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2016/05/14 17:16:28
Subject: Re:FDA makes a move to effective outlaw vaping
Spinner wrote: Again, it sucks that it would hurt small businesses, but if you can't afford to make sure your product is safe, you shouldn't be selling it.
I find it kind of ridiculous that we have a number of laws that protect consumers from unsafe/defective products, and yet there are people here who don't want that same standard applied to them.
2016/05/16 07:24:26
Subject: Re:FDA makes a move to effective outlaw vaping
Spinner wrote: Again, it sucks that it would hurt small businesses, but if you can't afford to make sure your product is safe, you shouldn't be selling it.
I find it kind of ridiculous that we have a number of laws that protect consumers from unsafe/defective products, and yet there are people here who don't want that same standard applied to them.
I think the general mood is that manufacturers would love to comply but under this scheme cannot afford to, these regs effectively gift the industry to big tobacco and pharma. Neither of which are particularly trusted.
So it's not that they don't want regulation but rather a fair playing field to be able to comply.
2016/05/16 16:35:10
Subject: Re:FDA makes a move to effective outlaw vaping
I think the general mood is that manufacturers would love to comply but under this scheme cannot afford to, these regs effectively gift the industry to big tobacco and pharma. Neither of which are particularly trusted.
So it's not that they don't want regulation but rather a fair playing field to be able to comply.
IMO, the "easy" fix to that is to have a grandfather clause, and a timetable for compliance to allow the better set up small guys to do things incrementally.
The image that I'm getting from some posters here, is that many of these vape shops are running like that ill-fated new hobby shop.... You know, the one where the owner is a "hobbyist" as well, and doesn't treat it as much as a business as they should... Only the vape guys haven't reached the point of closing up shop because they are still doing enough business to stay open.
I'd suggest that the smart business person in this industry would have seen that the situation was not going to remain this way forever, and set something aside to deal with the eventual tightening of the industry. Those who didn't have any kind of plan kind of deserve what they get. I mean, we know how quickly a poorly run gaming shop, restaurant, bar or any other store can go under, and I see shops who cannot keep up with impending regulations in the same way.
2016/05/16 16:51:33
Subject: Re:FDA makes a move to effective outlaw vaping
I think the general mood is that manufacturers would love to comply but under this scheme cannot afford to, these regs effectively gift the industry to big tobacco and pharma. Neither of which are particularly trusted.
So it's not that they don't want regulation but rather a fair playing field to be able to comply.
IMO, the "easy" fix to that is to have a grandfather clause, and a timetable for compliance to allow the better set up small guys to do things incrementally.
The image that I'm getting from some posters here, is that many of these vape shops are running like that ill-fated new hobby shop.... You know, the one where the owner is a "hobbyist" as well, and doesn't treat it as much as a business as they should... Only the vape guys haven't reached the point of closing up shop because they are still doing enough business to stay open.
I'd suggest that the smart business person in this industry would have seen that the situation was not going to remain this way forever, and set something aside to deal with the eventual tightening of the industry. Those who didn't have any kind of plan kind of deserve what they get. I mean, we know how quickly a poorly run gaming shop, restaurant, bar or any other store can go under, and I see shops who cannot keep up with impending regulations in the same way.
This. I think that not expecting to get hit with regulations and just stay a free trading shop forever is silly. Almost every industry and business is regulated to an extent, not expecting the government to come in and want some fees is just silly.
There's nothing sudden about this. They knew it was coming, and if they pretended it wasn't then it's their fault. The only surprise is that the FDA didn't drag it's feet for years before reaching a final ruling, but it was obvious to anyone in the industry that regulation was coming.
feeder wrote: Frazz's mind is like a wiener dog in a rabbit warren. Dark, twisting tunnels, and full of the certainty that just around the next bend will be the quarry he seeks.
2016/05/16 21:43:51
Subject: Re:FDA makes a move to effective outlaw vaping
Inquisitor Lord Bane wrote: There's nothing sudden about this. They knew it was coming, and if they pretended it wasn't then it's their fault. The only surprise is that the FDA didn't drag it's feet for years before reaching a final ruling, but it was obvious to anyone in the industry that regulation was coming.
