You ARE part of the problem--just another blowhard who likes to hear himself talk. Is there something positive you plan to do to help stop e-cig bans--donate time,donate money,work in your city and State to educate local and statewide politicians on positive research concerning e-cigs? Until you decide to help in a positive way,it might be wise not to show your total ignorance and listen and learn from those who have worked in a positive way to help all of us.
FDA opens comment periods on two issues regarding Substantial Equivalence Requirements
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Jman, regarding your last two points...
I can't seem to open the pdf on my tablet just now, but I do remember reading the 4 year grace period for small companies before. If I remember correctly, "regulation under subparagraph A" didn't include the marketing requirements. I remember looking closer because that sounded promising to me, as well. I'll double check when I can get on my laptop.
Regarding flavors, no, the cigarette flavor rule does not apply to e-cig liquid. Any rules about e-cig flavors would be special rules deemed by the FDA for e-liquid on top of the marketing rules. With as much stink the FDA has made over the past 4 years "worrying" about e-cigarette flavors attracting youth, just as it claimed cigarette flavors attracted youth, it seems highly likely that the FDA would at least propose special rules regarding e-liquid flavors.
I can't seem to open the pdf on my tablet just now, but I do remember reading the 4 year grace period for small companies before. If I remember correctly, "regulation under subparagraph A" didn't include the marketing requirements. I remember looking closer because that sounded promising to me, as well. I'll double check when I can get on my laptop.
Regarding flavors, no, the cigarette flavor rule does not apply to e-cig liquid. Any rules about e-cig flavors would be special rules deemed by the FDA for e-liquid on top of the marketing rules. With as much stink the FDA has made over the past 4 years "worrying" about e-cigarette flavors attracting youth, just as it claimed cigarette flavors attracted youth, it seems highly likely that the FDA would at least propose special rules regarding e-liquid flavors.
Whenever the FDA's deeming is discussed its always about nicotine that makes it a tobacco product supposedly but every time I'm left wondering one thing: What about zero nic vaping? When I've brought this up before it was kinda poo poo'd because nic is all anyone is concerned about. I still think its important. What category under FDA control does zero nic vaping fit in? I can't believe they would just let it go. Its the vapor ANTZ don't like and have used the "looks like" argument in NY. How will the FDA bring all vaping under their control? Surely they will find a way.... right? Zero nic vaping is not tobacco, food nor a drug so how will they do it? Is that where the hardware comes in? Or will they leave controlling vapor in the air, with or without nic, to the EPA to attempt stamping out regardless of the second hand smoke issue being recently dis-proven. I keep thinking about enforcement issues and it always leads back to this nic/zero nic or other ingredients like herbs, just food flavors, etc. I know from experience that some will consider this zero nic matter unimportant but I don't think it is and more products/industries are going to be affected outside the ecig one. I think its something they're already thinking about along with nic vaping knowing they have to put controls on no nic simply because you can't tell. Has anyone looked into what those companies are doing or if they think they're untouchable because nicotine isn't involved?
Edit: Ugh... I just read that... what a mess. Its wee hours of the morning and I should have waited. I'll get in here later after I've slept and try to make my point a bit clearer. I know we're only concerned with nic here but I think the Feds, whether FDA or not, are concerned will ALL forms of vaping and will do something about it. That will affect those of us who have gone to zero nic but want to continue vaping.
Edit: Ugh... I just read that... what a mess. Its wee hours of the morning and I should have waited. I'll get in here later after I've slept and try to make my point a bit clearer. I know we're only concerned with nic here but I think the Feds, whether FDA or not, are concerned will ALL forms of vaping and will do something about it. That will affect those of us who have gone to zero nic but want to continue vaping.
