FDA -- Unapproved yet, but remain on the market until replaced by an approved version

[LaceyUnderall]

Well... and the other day I ran across a very interesting blurb on the FDA website regarding the ability for the FDA to use "morality" in their decisions regarding products.

"Excerpt Text:
C. FDA's Jurisdiction Over the "Safety and Efficacy" of Drugs Provides it With Sufficient Authority to Consider Potentially Negative Societal Ramification Related to the OTC Sale of Plan B

FDA's jurisdiction over the "safety and efficacy" of drugs provides it with legal authority to consider morality, misuse, age-appropriate sexual behavior, and related social issues in the context of the Plan B approval for OTC marketing. " http://www.fda.gov/oc/planb/excerpt.html#_Toc135799934 3.11 is where you are going for full content.

At first it kind of miffed me that the FDA can use morality as a basis for decisions concerning something. Especially in the above context because it does use it for the "morning after pill" and morality in the US would mean the Christian view of life starting at conception... after all, us heathens have no morality right?

But, it does allow for the FDA to make cases such as this one where patients are in severe pain and even though they shouldn't have taken away the med in the first place and caused them all of this grief, they did give it back. So were they in the wrong? Sure. Did they do right? Yes. Is this hope for our side? You bet. It's presidence and heaven forbid they act like they did in this scenario. At least we can prove that they have given back before. A lawyer would eat this up!

And Willpower - Industry self-regulation is on its way.

[LaceyUnderall]

the fda should be paying more attention to the 'f' in their title:

isn't that the truth!

[OutWest]

Agree with ya Strayling. The liquid morphine is only "unapproved" because it's been in use since before they started requiring clinical trials and such. It's proven itself as a beneficial drug. And, frankly who cares if it's harmful, after all it's being used by people on their deathbeds to ease their suffering. IMHO, the only reason they banned it is because some pharmaceutical company is coming out with a patented version that will cost a lot more than the currently sold generic. And like you mentioned, note the fact that they said it will be banned as soon as a substitute is found.

In my opinion, big pharma controls the FDA and it's my opinion that big pharma is the one that got the FDA to refer to ecigs as "a new, unapproved drug" (and thus considered to be a prohibited item).

[LaceyUnderall]

Agree with ya Strayling. The liquid morphine is only "unapproved" because it's been in use since before they started requiring clinical trials and such. It's proven itself as a beneficial drug. And, frankly who cares if it's harmful, after all it's being used by people on their deathbeds to ease their suffering.

And if we allowed people to accept their own deaths and move on into their next world, life, heaven whatever, and end their own pain in a medically responsible way, this wouldn't be an issue. But that's another thread and probably on another forum.

[strayling]

I read these threads and keep thinking "Stockholm Syndrome". Still, the FDA are in a position to do us all a lot of good if only they would stop with the power grabs.

[WillPower]

And Willpower - Industry self-regulation is on its way.

Music to my (our) ears!

I would request the following three items:

1) Keep us in the loop -- it would be helpful if consumers campaigning for you know about the self-regulation, especially when they are sending letters to their senators and FDA.

2) Consumer representation in the self-regulating org -- It goes a long way for building legitimacy if actual consumers involved in self-regulation.

3) Protection of consumer interest and suppliers' interest from the patent holder -- NDA approval or even moratorium gives a tremendous legal and financial advantage to the patent holders and licensed manufacturers. After consumers and suppliers rally behind e-cig, after the approval or moratorium, I hate to see the patent holders going "NJoy" on us--raising price, go national advertising, cut our suppliers in favor of national chains, and offering only highpriced prefilled carts.

Not trying to be paranoid, but I haven't seen any benevelent firms after they received a nod from FDA. The patent holders and their licensee should keep in mind that U.S. suppliers and consumers are essentially financing the NDA process by rallying to keep e-cigs in the market during the approval process.

[LuckyCharm]

...let them reverse the e-cig ban.

Whoa whoa whoa... Is there now a BAN in place?

~~Cheryl

[united-one]

And if we allowed people to accept their own deaths and move on into their next world, life, heaven whatever, and end their own pain in a medically responsible way, this wouldn't be an issue. But that's another thread and probably on another forum.

Yeah, next thing you know they'll be banning guns because that's the only thing available/left to end the personal pain and misery? Thought we've been here already with that one.

Jeez. This country is wacked! Tell the conservative bible thumpers to get a life! (I used to be one of them - conservative that is -).

[WillPower]

Whoa whoa whoa... Is there now a BAN in place?

~~Cheryl

In short, YES. Manufacturers and vendors are not allowed to sell a new drug without FDA approval.

But it gets tricky. Being classified as drugs has something to do with intended usage (how the products are promoted) and having nicotine in e-liquid. So if a vendor does not make any claim of smoking cessation products (Nicotine Replacement Therapy) and don't include
nicotine then that e-cigs are no longer a drug. So those are not "banned." There is some gray areas in terms of determining a drug or not. This is why FDA is looking into this, case-by-case.

IN ANY CASE, it is only illegal for manufacturers and vendors to market and sell them. It is perfectly legal for consumers to buy and use them. Nicotine is not a controlled substance like the narcotics specified in the Controlled Substances Act.

[LuckyCharm]

IN ANY CASE, it is only illegal for manufacturers and vendors to market and sell them. It is perfectly legal for consumers to buy and use them. Nicotine is not a controlled substance like the narcotics specified in the Controlled Substances Act.

So my NJOY distributor is technically afoul of the law, but I can order from Ruyan and other overseas suppliers without worry? Hmmm, sounds very regressive to me, in an economy where we want as many people on our OWN shores making money as possible!

~~Cheryl