FDA and Congress

[taz3cat]

FDA has been given the "Mission Impossible" by congress. You must read this is so funny.this message will explode in 30 seconds and we don't know you.


FDA is to regulate tobacco but no one is supposed to know. tobacco companys are suppost to pretend they are not regulated. Cannot admit they are regulated.


http://tobaccoanalysis.blogspot.com/2009/03/fine-print-in-fda-legislation-shows.html

 

[dEFinitionofEPIC]

Hey man... no surprise here.... this behind-the-scenes shadiness goes on everyday with all types of legislation.

 

[TropicalBob]

The reasons for this ironic situation are not as convoluted as the author implies. The legislation to give FDA authority over tobacco products had to undergo compromise, as most bills do. Those opposed to handing over authority (count me among them!) argued that if the FDA regulates, it de facto approves cigarettes, cigars, etc. This is the Republican strategy to try to defeat the bill in the Senate. A health agency cannot be seen as approving cigarettes!

At the same time, the bill was forced to specify that the FDA could never ban tobacco. Never. That's not a card that can be played. The FDA can, however, make cigarettes undesirable, and -- with a smirk -- that's what the proponents of this bill settled for.

You can expect FDA orders that are impossible to comply with. "Get rid of carcinogens. But they're a natural byproduct of combusting tobacco. Don't care. Just get rid of them. They're dangerous and cause people to die. How do we remove them? Not the FDA's problem; it's your problem." Oh.

Get rid of flavors. Lower nicotine levels so that each cigarette can never deliver more than 0.5mg of nicotine. Those are the kind of proposals the proponents of this bill are pushing.

The part I find unconstitutional is the vast limiting of tobacco to advertise its legal products. I cannot believe a court will uphold such a throttling of standard business practice. What First Amendment?

But the author of this blog piece is the guy we're depending on, to be on our side? Frightening. That's all. Just frightening. Something tells me his currency among lawmakers was spent long ago.

 

[Calaban]

Lower nicotine levels so that each cigarette can never deliver more than 0.5mg of nicotine. Those are the kind of proposals the proponents of this bill are pushing.

The logic here, or lack thereof, is astounding.

Lowering nicotine levels will cause people to smoke more in order to satisfy their cravings. If I understand correctly, it is the burning of plant material that is the main culprit in lung cancer and other smoking related diseases. Smoking more to satisfy nicotine cravings means more burning plant material being inhaled, therefore causing more damage to smokers.

Just plain stupid.

Anyway, sorry if that was a bit off topic. Carry on!

-Cal

 

[TropicalBob]

No, not off the point. You are absolutely correct. Same thing happened when "light' cigarettes were introduced. Did anyone care that smokers inhaled deeper, smoked more of each cigarette, and smoked more cigarettes? No. And they won't care again. But the result will be crazed smokers, many of whom will throw in the towel on cigarettes. And that's the goal. Mission accomplished.

 

[dEFinitionofEPIC]

No, not off the point. You are absolutely correct. Same thing happened when "light' cigarettes were introduced. Did anyone care that smokers inhaled deeper, smoked more of each cigarette, and smoked more cigarettes? No. And they won't care again. But the result will be crazed smokers, many of whom will throw in the towel on cigarettes. And that's the goal. Mission accomplished.

You're absolutely right. These agencies are not looking at it the way we're looking at it. They're so anti-nicotine that "harm reduction" isn't really something most of them care about. They're pretty much looking for no-compromise policy. And if we all get fed up and quit nicotine all together... well then they got what they wanted and that works for them.

 

[lordmage]

well not related but i wrote the fda eariler and this was the response

Thank you for your comments to the Division of Drug Information in Center for Drug Evaluation and Research at the Food and Drug Administration.

Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.” In making that determination, the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources. In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.

FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims. We have detained and refused several such products on the grounds that they were unapproved new drugs as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. Additionally, because they were drug-device combinations under 21 U.S.C. 353(g)(1), they were also adulterated devices.

We will continue to review these products on a case by case basis.

If, after reviewing this information, you have any unanswered questions, please contact the Division of Drug Information by phone (1-888-463-6332) or e-mail (druginfo@cder.fda.gov). Thank you again for your message.

Division of Drug Information
Center of Drug Evaluation and Research
Food and Drug Administration
kcd
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed

all i can get out of this is thier are to many new devices out there and not enough of these devices are not approved and it is the nic liquid that is the new drug but becuase the delivery system is the device they too are considered part of this new drug

 

[OutWest]

the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources

Bingo! It's primarily about the health claims and quit smoking claims (In the ecig manual, the info on the website, etc)

That's not all there is to it, for theyre also going after the liquid, but...

 

[Vicks Vap-oh-Yeah]

In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.

So - the vendors and suppliers out there who are making the health and/or NRT claims will be the ones with products impounded?

If you sell it as a personal vaporizer, it's not a drug delivery devise, it's not claiming to cure or treat a disease?

Whole lot of political double-speak here. typical.

