Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[TheIllustratedMan]

So am I wrong in thinking that at this point, barring the judge ruling that PVs don't need FDA approval, that the FDA needs to hold the PV to the same standards as any other product they would be reviewing for approval, and can't use the new law as leverage to not approve it? If they tried, anyone could just point to today's brief.

 

[eric]

It actually sounds to me the FDA is grabbing at straws. More so than either Smoking Everywhere or njoy, and their arguments seemed pretty weak to me previously. I'm actually less worried now than I was.

 

[Sun Vaporer]

So am I wrong in thinking that at this point, barring the judge ruling that PVs don't need FDA approval, that the FDA needs to hold the PV to the same standards as any other product they would be reviewing for approval, and can't use the new law as leverage to not approve it? If they tried, anyone could just point to today's brief.

The FDA is arguing that the E-Cig needs to go though the proper application and approval process, and there is nothing in the new legislation that changes that. The FDA is further arguing that the way the product is marketed is not defining for FDA approval, rather it only a part of the totality of the circumstances and the most important aspect to be considered by the Court is to look at the "indented use" of the e-cig as a product. The FDA further argues that it is not imposing a "ban" on the e-cig just because it is requiring it to go through the proper approval process. The FDA contends that such a definition would define a "ban as one that is too narrow------Sun

 

[TropicalBob]

To me, a reasonable extension of this stance would be that the e-cig must undergo the same testing and meet the same standards and regulations as Big Pharma's nicotine inhaler, as an example. Both products deliver the drug nicotine to addicts. Neither do so with tobacco. Both must be approved by the FDA and strictly regulated for content and sales.

 

[cdmcfud]

[FONT="]Philip Morris USA Files Lawsuits to Stop the Sale of Counterfeit Cigarettes [/FONT]
[FONT="]Congress Takes up Legislation to Address Illegal Cigarette Trade[/FONT]
[FONT="]RICHMOND, VA (May 18, 2009) - Philip Morris USA filed lawsuits today against retailers selling counterfeit versions of the company’s Marlboro® brand cigarettes. PM USA conducts periodic marketplace purchases of cigarettes and found each of the named defendants selling counterfeit cigarettes during 2009.

PM USA continues to pursue counterfeit sellers in New York. Following last week's filing against Mastic, N.Y.-based Tammy's Smoke Shop, PM USA filed three lawsuits today against seven retailers in federal courts as follows:[/FONT]
[FONT="]Eastern District of New York[/FONT]
[FONT="]Ashley One Stop Deli

88 Stop & Go Newsstand

Prospect Park Deli[/FONT]
[FONT="]111-20 101 Avenue, Richmond Hill, NY 11419

106 21 71st Avenue, Forest Hills, NY 11375

155 Prospect Park SW, Brooklyn, NY 11218[/FONT]
[FONT="]Southern District of New York[/FONT]
[FONT="]336 Deli Grocery

Manhattan Tobacco & Grocery[/FONT]
[FONT="]336 Est. 106 Street, New York, NY 10029

881 9th Avenue, New York, NY 10019[/FONT]
[FONT="]District of New Jersey[/FONT]
[FONT="]Jaritza II Supermarket

New York Deli Grocery[/FONT]
[FONT="]1085 Summit Avenue, Jersey City, NJ 07307

1102 New York Avenue, Union City, NJ 07087[/FONT]
[FONT="]
Increases in federal, state and local excise taxes have provided new incentives for tax evasion and other criminal activity related to cigarettes. In New Jersey, the average retail price for Marlboro® brand cigarettes is $7.25, of which $3.58 is excise taxes*. By comparison, the average retail price for Marlboro® brand cigarettes is $9.64 in New York City, of which $5.26 is excise taxes. The counterfeit cigarettes purchased from the retailers above bore no tax stamp or a counterfeit tax stamp. As a result, the applicable excise taxes were not paid.

“While the illegal cigarette trade in New York is becoming increasingly complex, Philip Morris USA remains committed to taking steps necessary to protect our brands and the legitimate cigarette trade,” said Joe Murillo, vice president and associate general counsel, Altria Client Services, speaking on behalf of PM USA.

PM USA pursues numerous strategies to address the sale of counterfeit, illegally imported, stolen and untaxed or under-taxed cigarettes. In addition to litigation, these include working closely with law enforcement authorities in New York to address the state’s continuing contraband cigarette trafficking problems and advocating for legislation with more stringent penalties for the violation of laws related to contraband trade in cigarettes. PM USA supports H.R. 1676, the Prevent All Cigarette Trafficking Act (the “PACT” Act), introduced by Congressman Anthony Weiner (D-NY), which is scheduled to be considered by the U.S. House of Representatives on Tuesday, May 19.

The PACT Act includes provisions designed to bring an end to tax-evading sales of cigarettes and smokeless tobacco products over the Internet and provides the Bureau of Alcohol, Tobacco, Firearms and Explosives – the key crime fighters in this area – with more resources and tools to accomplish this goal. These include creating six regional contraband cigarette trafficking teams, including one in New York City; a new national Tobacco Intelligence Center to monitor and coordinate illegal cigarette trafficking investigations in the United States; and a computer database that will track and analyze information from remote sellers of tobacco products.