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Liquid without nicotine is clearly NOT a tobacco product, because it doesn't contain anything "derived from tobacco." The FDA could only go after non-nicotine sellers if they make therapeutic claims. That doesn't mean state and local governments can't include non-nicotine vaping in smoking bans (but they can't tax it as tobacco without the nicotine, either.) I honestly think the FDA has no power over non-nicotine liquids. It's all basically food products. How people choose to use it is up to them. Unless people start dropping dead or the company makes therapeutic claims, I don't belive the FDA can do anything about it. It's the nicotine and health claims that gave them jurisdiction.
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Well I guess it was a little clearer than mud. Then I suspect they'll go the harmful-to-health route inhaling flavorings and the nic issue is strictly about money.
The FDA did test some E-Juices that contained diacetyl, most E-Juice companies have removed it if they used it, but some still do. It was entirely reasonable that the FDA tested what was in the E-Juice and they found a couple of problem, literally 2 of 18.
Back in 2009 products from China were in question, many thousands of dogs were sickened and killed by dog food tainted with Melamine in dog food. Testing anything so new from China, was a good move. So they found a problem, and the industry reacted quickly. Some did have a dangerous chemical in 2009, don't act if nothing wrong was found. It has been quickly solved, but denying its history and its continued very limited use, is wrong. Most E-Liquid companies actively state they do not use Diacetyl now....that is for cause. I do believe one E-Juice did have anti-freeze in it, something that Kristin has said was at a level that was most likely not a problem...but they found it in 1 of 18.
Here is some information on Diacetyl and why the vaporizing of it was such a reasonable concern. It does help to know history.
--------------------
Diacetyl is a butter flavoring used in some food products like butter, butterscotch, butter flavoured popcorn and some alcoholic beverages. It has also found it's way into the ingredients of some e-lquids. The FDA and the EU regard it as GRAS (Generally recognized as safe) and permit it for consumption though it has come to light it might not be suitable for inhaling:
The United States National Institute for Occupational Safety and Health has suggested that diacetyl, when used in artificial butter flavoring (as used in many consumer foods), may be hazardous when heated and inhaled over a long period.
Workers in several factories that manufacture artificial butter flavoring have been diagnosed with bronchiolitis obliterans, a rare and serious disease of the lungs. The cases found have been mainly in young, healthy, non-smoking males. There are no known cures for bronchiolitis obliterans except for lung transplantation.
While several authorities have called the disease "Popcorn Worker's Lung," a more accurate term suggested by other doctors may be more appropriate, since the disease can occur in any industry working with diacetyl: diacetyl-induced bronchiolitis obliterans.
After the workers filed a lawsuit against the manufacturers, the United States Environmental Protection Agency began an investigation into the chemical properties of microwave popcorn butter flavoring. In March 2004, former microwave popcorn plant employee Eric Peoples, of Joplin, Missouri, was awarded $20 million for permanent lung-injuries sustained while on the job. On July 19, 2005, jurors awarded $2.7 million to another popcorn plant worker in Missouri for his claim of diacetyl-induced respiratory problems
Indeed the local problem in Chicago is going foward without anything from the FDA, and no Sottera stopped the FDA from regulating E-Cigs are a drug. The 2009 Tobacco Control Act does not have a lot of teeth, because it can NOT ban classes of Tobacco, it Can Not Ban E-Liquid, which the Courts will find as the clear intend of Congress, if the FDA was to overstep. Lots of confulted theory of what the FDA can do, most are pure paranoid constructions without legal basis. If the power of the 2009 Act was so powerful, and not aimed at marketing mostly, they would have done something with it, in the last 3 years. Guess what, they have not. All the same fear monger about the FDA was going on, 2 and 3 years ago. The history of the last 3 years, proves the urgency of the threat as proven false. Time has spoken, you can not avoid the last 3 years of history.
Meanwhile you have a link posted, a very timely link, about Chicago acting much like Hayward.....lining up the dominos of the local bans, and they will be fast and furious, in part because of lack of focus on the real.