 

[b00stzx3]

I'm worried about importing. When they say its illegal to import e-cigs, what is that? Are they opening packages and looking for certain models, looking for carts or juice or what? I mean, if someone sent me some atomizers and labeled them paintball gun parts or radio antennaes would they know the difference? Customs only opens 10% of packages anyways right?

 

[taz3cat]

The point is how can the FDA regulate somthing they don't approve. All products regulated by FDA or either Approved or recalled, or banned. That is the job assigned to the FDA.

FDA control of tobacco is a farce. If they can't approve, recall, or ban it what is the reason for their oversite of the product.

They can't even keep our food safe and approve drugs that kill people faster than analogs do.

I think I will send a letter to my lawsnakes and tell them I do not want approval by the FDA for tobacco products, and FDA control is appproval as far as I am concerned.

 

[TropicalBob]

You should write that letter. The present tobacco control situation is fine; let the FDA do its job on food and drugs, not tobacco. If control MUST moved, send it to the Department of Health and Human Services.

The FDA is the wrong agency and now is 100 years the wrong time.

 

[yvilla]

Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.” In making that determination, the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources. In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.

FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims. We have detained and refused several such products on the grounds that they were unapproved new drugs ...

***

We will continue to review these products on a case by case basis.

This is what I have been saying over and over - it is crystal clear, and it is what FDA spokesperson Christopher Kelly has been quoted as saying in several news articles: Not all ecigs are regarded as containing a "new drug" or as being "drug delivery devices". Only those labeled, advertised and promoted as NRT or smoking cessation devices, or with health claims, will run afoul of the FDA.

Take a look at NJOY's site: NJOY Electronic Cigarettes - The Smoking Alternative with All the Pleasures Without All the Problems

It's a textbook example of ecig marketing that has been designed and carried out (with the advice of attorneys to be sure) to avoid FDA problems. Their ecig is a a smoking alternative, nothing more, and I'd lay odds with any of you that their stuff will not face FDA or customs problems.

 

[jolleygoodfellow]

That is very true. They sell the Njoy at a pilot down the street from me and they are still available.

 

[Vicks Vap-oh-Yeah]

I got my NJoy on Amazon - no problems....

 

[Monkeylurv]

I'm very new to this, but after reading the Ruyan independent studies, I don't understand why this is happening. The studies show a very clear difference in traditional cigarettes compared to e-cigs. ZERO changes in carbon monixide, way less toxic chemicals, and no second hand smoke risk (only PG is emitted in vapor).

Why doesn't Ruyan get involved in this? Don't they have the money to throw some weight into the fight?? Lawyers...studies??? Heck, they sucked up peoples money with all this paraphanelia.

I would think that FDA approval would be more clearcut too. As opposed to doing long term studies to see health effects, it should be a confirmatory study of Ruyan's study. Because PG has been used as a vapor in health care settings with positive affects on bacterial infection. And it should be as easy as examing the vapor in atomizers compared to analogs. Because everything that is in the vapor from atomizers is already in cigarettes. But way less. And cigarettes as we know are legal. And cigarettes of course have PG in them.

There's just not a reasonable argument. If they argue that nicotine is a toxic substance, well heck, someone can put 10 patches on their body at the same time, or smoke 10 packs of cigs in a day. If they argue it's a caustic substance, dangerous to congest, well I can go into my cleaning supplies & toss back some tilex, or rub some lime away on my skin.

Just doesn't not make sense in my mind.

 

[TropicalBob]

The Ruyan studies are encouraging, that's for sure. They're not complete and have not been peer-reviewed, however, so they mean little as "evidence." Also, they are paid for by Ruyan and use Ruyan products. The study WILL NOT apply to any other e-cig, carts or e-liquid. Formulations of e-liquid vary; Sedanza just dropped propylene glycol, in fact. Each mix must be individually tested and approved. Flavorings could be a problem.

The FDA is mandated to review and approve new drugs in the U.S. The e-liquid mix -- comprised of many ingredients -- is a new drug. And it is meant to be inhaled for untold years! There are many, many unknowns about using this liquid in vapor form. And the only people who can request approval and submit studies are manufacturers.

So whose fault is all this mess?

 

[Duckies]

So whose fault is all this mess?

You answered you own question (adding (yet to be defined) peer review requests):

...the only people who can request approval and submit studies are manufacturers.

 

[Monkeylurv]

Aren't there only a handful of mfg's anyway? That ultimately this comes from a few chinese mfg's & 1 US mfg? I can see the flavorings making testing more difficult. But they could do studies on unflavored & drop the flavors. And customers would have to flavor themselves. At least until later studies on the flavored e-liquids.

Why did Sedanza drop PG?

Yes, the mess is theirs. The mfg's should have anticipated & prepared for this. Pretty ignorant not to see this coming.

 

[Monkeylurv]

Ok, I see Sedanza is a U.S. mfg. So that makes 2 US mfg's?

ETA: Oops, nevermind - Sedansa is Belgium.