“This latest round of counterfeit activity illustrates the need to provide law enforcement authorities with the tools they need to decisively address these problems,” Murillo said. “We strongly support the PACT Act and applaud the sponsors for recognizing the importance of this issue.”

Philip Morris USA is an operating company of Altria Group, Inc. (NYSE: MO).

*excise taxes include federal (FET), state (SET) and, where applicable, locality excise taxes


[/FONT]
[B][FONT="]Press Contact
[/FONT][/B][FONT="]Philip Morris USA Media Relations
(804) 484-8897

Philip Morris USA assumes no obligation to update, correct or otherwise modify any of these communication materials. We recommend that you view the most recent press releases and statements in order to receive the most current information.


It seems to me Philip Morris was putting presser on the FDA. When it started this action customs started holding shipments didn't they?
[/FONT]

 

[jaja87]

hey all. i'm a new user here. been following the news on e-cigs vs FDA for a while with great disgust. i'm a nursing student so health issues like this interest me alot. i was just wondering if this new update is good news to e-cigarette users, or is it more of the same nonsense that the FDA is trying to pull?

 

[Sun Vaporer]

hey all. i'm a new user here. been following the news on e-cigs vs FDA for a while with great disgust. i'm a nursing student so health issues like this interest me alot. i was just wondering if this new update is good news to e-cigarette users, or is it more of the same nonsense that the FDA is trying to pull?

The only good news would be if Judge Leon finds for SE and NJOY. The FDA left no middle ground for Judge Leon---Sun

 

[DyZiE]

did the FDA just attack SE's argument by addressing the weak point of how a product is labled being relative to the intended uses by the purchaser?

water pipes are labled and sold as "tobacco products" but of the 2 i own and the hundreds that ive seen in private possession ive only seen one that was indeed used soley for tobacco. as a matter of fact its not even accepted publicly that anyone purchasing a water pipe is likley to us it for tobacco. Im sure there are exceptions but i dont think more than 2% of america honestly believes that head shops are found on every other corner b/c of tobacco use.

 

[Sun Vaporer]

The FDA went on to contend that the Plaintiff’ incorrectly asserts that a product is not a "drug" within the meaning of the FDCA unless the manufacturer makes "medical or therapeutic claims . . . on the product’s labeling or promotional materials." ..........The "intended use" of a product refers, in turn, "to the objective intent. That is the standard---Sun

 

[DyZiE]

The FDA went on to contend that the Plaintiff’ incorrectly asserts that a product is not a "drug" within the meaning of the FDCA unless the manufacturer makes "medical or therapeutic claims . . . on the product’s labeling or promotional materials." ..........The "intended use" of a product refers, in turn, "to the objective intent. That is the standard---Sun

ahhhhhh, so my water pipe argument actually helps the FDA's point. 8-o

oops

 

[Sun Vaporer]

ahhhhhh, so my water pipe argument actually helps the FDA's point. 8-o

oops

The water pipe argument is in a whole other section of case law then what is being argued here. Even SE and NJOY conceed that issue. It is too bad the E-Cig manufactures did not think this out better a long time ago. But hindsight is 20/20-----Sun

 

[Mac]

So if the judge rules against SE will this become law or will it still be a gray area under which they can be openly sold but are difficult to import as the case goes through an appeals process?

 

[iduditz]

And the intended use of crack pipes?! The problem with the ecigs is that they 1) look like cigarettes, 2) come with nicotine liquid included

 

[Wally]

Is nicotine itself, sold separately (from a delivery device) and sold with no claims made for it (use, benefit, etc.), regulated by the FDA? Is it a scheduled drug?

 

[Sun Vaporer]

So if the judge rules against SE will this become law or will it still be a gray area under which they can be openly sold but are difficult to import as the case goes through an appeals process?

If Judge Leon holds for the FDA, it will confirm the power the FDA --to ban the importation, sale, and marketing of e-cigs until they go though the entire application and approval process and then only if they are in fact approved by the FDA. A stay pending an appeal is very rare in a case where the FDA is involved.

Is nicotine itself, sold separately (from a delivery device) and sold with no claims made for it (use, benefit, etc.), regulated by the FDA? Is it a scheduled drug?

When used for human consuption, nicotine is considered a drug subject to FDA mantates.


Sun

 

[jaja87]

how long do you think it will take for the judge to make a ruling?

 

[Sun Vaporer]

how long do you think it will take for the judge to make a ruling?

Jaja--by the end of the month is a reasonable expectation.


Sun

 

[Dorian_Gray]

Before the end of the month would be a very reasonable estimate.----Sun

Plenty of time for them to receive their bribes from the bad guys

 

[Sun Vaporer]

Plenty of time for them to receive their bribes from the bad guys

Dorian--talking about anyone taking a bribe in a Federal Court where Judge Leon presides is just not realisitic and lacks merit---maybe in some move, but not here in the real world and not in his courtroom.

Sun

 

[Dorian_Gray]

Sun,
Not meant literally. Just a comment on the state of affairs.

To paraphrase Aristotle (I believe in the Nichomachean ethics, but could be wrong) The only good monarch (read that politician) is one who does not wish to be one.