Selling To U.S.

[rickcharles606]

ain't there a maximum amount of time the FDA can sit on an application before they have to rule on it? I have read the law but it's been a while. it seems like when i read it I thought yea they will make everyone wait the max time. maybe i will go back and read. not trying to say i know more than the attorneys or anything. law is sort of a hobby of mine haha

ding, ding, ding....yes, but they don't give a shit and have only sent letters to the applicants saying "thanks, we are reviewing your application". This was the meat of the Lorrilard legal action against the FDA recently. Prior to the suit, the FDA hadn't even sent "we got your shit" letters out, then after the suit, they started acknowledging the applications. Yet, no approvals to date.

[SnusoMatic]

" "(1) In general.-- Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)--"
http://www.fda.gov/TobaccoProducts/G.../ucm237092.htm

One must be an attorney to split all the hairs. but that makes it sound like the manufacturer must submit 90 days before they start selling a new product. I just skimmed it but it seems like once they submit 90 days ahead of time they are good to go. Then if the FDA says no then I guess they have to stop selling.

The following seems to back that up. Of course it don't matter what it reads to me. Just my two cents i guess haha.

"Since June 2009, when the law allowing the agency to regulate tobacco went into effect, the tobacco industry has submitted nearly 3,500 product applications, according to data obtained under a Freedom of Information Act request. While none have been ruled upon, the vast majority of these products are already being sold."
http://www.sfgate.com/health/article...DA-4117527.php

[halocog]

Part of the problem could also be that the FDA is massively underfunded

[rickcharles606]

" "(1) In general.-- Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)--"
http://www.fda.gov/TobaccoProducts/G.../ucm237092.htm

One must be an attorney to split all the hairs. but that makes it sound like the manufacturer must submit 90 days before they start selling a new product. I just skimmed it but it seems like once they submit 90 days ahead of time they are good to go. Then if the FDA says no then I guess they have to stop selling.

The following seems to back that up. Of course it don't matter what it reads to me. Just my two cents i guess haha.

"Since June 2009, when the law allowing the agency to regulate tobacco went into effect, the tobacco industry has submitted nearly 3,500 product applications, according to data obtained under a Freedom of Information Act request. While none have been ruled upon, the vast majority of these products are already being sold."
http://www.sfgate.com/health/article...DA-4117527.php

The key here is that to be considered a "grandfathered" product, it must have been on the market as of Feb 15, 2007, and Melon wasn't. If a product is introduced between the Feb 15 2007 date and the deadline in 2011 (I forget what it is) then a 905-J must be submitted and it can be sold until the FDA says otherwise, as long as they met the submission deadline. If they missed the filing deadline of let's say March 2011, they have to go to the back of the line, even if their product was released between 2007 and 2011. If a company releases a product after the deadline in 2011, then they have to file the 905-J and wait for an FDA approval before they can legally market or sell in the US. Truthfully, if Gotlands can prove to me, beyond a shadow of doubt, that they've met the submission deadlines...I'd pick up Melon in a heartbeat. I've always planned on doing so, as a matter of fact, it's already "set up" in our system...all I have to do is add it to our next purchase order ;-)

Regarding the 3500 apps, and "vast majority...being sold" statement, this is true, but only because the vast majority of these products were on the market prior to 2007.

That's the way our FDA lawyers see it, and they're far more intelligent in these matters than I am, and that's what we pay them for....to limit our corporation's exposure to criminal and financial liability. Go look up the fines for infractions of these laws, they're hefty, lol.

I don't know if the FDA is underfunded, but I know for certain they are understaffed. On top of that, they have zero idea how to enforce these regulations. I'm sure there are distribution/manufacturering companies out there skirting the law, but we don't operate that way.

[resnor]

So my question still remains, why does Northerner sell Melon? It just seems very surprising to me.

[rickcharles606]

So my question still remains, why does Northerner sell Melon? It just seems very surprising to me.

It would be my guess that, online retailers have less exposure to FDA litigation....and the further they are from the US, the less exposure they have ;-)

[resnor]

I guess...just surprising that they don't sell others that aren't FDA approved. It's just weird.

[rickcharles606]

I guess...just surprising that they don't sell others that aren't FDA approved. It's just weird.

who knows buddy.....sad though that ALL snus isn't sold in the US. I'd love to walk into a shop and pick up some Lucky Strike, Camel or Grov for a change of pace :-)

[SnusoMatic]

I find this interesting. Guess the FDA ain't doing their job huuh?

Action on Application

Deadline

In General. As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall

issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or

issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.

[rickcharles606]

I find this interesting. Guess the FDA ain't doing their job huuh?

Action on Application

Deadline

In General. As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall

issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or

issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.

did we ever really expect them to act above board? TPSAC is nothing but a bunch of anti tobacco guys that aren't open to listen to logic or reason. I was just in Vegas last week and was talking to our attorney about the 180 day deadline, and many many companies have reminded the FDA of this part, but to no avail.

I did get to spend some time with Dr. Brad Rodu and he's a real asset to educating the US retailers, consumers and hopefully the FDA. I'm not holding my breath about the FDA though ;-)

[johnh123]

I just got some LS from Northerner - was that a mistake by them? I love and miss Camel as well - those were my two favorites.