FDA FDA regulations and the impact on small juice vendors | another side

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LDS714

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BTW - I wonder if when the FDA Finalizes their Authority on e-liquids, if this Guy would consider doing a Series about Nicotine Extraction?

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Ol' Skool Biker Nicotine!
 

AndriaD

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All the basic juice components will still be available, but as the current conversation points out, nicotine could go away. There's always vaping at 0 nic, but I think that a little nic is a good thing, especially as we grow older and our brain cells need a little stimulating.

I'd hate to depend on Nicorette for Nic. Isn't it strange that you can buy nicorette products at the pharmacy without a prescription, but we are discussing control of the basic ingredient for ecigs?

Not really strange, considering that FDA is IN BED with big pharma, but guess who gets screwed? The consumer. I used to be really gung-ho patriotic, but now I have no choice but to concede that the ideals this country was founded on have been subverted and perverted by those who have enough money to buy the government they want, and it just makes me sick, not that they're that rich, but that this government is willing to sell out at ANY price. It hasn't been that long, a few years at most, since the republicans were all "free market! laissez faire!" but do they REALLY want a free market? Of course they don't, they want more money in their own pockets, period. If they wanted a free market, they wouldn't be trying to suppress the e-cig market, where the CONSUMER has decided to spend money, rather than on poisonous death sticks or poisonous pills to get off the poisonous death sticks. Bunch of lazy, no-good, evil HYPOCRITES.

Andria
 

zoiDman

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A portable light source isn't going to do much for our nicotine fits, if the FDA starts having the Customs dept start seizing and destroying shipments of cartos, clearos, RDA, etc... (as they did in the past, even deifying some court orders).

Very True.

But what the Court Reminded the FDA in the reference that you made was that the FDA has to Operate within the Laws that Congress gives them.

If you want to sell a something as a Finished Tobacco Product, like a Pre-Filled Carto, or if you want to Advertise something as being used to with a Tobacco Product, like a Clearo with a Picture of it Attached to a PV, then Yes, the FDA is going to Require that it be FDA Approved.

But if the Item you want to sell is Not a Finished Tobacco Product or has Not References to Tobacco Products or e-Cigarettes for Intended Use, then the FDA Doesn't have any Legal Grounds to Seize or Restrict the Item.

Most probably saw My Post #130 as being Tongue & Cheek, but it was Really to Illustrate the Point about Intended Use.

I Don't think Most people understand what the FDA wants to Accomplish by having the Indented Use verbiage their deeming. It Isn't so much that they Feel they can Stop Items from being sold. They know that Many Can't be.

It's there to Stop the Marketing of Items as e-Cigarettes. And to Break the Web Search engine being able to Easily point a person to Something that the FDA would Not Like someone to Buy.

But Please don't Take this as that Everything is Going to Remain just like it is Today. And please Do Not wait until 2020 to start consider Stocking Up and Hardware.
 
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DaveP

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Not really strange, considering that FDA is IN BED with big pharma, but guess who gets screwed? The consumer. I used to be really gung-ho patriotic, but now I have no choice but to concede that the ideals this country was founded on have been subverted and perverted by those who have enough money to buy the government they want, and it just makes me sick, not that they're that rich, but that this government is willing to sell out at ANY price. It hasn't been that long, a few years at most, since the republicans were all "free market! laissez faire!" but do they REALLY want a free market? Of course they don't, they want more money in their own pockets, period. If they wanted a free market, they wouldn't be trying to suppress the e-cig market, where the CONSUMER has decided to spend money, rather than on poisonous death sticks or poisonous pills to get off the poisonous death sticks. Bunch of lazy, no-good, evil HYPOCRITES.

Andria

Yep, our lawmakers are generally well off. One is worth $464M - Rep. Darrell Issa (R-Calif.).

Here’s the breakdown: the median net worth for all House members was $896,000 (Democrats averaged $929,000 to Republicans’ $884,000) and, for Senators, $2.5 million. The median net worth for Senate Democrats was $1.7 million, down from $2.4 million in 2011; for Republicans: $2.9 million, up from $2.5 million in 2011.

Richest and Poorest Members

Rep. Darrell Issa (R-Calif.), the chairman of the House Oversight Committee who made his millions in the car alarm business, was the richest lawmaker in Congress with an average net worth of $464 million in 2012.

The least-wealthy member was Rep. David Valadao (R-Calif.), who reported an average net worth of negative $12.1 million. Valadao is in the red, the Center found, due to loans for his family’s dairy farm.
The Majority of Congress Are Millionaires - TIME
 

Stosh

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Problem becomes can you afford to defend yourself in court for a few years against an adversary with unlimited funds for lawyers? While you're defending yourself, your stock may be seized, the DOJ has your bank denying you loans (Operation Choke Point) and closing your bank accounts.