I think most people expected regulation and knew it would happen, however I don't think any small to medium business could realistically afford these fees
The FDA estimate the fee for each item tested at $333,330 but some other estimates go as far as millions per item
It's a bit of a stretch to argue that a manufacturer making a line of e liquid with ten or so flavors should have enough capital put aside to afford these as each different strength of liquid would be classed as a separate item. Most e liquids come in 18,12,6 and 3mg nicotine so it would require our hypothetical e liquid company 40 applications at the FDA figure of $333,330 that's $13,333,200 with no garentee that they would even get approved. I can see why you would just fold rather than pay out. I wouldn't have thought most small businesses could call on that sort of capital.
People knew regulations where coming but I think they weren't expecting to be priced out of the market quite so drastically and so soon the FDA has basically regulated everyone but big tobacco and pharma out of the business.
The FDA should have worked with the industry to benefit the public but instead has given the whole thing over to big business which won't benefit the consumer or anyone currently making their living through vaping.
2016/05/16 21:48:48
Subject: FDA makes a move to effective outlaw vaping
Definitely, it's almost as if the regulations have been set up to make it as hard as possible to quit via vaping. These regs will harm the vaping market and keep people on tobacco despite the recommendations to do the opposite
2016/05/16 22:32:01
Subject: FDA makes a move to effective outlaw vaping
I agree that the cost of the PTMAs are excessive for how young the industry is, and Congress is working on addressing that. My issue is all the people crying that the FDA shouldn't be regulating it, or how they were shocked it happened. My company is dumping tens of millions down the hole just for preliminary approval for current products. Any new products (which is a must in the tobacco industry) will cost astounding amounts of money. The G-men aren't out to eliminate the industry, so they will most likely comprimise on the cost of the PTMAs. They can't make money on a bankrupt industry
feeder wrote: Frazz's mind is like a wiener dog in a rabbit warren. Dark, twisting tunnels, and full of the certainty that just around the next bend will be the quarry he seeks.
2016/05/16 22:34:38
Subject: FDA makes a move to effective outlaw vaping
Inquisitor Lord Bane wrote: I agree that the cost of the PTMAs are excessive for how young the industry is, and Congress is working on addressing that. My issue is all the people crying that the FDA shouldn't be regulating it, or how they were shocked it happened. My company is dumping tens of millions down the hole just for preliminary approval for current products. Any new products (which is a must in the tobacco industry) will cost astounding amounts of money. The G-men aren't out to eliminate the industry, so they will most likely comprimise on the cost of the PTMAs. They can't make money on a bankrupt industry
It really comes down to money here. Big tobacco invests millions in lobbyists to ensure their livelihood. For god sakes, they sued Australia over their plain packaging laws. When companies are big enough to sue a country, I have no doubt in my mind that they would press the FDA to require regulations that will run smaller companies out of business.
Lets look at the cost of an Abbreviated New Drug Application for the FDA. In 2014 it was $63,860. A drop in the bucket in for a large tobacco company, but for a small company, that adds up fast. Especially when you need to file that for every juice you plan to sell. Look at Dr. Crimmy's, they are small high quality juice business with a ton of flavors. They are also a little more expensive than the affordable stuff you see in most stores. On their best sellers list alone, they have 15 flavors. So just to regulate those 15, it will cost them $957,900. Not including legal fees. I assure you that they have more than 15 flavors too. If your asking a small business to shell out a million dollars to just keep selling their product, they are gonna be mad about it. Especially when they then lose business because they can no longer support all their products and have to double the cost of their current ones just to cover regulation costs. Most likely leading to a slow death. This is literally the equivalent of a Walmart moving in and running all the small businesses out of town.
I agree that vapes should be regulated, but they need to be regulated appropriately. Not how the tobacco companies want it done.
I assure you that big tobacco companies are not concerned about your health, or saving the children, or anything not related the green in their pockets. If they did, they wouldn't sell cigarettes in the first place.
If you haven't seen it, John Oliver did a piece on big tobacco. Like him or hate him, his points are pretty solid.
"Because we couldn't be trusted. The Emperor needed a weapon that would never obey its own desires before those of the Imperium. He needed a weapon that would never bite the hand that feeds. The World Eaters were not that weapon. We've all drawn blades purely for the sake of shedding blood, and we've all felt the exultation of winning a war that never even needed to happen. We are not the tame, reliable pets that the Emperor wanted. The Wolves obey, when we would not. The Wolves can be trusted, when we never could. They have discipline we lack, because their passions are not aflame with the Butcher's Nails buzzing in the back of their skulls.
