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Post by papipeguy on Jul 11, 2017 18:22:40 GMT -5
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Zach
Pro Member
If you can't send money, send tobacco.
Posts: 4,366
First Name: Zach
Favorite Pipe: Too many currently, bound to change
Favorite Tobacco: Haunted Bookshop, Big 'N' Burley, Pegasus, Habana Daydream, OJK, Rum Twist, FVF, Escudo, Orlik Golden Sliced, Kendal Flake, Ennerdale
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Post by Zach on Jul 11, 2017 18:56:17 GMT -5
You posted the wrong link here, I'm assuming.
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Post by papipeguy on Jul 11, 2017 18:58:28 GMT -5
Dang it. I'll try to fix it.
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Post by papipeguy on Jul 11, 2017 19:00:20 GMT -5
FDA Issues Warning Letter to Company for Marketing Unauthorized Tobacco Products
The FDA is announcing the issuance of a warning letter to Kretek International, Inc. for importing and distributing adulterated and/or misbranded smokeless tobacco products.
Four products are adulterated because they are new tobacco products and do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products are also misbranded because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act.
The FD&C Act requires premarket review for any “new tobacco product,” meaning any tobacco product that was not commercially marketed in the United States as of Feb. 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after Feb. 15, 2007. A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act is required unless the FDA issues an order finding the product to be substantially equivalent (SE) to a predicate tobacco product or to be exempt from the requirements of SE and a required submission is made under section 905(j)(1)(A)(ii) for the FD&C Act.
Additionally, nine products are misbranded because the product labels do not contain the statement, “Sale only allowed in the United States”, as required under section 920(a) of the FD&C Act.
The warning letter states that Kretek International, Inc. should respond in writing within 15 days and provide the specific steps the firm has taken to correct violations. If the company is unable to adequately respond to the charges in the warning letter, it may not continue to introduce the adulterated and misbranded tobacco products into interstate commerce in the United States.
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Zach
Pro Member
If you can't send money, send tobacco.
Posts: 4,366
First Name: Zach
Favorite Pipe: Too many currently, bound to change
Favorite Tobacco: Haunted Bookshop, Big 'N' Burley, Pegasus, Habana Daydream, OJK, Rum Twist, FVF, Escudo, Orlik Golden Sliced, Kendal Flake, Ennerdale
Location:
Member is Online
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Post by Zach on Jul 11, 2017 19:47:08 GMT -5
Well, here we go. It's hoarding and stockpiling 2017. As was 2016.
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Post by danno44 on Jul 11, 2017 20:39:51 GMT -5
So if true, apparently "smokeless tobacco" does not fall within the guidelines of the FDA Deeming Regulations 3 month extension issued in May 2017?
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Post by papipeguy on Jul 11, 2017 20:54:31 GMT -5
Who knows at this point. The main thrust is that the FDA claims that no approval has been sought. Funny when I see how many new cigars are coming out.
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Post by danno44 on Jul 11, 2017 21:17:27 GMT -5
New pipe baccy as well. As like last year, no one knows what's going on is about all we do know.
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Deleted
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Post by Deleted on Jul 12, 2017 11:04:33 GMT -5
Someone please dumb this down for me.
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Post by trailboss on Jul 12, 2017 13:17:25 GMT -5
Someone please dumb this down for me. Under the FDA regulations, any tobacco product/blend made after 2007 in the USA is arbitrarily deemed unsafe and wil bring on the end of life as we know it....Zombies will roam the streets, viral outbreaks on the scale of the dark ages will ensue, and Brad will give up his Nitecap for captain Black cherry blend. Brought to you by idiots that believe regulating our lives is the be all, end all.... |
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Post by papipeguy on Jul 12, 2017 13:26:27 GMT -5
Excellent explanation, Charlie.
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Post by Darin on Jul 13, 2017 9:48:51 GMT -5
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Post by bonanzadriver on Jul 13, 2017 10:02:18 GMT -5
Someone please dumb this down for me. Under the FDA regulations, any tobacco product/blend made after 2007 in the USA is arbitrarily deemed unsafe and wil bring on the end of life as we know it....Zombies will roam the streets, viral outbreaks on the scale of the dark ages will ensue, and Brad will give up his Nitecap for captain Black cherry blend. Brought to you by idiots that believe regulating our lives is the be all, end all.... To expand a little... The FDA released it's "Deeming Rules". by which it, without any congressional oversight, extended the agency's regulatory authority to all tobacco products, including electronic smoking devices, cigars, pipe tobacco and hookah tobacco. It did all of this under the auspices of the big tobacco lawsuit settlements and somehow distorted it's understanding of the part about making an effort to curb the marketing and sale of tobacco products to minors, to somehow allow them, the Food and Drug Administration, to start "Deeming" (deciding to interpret things as they want) thereby giving them free reign to impose their "beliefs" into an area that they have never had any place or authority. Supposedly we can thank all of the "vape heads" for this and their e-cig run amuck phenomenon. Regardless, it's an over reach by yet another three letter organization that is comprised of "appointed" employees vs "Elected" ones. Further yet, they are "Creating" Law. Yup, what was once only the domain of the "Legislative" branch has now been usurped, not only by our Judicial branch, as we see played out on tv every night, but now the Bureaucracies of our nation have all somehow achieved "self awareness" , not unlike Skynet, and have adopted the "Better to ask for forgiveness than for permission" as it applies to their actions, thereby allowing them to "Create" new regulation (Laws) but to also the ability to "Deem" whether or not their new Laws are being violated, and then they get to "Determine" the punishment. We also need to remember that in their "deeming' they decided that a pipe, by their definition, has become part of the "tobacco" family, and that they can regulate it. Welp, I've gone on long enough. Think I'll step out to the employee Pipe lounge and have a nice bowl of MM 965. |
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Zach
Pro Member
If you can't send money, send tobacco.