In your link, BLU is pointing to the what the FDA can do as a measure of its capability. The FDA can not do what the Cities are doing, the Cities are going way over. Again the real problem is the local Bans, as your link clearly shows, the FDA has a more or less toothless 2009 Act, that recognizes that Tobacco is legal, and will remain so. And it wants it away from kids. Big deal, not a major problem.
This is why Godshall is so wrong on the substance of the problems coming at Vapers. The FDA has 3500 products being legally sold now, which are waiting on paperwork. That is how dangerous the regulations from the 2009 Tobacco Act, are to products currently being sold. The FDA has not even put E-Cigs into the Act, even thought for a full 2 years, they have said it is coming annnnnnyyyy day now. Deeming.....you realize that Deeming just means that the are part of the 2009 act, it is not a whole new creation of the act itself, it is not a set of specific rules, other that what the act currently provides for. Ayyyy yiiii yiiiii yiiiiii its just not registering. At least Kristin has given up on the 2007 date set in stone. Poof, vaporized theory of doomsday prep
The link above says it all.....the real problem is local bans, how on earth does this not register????????????????????????????????????????????????????????????????????????????????????????????????
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I for one, am very impressed by you factual presentation here, will take some time to absorb....thanks
Sigh. Much of this "quoting existing tobacco regs" is a moot point. Not all of it, but a lot of it. Example:
Vendors sell flavor vials WITH NO NICOTINE (not a tobacco product). Along side they also sell unflavored nic base in whatever PG/VG ratio.
PG/VG/Nic are already approved. Or would be the only thing that needed approval. Once. For everyone.
That solves all the content problems with "tobacco derived juice". It doesn't solve the total ban issue.
Summary: Flavoring is not an issue here. Other aspects, sure. But not flavoring. Or any regs that restrict flavoring.
It's about the nic extract. Always has been. Also the "save the children" or "gateway" or "antifreeze" or "whatever" logic that gets local/state/national bans enacted....while current smokers die due to lack of effective options.
On a side note: Anyone see the new Nicorette commercial? Now some guy quits for 15 days "but not all in a row". lol. That's ALWAYS been possible, but the "rules" were in the way and they couldn't SAY that (I think). Now NRTs are all of a sudden approved for long term use and intermittent use. ROFL. How many years did that take?
So yeah, the rules and regs part is nasty. So keep it limited to the minimal impact.....the nic base. Sell other stuff as "extras" outside of the FDA's influence.
If I was a vendor right now, I'd consider having two on-line store fronts: e-cig hardware and flavoring as one, and nic base as another.
Vendors sell flavor vials WITH NO NICOTINE (not a tobacco product). Along side they also sell unflavored nic base in whatever PG/VG ratio.
PG/VG/Nic are already approved. Or would be the only thing that needed approval. Once. For everyone.
That solves all the content problems with "tobacco derived juice". It doesn't solve the total ban issue.
Summary: Flavoring is not an issue here. Other aspects, sure. But not flavoring. Or any regs that restrict flavoring.
It's about the nic extract. Always has been. Also the "save the children" or "gateway" or "antifreeze" or "whatever" logic that gets local/state/national bans enacted....while current smokers die due to lack of effective options.
On a side note: Anyone see the new Nicorette commercial? Now some guy quits for 15 days "but not all in a row". lol. That's ALWAYS been possible, but the "rules" were in the way and they couldn't SAY that (I think). Now NRTs are all of a sudden approved for long term use and intermittent use. ROFL. How many years did that take?
So yeah, the rules and regs part is nasty. So keep it limited to the minimal impact.....the nic base. Sell other stuff as "extras" outside of the FDA's influence.
If I was a vendor right now, I'd consider having two on-line store fronts: e-cig hardware and flavoring as one, and nic base as another.
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@Tombaker: (re: top of post 166)
PG is an antifreeze. It's is the main agent in RV antifreeze.
So is salt, BTW. Meh.
You're talking about DEG, I think. It was a contamination mistake.
There were a few other mishaps too.
