Against FDA Over Label Regulations - NASDAQ.com
U.S. Tobacco Companies File Suit Against FDA Over Label Regulations - WSJ
UPDATE 3-Tobacco companies sue U.S. FDA over label approvals | Reuters
http://consumerist.com/2015/04/14/tobacco-companies-sue-fda-over-cigarette-packaging-guidelines/

 

[AndriaD]

I don't really know enough about how all these things are going to know if this is good for our cause, or not, or how to feel about it. I wonder if anything has come of that request from Boehner about moving the "grandfather" date.

Andria

 

[DEA7H INC]

I don't really know enough about how all these things are going to know if this is good for our cause, or not, or how to feel about it. I wonder if anything has come of that request from Boehner about moving the "grandfather" date.

Andria

The FDA I believe have stated they do not have the authority to change the date and it must be done through congress.

 

[DC2]

The FDA I believe have stated they do not have the authority to change the date and it must be done through congress.

The FDA said they did not think they had the authority.
But then some Congressmen sent them a letter asking them to change the date.

So either the FDA, or the Congressmen, don't know what the hell they are doing.
Or maybe the FDA was just lying.

 

[DEA7H INC]

The FDA said they did not think they had the authority.
But then some Congressmen sent them a letter asking them to change the date.

So either the FDA, or the Congressmen, don't know what the hell they are doing.
Or maybe the FDA was just lying.

Pretty much. It's obvious they have no intention of changing the Substantial Equivalence date so were screwed anyway when they finally throw down the gauntlet.

 

[squee]

The FDA I believe have stated they do not have the authority to change the date and it must be done through congress.

And they are correct. That date was part of the law and the FDA cannot simply change that. Congress is who decided that date and Congress is who can change it.

If John Boehner wants to change it, tell him to pass a bill to do so. Writing letters to the FDA is pointless (the same as those senate dems who wrote asking them to speed up the regulatory process - pointless)

 

[DC2]

And they are correct. That date was part of the law and the FDA cannot simply change that. Congress is who decided that date and Congress is who can change it.

I don't recall the FSPTCA saying anything about any dates.

 

[squee]

I don't recall the FSPTCA saying anything about any dates.

REPORT PRECEDING INTRODUCTION OF CERTAIN SUBSTANTIALLY EQUIVALENT PRODUCTS INTO
INTERSTATE COMMERCE.—‘‘(1) IN GENERAL.—Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15,2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—‘‘(A) the basis for such person’s determination that—‘‘(i) the tobacco product is substantially equivalent,within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that is in compliance with the requirements of this Act; or

Page 20 http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf

 

[DC2]

]http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf

...............

 

[stevegmu]

If BT if for something, we must be against it...
Odd, I thought BT wanted to kill vaping. Perhaps I was correct, when I have said BT sees the future and wants in the game, as well. They, along with NJOY are also the only ones with the money and ability to pursue litigation to 'save' and 'normalize' vaping...