FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

[DC2]

And writes like an Attorney.

Actually, I have been thinking for some time now that the word "sophist" describes him perfectly.

 

[Jman8]

Perhaps tombaker can inform us who he really is, and who is paying him to post many false, divisive and ad hominem claims on critically important ECF legislative threads.

Instead of going ad hom yourself, could you directly refute what he's conveying?

I am curious if you believe all/most existing ecig devices will be (outright) banned, by the FDA, sometime in 2014? And/or if you believe most flavors will be (outright) banned as well? If yes, how confident are you that these types of bans will occur?

Thanks!

 

[tombaker]

Perhaps tombaker can inform us who he really is, and who is paying him to post many false, divisive and ad hominem claims on critically important ECF legislative threads.

1. Bill telling people that I lie, and that my facts are wrong, without even saying what it is where I am wrong, and that everything I say should be ignored, and that only the stickies are important, which you wrote.....seems to me as something one does when they know that facts are not on their side. It reads like a concession speech.

2. I posted a reasoned response to what I view as wrong legal arguments, why the OMB dismissed your presentation, why E-Cigs companies do not share your logic. Would you please respond with substance.

3. Conspiracy theories now?, that I paid to show you how your are sending people down a path that is in the wrong direction. I posted a clear message, that I am not paid, nor associated with lobbyist, E-Cig company's, legislators. I can find it for you if needed, I specifically said there was no "depends what "is" is" ambiguity. I read your stickies of panic and alarm, and found them to be factually inaccurate.

4. Again, what am I saying that is false? Dozens and dozens of them as you report. How about just in my specific reply to you? http://www.e-cigarette-forum.com/fo...-equivalence-requirements-4.html#post11830318 What did I get wrong?

For example I pointed out that while many vapers are concerned about flavors withing E-Cigs it is your postion the FDA does not have at is power the ability to control E-Cig flavors.

For example You post this thread saying the FDA will ban all E-Cigs, (V2, BLU, everything under the sun) with it follows through with its stated goal of Deeming E-Cigs as a tobacco product. http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

There is not causation between that filing, and your conclusion, and considering all the major E-Cig makers do not agree with your assessment, it seem it would give you some pause to re-evaluate you legal conclusion. What do you define as an E-Cig? Because you have posted that clearomizers, MODs or batteries would all be included. Would NJoy start a 30 milliion dollar Ad campaign, if the only thing the FDA had to do was DEEM, and all E-Cigs would be banned.

It just does not pass the sniff test. FDA deems, all E-Cigs banned. Am I confused by the exact wording of your thread title?

If you would be kind enough to reply with some substantial explanations of your positions, and just what on earth you are calling me out on. I will admit it when I am wrong, as we all are able, I would hope.
Thanks

 

[Sundodger]

Instead of going ad hom yourself, could you directly refute what he's conveying?

I am curious if you believe all/most existing eCig devices will be (outright) banned, by the FDA, sometime in 2014? And/or if you believe most flavors will be (outright) banned as well? If yes, how confident are you that these types of bans will occur?

Thanks!

Page 12, post 111, right above a post by you.

 

[Sundodger]

Regarding SE applications, it is important for vapers and e-cig companies to submit comments to FDA urging them to quickly act on the 4,000+ SE applications (by cigarette, smokeless and RYO companies) that have already been submitted to FDA, to sharply scale back the agency's ever growing demands for additional information and its arbitrary decision making process (i.e. it can deny any application by simply saying "inadequate information provided by applicant" for SE approvals (and for exemptions from SE).

FDA's policy on SE applications since 2009 has been to indefinitely delay the processing of SE applications, and to demand more and more information from applicants (costing them ever increasing amounts of money) in order to prevent new tobacco products from being marketed in the US. By failing to process SE applications in a timely manner, FDA has prohibited several hundred new but SE tobacco products from being marketed since 2011.

Regarding the deeming regulation, unless FDA exempts e-cigs from the 2007 and 2011 deadlines in Section 905(j) and Section 910, ALL e-cig products will be banned.

But even if the FDA exempts e-cigs from the 2007 and 2011 deadlines to avoid losing another lawsuit (e.g. by extending those dates to 2013 and 2015), the deeming reg would still require every manufacturer of every single e-cig product to submit SE applications or New Product applications to FDA, and FDA would have to approve, before those products can be marketed. That's why the deeming and other e-cig regs will give the e-cig industry to Big Tobacco.


On another matter, in the past ten days, tombaker has posted nearly half of all the comments he's ever posted on ECF on this thread and on another thread (that I created describing my meetings several weeks ago with the White House OMB, and staff of House E&C Cmte and Reps. Pitts and Murphy regarding the FDA deeming and other e-cig regs).

