FDA Big news coming out of FDA

[DrMA]

a Bit of background for this c/o our frenemy, Dr. M. Siegel. Note the date of this post
http://tobaccoanalysis.blogspot.com/2013/01/usefulness-in-smoking-cessation-or.html

 

[Sirius]

The FDA proposed banning even more truthful claims about e-cigs, and is further challenging Judge Leon’s 2010 ruling that an e-cig is a “tobacco product” unless the manufacturer makes a “therapeutic claim”: agency proposes redefining and regulating/banning any “tobacco product” as a “drug, device or combination product” if the agency believes it is “intended for use in the . . . prevention of disease” or “intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.”
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf

Note that FDA’s proposal above follows warning letters FDA sent on 9/8/2010 to five e-cig companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to use their e-cig product) violated the FDCA despite Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of marketing claims cited by FDA could be considered a “therapeutic claim”)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm (Johnson Creek)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225177.htm (Gamucci)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225178.htm (E-CigaretteDirect)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225181.htm (Ruyan America)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225187.htm (E-Cig Technology Inc)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 (Judge Leon’s 1/14/2010 ruling striking down FDA’s e-cig ban as unlawful, and stating that FDA could only regulate e-cigs as drugs or devices if a manufacturer made a “therapeutic claim”).

Totally awesome post. Thanks!
Funny how the laws work. Some government judge rules eliquid is a tobacco product and it makes it so. Hopefully that's as far as it goes.

 

[crxess]

Big Brother Syndome

The assertion by government that people are incapable of thinking for themselves and therefore legislation costing Citizens Billions must be put into place.

The Ruling does nothing more than Clarify for all other government divisions and agencies, which piece of the pie they can go after.

*Avoiding increased Manufacturing cost(Nicotine) <but may eventually restrict sales.>
So, now manufacturers will have to increase pricing to recover loses through restrictions.

Odd how first the EU and now the FDA so quickly made releases on the Heels of the WHO Summit.........................or is it?

 

[r77r7r]

I say everybody go take frustrations out on this lady. It is nice that Con-sumer Reports will take some feedback.
http://www.consumerreports.org/cro/health/e-cig-uspstf-advice

 

[stevegmu]

From what I get after skimming it is that this is just the proposal. So still wait and see, and some time to go.
There is a 60 day comment period.
Then:
B. Proposed Effective Date
The Agency proposes that any final rule based on this proposal will become effective 30
days after the date of publication of the final rule in the Federal Register. During the pendency
of this rulemaking, manufacturers will continue to be under an obligation to comply with all
applicable provisions of the FD&C Act and applicable regulations.

Like all the other federal proposals which go on for years and years. I bet the vendors are pleased, however...

 

[Sirius]

I don't care how they are labeled as long as they're available and not taxed insanely. We have a problem in the country, "bartering with god". I see many people saying "keep them legal I'll pay the tax", but they shouldn't be taxed. The cigarette and booze taxes are wrong, and taxes on ecigs are even more wrong. We already pay sales tax. It gives capitalism a bad name. We have a free market, but we don't. My governor wants to ban them completely.. I think the fear is that if they can find a way to make money from them, like cigarettes, they will keep them around. But that's totally backwards logic. It shouldn't be up to them if ecigs are available or not.

Corporateizm and Capitalism are two different things. I think that's where Socialist confuse people. Suck them in if you will. BT and BP need to reighned in. And not at the expense of us citizens. But crap always runs down hill. Especially in a country with a government on steroids.

 

[thedeval]

I say everybody go take frustrations out on this lady. It is nice that Con-sumer Reports will take some feedback.
http://www.consumerreports.org/cro/health/e-cig-uspstf-advice

ok... Done...

""they worked for me... I quit smoking... lost weight... got better looking... even reversed time and started getting younger rather than older... (did i mention I got better looking?? you should try them)

If you don't belive me, then just ask me again, And I will tell you again... 8)
Like · Reply · Just now""

 

[Rabbit Slayer]

THE SKY IS FALLING YET AGAIN woohoo

 

[r77r7r]

Uh, Oh, I sidetracked the Bosses thread.

