FDA Big news coming out of FDA

[f1vefour]

That doesn't make a difference with the proposed ruling. A company must have commonly marketed cigarettes or chewing tobacco as having these health benefits. A poster or even video won't pass muster and certainly not studies...

Don't get me wrong, I'm certainly not defending nutricigs laughable marketing.

Just trying to understand each angle.

 

[stevegmu]

Don't get me wrong, I'm certainly not defending nutricigs laughable marketing.

I think the proposed ruling is because of companies like Nutricigs. They won't get FDA approval no matter what...

 

[f1vefour]

I think the proposed ruling is because of companies like Nutricigs. They won't get FDA approval no matter what...

And this is a great thing, it's not quite as bad as targeting children but it's bad enough.

 

[stevegmu]

And this is a great thing, it's not quite as bad as targeting children but it's bad enough.

It makes the industry look shady...

 

[f1vefour]

It makes the industry look shady...

I agree, anything that can be used will be.

I don't think it would help but it would be a nice gesture to see a vaper oriented campaign against offensive companies like this, we certainly don't agree or support what nutricigs is doing yet we will likely be made out to.

 

[stevegmu]

I agree, anything that can be used will be.

I don't think it would help but it would be a nice gesture to see a vaper oriented campaign against offensive companies like this, we certainly don't agree or support what nutricigs is doing yet we will likely be made out to.

Professionalism in the industry would go a long way....

 

[Oliver]

I am having a hard time digesting this. Does this mean since my health has improved by using
e-cigs instead of smoking that my physiology has changed and that could be a bad thing?

Regards
Mike

No, just that something has changed!

 

[Katya]

Here is an exert from the FDA Clarification...


"2. How Intended Use Is Determined


In determining a product’s intended use, the Agency may look to “any . . . relevant
source,” including but not limited to the product’s labeling, promotional claims, and advertising
(see, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); United
States v. Storage Spaces Designated Nos. “8” and “49,” 777 F.2d 1363, 1366 (9th Cir. 1985),
Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff’d, 540 F.2d 947 (8th Cir. 1976)).
For example, FDA may take into account any claim or statement made by or on behalf of a
manufacturer that explicitly or implicitly promotes a product for a particular use (see, e.g.,
§ 201.128 (drugs), § 801.4 (devices)).


To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may
include a variety of direct and circumstantial evidence. Thus, FDA may also take into account
any circumstances surrounding the distribution of the product or the context in which it is sold
(see id.; see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of
medical products, generally, circumstantial evidence often ensures that FDA is able to hold
accountable firms that attempt to evade FDA medical product regulation by avoiding making
express claims about their products. As FDA has previously stated, however, the Agency would
not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by
doctors for such use (Ref. 5).


Thus, when a product made or derived from tobacco is marketed or distributed for an
intended use that falls within the drug/device definitions, it would be regulated as a medical
product, subject to the limitations discussed further in this document. Courts have recognized
that products made or derived from tobacco marketed with “disease” claims and certain
“structure/function” claims are drugs (see United States v. 46 Cartons . . . Containing Fairfax
Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of
respiratory diseases); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178
F.Supp. 847, 851 (D. N.J. 1959) (cigarettes marketed for weight reduction))."

https://s3.amazonaws.com/public-ins...ivery&utm_medium=email&utm_source=govdelivery

The more I think about it, the scarier it gets. Who wrote this stuff? What do they want, really? Catch 22? Orwell? Politburo?

They want to eat their cake, and keep their cake, and tax their cake, reclassify their cake and ban their cake all at once?

IOW, "deadly" tobacco products (cigs, cigars etc.) are OK and are not drugs, but potentially "healthier" tobacco products or tobacco products that can help people quit smoking are drugs? And will be available by prescription only? "All animals are equal but some animals are more equal than others" ?...

 

[Katya]

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

I don't get it. Let's say, for the sake of argument, that nicotine addiction can be classified as disease. OK. What about alcohol? Isn't' alcohol addiction a much more dangerous addiction/disease? If so, why is alcohol served at every event/dinner/gala hosted by the White House, the FDA, the NIH, AMA, ACS, etc? Why are free samples of alcohol being offered in grocery stores in CA--the state where everybody DRIVES to their grocery store????

 

[MagnusEunson]

I wonder if the way around this sort of regulation is to simply label everything novelty and sell components in separate store locations as they do e-liquid in much the same way that the adult toys and "water pipes" do in certain shops. Of course, you would still have to be VERY careful about your advertising but that's not too much of a surprise.

THIS ..

At the end of the day the strongest independants will survive following the footsteps of 'Deadhead Shops' and everything else will be replaced by big tobacco alternatives like Vuse.

There is just too much money at stake by both big tobacco and the States that have budgets that hinge on tobacco settlement monies (even loans against future revenue). The only way to restore that political balance is by making nicquids part of the equation for them. Sad but likely inevitable. -Mags

 

[Katya]

I wonder if the way around this sort of regulation is to simply label everything novelty and sell components in separate store locations as they do e-liquid in much the same way that the adult toys and "water pipes" do in certain shops. Of course, you would still have to be VERY careful about your advertising but that's not too much of a surprise.

 

[trying]

Nuticigs contian 1.8% nicotine which makes them tobacco in the eyes of the FDA. Nicotine content trumps supplement regulations and as FDA has said it is the FDA that decides on how to regulate.

 

[Max0819]

VHRB2014,

Not a dig and no hate meant, just an observation.

Seems you should change either your sig or posts. They appear to be quite in disagreement.

As to just "DIY", well I think that misses the point entirely. Enough already with the Nanny State and moral minority subverting rights of the populace by enacting laws alleged for our protection.

