An idea for avoiding FDA approval or control

[SpaceCadet]

Smooth, that is utterly sickening. I'm so sorry to hear that.

Bad news indeed

[TropicalBob]

This has rocked my world, that's for sure. We knew it was coming ... knew it .. but now the timer has been activated and the clock is ticking loudly. My mind is racing with 'what will I do, what will I do?' thoughts.

[efaglil]

As a matter of interest, how big was your order Smooth? Was it a bulk order or just a few bits for personal use?

[TropicalBob]

Title says 500.

[Myk]

Read 201-g for yourselves and see if you come up with what I come up with. (I'm getting a migraine so I could be seeing wrong.)
FD&C Act Chapters I and II

I would send something like this to them. I'm assuming you're not a business so you really don't have anything to lose. If you are a business you should hire a lawyer.

You are claiming the E-cigarette liquid is a "new drug" according to 201-G.
I am claiming you are overstepping your lawful bounds and treading where Congress and the Supreme Court has forbidden you to go.

201-G clearly says something IS NOT a new drug solely because of claims made by the product. So you would have no grounds to claim that because China or anyone else claims e-cigarettes are nicotine replacement therapy they qualify as a new drug. At best you could tell people to stop making those claims.

The nicotine found in the e-cigarette liquid is derived from tobacco leaves and stems. It doesn't have to contain the roughage to be a tobacco product. As far as the reports I've seen it is not so pure that it can't be traced back to tobacco, so you have no grounds to claim it is a drug unless your tests have proven that it is a different form of nicotine than is found in tobacco.

Your claims that since e-cigarettes are not subject to the FCLAA or CSTHEA they do not qualify as tobacco would mean that pipe tobacco is not tobacco and neither are tobacco plants.
Sorry but that doesn't fly either.

Should I contact some of the pro-tobacco organizations and see if they'll give me a lawyer pro bono or would you like to release my shipment and work your ban the right way through the checks and balances of our government and prove the product is harmful before you ban it?

[TropicalBob]

The FDA earlier made a clear distinction between natural nicotine in a tobacco product and the derived chemical nicotine used in e-liquid. Makes no difference whether our nicotine comes from tobacco or eggplant or tomatoes. It's a drug when separated from a plant and sold in chemical form.

Course, before long, the FDA will get regulatory authority over all tobacco products, but that's another battle. Shipping via the Postal Service of any tobacco product is being proposed for a ban by Congress. Ditto for all private shipping not to a business address. So much for my Blatter Reserve. It's gotta be Carter Hall from my local store.

The ONLY argument that might stand any chance at all would be that nicotine, in normally consumed quantities, is no more a drug deserving a ban than caffeine now used in soft drinks, chewing gum and energy products. Both are stimulants with dangers. Both are widely used as found in their natural state.

Nicotine liquid will be regulated, of that we can be assured. But a ban is difficult to take. Set poison limits, as England did, and take it off the banned list.

It's hard to imagine the FDA paying attention to anyone, shyster lawyer or otherwise, who says that agency doesn't have authority to regulate and/or ban drugs!

[Keltrey]

This goes back to the stockpiling thread, this is what they started doing quietly back in November with Cixi.

[GabbyD]

This is horrible news.

[leaford]

That's a shock, that's for sure. But lets just wait and see. That may be one local agent or supervisor speaking, and not FDA policy.

[GabbyD]

Here's an example of big pharma trying to interrupt another company from getting a product approved so easily. Since this product involves nicotine, I thought it interesting to read.

http://www.fda.gov/OHRMS/DOCKETS/dai...00001-vol1.pdf