Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Thulium]

No one is going to jail over this, independent of the ruling.

Don't be too sure of that. It's happened before: How to beat the FDA: A case study

[Sinless1]

I'm for banning all animal-based milk in schools. Call me ultra-silly...

~~Cheryl

I'm for limited government, low taxes, free markets, and a return to sound money, and getting the government our of my personal life!

guess you can call me ultra silly too!

my 95 year old grandfather has lived thru what 8 or so wars, Great depression and who knows what all else! they didn't have the FDA then or many other bloated useless government agencies and wow he is now 95 and still kickin!

The only benefit to the fda i can see possibly is preservation of our agriculture.
It sure the hell isn't drugs legal or illegal, they got a pill for everything , your depressed here take a pill , too fat take a pill. too skinny take a pill, didn't pass you sem test oh here take a pill, "FDA Approved" but beware may cause 200 minor to life threatening side affects but trust us cause it's FDA approved!

Am i the only one here sickened from the fact that the majority believes we need permission from the FDA for every damned thing we put in our body?

[PhiHalcyon]

It sure the hell isn't drugs legal or illegal, they got a pill for everything , your depressed here take a pill , too fat take a pill. too skinny take a pill, didn't pass you sem test oh here take a pill, "FDA Approved" but beware may cause 200 minor to life threatening side affects but trust us cause it's FDA approved!

Am i the only one here sickened from the fact that the majority believes we need permission from the FDA for every damned thing we put in our body?

The FDA grants authorizations to SELL drug products; not to take them. Furthermore, when rightly understood, potential side-effect warnings are actually a sign that the FDA is recognizing our right to make informed decisions of our own. Otherwise, it would only be those drug products with no potential side effects at all that would ever be approved.

[TropicalBob]

Gotta speak up: PhiHalcyon is the only person is the present debate with a firm grip on reality (Sun has a grip, but prefers not to hammer home the truth the way Phi does).

Once upon a time, the happy campers here wearing rose-colored glasses were referred to as bunnies living in La-La Land.

Pathetically, La-La Land lives on, right here.

Many in this thread reside there. Their avatar should be the see-no-evil, hear-no-evil, speak-no-evil monkey.

P.S. I guarantee you I'm no troll ... either.

[tvujec]

Don't be too sure of that. It's happened before: How to beat the FDA: A case study

Indeed possible, but it is beside the point. In the linked example, FDA broke the law and used unlawful methods. You can end up in jail for drinking water this way as well.

[tvujec]

Gotta speak up: PhiHalcyon is the only person is the present debate with a firm grip on reality (Sun has a grip, but prefers not to hammer home the truth the way Phi does).

While I fully agree with many of PhiHalcyon assesments, I do allow for two separate attitudes here. There is a legal way, and there is a rational way. Legal way will get modified by regulation and doesn't even have to make sense, rational way is rational way, and can only get changed by science. When you say that nicotine can only be on the market as a drug or tobacco product, I understand that this is what legal rules currently imply. Calling that rational (or even sensible) is as ridiculous as expecting that FDA will just give up and we'll have access to all the product that we want.

Thinking that our laws and current rules are capable of handling all aspects and protect every person of all harm is also living in the La La land. Why would suppliers test their product? They assume that they are doing a good job already, there's the market that wants the product and any additional testing is just added cost that will only help the competition. This applies to every single product on the market, not just electronic cigarette.

Case for manufacturers is even worse, as they are not US companies anyway. Now it might be a sensible business decision to address the US market situation carefully, since it is a leading free market, where companies either make it or go broke, especially since many other countries might just adopt all future regulation. But again it brings the additional cost, and in today's business environment, every single cost item gets removed unless there is clean, simple and definite justification for it.

To summarize, I agree that expecting FDA to just go away is living in the La La land. But thinking that manufacturers and suppliers did something wrong for not "testing it sooner" is also a La La land experience. They are not people that can do right or wrong, they are companies, driven by responsibility to their investors.

[Angela]

Just because your delusion-laden prejudice perceives the truth as being negative doesn't render my posts 'useless chit chat'. Some people, namely those with a brain, actually want to understand what the truth is, rather than keep their head in the clouds. It helps with future planning; and may even keep a few people out of jail.

