FDA Big news coming out of FDA

[Bill Godshall]

By proposing this new regulation, FDA is trying to ensure that the agency can ban any e-cig product and can ban any marketing claim for an e-cig that it wants to ban, even if Cole's bill is enacted by Congress and/or even if the deeming regulation and/or Section 911 of the TCA (banning MRTP claims) is/are rejected by the federal courts.

While FDA's 9/8/11 letters sent to five e-cig companies made similar assertions (i.e. only FDA approved drugs can legally make smoking cessation or cigarette reduction claims), those letters were sent before FDA made the following statement in its April 25, 2011 announcement at
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm

"The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.

The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera."

By proposing this new regulation, FDA has decided to NOT comply with, and instead challenge, Judge Leon's 2010 ruling in Sottera vs FDA.

 

[Lessifer]

But they have really started gaining some ground throughout the world in the last few years.
And it's mainly due to electronic cigarettes, and the passion of the users of electronic cigarettes.

No doubt there have been some great strides in the public perception of Harm Reduction. I agree that a large part of that has been vaping, however, I don't see vaping as THR, I see it as Harm Reduction, and I think the growing acceptance of it is the fundamental recognition by most that vapor products are not tobacco products. I don't see any headway being made policy-wise for lower harm tobacco products, though I do hope I'm wrong.

For some reason, I don't see the FDA backpedaling and coming out to say that some tobacco is much less harmful than other tobacco.

 

[DC2]

I don't disagree with what you said.
But I do like that THR scientists are gaining momentum from us.

It would be nice if there were more scientists aimed at HR rather than THR.
Because, yeah, tobacco is not the boogeyman here.

Inhaling smoke of any kind is the issue.
Always has been, and always will be.

Well, for those that understand the issues involved.
And for those that the media has not bent into a perverse shape of misunderstanding.

 

[skoony]

@Bill Godshall
Thanks Bill. I have been saying for quite some time this is a all or nothing push for the FDA.
They government can't incrementally add regulations over time. Vaping is too safe. It simply
will not work that way.

Regards
Mike

 

[DC2]

@Bill Godshall
Thanks Bill. I have been saying for quite some time this is a all or nothing push for the FDA.
They government can't incrementally add regulations over time. Vaping is too safe. It simply
will not work that way.

Regards
Mike

I'm starting to appreciate your viewpoint on this more and more.

Because as time goes by our numbers grow.
And more and more truth becomes accessible.

The FDA should go for the jugular before it's too late.
But perhaps it is already too late.

We shall see.

 

[stevegmu]

This. This right here is why the FDA is making this rule. There are countless sites and products being marketed as weight loss products, ones that have juice with added caffeine, Vitamin C or E and some offering ......-like effects (as in, don't need a boner pill, have a boner vape instead! Woo!)

They would look incompetent if they didn't make these rules and put some companies like Nutricigs out of business. it was inevitable...

 

[ScoobD]

Ignorance and Greed... a horrible combination.

 

[Oliver]

They would look incompetent if they didn't make these rules and put some companies like Nutricigs out of business. it was inevitable...

Thing is, Steve, I'm not sure these rules do put Nutricigs et al out of business, do they?

 

[stevegmu]

Thing is, Steve, I'm not sure these rules do put Nutricigs et al out of business, do they?

I think so and they will be made an example of. They are making claims the supplement industry can't get away with in many cases...


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.

If they are regulated as a combination product, my guess is they will never meet the FDA's standards for such a product...

 

[Katya]

By proposing this new regulation, FDA has decided to NOT comply with, and instead challenge, Judge Leon's 2010 ruling in Sottera vs FDA.

But only if therapeutic or smoking cessation claims are made, right?

• The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.

In other words, as long as no such claims are made, the Sottera decision is unassailable. Or am I reading it incorrectly?

 

[Oliver]

I think so and they will be made an example of. They are making claims the supplement industry can't even make...


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.

If they are regulated as a combination product, my guess is they will never meet the FDA's standards for such a product...

But nutricigs are in the supplements industry, no? So the FDA can just take them down already, surely?

 

[Oliver]

This rule is, in other words, squarely aimed at nicotine-containing products, soon to be deemed as tobacco products.

It doesn't do anything to shonky inhalable snake oil sellers, and nor should it: there's already legislation for that.

 

[Lessifer]

As a supplement, isn't all they need this particular line?: *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

It did seem that they were pretty careful with their "claims" and how they are worded.

 

[Oliver]

As a supplement, isn't all they need this particular line?: *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

It did seem that they were pretty careful with their "claims" and how they are worded.

Honestly, I don't actually know. Can they simply disclaim away medical claims like that?

 

[DC2]

But only if therapeutic or smoking cessation claims are made, right?

• The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.

In other words, as long as no such claims are made, the Sottera decision is unassailable. Or am I reading it incorrectly?

They are trying to change the definition of "therapeutic claims" from how I read it.
They are trying to make "intended use" a therapeutic claim, even though Judge Leon already shot that down.

 

[Oliver]

Blimey - apparently they can. Just looked it up.

 

[zoiDman]

Honestly, I don't actually know. Can they simply disclaim away medical claims like that?

And Doesn't this get us Full Circle back to "Intended Use"?

 

[Lessifer]

Honestly, I don't actually know. Can they simply disclaim away medical claims like that?

What claims? Look closely at their copy, it doesn't actually say that the nutricigs DO anything. At least from what I've seen.

 

[stevegmu]

But nutricigs are in the supplements industry, no? So the FDA can just take them down already, surely?

Are they? From what I understand, they are in the e-cig business. Nutricigs is IVG's 'health' line. Going by the description, they are exactly what this part of the proposed rule will deal with-

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.

If their e-cigs contained no nicotine, it may be a different story...

 

[Oliver]

Bloody hell, ok, these guys are for real. Apologies, I thought they were without nicotine.

So, yeah, the FDA rule will see to them.