Oh my goodness Wethepeople, where to begin?
Bitey, obviously this discussion assumes that the FDA will makes these products illegal.
The FDA does not "make" any product illegal. It follows it's legislative mandate, as laid out in the FD&C Act. Pursuant to letters we've seen sent to suppliers, as well as the pleadings in the currently pending litigation between SE and Njoy and the FDA, we know that the FDA has taken the position that the ecigs it has examined fall within the statutory definition of "drug-device combinations under section 503(g)(1)" of the Act, and that they are "new drugs" as defined by section 201(p), thus requiring approval of an NDA (new drug application) under section 505 of the Act. See the letter I am quoting here:
http://www.e-cigarette-forum.com/forum/e-cigarette-news/11172-important-email-fda-supplier.html
Ecig makers and marketers don't agree with that interpretation of the law, and the essence of SE and Njoy's claims are that their ecigs are merely the functional equivalent of cigarettes, and not a "new drug" nor "drug-device combination" at all. It still remains to be seen how the presiding judge will decide this issue.
Nor does the recently passed tobacco legislation make this issue moot, as it is still essential to know whether ecigs are to be legally defined as a drug device to be regulated under the FD&C Act as currently written, or as a tobacco product to be regulated (and maybe even banned?) under the new legislation, or possibly even as falling within a yet to be defined new category. While such a third option would probably be ideal for all of us consumers, it is probably not likely to be the route taken.
In any event, it is highly unlikely that any domestic enforcement actions will occur until after Judge Leon settles the question before him as to whether ecigs are to be deemed a new drug-device combination as urged by the FDA.
If the FDA's position on this is upheld, people need to understand that if and when domestic enforcement actions occur, which is the scenario the OP was asking about, they will involve marketing, sales and distribution only, and NOT possession and use. As nicotine itself is not a controlled substance, and is lawfully obtainable in cigarettes and other tobacco products, not to mention over the counter NRT products, there simply is no basis upon which to criminalize the possession and use of ecigs for their nicotine content.
I pointed you to the penalty provisions of the Act, and you came back with this:
Yvilla, lines 2 and 3 read as follows:
Any person who violates a provision of section 301 shall be imprisoned for not more than one year or fined not more than $1,000, or both. Prison isnt civil.
In my post, I invited you to "parse the statute", not to read just the first couple of lines and jump to a conclusion! The FD&C Act is a lengthy and complex piece of legislation, replete with definitional provisions and cross references to it's various sections, and in order to understand the consequences for a given alleged violation of it you have to read those definitions, and jump back and forth through many different sections.
So sure there are criminal sanctions for violations of section 301, as I acknowledged in my previous post, but what exactly constitutes a violation of that section is the relevant question. As seen in the FDA letter cited to above, the FDA maintains that "the marketing of the "electronic" cigarettes, cigars, and pipes, described above, in the United States without an approved NDA violates sections 505 and 501(f)(1)(B) of the Act (21 U.S.C. 355 and 351(f)(1)(B))".
Then looking more carefully at section 301(d), you can see that violations of 505 are included here, but only as follows:
"(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404, 505 or 564."
SEC. 301. [21 USC §331] Prohibited acts
What is interstate commerce? Well, that is defined in section 201(b) of the Act:
"(b) The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."
SEC. 201. [21 U.S.C. 321]
The OP asked about sales out of his kiosk, and he lists his location as Virginia Beach. As that constitutes retail sales within a state, and not commerce between states, and is not within DC, it simply does not fall within the definition of a violation of 301(d).
And as for the "device" related violation under 501(f) mentioned in the FDA letter, that doesn't appear to fall under section 301 and it's criminal penalties at all, but rather under the civil penalties found in section 303 that I intially referred you to (only farther down the page), to wit, under 303(f).
SEC. 303. [21 USC §333] Penalties
Bottom line, it remains my belief that the most likely scenario if domestic enforcement actions are undertaken, once the current litigation is decided, is that someone like the OP would receive a cease and desist letter. I
never said that was the worst that could happen.
For those engaged in interstate sales, however, there is the possibility of criminal sanctions under section 301(d), but even in that situation there is still a great probability, in my opinion, that warning letters will be the first step.
And I continue to believe, as I have posted many times previously, that it is really important to dispell here the frequently seen misapprehension and confusion that exists between controlled substances, commonly referred to as "illegal drugs", that are subject to criminal sanctions for possession as well as sale, and the kind of "illegality" meant by the FDA when it speaks of ecigs - and that does not extend to possession and use at all, but only to distribution, marketing and sales. Witness the OP's original question focusing on the DEA, which would have absolutely nothing to do with the issue at hand.
Finally, it would be foolish indeed for anyone to rely on an internet forum for legal advice, and it should be obvious to all here that if they actually need legal advice they should indeed seek it out from an attorney in their locality.