Posts: 4,366
First Name: Zach
Favorite Pipe: Too many currently, bound to change
Favorite Tobacco: Haunted Bookshop, Big 'N' Burley, Pegasus, Habana Daydream, OJK, Rum Twist, FVF, Escudo, Orlik Golden Sliced, Kendal Flake, Ennerdale
Location:
Member is Online
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Post by Zach on Jul 13, 2017 10:15:19 GMT -5
Someone please dumb this down for me. Under the FDA regulations, any tobacco product/blend made after 2007 in the USA is arbitrarily deemed unsafe and wil bring on the end of life as we know it....Zombies will roam the streets, viral outbreaks on the scale of the dark ages will ensue, and Brad will give up his Nitecap for captain Black cherry blend. Brought to you by idiots that believe regulating our lives is the be all, end all.... I think we should regulate their lives. |
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Zach
Pro Member
If you can't send money, send tobacco.
Posts: 4,366
First Name: Zach
Favorite Pipe: Too many currently, bound to change
Favorite Tobacco: Haunted Bookshop, Big 'N' Burley, Pegasus, Habana Daydream, OJK, Rum Twist, FVF, Escudo, Orlik Golden Sliced, Kendal Flake, Ennerdale
Location:
Member is Online
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Post by Zach on Jul 13, 2017 10:18:22 GMT -5
Under the FDA regulations, any tobacco product/blend made after 2007 in the USA is arbitrarily deemed unsafe and wil bring on the end of life as we know it....Zombies will roam the streets, viral outbreaks on the scale of the dark ages will ensue, and Brad will give up his Nitecap for captain Black cherry blend. Brought to you by idiots that believe regulating our lives is the be all, end all.... To expand a little... The FDA released it's "Deeming Rules". by which it, without any congressional oversight, extended the agency's regulatory authority to all tobacco products, including electronic smoking devices, cigars, pipe tobacco and hookah tobacco. It did all of this under the auspices of the big tobacco lawsuit settlements and somehow distorted it's understanding of the part about making an effort to curb the marketing and sale of tobacco products to minors, to somehow allow them, the Food and Drug Administration, to start "Deeming" (deciding to interpret things as they want) thereby giving them free reign to impose their "beliefs" into an area that they have never had any place or authority. Supposedly we can thank all of the "vape heads" for this and their e-cig run amuck phenomenon. Regardless, it's an over reach by yet another three letter organization that is comprised of "appointed" employees vs "Elected" ones. Further yet, they are "Creating" Law. Yup, what was once only the domain of the "Legislative" branch has now been usurped, not only by our Judicial branch, as we see played out on tv every night, but now the Bureaucracies of our nation have all somehow achieved "self awareness" , not unlike Skynet, and have adopted the "Better to ask for forgiveness than for permission" as it applies to their actions, thereby allowing them to "Create" new regulation (Laws) but to also the ability to "Deem" whether or not their new Laws are being violated, and then they get to "Determine" the punishment. We also need to remember that in their "deeming' they decided that a pipe, by their definition, has become part of the "tobacco" family, and that they can regulate it. Welp, I've gone on long enough. Think I'll step out to the employee Pipe lounge and have a nice bowl of MM 965. You forgot to mention the Deeming Act ALSO regulates pipes themselves, not just tobacco. Under the Deeming Act, a pipe is also tobacco. Even though a spokesperson from the FDA did state that as long as the pipe is made out of the same old materials it always has been, briar,meer, clay, woods, the FDA also now has the heinous right to stop any and all pipe makers s from selling pipes! The main reason it all started was due to vaping but the reason is actually because Marlboro is getting out of tobacco altogether over the next few years because they've developed tobacco free nicotine vaporizers and they want to crush the competition. These new juices Marlboro uses don't acquire nicotine from tobacco plants but rather from potatoes and eggplants. All plants in the nightshade family contain nicotine, so theoretically you can also get nicotine from tomato vine concentrate extraction. There's no real regulation on nicotine as an isolate but rather tobacco through legislation. Marlboro and others lobbied billions of dollars to the FDA and whoever else to get vaping devices regulated, with that, they put out a blanket clause in the Deeming Act to regulate all tobacco devices. Hence, pipes can also be regulated and require very expensive registrations and patents just to create and sell an artisan pipe. |
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Post by bonanzadriver on Jul 13, 2017 11:29:57 GMT -5
P12,
I thought that's what I was saying on my 2nd to last paragraph. (darned interweb, sometimes hard to say what ya mean to say)
Thanks
dino
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Zach
Pro Member
If you can't send money, send tobacco.
Posts: 4,366
First Name: Zach
Favorite Pipe: Too many currently, bound to change
Favorite Tobacco: Haunted Bookshop, Big 'N' Burley, Pegasus, Habana Daydream, OJK, Rum Twist, FVF, Escudo, Orlik Golden Sliced, Kendal Flake, Ennerdale
Location:
Member is Online
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Post by Zach on Jul 13, 2017 11:44:54 GMT -5
Oh sorry, Dino. Somehow I missed that line there.
I hope this Deeming Act gets thrown out.
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