Deeming Regulations have been released!!!!
- Thread starter Oliver
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makes me wonder how many actually good drugs never made it to market because they didn't have the money to kickback the powers to be at the FDA. i remember when anything herbal was being bashed,,, by big pharma of course
This is the killer right here. vaping will be dead.
"Section 910(c)(1)(A)(ii) of theFD&C Act requires that FDA deny a PMTA and issue an order that the product may not be introduced or delivered for introduction into interstate commerce where FDA finds that:
You have not shown that the product is appropriate for the protection of the public health"
Cheese and rice! Now we're poisoning the children. I wonder how many kids have DIED from those pod things. I hate how BT has the media ear but truth is being ignored. I am so mad I could spit nails.
Yep, this is the kicker. And this is why these deeming regulations an out and out ban. As I mentioned above, nothing can be proven good for public health. Even if studies (presumably from other countries now) show that 'vaping' is good, gets people off cigarettes, does not cause health problems, etc... FDA will just say, "yes, but not _this_ product specifically. We want to know about this product." Of course, no data can be obtained for _this_ product, because it can't be made and sold. This is a species of a requirement that is some hybrid of a Catch-22 and a sheer impossibility.
This is an action plan the FDA had in place prior to the Final Rule (if you skim through it you'll see that it lists goals to be accomplished during the first quarter of 2016.)
FDA Program Alignment Tobacco Fiscal Year 2016 Action Plan
"In May 2014, five individuals were selected to start the new Tobacco Inspection Cadre for ORA. These product-specific investigators will be trained and dedicated to do tobacco-related work, including inspections of registered tobacco manufacturing facilities, investigations of smokeless tobacco free sample events, internet surveillance to ensure tobacco products that are in violation of the law are not sold to U.S. consumers, including minors, and other tobacco investigative activities.
For future years, ORA and CTP will work to build longer term plans for inspectional resource needs to prepare for new regulation and guidance implementation and to ensure continuing investments in training and building of the specialization program."
I wonder if/when this plan will be updated to encompass their upcoming over-reach?
FDA Program Alignment Tobacco Fiscal Year 2016 Action Plan
"In May 2014, five individuals were selected to start the new Tobacco Inspection Cadre for ORA. These product-specific investigators will be trained and dedicated to do tobacco-related work, including inspections of registered tobacco manufacturing facilities, investigations of smokeless tobacco free sample events, internet surveillance to ensure tobacco products that are in violation of the law are not sold to U.S. consumers, including minors, and other tobacco investigative activities.
For future years, ORA and CTP will work to build longer term plans for inspectional resource needs to prepare for new regulation and guidance implementation and to ensure continuing investments in training and building of the specialization program."
I wonder if/when this plan will be updated to encompass their upcoming over-reach?
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Whatever the cost, we the tax payers will be able to pay for it.
That's the joke, I know, but it is something to consider when enlightening taxpayers who don't give a fruit bat about vaping what they are going to pay for.
Imports are covered as well. Not sure how they will enforce though.
I'm sure pills from India are as well, but...
Here's more info to obsess over.
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM438022.pdf
"FDA is also collaborating with U.S. Customs Border Patrol (CBP) and the International Trade Data System (ITDS) Board of Directors to establish a fully electronic “single-window portal” through which industry can submit the data required by all government agencies for international trade. FDA is one of 47 participating government agencies (PGAs) engaged in the modernized ITDS technology which includes Automated Commercial Environment (ACE). ACE will ultimately become the single-window for all trade and government agencies involved in cargo processing of imports and exports. ACE will allow FDA and other agencies to obtain more data quickly and process cargo more expeditiously. This additional data will allow FDA to more easily identify unsafe, dangerous, or prohibited shipments."
"ORA’s Office of Criminal Investigations (OCI) has increased its international presence and, as part of these efforts, is working with Europol and Interpol to more effectively target those responsible for manufacturing and distributing violative FDA-regulated products. In FY 2014, OCI placed an agent at Europol, located in the Netherlands, to assist with international FDA cases with a nexus to any of Europol's 28 member states.
OCI has also formed a Cybercrime Investigations Unit (CcIU) which combines a team of agents and an intelligence research specialist. CcIU targets the infrastructure that supports the illegal sale of FDA-regulated products on the internet. CcIU’s main objective is to disrupt and dismantle organized criminal networks that illegally sell FDA-regulated products on the internet. CcIU also provides training and field agent support and is responsible for intelligence collection and smart dissemination of this information. As part of Interpol’s annual Operation Pangea, OCI's CcIU was responsible for seizing and shutting down more than 1,600 websites involved in the sale of violative FDA regulated products."
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM438022.pdf
"FDA is also collaborating with U.S. Customs Border Patrol (CBP) and the International Trade Data System (ITDS) Board of Directors to establish a fully electronic “single-window portal” through which industry can submit the data required by all government agencies for international trade. FDA is one of 47 participating government agencies (PGAs) engaged in the modernized ITDS technology which includes Automated Commercial Environment (ACE). ACE will ultimately become the single-window for all trade and government agencies involved in cargo processing of imports and exports. ACE will allow FDA and other agencies to obtain more data quickly and process cargo more expeditiously. This additional data will allow FDA to more easily identify unsafe, dangerous, or prohibited shipments."
"ORA’s Office of Criminal Investigations (OCI) has increased its international presence and, as part of these efforts, is working with Europol and Interpol to more effectively target those responsible for manufacturing and distributing violative FDA-regulated products. In FY 2014, OCI placed an agent at Europol, located in the Netherlands, to assist with international FDA cases with a nexus to any of Europol's 28 member states.
OCI has also formed a Cybercrime Investigations Unit (CcIU) which combines a team of agents and an intelligence research specialist. CcIU targets the infrastructure that supports the illegal sale of FDA-regulated products on the internet. CcIU’s main objective is to disrupt and dismantle organized criminal networks that illegally sell FDA-regulated products on the internet. CcIU also provides training and field agent support and is responsible for intelligence collection and smart dissemination of this information. As part of Interpol’s annual Operation Pangea, OCI's CcIU was responsible for seizing and shutting down more than 1,600 websites involved in the sale of violative FDA regulated products."
Actually, India has some of the best pharmaceutical manufacturing companies in the world. If you have ever taken a generic drug, it was most likely produced in India.
Anyone seen this? Sorry if it is a re-post
http://nypost.com/2016/05/01/why-is-the-government-out-to-destroy-vaping/
http://nypost.com/2016/05/01/why-is-the-government-out-to-destroy-vaping/
200,000,000,000
But here's something to numb the pain and keep America safe ( junkies )
Text - S.954 - 114th Congress (2015-2016): FDA Accountability for Public Safety Act
The vast majority of our prescription drugs are manufactured overseas.
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