In those postings, tombaker has made dozens of totally inaccurate statements about FDA's administration of SE applications and approvals, the impact of the deeming regulation on e-cigs, CASAA and many other e-cig legal and legislative issues.

It appears that tombaker's sole purpose of coming to ECF was/is to lie about FDA tobacco regulation and the agency's forthcoming deeming and other regs for e-cigs, and to attack leaders of our now five year campaign to keep e-cigs legal to manufacture/import/sell/use.

If anyone wants to know about the impact of the FDA deeming regulation, I suggest ignoring everything written by tombaker, and instead reading the sticky posts regarding FDA deeming regs (at the top of the legislative news section).

Here ya go tom, because you must have missed it the first time. Note where Bill includes dates and such things, they are important, not just willy nilly predictions.

 

[Jman8]

Page 12, post 111, right above a post by you.

With that in mind, I don't get how we (vapers who write to congress people) would be able to get around:

a) FDA's arbitrary decision making process
b) FDA's demand for more and more information from applicants

I also am in camp that doesn't see FDA banning all devices and have read the legal stuff (Section 905(j) and Section 910). Yet, I realize I may be wrong in how I interpret that. Yet if I am wrong in my interpretation and FDA is moving in this direction regardless of how often we all write to congress people, then not sure what it matters, as it seems we are convinced FDA is corrupt and hell bent on outright banning all eCig products.

Thus, I am still curious if Bill and any other person that has been in the game longer than I have, truly feels confident that outright bans on devices and flavors are likely to occur in 2014.

And admittedly, I question those who have gone on record before to say it will happen at x time, and x time has come to pass without it happening.

Both Tom and Bill speak with such authority and conviction in their message and both I believe are ultimately on the same side of things, yet here on a forum we get to observe them bickering and accusing the other of lying. Well Tom seems willing to engage on his commentary, and I hope Bill is willing to do the same. If not, then Bill seems as distant to me as whatever it is I'm supposed to be doing that will hopefully someday soon get thru to the FDA.

 

[Sundodger]

With that in mind, I don't get how we (vapers who write to congress people) would be able to get around:

a) FDA's arbitrary decision making process
b) FDA's demand for more and more information from applicants

I also am in camp that doesn't see FDA banning all devices and have read the legal stuff (Section 905(j) and Section 910). Yet, I realize I may be wrong in how I interpret that. Yet if I am wrong in my interpretation and FDA is moving in this direction regardless of how often we all write to congress people, then not sure what it matters, as it seems we are convinced FDA is corrupt and hell bent on outright banning all eCig products.

Thus, I am still curious if Bill and any other person that has been in the game longer than I have, truly feels confident that outright bans on devices and flavors are likely to occur in 2014.

And admittedly, I question those who have gone on record before to say it will happen at x time, and x time has come to pass without it happening.

Both Tom and Bill speak with such authority and conviction in their message and both I believe are ultimately on the same side of things, yet here on a forum we get to observe them bickering and accusing the other of lying. Well Tom seems willing to engage on his commentary, and I hope Bill is willing to do the same. If not, then Bill seems as distant to me as whatever it is I'm supposed to be doing that will hopefully someday soon get thru to the FDA.

I won't get lulled by the FDA doing nothing at this point. The FDA is the ones saying they will do something on such and such a date, not CASAA or Bill. CASAA and Bill are only letting us know what the FDA is putting out there. So it seems when the FDA doesn't do anything some people believe that CASAA or Bill all of a sudden don't know what they are talking about.

I, for one truly believe that our Reps/Senators getting a lot of communication from vapers and those on the side of keeping vaping available (with age restrictions, content verification) are making those Reps/Senators let the FDA know that the people are watching and so are they. That to me is why this has been put off and off and off. The FDA is trying to cover every single issue before making public and starting the clock on public input.

 

[DC2]

For those that are not aware of this...

The debate about what the FDA can regulate centers around the following definition:
Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) Updated October, 2010

What products are considered to be tobacco products as defined by the Tobacco Control Act?

The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco product.

 

[DC2]

I won't get lulled by the FDA doing nothing at this point. The FDA is the ones saying they will do something on such and such a date, not CASAA or Bill. CASAA and Bill are only letting us know what the FDA is putting out there. So it seems when the FDA doesn't do anything some people believe that CASAA or Bill all of a sudden don't know what they are talking about.

Exactly.

And the fact that the proposed deeming regulations are now in the hands of the OMB means things are moving forward.
It may have taken them a lot longer than they hoped, but they are further along now than ever before.

We'll see what happens...

I, for one truly believe that our Reps/Senators getting a lot of communication from vapers and those on the side of keeping vaping available (with age restrictions, content verification) are making those Reps/Senators let the FDA know that the people are watching and so are they. That to me is why this has been put off and off and off. The FDA is trying to cover every single issue before making public and starting the clock on public input.