Max

Hey! I label all my DIY. "Some of this, some of that, more of the good stuff" LOL.

More to the point. I get less and less concerned with what the shrieking mobs tell me nowadays, and more concerned with what "I" know.

 

[VHRB2014]

Hi Max.Say gooood bye. :?)

 

[Max0819]

Quite the opposite really. If in the 60s and 70s we would have had access to worldwide instantaneous communication, the result would have been much MUCH larger gatherings. Oh my the things we could have done. Now approaching 60, I don't really have the energy. The problem as I see it is a couple of generations of people who seem to think government should control your lives and that it is perfectly normal. It is not, and they should not.

Send the first message, vote out ALL incumbents. Never again vote for anyone in office. Vote NO on every new law. Vote NO on every new fee/tax/charge/etc.

Gather together in an open public area with as many friends as you can. Have peaceful demonstrations (which also means police them yourselves and kick out radicals - I can't tell you how many 'friends' we used to haul off). GET OUT AND DO SOMETHING! Do NOT use the web for demonstrating , use it for setting up demonstrations. And so on.

Max

It's hard to revolt now. Back in the 70s before technology and social media, it was a lot easier. But you catch a record now and you're screwed if your revolt fails. Even your car ins is affected by your criminal record. It's a crappy time to start a rebellion. I'd leave the country before I revolted lol.. You guys can fix it and maybe I'll retire here. Depends on if social security still exists

 

[Ou2mame]

Quite the opposite really. If in the 60s and 70s we would have had access to worldwide instantaneous communication, the result would have been much MUCH larger gatherings. Oh my the things we could have done. Now approaching 60, I don't really have the energy. The problem as I see it is a couple of generations of people who seem to think government should control your lives and that it is perfectly normal. It is not, and they should not.

Send the first message, vote out ALL incumbents. Never again vote for anyone in office. Vote NO on every new law. Vote NO on every new fee/tax/charge/etc.

Gather together in an open public area with as many friends as you can. Have peaceful demonstrations (which also means police them yourselves and kick out radicals - I can't tell you how many 'friends' we used to haul off). GET OUT AND DO SOMETHING! Do NOT use the web for demonstrating , use it for setting up demonstrations. And so on.

Max

They tried that. They ended up just costing cities hundreds of thousands of dollars without even a unified message, to basically camp out. I think our problems stem from social and federal dependence, and no amount of protesting is going to cure that. Society has changed. They can't protest. They're consumers. Everybody thinks they deserve everything that they want and they go into debt doing it. I've got friends who can't even afford rent buying brand new sports cars.

You can't protest stupidity. The school system here is a joke. I'm 34 and went back to college when I was 28 to finish off a degree, and it was the most depressing thing I've ever seen. I was sitting in a class, and nobody knew what the word "prejudice" meant. It was horrifying. And this is an expensive private college. These kids can't protest, they don't even have basic language skills. And the adults are all in debt, they can't take the time off lol.. So yeah. If there's a rebellion I'm out of here, we are going to lose so badly. These people can't even drive to the supermarket without texting, how are they going to risk their precious cellphones to have a real rebellion. I'll just get my dual citizenship in Cyprus and chill on a beach sucking at the teet of the eu until that dries up.

 

[Max0819]

Mags,

I think you will find that most states sold their Public Health Money contracts to investors long long ago for something like 40c/dollar. That future money has been spent, with little to none of it going for purpose.

I know its hard to believe, that our government would lie and rip us off, but there you have it.

Blame tobacco for all sorts of maladies, proven and especially unproven, force money from corporations for their deceit, lie to public about why the gov is suing companies (health care, public health, etc). Take money, place in general fund, buy swimming pool. Tax product at over 5times its value. Put most tax in general fund, spend on pet projects. Find new product, rinse, repeat.

Max

THIS ..

At the end of the day the strongest independants will survive following the footsteps of 'Deadhead Shops' and everything else will be replaced by big tobacco alternatives like Vuse.

There is just too much money at stake by both big tobacco and the States that have budgets that hinge on tobacco settlement monies (even loans against future revenue). The only way to restore that political balance is by making nicquids part of the equation for them. Sad but likely inevitable. -Mags

 

[skoony]

I think the proposed ruling is because of companies like Nutricigs. They won't get FDA approval no matter what...

I agree this certainly doesn't help maters but,even with out company's like this,the kiddy flavors
or supposed advertising to children the regulations would still come and be as onerous as proposed.
With a total lack of any negative behavior on our part they would still accuse us of every heinous tactic
and pretend we were actually doing whatever it was they made up. If they wanted cake mix deemed
as a tobacco product it appears they very well could judging by the way they have been treating us
now and how they treated smokers in the past.
Don't bring that cake in here regards,
Mike

 

[crxess]

Worries me when a Pro troll can derail a thread into focusing on a single entity.

A company that has not had a FB hit in over a year on their main page. One whose main stay of Praise is self promoted. One which has product being Bottom listed in clearance areas of Scammed vendors

Is this where the FDA is Focused?

I seriously doubt this.

 

[stevegmu]

I agree this certainly doesn't help maters but,even with out company's like this,the kiddy flavors
or supposed advertising to children the regulations would still come and be as onerous as proposed.
With a total lack of any negative behavior on our part they would still accuse us of every heinous tactic
and pretend we were actually doing whatever it was they made up. If they wanted cake mix deemed
as a tobacco product it appears they very well could judging by the way they have been treating us
now and how they treated smokers in the past.
Don't bring that cake in here regards,
Mike

How is the FDA treating anyone? Has the 'deeming' even been published?