The court slapped them down in their first try to snuff out vaping, but pointed them to a route to accomplish their aim. To think their ultimate goal has changed, their views softened, not likely, just a bit more complicated.

I would also fear the bureaucratic "death by 1,001 paper cuts". You did submit form MBt-BSDE-100485/g in triplicate, certified and notarized with copies to your local and state offices? No, slipped your mind, oh, well - see you in court....

The deeming regulations are the very first baby step, the "intended" language in there to give them wiggle room for more expansive regulations. Comes down to who defines and how the word "intended" is defined, both at the federal and state/local level. Do they have to prove it is "intended" or do you have to prove it's not "intended", a few years in court will smooth that out.

Bet you can't name one regulation coming out of D.C. that has become progressively simpler over the years....:)

Very True.

But what the Court Reminded the FDA in the reference that you made was that the FDA has to Operate within the Laws that Congress gives them.

If you want to sell a something as a Finished Tobacco Product, like a Pre-Filled Carto, or if you want to Advertise something as being used to with a Tobacco Product, like a Clearo with a Picture of it Attached to a PV, then Yes, the FDA is going to Require that it be FDA Approved.

But if the Item you want to sell is Not a Finished Tobacco Product or has Not References to Tobacco Products or e-Cigarettes for Intended Use, then the FDA Doesn't have any Legal Grounds to Seize or Restrict the Item.

Most probably saw My Post #130 as being Tongue & Cheek, but it was Really to Illustrate the Point about Intended Use.

I Don't think Most people understand what the FDA wants to Accomplish by having the Indented Use verbiage their deeming. It Isn't so much that they Feel they can Stop Items from being sold. They know that Many Can't be.

It's there to Stop the Marketing of Items as e-Cigarettes. And to Break the Web Search engine being able to Easily point a person to Something that the FDA would Not Like someone to Buy.

But Please don't Take this as that Everything is Going to Remain just like it is Today. And please Do Not wait until 2020 to start consider Stocking Up and Hardware.
 

zoiDman

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Problem becomes can you afford to defend yourself in court for a few years against an adversary with unlimited funds for lawyers? While you're defending yourself, your stock may be seized, the DOJ has your bank denying you loans (Operation Choke Point) and closing your bank accounts.

The court slapped them down in their first try to snuff out vaping, but pointed them to a route to accomplish their aim. To think their ultimate goal has changed, their views softened, not likely, just a bit more complicated.

I would also fear the bureaucratic "death by 1,001 paper cuts". You did submit form MBt-BSDE-100485/g in triplicate, certified and notarized with copies to your local and state offices? No, slipped your mind, oh, well - see you in court....

The deeming regulations are the very first baby step, the "intended" language in there to give them wiggle room for more expansive regulations. Comes down to who defines and how the word "intended" is defined, both at the federal and state/local level. Do they have to prove it is "intended" or do you have to prove it's not "intended", a few years in court will smooth that out.

Bet you can't name one regulation coming out of D.C. that has become progressively simpler over the years....:)

All Good Points Stosh.

And I'm pretty Much in Agreement with Most of what you are Saying.

One thing I would mention though is Todays Market is Vastly Different than what things looked like in when the FDA ordered Customs agents to Seize Shipments at LAX and at the Port of LA/Long Beach.

e-Cigarette Aren't perceived as some kinda Fad that only Kids are Doing. It's grown into a True Harm Reduction tool that people can use who Smoke. There has Also be some Studies Done that Show that the Risk to Users is Much Smaller than Combustible Tobacco. And the Risk to People around e-Cigarette users is Extremely Small.

Is the FDA going to Pull some Stunts and do some Nuisance Actions. I'm Sure they will. But for the Most Part, they are going to Operate inside the Authority that Congress has Given them.

Because today there is a degree of Legal Precedence regard what happens when the FDA Oversteps it's Powers.
 

Stosh

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All Good Points Stosh.

And I'm pretty Much in Agreement with Most of what you are Saying.

One thing I would mention though is Todays Market is Vastly Different than what things looked like in when the FDA ordered Customs agents to Seize Shipments at LAX and at the Port of LA/Long Beach.

e-Cigarette Aren't perceived as some kinda Fad that only Kids are Doing. It's grown into a True Harm Reduction tool that people can use who Smoke. There has Also be some Studies Done that Show that the Risk to Users is Much Smaller than Combustible Tobacco. And the Risk to People around e-Cigarette users is Extremely Small.

