i was wondering how long businesses will be able to stay in business if this thing gets passed. are they out of business effective immediately or do they have a 2 year window to make as much as they can and then exit the business in a timely manner? i just wondered how this will go down if it gets passed? are we going to wake up one morning in the fairly near future and find all stores both online and B&M shut down?
FDA how long can vendors sell their product if the regulation is passed?
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FDA says they will take no enforcement action for 2 years against anyone selling, as long as the seller has registered and submitted their applications.
On the other hand, they say they are in a position to review applications right away.
So, if they start reviewing and rejecting applications right away, the two years are not a guarantee.
Would probably behoove vendors to wait until the end of the compliance period to submit their applications.
On the other hand, they say they are in a position to review applications right away.
So, if they start reviewing and rejecting applications right away, the two years are not a guarantee.
Would probably behoove vendors to wait until the end of the compliance period to submit their applications.
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also anyone submitting an application would have to pay for the application immediately? if thats the case i dont see to many small vendors bothering to pay for that HUGE chunk of cash. i could see most businesses folding up when?? as early as July??
Very roughly, e-liquid sellers will have 6 months after the proposed rule become final to register. Registration includes an ingredient listing (which is fairly detailed - I don't think "Lorann Cinnamon flavoring" is going to pass muster). This also would apply to sellers of high-concentration nic. base, and equipment manufacturers. Of course online vendors and B&Ms couldn't sell a product unless the manufacturer had registered. (That applies to backstock, too.)
So the market might start to thin out based on just the registration requirement (which will be enforced before the 2-year clock starts to run, according to the FDA). Get ready for some great sales.
Applications will be required before the 2 year window closes (clock starts when the proposed rule becomes final). Applications must include data that will permit the FDA to authorize the product as "appropriate for public health," so my guess is that your local B&M which mixes e-liquid is not going to be able to commission a study - even if it wants to register.
So the market might start to thin out based on just the registration requirement (which will be enforced before the 2-year clock starts to run, according to the FDA). Get ready for some great sales.
Applications will be required before the 2 year window closes (clock starts when the proposed rule becomes final). Applications must include data that will permit the FDA to authorize the product as "appropriate for public health," so my guess is that your local B&M which mixes e-liquid is not going to be able to commission a study - even if it wants to register.
I wasn't aware of that 6 month window.
It also seems redundant to include ingredient listing for already approved FDA regulated flavors. If at some point the FDA wants to regulate flavors used in the vaping market, they could do that but essentially they are requiring the same thing twice when there's no alternative standard.
It also seems redundant to include ingredient listing for already approved FDA regulated flavors. If at some point the FDA wants to regulate flavors used in the vaping market, they could do that but essentially they are requiring the same thing twice when there's no alternative standard.
They are approved for ingestion, not inhalation. Not sure, but I think that's the snag there?
And I've followed all of these threads pretty closely, and still find myself just saying, "I so hope this isn't going to happen, and I don't know." I can only sway with whatever seems the most persuasive analysis/speculation current. I do tend to pay the most attention to veteran ECF'rs who were significantly engaged in the 2010 crisis.
But no idea, finally, what's speculative opinion (sometimes stated as obvious fact) and what's at least close to the facts re actual outcome.
While flavors and ingredients are approved separately, once combined in varying amounts I suppose the final concoction is deemed a different product.
Shouldn't pose a problem for the DIY crowd. Of course then there's that little nicotine hurdle. I'm going to try vaping a tomato. Stand by.
Some things right now are just 'made up.' FDA has alternative in supplemental doc whereby all vendors existing today would have all products grandfathered to the date the rule goes into effect. One would think all vapers would be pushing for this as it makes point of this thread defunct, while easing burden on FDA/government. Instead, no CTA yet on this vital point, and so instead, we make up worst case scenarios, all of which strike me as defeatism at work.
The guidance documentation from the FDA...the regulations they are deeming e-cigarettes to be part of...
Applications for Premarket Review of New Tobacco Products
Applications for Premarket Review of New Tobacco Products
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