90 days
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The FDA is currently setting up Customs enforcement for their regs and Net monitoring for catching violators of their regs.
What else is happening in the next 90 days? There's so much information to digest and it seems everyone has a different perspective.
Ahh. In 90 days you cannot sell any vape stuff to minors.
In 90 days you cannot sell any vape stuff that you did not sell before the 90 day date. Or that was not sold in the USA.
You can sill sell the same stuff. But not that 500Watt single 18650 mod that boomsalot came out with on 90 days +1. Or the new juice flavor that gagamaggot came out with. Or even a New diamond ceramic coil that goes in the leaksalot tank that you have been selling for a year.
For all the existing vape products you have 2 years to file to get that device legal to sell in the US. the manufacturer or modifyer of the device/juice is the one that files. If a vape shop makes their own juice they file, but for the Clowdz fer DAze brand of juice the the gagamaggot company makes and the vape shop just sells, the gagsamaggot company needs to file for that one.
After 2 years if what you are selling has not either been approved or ad not been filed for with the FDA it can no longer be sold.
However when something is filed you have 1 Year or until it is approved or disapproved to sell it.
So if you file right at the 90 days + 2 year date you can theoretically get up to 3 years before it cannot be sold unless approved.
clear as mud.
In 90 days you cannot sell any vape stuff that you did not sell before the 90 day date. Or that was not sold in the USA.
You can sill sell the same stuff. But not that 500Watt single 18650 mod that boomsalot came out with on 90 days +1. Or the new juice flavor that gagamaggot came out with. Or even a New diamond ceramic coil that goes in the leaksalot tank that you have been selling for a year.
For all the existing vape products you have 2 years to file to get that device legal to sell in the US. the manufacturer or modifyer of the device/juice is the one that files. If a vape shop makes their own juice they file, but for the Clowdz fer DAze brand of juice the the gagamaggot company makes and the vape shop just sells, the gagsamaggot company needs to file for that one.
After 2 years if what you are selling has not either been approved or ad not been filed for with the FDA it can no longer be sold.
However when something is filed you have 1 Year or until it is approved or disapproved to sell it.
So if you file right at the 90 days + 2 year date you can theoretically get up to 3 years before it cannot be sold unless approved.
clear as mud.
I'm aware of the costs, and the figures. Thanks for the link, i hear it's a very good webinar. Siegel's blogs are generally pretty good.
There are testing costs, there are application fees, and they're based on the fact that everry formulation is considered a separate product. You have paid all of it and submit your application. Thye can still let it sit and whether or not they have acted, your products must be pulled.
There are testing costs, there are application fees, and they're based on the fact that everry formulation is considered a separate product. You have paid all of it and submit your application. Thye can still let it sit and whether or not they have acted, your products must be pulled.
I read a news story that seemed informed that says in 90 days it will be illegal to offer any new hardare or e liquid product for sale in the US. But can there be a new e liquid product if it contains 0 mg of nic? Can I buy a newly introduced tank or mod to consume e liquid with 0 mg nic? WIll the Federal Drug Administration say a product that can be used for liquid with 0 mg nic can't be sold because it might be used for vaping nicotine?
as far as i know, all new products (liquids as well as hardware?) need to be on the market by aug 10. After that then there are two years to submit either a new product application or substantial equivalence application (with massive costs to gather the data required). If products are not approved within 1 year after that, they go off the market.
ATM, the substantial equivalence date is 2007, but there is an amendment to an agriculture bill,as well as a specific stand alone bill to have congress change that predicate date to now.
the deeming regs are 499 pages of legalese, so there's lots of reading and analysis going on...your best bet for good information and for steps to take to be active in however we fight this are through joining the national advocacy group www.casaa.org and the local advocacy group Breath Easy Alliance of Alabama |
there is also an entire ECF subforum dedicated to looking at FDA regs. FDA Regulations and a really long thread hashing some of this out- even though no one has all of the answers yet Deeming Regulations have been released!!!!
ATM, the substantial equivalence date is 2007, but there is an amendment to an agriculture bill,as well as a specific stand alone bill to have congress change that predicate date to now.
the deeming regs are 499 pages of legalese, so there's lots of reading and analysis going on...your best bet for good information and for steps to take to be active in however we fight this are through joining the national advocacy group www.casaa.org and the local advocacy group Breath Easy Alliance of Alabama |
there is also an entire ECF subforum dedicated to looking at FDA regs. FDA Regulations and a really long thread hashing some of this out- even though no one has all of the answers yet Deeming Regulations have been released!!!!
funny part is most states, including Alabama i think, already prohibit sales to minors.
No new juice varieties after Aug 10, No new hardware, No new vaping stuff at all after August 10.
Stuff existing prior to August 10 can be sold for 2 years but not after that unless approved by the FDA.
Might be up to 3 years depending on when you apply for your vape product with the FDA.