Many vendors want some degree of quality control...they either implement them or count on their suppliers to implement them. A bit of occasional checking is healthy...but expensive...so some low-cost checking would be a good thing IMO. How to keep the costs down....IDK.
PG is an antifreeze. It's is the main agent in RV antifreeze.
So is salt, BTW. Meh.
You're talking about DEG, I think. It was a contamination mistake.
There were a few other mishaps too.
Many vendors want some degree of quality control...they either implement them or count on their suppliers to implement them. A bit of occasional checking is healthy...but expensive...so some low-cost checking would be a good thing IMO. How to keep the costs down....IDK.
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After reading thru these postings, though not all, I'd have to agree with tombaker on this. FDA is not the immediate problem and I would agree that some form of regulation on the liquid ingredients used in E-juices is needed by the FDA to insure quality. However I would not just ignore the FDA entirely, they after all to quote a phrase can and do "Dance like a Butterfly and sting like a Bee". The real current problem are the locals who have a tendency to act like moral police like most politician do, "I don't like it therefore it is bad or wrong and must impose it upon all" attitude and they will especially if there is no opposition, old information, non factual information, lack of current testing, not put in their place and or just out right don't care of the true facts. I don't know what the animosity is between tombaker and Bill Godshall is or if there is any but you guys need to start working as a team not as a one man band if that is even possible. You know what they say knowledge is power and two heads is better than one.
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Are there any pamphlets made by CASSA that can be downloaded with all the current info, facts, lies etc that local members can use so when a situation comes up they can grab and go to help fight the non informed politicians who are trying to sideswipe the Vapor community?
(snipped for brevity)
Wrong and wrong. The 2009 FDA tests did not find diacetyl or melamine in the small sampling of cartridges tested. The DEG ("anti-freeze") found in 1 sample was at such a minuscule level as to be irrelevant and has never been found in subsequent tests. The FDA has not conducted any tests on e-cigs since 2009. The rest of your post is also irrelevant as it has nothing to do with e-cigs.
It does help to know history. You don't. Elaine, Bill, Kristen, CASAA, and many other posters here helped make that history. You're a Johnny-come-lately and have contributed nothing to that history.
I have a question.
If a manufacturer specifies in their design documentation, instruction manuals, advertising materials, and other literature that a product was built expressly to be used for inhaling a mixture of unflavored PG/VG with NO nicotine or flavorings added, how would that impact the FDA's ability to classify that product as a tobacco product? Consumers inserting flavorings and nicotine on their own into a device that was not expressly designed and sold for that purpose, would seem to remove the manufacturer from the equation. Rolling papers marketed for the purpose of rolling tobacco cigarettes have been used for years by consumers for "other" purposes yet the FDA has never intervened to remove them from the market. Top (insert rolling paper manufacturer of your chioce here) never claimed that their products were designed to be used for recreational purposes not related to the smoking of tobacco.
PVs with a 510 connection are simply power supplies. If manufacturers include a .50 cent LED flashlight head in the package, and make no mention of e-liquid, vaping, inhaling, etc., the FDA has no power to touch them. The FDA has zero regulatory power over flashlights. The fact that we can slap any of the available clearomizers, tanks, RDAs, etc. on it really does not matter if the manufacturer does not indicate that their product was built for that purpose. The plastic, glass, and metal parts used to make our "toppers" clearly do not fall under the FDA's domain until after they are sold as a complete unit, and documentation is written describing how to assemble and use them as "vaping" products. Consider that Kanger could develop a small base with an air pump that could be plugged into a wall outlet, and a pro tank screwed into it. If they marketed the base, as well as the Pro Tank as devices to be filled with a "vaporizing material designed for solely olfactory purposes using scented liquids to simulate the olfactory satisfaction of cooking, melting scented wax pellets, or the burning of incense or candles." and called it an "electronic candle", how would the FDA rules apply to it?