Gotta speak up: PhiHalcyon is the only person is the present debate with a firm grip on reality (Sun has a grip, but prefers not to hammer home the truth the way Phi does).

Once upon a time, the happy campers here wearing rose-colored glasses were referred to as bunnies living in La-La Land.

Pathetically, La-La Land lives on, right here.

Many in this thread reside there. Their avatar should be the see-no-evil, hear-no-evil, speak-no-evil monkey.

P.S. I guarantee you I'm no troll ... either.

I'm sure that everyone here thinks that each person is entitled to their opinions, but, for me, I have stopped reading PhiHalcyon's posts - not because I either disagree/agree with his views, but because I find his way of expressing them expremely rude.

[JerryRM]

I'm sure that everyone here thinks that each person is entitled to their opinions, but, for me, I have stopped reading PhiHalcyon's posts - not because I either disagree/agree with his views, but because I find his way of expressing them expremely rude.

I agree Angela, I won't even bother to respond to his posts anymore, whether directed to me or others.

[Vocalek]

You obviously fail to grasp the fact that our having had the opportunity to use a new type of indefinite-term nicotine replacement product before it has been fully tested and approved does not in any way, shape, or form, excuse the manufacturers from going through at least the same safety testing and approval process that an ordinary short-term nicotine replacement product does. Like it or not, drug companies that have spent millions of dollars in getting their nicotine replacement product approved before being legally permitted to market their product DO have rights. And, like it not, the FDA DOES have the responsibility to ensure that a drug product is safe for its intended use BEFORE that product should be permitted to be sold.

I'd rather be forced to find or create my own ecig alternative, than to become some feckless stooge for copycat outlaw manufacturers.

There is no such thing as an "indefinite-term nicotine replacement product" in the wonderful world of Tobacco Control. FDA will be the first ones to tell you that the products they collectively refer to as "nicotine replacement therapy" (NRT) are not intended to actually replace your tobacco cigarettes. Their purpose is to wean the user off nicotine.

During the approval process of existing NRTs, one of the issues that was of large concern to the review board was whether NRTs could create new nicotine addicts. To guard against that, the nicotine dosages in NRT products have purposely been kept well below the amounts smokers obtain from cigarettes. The products must be distributed with instructions on how to taper down, and then all the way off, their use.

The concept of nicotine maintenance therapy is foreign to the Tobacco Control Community. They believe that because nicotine is addictive, it is bad. They believe they know what is best for you. They believe that you will be healthier if you do not use nicotine at all.

They do not live inside my body. But that's an aside.

Prominent members of the Tobacco Control Community (pulmonologists, cardiologists, and oncologists) sit on the review boards that are formed to evaluate the results of clinical trials for products that are intended for treatment of "nicotine addiction."

Now, given all the above information, how far do you think that Ruyan would have gotten if they walked in and said, "I want you to approve a product that gives smokers so much nicotine that they will be able to permanently substitute it for their cigarettes"?

Why would it have occurred to Ruyan that they needed to go seek FDA approval in the first place? They see themselves as meeting a consumer need with a commericially marketed product. They are not a pharmaceutical / medical device company. They have no staff with the expertise to conduct clinical trials.

Finally, they don't have the millions of dollars in capital sitting around to conduct these tests. Even if they had the capitol, they would be foolish to do so, when the odds of FDA buying into the concept of Nicotine Maintenance Therapy are so very slim.

I don't consider this a "drug product." Nicotine is a naturally occurring alkaloid, just like caffiene. Did the makers of Jolt or Red Bull have to conduct clincial trials to get their products approved? In point of fact, Ruyan did have lab tests conducted on the purity of their product and testing on how well smokers would accept the product.

I would like to see standards and testing for consistent nicotine content, making sure no contaminants are present, proper labeling that provides warnings and a complete list of ingredients, and options for child-proof packaging. None of these require clinical trials and a drug approval process. These could be handled as product safety issues, not medical issues.

[LameBMX]

"the FDA DOES have the responsibility to ensure that a drug product is safe for its intended use BEFORE that product should be permitted to be sold."

Since when do they actually do this without big tobacco footing the bill? Have you noticed how dangerous medicines are these days? Have you noticed how many more lawsuit commercial due to undisclosed risks? I say they should just treat the E-Cig as a regular cigarette and let it be.