FDA Big news coming out of FDA

[Endor]

Not sure what the problem here is.
...
These same standards are applied to virtually all products being sold as health aids or having medicinal value.

You are correct. We've all seen the disclaimers (in 2pt type that nobody over the age of 45 can read) at the bottom of commercials for vitamins and the like... "This product is not approved by the FDA for the cure of any disease..."

However, smoking is not disease, it is a behavior. Nicotine addiction is a disease, yet none of the examples given by the FDA in the violation letters indicated it was a cure for nicotine addiction, simply a change of behavior (no longer smoking cigarettes). I would venture to say that a fair amount of vapers have no intent of stopping the use of nicotine (myself included), we're simply switching to a different delivery mechanism that we feel is healthier.

This is where, I think, the FDA is overstepping on this.

 

[stevegmu]

You are correct. We've all seen the disclaimers (in 2pt type that nobody over the age of 45 can read) at the bottom of commercials for vitamins and the like... "This product is not approved by the FDA for the cure of any disease..."

However, smoking is not disease, it is a behavior. Nicotine addiction is a disease, yet none of the examples given by the FDA in the violation letters indicated it was a cure for nicotine addiction, simply a change of behavior (no longer smoking cigarettes). I would venture to say that a fair amount of vapers have no intent of stopping the use of nicotine (myself included), we're simply switching to a different delivery mechanism that we feel is healthier.

This is where, I think, the FDA is overstepping on this.

I don't see any addiction as a disease, but that's beside the point.

Yes, vaping with nicotine is simply a different method of obtaining pleasure through the use of nicotine. The FDA and federal government believe nicotine is a tobacco product, thus will regulate e-nic as they do cigarettes and other tobacco products...

 

[Jman8]

You are correct. We've all seen the disclaimers (in 2pt type that nobody over the age of 45 can read) at the bottom of commercials for vitamins and the like... "This product is not approved by the FDA for the cure of any disease..."

However, smoking is not disease, it is a behavior. Nicotine addiction is a disease, yet none of the examples given by the FDA in the violation letters indicated it was a cure for nicotine addiction, simply a change of behavior (no longer smoking cigarettes). I would venture to say that a fair amount of vapers have no intent of stopping the use of nicotine (myself included), we're simply switching to a different delivery mechanism that we feel is healthier.

This is where, I think, the FDA is overstepping on this.

Does anyone care to explain why industry would need to market itself with the part I chose to emphasize with red text?

IMO, that's where the FDA is not overstepping.

But clearly the FDA is overstepping in other ways based on policy that is epitome of overstepping (FSPTCA).

I do not see the healthier claim being necessary to be stated by industry any more, and do feel that a newbie consumer would have to be entirely isolated to not hear that message.

 

[Oliver]

Just a quick heads up - there's something extraordinary afoot in the UK. A friend of mine just had Populus conduct a poll over the weekend. It used similar methodology to the ASH survey back in March (which estimated apprx 2.6 million UK vapers). The survey came in at an estimated 3.9 million regular vapers in the UK.

Now, here's where things get interesting.. The Smoking Toolkit study (remember, this is the world's highest-resolution continuous study of smoking behavior) has shown e-cig growth flatlining throughout the year up to June.

The only thing that's happened of note since June is the Public Health England announcement in August, and the publication of the "95% safer" figure. The same friend has contacted several industry people, all of whom are reporting exactly the same thing - since the report, they've seen a 30-60% increase in units sold.

So, at last we may have a naturalistic figure of precisely what the effect of FUD over these products is.

Sadly, because the study was industry funded the press have declined to pick up on it. That said, my friend has shown it to some friendly academics and they have told him they see no issues in the methodology, and no reason not to think this is real.

 

[Rossum]

The survey came in at an estimated 3.9 million regular vapers in the UK.

Amazing. That's roughly 6% of the population, and somewhere between 1/4 and 1/3 of the smokers in recent years.

 

[Oliver]

Yeah, it's totally extraordinary. To be honest, I've shied away from reporting this, because it seems to good to be true, but the triangulation I'm getting (from other suppliers) seems to confirm.

 

[Jman8]

From p. 20 of the linked (FDA) document:

FDA believes this proposed rule will provide clarity to manufacturers about how products made or derived from tobacco will be regulated if they are marketed or distributed for certain intended uses. This clarification will allow regulated industry to plan accordingly during the product development and postmarketing phases and will help researchers understand the applicable regulatory requirements associated with the investigational use of products made or derived from tobacco.

In addition, we believe this proposed rule will help to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use (i.e., as a drug/device) versus for a recreational use. Specifically, FDA wishes to avoid situations where products intended to be sold as tobacco products are marketed with the same claims as products sold as drugs or devices. If tobacco products are marketed in ways that make them hard to distinguish from certain medical products, consumers may use tobacco products, which are inherently dangerous, in place of FDA-approved medical products that have been determined to be safe and effective for their intended use.

Part in red is what I think gets to meat from consumer perspective. I would think it is getting at meat from most perspectives, but to be fair the line I emphasized follows from paragraph that FDA chose to note as primary reason for proposed rule.

And I think it helps the FDA cause that many people (vast majority, includes most vapers) believe that certain tobacco products (namely smoking) are inherently dangerous, regardless of intended use (aka if used in moderation, rather than abusively).