“Smoke” means the gases, particles, or vapors released into the air as a result of
combustion, electrical ignition or vaporization, when the apparent or usual purpose of the
combustion, electrical ignition or vaporization is human inhalation of the byproducts,
except when the combusting or vaporizing material contains no tobacco or nicotine and
the purpose of inhalation is solely olfactory, such as, for example, smoke from incense.
The term “Smoke” includes, but is not limited to, tobacco smoke, and electronic cigarette
vapors.
Clearly, the local requlation indicates that the hypothetical "Kanger electronic candle" would not be banned from the market, but it would still apply from the usage ban perspective if consumers added eLiquid to it and started vaping. Could the FDA actually prevent Kanger from selling those products as the intended use was not vaping? How is that different from the Top paper analogy?
Food flavorings are already FDA approved and sold as food products without any mention of vaping. Is the FDA likely to stop craft stores, cake shops, grocery stores, etc. from selling them because "some" consumers use them for something other than flavoring food products? I don't see how that would be possible. What if eLiquid companies started manufacturing their products without nicotine and marketing them as "scent packs" to be used in the "Kanger electronic candle"? Consumers could still add their own nicotine, attach the tank to a battery with a drip tip, and vape it if they wish. Kanger would be able to claim that they did not design the product for that use and do not endorse using the product in that manner. The FDA can't stop a company from manufacturing a product just because consumers are disassembling it and using some of the component parts for other purposes.
PG and VG all have valid non-vaping uses. I suspect that they would likely remain readily available as they are now.
Nicotine, on the other hand, is clearly a tobacco product until a manufacturer develops a way to make it entirely via synthetic means, or produce it in mass quantities using only eggplant. Then, it would be somethign other than a tobacco product. Wouldn't that put the FDA back to square one?
Finally, smoking bans work because the evidence that someone has been smoking is apparent long after the smoker extinguishes the cigarette. I have vaped in many places where it is not allowed. The "evidence" either never appears (stealth vaping), or dissipates within seconds if I do it where nobody can see me do it. In reality, if I pull out my PV in a bar in NYC, inhale, and hold the vapor until it is gone before I exhale, can the ban on vaping be enforced? It becomes nothing more than a "flavor dispenser" if I exhale no vapor. Where there is no visible vapor, there is no vaping. Do we honestly think that the college campus bans are having any effect at all? I'd bet that the students at these colleges who vape are still doing it as much as they like, as often as they like, wherever they like. They just understand that they can only let trusted friends and associates know that they are doing it, just as they have always done with the "recreational" non tobacco product.
It is my belief that there will always be a way to vape from today forward. The cat is out of the bag, and there is no putting it back in. It just might become a little more difficult. Nicotine availability and usage bans are my only concerns at this time.
My government cannot force me to go back to smoking. I will excercise civil disobedience at every turn in order to save my own life.
If a manufacturer specifies in their design documentation, instruction manuals, advertising materials, and other literature that a product was built expressly to be used for inhaling a mixture of unflavored PG/VG with NO nicotine or flavorings added, how would that impact the FDA's ability to classify that product as a tobacco product? Consumers inserting flavorings and nicotine on their own into a device that was not expressly designed and sold for that purpose, would seem to remove the manufacturer from the equation. Rolling papers marketed for the purpose of rolling tobacco cigarettes have been used for years by consumers for "other" purposes yet the FDA has never intervened to remove them from the market. Top (insert rolling paper manufacturer of your chioce here) never claimed that their products were designed to be used for recreational purposes not related to the smoking of tobacco.
PVs with a 510 connection are simply power supplies. If manufacturers include a .50 cent LED flashlight head in the package, and make no mention of e-liquid, vaping, inhaling, etc., the FDA has no power to touch them. The FDA has zero regulatory power over flashlights. The fact that we can slap any of the available clearomizers, tanks, RDAs, etc. on it really does not matter if the manufacturer does not indicate that their product was built for that purpose. The plastic, glass, and metal parts used to make our "toppers" clearly do not fall under the FDA's domain until after they are sold as a complete unit, and documentation is written describing how to assemble and use them as "vaping" products. Consider that Kanger could develop a small base with an air pump that could be plugged into a wall outlet, and a pro tank screwed into it. If they marketed the base, as well as the Pro Tank as devices to be filled with a "vaporizing material designed for solely olfactory purposes using scented liquids to simulate the olfactory satisfaction of cooking, melting scented wax pellets, or the burning of incense or candles." and called it an "electronic candle", how would the FDA rules apply to it?