You have to apply within 2 years and up to 1 year for the approval process. If not approved within 1 year from when you filed the application you are forbidden to sell your product.
Stuff existing prior to August 10 can be sold for 2 years but not after that unless approved by the FDA.
Might be up to 3 years depending on when you apply for your vape product with the FDA.
You have to apply within 2 years and up to 1 year for the approval process. If not approved within 1 year from when you filed the application you are forbidden to sell your product.
yes, that's consistent with my understanding of the new regs.
unless the predicate date is changed. It'll be interesting to see how we (continue to ) fight this (I've been making calls and writing letters since early 2010), with CASAA, SFATA etc joining forces.
unless the predicate date is changed. It'll be interesting to see how we (continue to ) fight this (I've been making calls and writing letters since early 2010), with CASAA, SFATA etc joining forces.
Manufacturer, Distributor, and Importer Compliance
To legally sell a new FDA-regulated tobacco product in the United States, you must receive a written order from FDA permitting the sale of a new tobacco product under one of three pathways to market.
In addition, any products marketed with modified risk claims must have an FDA order in effect that permits such sale or distribution.
If your product is found to be Not Substantially Equivalent (NSE), it is illegal to sell or distribute the product in interstate commerce and to import the product into the United States.
Manufacturers may not distribute any smokeless tobacco product without a required warning statement for every smokeless tobacco package and advertisement.
If you are found in violation of FDA rules and regulations, your product will be considered "misbranded" and/or "adulterated," making it illegal to sell or distribute the product in interstate commerce and to import the product into the United States. Doing so may result in FDA initiating regulatory action (e.g., seizures, injunctions).
FDA restricts the way tobacco manufacturers, retailers, and distributers can advertise and regulated tobacco products, especially marketing efforts designed to appeal to youth.
Additional Resources
Compliance, Enforcement & Training
Compliance & Enforcement FDA Tobacco Compliance Webinars Report Potential Tobacco Product Violation
State, Local, Tribal and Territorial Governments
Retail
Manufacturing
Small Business Assistance
Resources for You
Compliance, Enforcement & Training
To legally sell a new FDA-regulated tobacco product in the United States, you must receive a written order from FDA permitting the sale of a new tobacco product under one of three pathways to market.
In addition, any products marketed with modified risk claims must have an FDA order in effect that permits such sale or distribution.
If your product is found to be Not Substantially Equivalent (NSE), it is illegal to sell or distribute the product in interstate commerce and to import the product into the United States.
Manufacturers may not distribute any smokeless tobacco product without a required warning statement for every smokeless tobacco package and advertisement.
If you are found in violation of FDA rules and regulations, your product will be considered "misbranded" and/or "adulterated," making it illegal to sell or distribute the product in interstate commerce and to import the product into the United States. Doing so may result in FDA initiating regulatory action (e.g., seizures, injunctions).
FDA restricts the way tobacco manufacturers, retailers, and distributers can advertise and regulated tobacco products, especially marketing efforts designed to appeal to youth.
- Guidance Documents
- Reports to Congress
- Inspection database
- Establishment Registration & Tobacco Product Listing database
Compliance, Enforcement & Training
Compliance & Enforcement FDA Tobacco Compliance Webinars Report Potential Tobacco Product Violation
State, Local, Tribal and Territorial Governments
Retail
Manufacturing
Small Business Assistance
Resources for You
Compliance, Enforcement & Training
Thanks for the links. Honestly, although i plan to write, call, make noise etc, I'm neither a supplier nor a lawyer, and i don't need the details about the mechanisms of compliance. I won't have to jump through the hoops myself and i hope that the suppliers who do have to jump through the hoops will get competent legal advice and join with the advocacy associations. CASAA, SFATA, AVA, for Alabama we also have the local Breathe Easier Alliance.
That said, SFATA has a nice overview document. http://sfata.org/wp-content/uploads/2016/05/SFATADeemingReuglationsAnalysis.pdf
New products (including flavors) need to be introduced by Aug 8th. I'm a little more concerned that suppliers will need to start submitting product lists this December.
While there is technically time to comply, much of that time will be needed to try to create the applications- the paperwork burden is huge and so are the costs. With needing to start submitting product lists, the need to generate reams of paper and research, and the fact that fees are per product, i wouldn't be surprised to see prices increase and the market begin to shrink. There will be some who will just hang on for two years and then close...
That said, SFATA has a nice overview document. http://sfata.org/wp-content/uploads/2016/05/SFATADeemingReuglationsAnalysis.pdf
New products (including flavors) need to be introduced by Aug 8th. I'm a little more concerned that suppliers will need to start submitting product lists this December.
While there is technically time to comply, much of that time will be needed to try to create the applications- the paperwork burden is huge and so are the costs. With needing to start submitting product lists, the need to generate reams of paper and research, and the fact that fees are per product, i wouldn't be surprised to see prices increase and the market begin to shrink. There will be some who will just hang on for two years and then close...
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