I think it is possible to believe smoking is a recreational product, that when used abusively (PAD or more) for many years, or decades, can carry with it a quantifiable degree of harm. But we don't operate in that sort of reality, and instead seem to have a whole lot of people who think, and will argue, that smoking is inherently dangerous. Attempt to dispute this and stipulate on any sub-points and you are the odd ball in the room who can't see the overwhelming amount of (so called) evidence which has 'righteously' concluded that smoking is, in all situations, inherently dangerous.

By deeming eCigs/vaping a tobacco product, then the "inherently dangerous" label can be applied. Most politically aware vapers see that as folly, me included. Yet, to not see it as folly for combustibles, is where I see us fighting uphill battle that isn't going to end well for THR advocates concerning vaping. As long as our adversaries get to skate on by with the biggest lie of them all (smoking kills), then it is only a matter of time that the mass culture comes to accept the notion that "vaping kills."

Probably will take another 5 to 20 years for that meme to set in, but as long as the "smoking kills" meme is unchallenged, it will be fairly easy to make sure that the abusive vapers (who need 3+ ml daily) will play right into hands of the propaganda battle that goes back 50 or so years.

 

[skoony]

As hard as I am trying I for the life of me can not get what they are saying here.
"Conceptually, the proposed rule follows the disease prong and the structure/function prong (with certain enumerated limitations) of the statutory definitions of “drug” and “device” (section 201(g) and (h) of the FD&C Act). Under the proposed rule, a product made or derived from tobacco and intended for human consumption would be regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is 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. The proposed rule also attempts to clarify remaining circumstances where a product would be or could be regulated as a tobacco product. In addition, FDA is proposing to amend its existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to the proposed rule to clarify the interplay between these regulations and this proposed rule, and to conform §§ 201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices."

The relevant part being,"Under the proposed rule, a product made or derived from tobacco and intended for human consumption would be regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is 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."
The first part is easy to understand. The second part however seems to say,prior to March 21,2000 one could not say cigarettes
were not addicting. Today however with the current state of knowledge concerning the addictive-ness of nicotine sans
tobacco this would affect the structure an functions of the body in a way that was different prior to the date.
The $64 question is,does this mean e-cigs can never claim they are less addictive than cigarettes even though
its demonstrably true or they can in fact say they are because its a statement of fact. In either case or if in both cases
none such claims can be made doesn't the fact that e-cigs affect the structure or any function of the body differently
allow the FDA to use it as circumstantial evidence and thus an excuse to put the whole kit and caboodle over into
the THR or medical device category?
I know this is a stretch but,if I can think this way I am sure they have people on the payroll
that can out think me.

Regards
Mike

 

[TheRac25]

I don't see any addiction as a disease

correct, addiction is a symptom

 

[john333]

Things are not looking good. This is absurd: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery …

Essentially, claims that e-cigs can help people to stop smoking will render the products subject to medical regulation.

Claims that e-cigs are safer will render them subject to "modified risk tobacco" authorisation.

E-Cig companies will be limited to marketing their products as being "satisfying", essentially using the language of the tobacco industry prior to 2000 (due to a Brown & Williamson loophole).

This rule is proposed to "remove ambiguity for marketers", but at the expense of any consumer-facing clarity.

The future looks bleak.

FDA wolves not far.

 

[stevegmu]

correct, addiction is a symptom

But a disease can't be brought on by one's self; addiction nearly always is...

 

[Lessifer]

But a disease can't be brought on by one's self; addiction nearly always is...

Are you saying that type II diabetes isn't a disease?

 

[stevegmu]

Are you saying that type II diabetes isn't a disease?

It's all about genetics. One can drink 25 sodas a day and not get diabetes; others who are pre-disposed to the disease through a genetic condition can drink none and still get it....

 

[Lessifer]

It's all about genetics. One can drink 25 sodas a day and not get diabetes; others who are pre-disposed to the disease through a genetic condition can drink none and still get it....

Same can be said for addiction, well, not the "none" part, but many people use various substances without becoming addicted. Even cigarettes.

 

[stevegmu]

Same can be said for addiction.

Not so much, when one who never takes a drink can't be an alcoholic, yet one who does not drink sugary drinks can still get diabetes...
I can never be addicted to illegal substances, as I don't use them...

 

[Lessifer]

Not so much, when one who never takes a drink can't be an alcoholic, yet one who does not drink sugary drinks can still get diabetes...

Yeah, that's why I edited to more fully respond. One can be predisposed to addiction just like one can be predisposed to type II diabetes.

 

[TheMike21]

I have two questions/suggestions.
1.- If we extracted the nicotine from Eggplants (not cost effective but for the sake of argument) would it still be a tobacco product?

2.- Why don't we get a list of every high government official and FDA guy who smokes and help them do the switch?

 

[zoiDman]

I have two questions/suggestions.
1.- If we extracted the nicotine from Eggplants (not cost effective but for the sake of argument) would it still be a tobacco product?

2.- Why don't we get a list of every high government official and FDA guy who smokes and help them do the switch?

1: No. It Wouldn't.

2: Can you generate a List of Names?

 

[Kent C]

1.- If we extracted the nicotine from Eggplants (not cost effective but for the sake of argument) would it still be a tobacco product?

The whole idea of 'deeming' is to change the definition of what is.

2.- Why don't we get a list of every high government official and FDA guy who smokes and help them do the switch?

Getting a list of gov't officials might show up at the NSA. :- ) ....and some already vape.

 

[TheMike21]

Then let's get every vaping Lawyer, Doctor, science dude, government official and FDA guy to help us all! (I might sound naive, but I know we can do this, and we don't even have to protest just make sure every vaper helps)