“Smoke” means the gases, particles, or vapors released into the air as a result of
combustion, electrical ignition or vaporization, when the apparent or usual purpose of the
combustion, electrical ignition or vaporization is human inhalation of the byproducts,
except when the combusting or vaporizing material contains no tobacco or nicotine and
the purpose of inhalation is solely olfactory, such as, for example, smoke from incense.
The term “Smoke” includes, but is not limited to, tobacco smoke, and electronic cigarette
vapors.
Clearly, the local requlation indicates that the hypothetical "Kanger electronic candle" would not be banned from the market, but it would still apply from the usage ban perspective if consumers added eLiquid to it and started vaping. Could the FDA actually prevent Kanger from selling those products as the intended use was not vaping? How is that different from the Top paper analogy?
Food flavorings are already FDA approved and sold as food products without any mention of vaping. Is the FDA likely to stop craft stores, cake shops, grocery stores, etc. from selling them because "some" consumers use them for something other than flavoring food products? I don't see how that would be possible. What if eLiquid companies started manufacturing their products without nicotine and marketing them as "scent packs" to be used in the "Kanger electronic candle"? Consumers could still add their own nicotine, attach the tank to a battery with a drip tip, and vape it if they wish. Kanger would be able to claim that they did not design the product for that use and do not endorse using the product in that manner. The FDA can't stop a company from manufacturing a product just because consumers are disassembling it and using some of the component parts for other purposes.
PG and VG all have valid non-vaping uses. I suspect that they would likely remain readily available as they are now.
Nicotine, on the other hand, is clearly a tobacco product until a manufacturer develops a way to make it entirely via synthetic means, or produce it in mass quantities using only eggplant. Then, it would be somethign other than a tobacco product. Wouldn't that put the FDA back to square one?
Finally, smoking bans work because the evidence that someone has been smoking is apparent long after the smoker extinguishes the cigarette. I have vaped in many places where it is not allowed. The "evidence" either never appears (stealth vaping), or dissipates within seconds if I do it where nobody can see me do it. In reality, if I pull out my PV in a bar in NYC, inhale, and hold the vapor until it is gone before I exhale, can the ban on vaping be enforced? It becomes nothing more than a "flavor dispenser" if I exhale no vapor. Where there is no visible vapor, there is no vaping. Do we honestly think that the college campus bans are having any effect at all? I'd bet that the students at these colleges who vape are still doing it as much as they like, as often as they like, wherever they like. They just understand that they can only let trusted friends and associates know that they are doing it, just as they have always done with the "recreational" non tobacco product.
It is my belief that there will always be a way to vape from today forward. The cat is out of the bag, and there is no putting it back in. It just might become a little more difficult. Nicotine availability and usage bans are my only concerns at this time.
My government cannot force me to go back to smoking. I will excercise civil disobedience at every turn in order to save my own life.
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Burning the night oil I see. The one saving grace on flavoring that I've thought about is that there should be nothing stopping a vendor from selling unflavored nicquid. From there, all options become possible.
The more Tom writes, the more you discover his actual knowledge is limited. He's in a learn by the post process. I like a lot of what he writes, but I like Doctor Who also.
This is NOT an FDA definition. It is the definition that has been proposed by Hayward's City Council for a new city ordinance, n'est pas?
I don't think so. If someone tried to sell nicotine that's produced synthetically or derived from eggplant, it seems to me the FDA could simply ban that as an "unapproved drug" instead of regulating it as a "tobacco product".