Is the FDA going to Pull some Stunts and do some Nuisance Actions. I'm Sure they will. But for the Most Part, they are going to Operate inside the Authority that Congress has Given them.

Because today there is a degree of Legal Precedence regard what happens when the FDA Oversteps it's Powers.

I've seen the swift changes in e-cigs over the years, the change in perception (for the general public) have been slower coming, but encouraging.

The studies and surveys are encouraging but in the 194 citations in the deeming dreck, the FDA didn't include even one....it makes my "spider-sense" tingle a bit .......:laugh:
 

DaveP

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The non smoking public generally views ecigs in three ways, IMO.

One, they see it as a possible safer alternative to tobacco, but with a cloud over its head in terms of medical acceptance.
Two, they want to know more about it so that they can buy one for their relative who can't stop smoking.
Three, they view it as an acceptable substitute and a way off of tobacco without having to deal with the stark reality of cravings after quitting tobacco.

ANTZ sees it as a barrier to stopping smoking and nicotine use in the world once and for all. The don't mind Nicorette products, but the electronic cigarette LOOKS like smoking and they don't want the icon to continue.

I think the FDA and the CDC would rather that cigarettes go away, driven off by the switch to electronic cigarettes.

Congress needs tobacco revenue, so they are against ecigs that could eventually take that away. Watch out for revenue transfers to occur in the form of taxation of ecigs.
 
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sonicdsl

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DaveP

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Nikkel

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I know there is a lot of talk saying that the FDA will drive out of business the small mixers but I don't think this is a real problem...

Small juice mixers and sellers are not my friends. I don't care if they are driven out of business. I can mix my own. The right to buy juice without knowing what is in it is a right not worth having and certainly not worth fighting for. CASAA, please don't fight for that right on my behalf. I don't want it. I don't need it. It is not in my best interest.
 

wv2win

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Small juice mixers and sellers are not my friends. I don't care if they are driven out of business. I can mix my own. The right to buy juice without knowing what is in it is a right not worth having and certainly not worth fighting for. CASAA, please don't fight for that right on my behalf. I don't want it. I don't need it. It is not in my best interest.

And you are not a "friend" of the vaping community. You are also completely ignorant on the ramifications of the Deeming Regulations or else you have a completely different motive for being on ECF than most other members.
 

Rossum

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Small juice mixers and sellers are not my friends. I don't care if they are driven out of business. I can mix my own. The right to buy juice without knowing what is in it is a right not worth having and certainly not worth fighting for. CASAA, please don't fight for that right on my behalf. I don't want it. I don't need it. It is not in my best interest.
Seriously?

"Small, independent restaurants are not my friends. I don't care if they are driven out of business. I can cook my own food. The right to eat in a restaurant without knowing what's in the food they're serving is not a right worth having and is certainly not worth fighting for. I don't need it, it's not in my best interest."

Is that the America you want to live in?
 

wv2win

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Seriously?

"Small, independent restaurants are not my friends. I don't care if they are driven out of business. I can cook my own food. The right to eat in a restaurant without knowing what's in the food they're serving is not a right worth having and is certainly not worth fighting for. I don't need it, it's not in my best interest."

Is that the America you want to live in?

If one value's the hot air put forth by the Harkins, Dubins, Pelosi's, Waxman's and Glantz's of this country, I would have to surmise that is exactly the America they want to live in. The gospel for these so-called citizens is George Orwell's 1984.
 

Nikkel

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Seriously?
"Small, independent restaurants are not my friends. I don't care if they are driven out of business. I can cook my own food. The right to eat in a restaurant without knowing what's in the food they're serving is not a right worth having and is certainly not worth fighting for. I don't need it, it's not in my best interest."
Is that the America you want to live in?

It would be in my best interest, and yours, if the restaurants were inspected occasionally for the presence of rats, roaches, and salmonella. I wouldn't fight for their right to not be inspected.
 

Oliver

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Before this gets ugly and political - let me try to broker a peace.

I think there are definitely small juice manufacturers out there with little concern for production standards. Just look at the Cuttwoods fiasco. For all we know, there are hundreds of vape stores selling similarly dangerous product - and I've got great sympathy with anyone who's worried about that.

The solution to this is a regulation that's proportionate to the issues. Unfortunately, the regulators heads are in the wrong place, and they think GMP is the way to go - GMP wipes out everything at a stroke.