 

[WillyZee]

The FDA will spin vaping whatever way they want ... as long as it gets the money rolling in

nicotine base is the easiest target ... and IMO, nicotine base will not be available in the near future.

we are about to see Prohibition 2.0 kick in

 

[philoshop]

a Bit of background for this c/o our frenemy, Dr. M. Siegel. Note the date of this post
http://tobaccoanalysis.blogspot.com/2013/01/usefulness-in-smoking-cessation-or.html

Smoking cigarettes is medically described as "Tobacco Use Disorder".
Seems to me a very fine line could easily be crossed here with regard to claims vs intended outcomes if one were to push hard enough. And who is to be tasked with setting the boundaries of 'therapeutic' use?

Thanks for the post DrMA. Right on topic as always.

 

[Ant G]

I know full well I'm stating the obvious, but I'm so bloody annoyed at things I'm thinking aloud...

All the while this crap is going on in the US, the EU and the rest of the world, it's totally ok to walk into a store and buy products that are known to KILL.

Sorry folks. As said, I know I'm stating the obvious, but it just makes my blood boil.

F****** outrageous.

 

[Jman8]

I don't see the huge concern here, sorry. I do see reasons to be concerned.

This is still the 2010 battle being played out, but also appears to me as clarification for Final Rule to be implemented.

I don't fully get why any eCig vendor feels a desire to make therapeutic claims, or anything that resembles that. In 2009, I could see why that would be very big deal, as no one had heard of this product and it would be advantageous to market a product that could plausibly lead to smoking cessation / reduction. But in 2010, that got significantly updated and I would think both industry and current user group would be aware of this to some degree. Potential users won't be, but this doesn't prevent word of mouth advertising. I think vaping will continue to be well known as a method by which to reduce or eliminate cravings for smoking. And I don't think industry needs to be involved in that message, even a little bit.

With all that said, I don't favor this regulation update, and do think in principle that it sucks. I think any vendor that was using testimonials and or News (blog) to convey studies that show why their product, or eCigs in general, are of benefit to the consumer (in a quasi medical way) will take a hit. That would be perceived as a huge hit if a vendor was relying on this. But IMO, they don't need that anymore. At one point, years ago, it made great sense why you might want to rely on that. Now, it strikes me as asking the FDA to come knocking on your door with a warning letter.

I do think it could impact the Supplier Forum here, as those threads are (arguably) "circumstantial" evidence, that could be used to show vendor was marketing product in way to lead consumers to believe they could benefit in some fashion (i.e. - love your product and it got me to stop smoking). In that way it would suck that legitimate speech by others is being repressed. But because everyone knows testimonials can be faked, then well, there ya go. I wonder how this would impact Facebook posts on vendor pages as well.

But how this plays out exactly will be interesting to learn and yet seems like it is years away, not months.

 

[Alien Traveler]

All of it does not bother an average vaper like me. Should it?

 

[Bad Ninja]

All of it does not bother an average vaper like me. Should it?

Not really.
Not yet.
However you may see companies become proactive and list ingredients on labels.

 

[oplholik]

Really, at this point, I'm more worried about what the state of Cal. is going to do than I am the FDA.

 

[zoiDman]

Really, at this point, I'm more worried about what the state of Cal. is going to do than I am the FDA.

A Lessor of Two Evils?

 

[oplholik]

It just seems that anything final on the FDA's end is pretty far out in time, as for the Calif. nutballs, anything can happen at almost any time.

 

[zoiDman]

It just seems that anything final on the FDA's end is pretty far out in time, as for the Calif. nutballs, anything can happen at almost any time.

I think that the Reason that California has Done what it is Trying to Do is because of the FDA's Lack of Action so Far.

But I Don't think we have Long to Wait.

 

[Dan011z]

This is ridiculous...