Agreed. I've got enough high-test nic (packaged for long-term storage in the freezer) to last me many years. But this isn't about you or me; it's about the 40 million or so smokers whose ability to switch to vaping could be dramatically reduced if the FDA does the wrong thing.
Okay, admittedly I bypassed this first link in my last post even though I have read this linked item about 6 times now. I think 90% of what is in that document doesn't exactly matter to concerned vapers (consumers). I see that 90% as FDA explaining history of how it got burned by Soterra judgment and indicating direction it will move in. The 10% that does matter, IMO, is in the last bullet point or any portion of the document that relates to that. Again, that reads as:
So, I wasn't sure which part to bold here to make my next point. Originally I bolded the part after "unless" to the period, as 'substantially equivalent' is what this thread is about and what we discuss often. Then I bolded the 'draft guidance' portion as that has to do with making the determination to grandfather. Then I bolded the 'new tobacco product' part I have bolded above, and decided to go with that. Then opened up about 7 other tabs in my browser, most of which came from the 'draft guidance' document.
Those tabs deal with Section 387 e, i and j. Where e and j contain language that bounces back forth to each other. 387e deals with Annual Registrations and 387j deals with Application for review of certain tobacco products. I'm choosing to emphasize 387i (Records and reports on tobacco products) as it states, "as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health" which deals with this item quoted above. And also loosely deals with general idea that eCigs are not currently deemed a tobacco product under FD&C. And in that section it states, "Regulations prescribed under the preceding sentence (Jman notes this as one I quoted right before this one) - shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this sub-chapter;"
Which tells me, again, that mom and pop manufacturer's (of eLiquid) aren't subject to same critera that big boys (and girls) are going to be subjected to. Which I kinda feel is common sense, but at same time, the act is written in such a way that it is really challenging to understand if you are coming (to favor of FDA guidelines) or going (subject to full enforcement under the penalty of law).
Thus, almost every time I read this act, I don't have too much of a problem understanding the language, though I do at least a little bit. But have tough time understanding how it doesn't see itself creating loopholes in way in which it is written, and thus do still think a legal team (presumably on the side of vapers or vaping manufacturers) would have field day with what's in this act, if the act is deemed entirely appropriate to all eCigs currently on market after 2007, and no special rules need apply.
Agreed, but it would mean applying them would open them up to litigation, which would be my guess as to why the delay between April 2011 writing by FDA and today as yet another day when FDA has not deemed eCig products as tobacco products.
Which is where I agree with tombaker. If FD&C is written so well, and pertains oh so well to what eCigs are / have been, then the delay is unwarranted, and at worst means if the deeming thing happens tomorrow, then certain deadlines to comply are pushed back for say 90 more days. Yet, I currently don't see how special rules wouldn't a) change substantial portions of the act to conform to eCigs, while b) essentially creating new rules that can only apply to eCigs. Almost like creating a sub-act within the act.
But of course that's just my opinion. I don't think I'm alone in it, yet because I haven't been in the game as long as others, I'm guessing anyone reading this will be able to take my opinion with grain of salt whereas if Bill G. says anything on this subject, it is time to sit up and listen because a 'real authority' on this subject is speaking not just opinion, but from experience and vast knowledge.
On everything but flavors of e-liquid, I think it is likely. With flavors in the mix, I think FDA will be petty enough to insist on approval for each and every flavor that is commercially distributed.
And if I were a manufacturer that was interested in commercially marketing my e-liquid product, I'd send that required paperwork, record my actions and keep on selling knowing that I followed the guideline. Would be interesting for them (FDA or other governmental body) to try and go with enforcement when I have met the requirement from my end. I may not be aggressive to sell the next day after I send in paperwork, but for sure no more than 90 days, I'd go that route and feel I was the one being most reasonable in the situation, so much so that I'd welcome a US court to take up the case to determine exactly, precisely what it is I was doing that was completely inappropriate given the wording of the act as it is, or was, written.
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