Food manufacturing is not a bad model - it's a set of regulations proportionate to the issues. And I don't think anyone would be particularly upset by that (except people who shouldn't be in the game to being with). But, what's also needed are some good standards for acceptable ingredients. These are being worked on internationally as we speak, but that in and of itself is going to be a long and arduous process...

But the whole issue comes down to harm reduction - that in the end the point of reference is the product that this is designed to replace: Smoked tobacco.
 

JMarca

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You make it sound like there's a federal license required to sell tobacco products at retail, much like one needs a federal license to sell firearms. I haven't done a whole lot of research, but I don't think that's the case. If I'm wrong, would you mind providing a cite?

Of course some states and local jurisdictions do require such licenses, but they can't be that hard to get. I mean think about it, what portion of the population lives within walking distance (call it 1 mile) of some kind of store that sells cigarettes? Is it 90%, or is it higher than that?

There is no license required to sell tabacco products over the internet and you only need one at the retail level if you sell over a certain amount, the exact stipulations are below but I'll be honest I couldn't be bothered to read everything.

TTB | Tobacco | FAQ
 

Rossum

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It would be in my best interest, and yours, if the restaurants were inspected occasionally for the presence of rats, roaches, and salmonella. I wouldn't fight for their right to not be inspected.
There's a big difference between inspecting a place occasionally and requiring said place to file an application for "Product Approval" (at a 6-figure cost) for every item on their menu. The former is what restaurants are subject to. The latter is what the FDA appears to be proposing as a requirement for juice manufacturers.
 

zoiDman

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There is no license required to sell tabacco products over the internet and you only need one at the retail level if you sell over a certain amount, the exact stipulations are below but I'll be honest I couldn't be bothered to read everything.

TTB | Tobacco | FAQ

This is Correct. The Sale of Tobacco Products over the Internet is the Same as if you Opened up a B&M.

From the FAQ you linked to...

T8: Does the TTB require anything to sell tobacco products on the Internet?

TTB has no special rules for sales conducted on the Internet. You are still subject to the same requirements for selling tobacco products or cigarette papers and tubes.

State or local law may restrict tobacco products or cigarette papers and tubes sold by e-mail or delivered by U.S. mail or other carrier. However, you must contact the appropriate State government agencies where you and your purchaser are located to find out if you need licenses or permits, need to pay taxes, or must comply with other requirements.

and

T6: What must I do if I want to start a business that sells, manufactures or imports tobacco?

You do not need a Federal license to sell tobacco products. There are Federal record keeping requirements if you sell more than 10,000 cigarettes in a month. Refer to part 46 of Title 27 of the Code of Federal Regulations (CFR). You should be aware of other requirements that may impact your sales of tobacco products. Please read Industry Circulars 99-2 and 2000-4 and part 46 of Title 27 CFR.

If you intend to manufacture tobacco products, or cigarette papers or tubes in the United States, you must apply for and receive TTB approval before you engage in business. These requirements are stated in TTB regulations at 27 CFR part 40. If you need information about applying, you may contact the National Revenue Center, 550 Main St., Cincinnati, OH 45203-3263, by phone 1-800-398-2282, or by e-mail. Also, you must contact the State government agencies where you will be making or selling tobacco products to find out their requirements.

If you intend to engage in the business of importing tobacco products, you must apply and receive TTB approval before you engage in business. This requirement is stated in 27 CFR part 41 . If you need assistance with applying for a Federal permit, you may contact the National Revenue Center, 550 Main St., Cincinnati, OH 45203-3263, by phone 1-800-398-2282 or by e-mail. Other TTB forms may be required and may be available from TTB's Forms page .

You must meet other customs duties and requirements from U.S. Customs and Border Protection. Also, you must contact the State government agencies where you will be selling tobacco products to find out their requirements. However, in general, you cannot import previously exported cigarettes, other tobacco products, cigarette papers or tubes. Refer to Industry Circular 2000-4 for further information. Also, refer to Industry Circular 99-2 about cigarette sales.
 

Jman8

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It would be in my best interest, and yours, if the restaurants were inspected occasionally for the presence of rats, roaches, and salmonella. I wouldn't fight for their right to not be inspected.

Wouldn't this be highly dependent on who is proposing to do the inspections and to what end? Would you want organization that claims vegan lifestyle is above all others inspecting a steak house?

If you ever share your DIY mix with anyone, would it not be grounds for inspecting your DIY set up? Let's say you claim that you never will, but someone else claims you have. You are now having to be inspected which ought to be non-issue from what you are saying. And why wouldn't you be okay with ANTZ-leaning group of regulators inspecting your DIY set up?
 
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