What the {edited} is wrong with this industry?
- Thread starter Lessifer
- Start date
- th_trl_thread_readers 0
- Status
If this is the actual question that was asked:"Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?" then it's actually not as simple as the good Dr. is suggesting. At least not according to some of the debates that have occurred here.
From what I've read, and I may be wrong, if he had asked "Are sealed disposable e-cigs that do not contain nicotine also covered by the regulations" then the answer should have been, No.
e-liquid that doesn't contain nicotine, which is what the Dr. is discussing, is actually specified in the regulations as being a covered product, if it's being sold directly to the consumer.
There's a schedule of fines following an initial letter for violating FDA tobacco regs. In place for when they catch you selling cigs to minors - which, by the way, is why they HAVE an on-foot force ready to go visit vape shops, and write them up.
The thing is, if they come a second time, they could probably fine you once for EVERY FLAVOR of mis-labeled juice, or every device (once they figure out how to identify unnapproved devices).
They could fine a shop out of existence as quickly or as slowly as they wanted...
The thing is, if they come a second time, they could probably fine you once for EVERY FLAVOR of mis-labeled juice, or every device (once they figure out how to identify unnapproved devices).
They could fine a shop out of existence as quickly or as slowly as they wanted...
Far too many vendors have been their own worst enemy for years now even though they couldn't understand what that meant and I'm afraid they are going to be learning the hard way in the near future exactly what it means.
I am die-hard in the camp of "you shouldn't need a special license or any extra regulations to squirt liquids from four different bottles into one bottle and shake it." However, I've also been following all of this for years now, and it's about surviving long enough to get your message across.Far too many vendors have been their own worst enemy for years now even though they couldn't understand what that meant and I'm afraid they are going to be learning the hard way in the near future exactly what it means.
Very true. I just didn't think there was a "warning." Even if there is a warning, it would likely shut you down until you figure out what you could sell that would be in compliance.
I would imagine it would depend on the severity of the infractions found. If it was a minor thing found, yeah, I could see a "warning" issued. But if they waltzed in and found infraction after infraction, dollar sign city.
I. in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer;
II. in the case of a second violation within a 12-month period, $250;
III. in the case of a third violation within a 24-month period, $500;
IV. in the case of a fourth violation within a 24-month period, $2,000;
V. in the case of a fifth violation within a 36-month period, $5,000;
and VI. in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.
o Violations of other FDCA requirements relating to tobacco products. In general, penalties for violating other FDCA requirements relating to tobacco products may not exceed $15,000 for each violation or $1,000,000 for all violations adjudicated in a single proceeding. Section 303(f)(9)(A) of the FDCA. Violations of certain FDCA provisions are subject to enhanced penalties. Section 303(f)(9)(B) of the FDCA.
II. in the case of a second violation within a 12-month period, $250;
III. in the case of a third violation within a 24-month period, $500;
IV. in the case of a fourth violation within a 24-month period, $2,000;
V. in the case of a fifth violation within a 36-month period, $5,000;
and VI. in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.
o Violations of other FDCA requirements relating to tobacco products. In general, penalties for violating other FDCA requirements relating to tobacco products may not exceed $15,000 for each violation or $1,000,000 for all violations adjudicated in a single proceeding. Section 303(f)(9)(A) of the FDCA. Violations of certain FDCA provisions are subject to enhanced penalties. Section 303(f)(9)(B) of the FDCA.
I would imagine any warning or fine would be accompanied with the clear warning that you are not to sell ANYTHING until you are compliant with the law.
I can't imagine them walking into a shop, issuing a warning or fine, and then walking out as a customer walks in to buy the illegally sold product the business was just warned about. It would be like failing a health department inspection, you would be effectively shut down until you could pass.
I can't imagine them walking into a shop, issuing a warning or fine, and then walking out as a customer walks in to buy the illegally sold product the business was just warned about. It would be like failing a health department inspection, you would be effectively shut down until you could pass.
That above - that's for tobacco retailers currently.
And again - they COULD figure a way to call every friggin' bottle a "violation" I'd imagine...
And again - they COULD figure a way to call every friggin' bottle a "violation" I'd imagine...
For the vendors who are in denial about the regs, perhaps a simple visual presentation will register.
Here's the future
Here's the future
I'm of the camp that thinks there is far too much regulation in everything these days, but the fact is, it is what it is and anyone in any business should be fully aware that there are regulations that either do or will likely in the near future effect their business. The fact that eigs were not under any deeming law up until this point has nothing to do with the fact that as a business owner one always stays on top of what's happening within and/or to their industry. Staying up with requirements or proposed requirements is part of doing business for every business owner no matter what industry if they want to have a future in that industry.
Staying alive right now should be a top proiority and the only way to do that is to be on top of requirements. We haven't lost the future yet, but man, it sure does feel sometimes like they are trying to give it away.
I know, I'm mostly talking to the choir here but its just so frustrating that so many of our vendors have had their head in the sand for so long and continue to.
Well, that's for a retailer violating with a sale to a minor, right? For the most part I'm talking about manufacturers selling mis-branded product, and I'm pretty sure the FDA takes that even more seriously.
The vape industry is about to shrink 10 fold ... all those quick buck vape shops will be the first to go.
Maybe - who knows.
I was just pointing it out as an in-place procedure for violations that they COULD simply roll out against vape shops...
I was just pointing it out as an in-place procedure for violations that they COULD simply roll out against vape shops...
It can get a little weird how that enforcement works, and I really can't figure how it will work for vaping. Separate from any age restriction issues or violations, anytime your product does not meet regs, whether your warnings are misspelled or in a type size too small, up to you have no records to show where your liquids come from, can be regarded as an adulterated and mis-branded product. So while that scary sounding label can be painted on anything from selling antifreeze as 0 mg nic vape juice to labeling deviations can trigger varying levels of enforcement action (extreme examples of course). Hopefully they realize the antifreeze is a bigger problem than misspelling minors as manors.
I'm still trying to figure out where all these inspectors are coming from to inspect the ~14,000 establishments I think was their figure. Especially when I personally would prefer more inspectors available for places that manufacture stuff like the food we eat. Of course, that's my personal opinion, and I guess Mr. Zeller has different priorities.
I was at work, and ran in to a guy whose family owns a vape shop. Doesn't everybody? But I digress...
He was bashing a "certain guy" for having declared bankruptcy in his business, who was running for office.
I then told him about the upcoming FDA regs and how most vape shops would be hard pressed to stay in business over the next two to three years as inventory dwindled from lack of FDA product approval. Knowing that most storefronts lease for 1/3/5yrs minimum, I told him, unless they can pay off their loans for the startups within two years, they too would be declaring bankruptcy.
Funny, have not seen him at work since. Must be working his tail off in sales. That or packing.
He was bashing a "certain guy" for having declared bankruptcy in his business, who was running for office.
I then told him about the upcoming FDA regs and how most vape shops would be hard pressed to stay in business over the next two to three years as inventory dwindled from lack of FDA product approval. Knowing that most storefronts lease for 1/3/5yrs minimum, I told him, unless they can pay off their loans for the startups within two years, they too would be declaring bankruptcy.
Funny, have not seen him at work since. Must be working his tail off in sales. That or packing.
And there are a lot of those in our neck of the woods. A few are good (like the chain with the store on Adelaide in Toronto), but most are "me too" businesses only in it for a quick buck. The latter will almost all likely be toast within 1-2 years. These folks really are mostly oblivious IME to any pending or coming legislation, which just amazes me.
- Status
Similar threads
- Locked
