FDA spokesman acknowledges tobacco product classifcation [Paducah Sun, Kentucky]

[Placebo Effect]

Electronic cigarette risks unclear

Jeff Ventura, spokesman for the U.S. Food and Drug Administration, said recent court cases prevent the FDA from classifying and regulating e-cigarettes as drug delivery products and must be listed as tobacco products. As e-cigarettes are relatively new, they are not regulated under the Family Smoking Prevention and tobacco Control Act of 2009.

Let me first note that the FDA's opposing brief in the Totally Wicked case is due today, and their argument may end up being the exact opposite of what is said in this article.

The article itself is not very good at all -- the e-cigarette user they talked to didn't like the product, the doctor they spoke to spouted the same garbage as usual, and the FDA person referenced carcinogens and antifreeze. However, that above quote is significant, as it might be the FDA's first acknowledgment of their intent to live with the Court of Appeals' decision.

I was so stunned I called the author, and he confirmed that what he wrote was an accurate summary of his conversation with Jeff Ventura. I also pointed out the facts about the carcinogen and antifreeze claims, and he found it amusing. I'm going to forward him some more info.

 

[JustJulie]

The docket shows that TW and FDA both agreed to a continuance for FDA's response to TW's motion for a temporary restraining order and preliminary injunction, and the motion for a continuance notes:

The parties are discussing whether this matter can be resolved without further litigation, and defendants hereby request a further extension of time to respond to plaintiff’s motion.

 

[StormFinch]

Could it possibly be that we've... won?

I'm guessing that with TW having precedence, not to mention a preponderance of party members in place that actually likes to reign in the FDA, that they may have decided they weren't getting anywhere in this battle?

 

[Placebo Effect]

Could it possibly be that we've... won?

I'm guessing that with TW having precedence, not to mention a preponderance of party members in place that actually likes to reign in the FDA, that they may have decided they weren't getting anywhere in this battle?

We probably won another battle, but the war is still on. Just wait until the FDA starts considering how to regulate e-cigarettes under the tobacco Control Act.

 

[Bill Godshall]

For clarification, the excerpt highlighted by Placebo Effect in The Paducah Sun is not a quote from Jeff Ventura (who replaced Siobhan Delancey as the FDA's media spokesperson at the beginning of this year), but rather a statement by the reporter indicating that Ventura acknowledged the court rulings against the FDA.

But according to the next paragraph in the article, the FDA hasn't changed its e-cigarette policy or its intentionally misleading claims about the products.

Ventura cited a FDA statement called “FDA and public health experts warn about electronic cigarettes” available at fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm. According to the report, laboratory analysis of electronic cigarette samples found some contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient of antifreeze.

 

[Bustastew]

Ventura!

YouTube - Ace Ventura - Yes Satan?


POST 200 MUHAHAHAHAHA, I still feel noobish here compared to many though =/

 

[Bustastew]

Jesus Christ Bill, 717 postings! Does your lawn ever get mowed?

 

[freakindahouse]

FYI, ECITA has produced a blog post about this today.

 

[Vocalek]

Yes, and the blog speaks quite highly of our own Julie.

 

[freakindahouse]

But of course, Elaine! No word of a lie! You guys are amazing! I seem to remember having quoted you before, too!

 

[DuncanDisordely]

Hi Guys,

This seems to be the root of knowledgeable people, could anyone break down the legal sschmaschmoo into simple terms for us newbies? Basically....whats the status in laymans terms? Are we winning? Does a ban look imminent? What does all of this mean for us?

Sorry if this is in the wrong place, and repeat apologies for this information being available already in tech format, but I'm not a lawyer and I'm guessing I'm not alone!

Thanks so much in advance you lovely lovely people.

Love to all!

Duncan

 

[ckc]

Hey up Duncan,

As your in the UK the best place to catch up on whats been happening here is this thread.The MHRA wanted to bring Ecigs under a medical definition.To me it's as if they're waiting to see what the FDA do in the USA.

http://www.e-cigarette-forum.com/forum/e-cigarette-news/97220-uk-regulation-reports-updates.html

The MHRA still haven't given out a final report/decision,they keep saying....next month,next couple of months.

There's also a Tobacco consultation going on in the EU,where they are after placing Ecigs under Tobacco regulations.

Tobacco - Public consultation on the possible revision of the Tobacco Products Directive 2001/37/EC | Public health in Europe

But E-Cigs seemed to feature more in the NRT side of things.

http://ec.europa.eu/health/tobacco/docs/ev_20101020_mipharma_en.pdf

Enjoy your vapes and as you start saving....start stocking up ;-)

I'll let someone else give you the USA story.

 

[JustJulie]

Hi, Duncan--

The U.S. end of things, well, it seems clear that the FDA will have jurisdiction over e-cigarettes. The real question is whether they'll be able to regulate them as pharmaceuticals (which would mean expensive and lengthy testing and probably being pulled from the market in the meanwhile) versus as tobacco. The NJOY v. FDA and Totally Wicked v. FDA cases are deciding that very issue right now. While there's no definitive decision, it seems as if the courts are VERY receptive to the argument that absent therapeutic claims, e-cigs should be regulated as tobacco.

While those court cases are ongoing, we battle attempts to restrict/ban e-cigarettes on a state and local level. For example, NY is currently considering legislation that would essentially ban the sale of e-cigarettes. Several other states are trying to include use of e-cigarettes in indoor bans on smoking, and at least one state (Utah) has launched a crusade to require flavors be banned in connection with e-liquids and that sales be conducted face-to-face.

Good times . . . not.

 

[kristin]

"....while the electronic cigarette is safer than a conventional cigarette, it would be a stretch to call it a ‘safe’ product.”

Can NRTs really claim to be 100% safe, either?

 

[Vocalek]

Can any product prove it is 100% safe?

 

[kristin]

LOL @ Elaine. EXACTLY! So why must e-cigarettes?

 

[MoonRose]

Life itself is not 100% safe.

 

[rothenbj]

It shouldn't take much to prove it's better than twice as effective as cold turkey, as NRT claims. Though more appropriately stated, it shouldn't take much to prove it succeeds more often than the 93% failure rate of NRT.

 

[freakindahouse]

Trouble is, if we prove this, then we prove it's a drug... and lose it!

Does appear to be a bit of Catch 22, but we're working on solutions.

 

[kristin]

Trouble is, if we prove this, then we prove it's a drug... and lose it!

Does appear to be a bit of Catch 22, but we're working on solutions.

Unless we can get them to admit that "quitting smoking" is not the same as "treating nicotine addiction." Smoking isn't an official disease in the U.S. - nicotine addiction is. Just because it helps you stop smoking doesn't mean it's a drug treatment for nicotine addiction anymore than sugar-free cookies are a drug treatment for diabetes.