The Wolves will always come to the heel when called. In that regard, it is a mystery why they name themselves wolves. They are tame, collared by the Emperor, obeying his every whim. But a wolf doesn't behave that way. Only a dog does.
That is why we are the Eaters of Worlds, and the War Hounds no longer."
- Eighth Captain Khârn
2016/05/18 00:08:53
Subject: Re:FDA makes a move to effective outlaw vaping
jasper76 wrote: Every person who vapes should do so with the knowledge that what they're using might be very harmful. A couple years back, the FDA published some test results, and they found all kinds of nasty chemicals. Do you really know where that Strawberry flavor vape fluid came from, and what's in it?
Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA
FDA conducted a preliminary analysis on some samples of electronic cigarettes and components from two leading brands. Due to the variability among products, this analysis should not be used to draw conclusions about what substances are or are not present in particular electronic cigarettes or brands of electronic cigarettes.
FDA's Center for Drug Evaluation, Office of Compliance purchased two samples of electronic cigarettes and components from two leading brands. These samples included 18 of the various flavored, nicotine, and no-nicotine cartridges offered for use with these products. These cartridges were obtained in order to test some of the ingredients contained in them and inhaled by users of electronic cigarettes.
FDA's Center for Drug Evaluation, Division of Pharmaceutical Analysis (DPA) analyzed the cartridges from these electronic cigarettes for nicotine content and for the presence of other tobacco constituents, some of which are known to be harmful to humans, including those that are potentially carcinogenic or mutagenic.
DPA's analysis of the electronic cigarette samples showed that the product contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.
DPA's testing also suggested that quality control processes used to manufacture these products are inconsistent or non-existent.
Specifically, DPA's analysis of the electronic cigarette cartridges from the two leading brands revealed the following:
Diethylene glycol was detected in one cartridge at approximately 1%. Diethylene glycol, an ingredient used in antifreeze, is toxic to humans.
Certain tobacco-specific nitrosamines which are human carcinogens were detected in half of the samples tested.
Tobacco-specific impurities suspected of being harmful to humans—anabasine, myosmine, and β-nicotyrine—were detected in a majority of the samples tested.
The electronic cigarette cartridges that were labeled as containing no nicotine had low levels of nicotine present in all cartridges tested, except one.
Three different electronic cigarette cartridges with the same label were tested and each cartridge emitted a markedly different amount of nicotine with each puff. The nicotine levels per puff ranged from 26.8 to 43.2 mcg nicotine/100 mL puff.
One high-nicotine cartridge delivered twice as much nicotine to users when the vapor from that electronic cigarette brand was inhaled than was delivered by a sample of the nicotine inhalation product (used as a control) approved by FDA for use as a smoking cessation aid.
This. This is the kind of testing I'd like to see. I know everyone thinks it's all big tobacco, but maybe vaping isn't that healthy.
The juice they tested, if I recall correctly, was Chinese. Second: Propylene Glycol is found in all manner of things. And the key thing to see in that study he posted "Electronic cigarette cartridge". That's a massive red flag. The only mainstream lines that use cartridges are Juul and Blue. What they are testing is junk. We sell the Blue e-cigs where I work and if you look it says "Between 5-9mg of nicotine". They aren't even attempting to make it consistent. They are in fact made by Phillip Morris.
I am fine with setting standards to compete in the market that are fair for everyone to attempt a go at and not just billion dollar companies.
Somewhere else in this post someone said something about "gas station cigars not being like good cigars". That's exactly how the vaping industry is. You have your gas station gak, and then you have your high end vape store gak. Once again: I am all fine with standards if they are fair.
WAR IS ALL WE KNOW In the grim darkness of the far future, there is only Brussels Sprouts.
2016/05/20 19:13:33
Subject: FDA makes a move to effective outlaw vaping
Diethylene glycol is the problem substance they found. It's highly toxic and the U.S. Code of Federal Regulations allows no more than 0.2% of diethylene glycol in polyethylene glycol when the latter is used as a food additive.
This is exactly why regulation is need- to keep this junk out and allow legit companies to not be associated with the poisonous ones. Cigars are regulated, too. The issue will be to not let big money interests turn it into an anti-competitive hammer.
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WAR IS ALL WE KNOW
In the grim darkness of the far future, there is only Brussels Sprouts. 