And I am personally of the opinion that the 5,000 comments submitted to the FDA by vapers gave them quite a shock.
I'm not so sure that prior to that they were aware of how serious or how passionate we are about this.

 

[kristin]

Putting aside the debate about whether or not the FDA will attempt to regulate devices, there is one fact that cannot be ignored. Should the FDA deem e-cigarette NICOTINE LIQUID to be tobacco products, they will be held to the same requirements as all other tobacco products. There is no arguing that the FDA has made it clear it intends to deem e-cigarettes to be tobacco products under FSPTCA: http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm

1) All other tobacco products are considered "new" unless they were on the market prior to a date yet to be confirmed by the FDA. Therefore, e-liquids, once deemed tobacco products, will be considered "new" unless they were on the market prior to that date.

2) Tobacco companies are required to submit a request to the FDA to rule that their new tobacco product is "substantially equivalent" to a product that already has been on the market prior to the deadline. The company must provide written reports and tests to prove to the product is substantially equivalent. The FDA will review the submission and decide if it agrees or not. Therefore, e-liquid companies selling e-liquid tobacco products must also submit a request to the FDA for it to rule its product is substantially equivalent to a prior product. Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

3) Tobacco companies must submit as a "new" product any products that have "any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after (deadline set by FDA.) That would mean any changes in nicotine content or ingredients such as flavors. Therefore, e-liquids deemed to be tobacco products will have to do the same. Section 910 of the Federal Food, Drug, and Cosmetic Act - Application for Review of Certain Tobacco Products

4) Tobacco products cannot be sold unless "the manufacturer has submitted a report under section 905(j); and the Secretary has issued an order that the tobacco product is in compliance with the requirements of this Act; OR the tobacco product is exempt from the requirements of section 905(j) pursuant to a regulation issued under section 905(j)(3) OR the product has been declared to be "substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of (deadline set by FDA). Therefore, e-liquid deemed to be tobacco products will have the same restriction. Section 910 of the Federal Food, Drug, and Cosmetic Act - Application for Review of Certain Tobacco Products

5) Because no e-liquid company has an order from the Secretary that each of their e-liquid deemed tobacco products meet the requirements listed in #4, every e-cigarette company would be required to apply for an "order under subsection (c)(1)(A)(i) for a new tobacco product" or submit to the FDA evidence the product was on the market prior to any deadline chosen by the FDA and have received the order from the Secretary that the product is grandfathered BEFORE they can be considered a legal e-liquid tobacco product by the FDA. If they continue to sell the e-liquid deemed a tobacco product without submitting a Substantial Equivalence Report to the FDA for each product they sell or being deemed "grandfathered," their product or products will be "deemed adulterated under Section 902(6) of the FD&C Act and misbranded under Section 903(a)(6) of the FD&C. Continued marketing of adulterated and/or misbranded tobacco products may result in FDA taking regulatory action, including but not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction." Questions & Answers

If anyone can read those links and find where e-liquid deemed to be a tobacco product would be exempt from the same regulatory rules required for other tobacco products, please point them out to me. But it seems pretty clear to me that if the FDA simply deems e-cigarette nicotine liquids to be tobacco products, every e-liquid on the market today would be considered "adulterated" and companies could face "regulatory action, including but not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction" until their products are reviewed and deemed either grandfathered or substantially equivalent.

This, of course, is only the case should the FDA just deem them tobacco products and doesn't create special rules for e-liquid. If it chooses to issue special rules for nicotine e-liquids, then the FDA will issue proposed rules and a public comment period will be opened.

 

[kristin]

Sorry, double post!

 

[tombaker]

Source? That's just so wrong of them. On so many levels. Scumbags.

Here it is, I just wrote it up. Its not too late, next meeting is 1-14-2014, the more I read it the worse it got, they have a goal of closing down the existing shops already open in the city.

http://www.e-cigarette-forum.com/fo...ps-urgency-ordinance-meeting-1-14-2014-a.html









Signature Text: Little tweets back and forth, the one liners of fluff, thinking their confusion and chirpings are substantive, and of interest to others, as they marvel of the echos of their own voice, they think everyone should share in their bliss. On they go, they want more food, the trolls fascinated with self, I doubt it I doubt it, see how they roll.

 

[rothenbj]

I won't get lulled by the FDA doing nothing at this point. The FDA is the ones saying they will do something on such and such a date, not CASAA or Bill. CASAA and Bill are only letting us know what the FDA is putting out there. So it seems when the FDA doesn't do anything some people believe that CASAA or Bill all of a sudden don't know what they are talking about.

I, for one truly believe that our Reps/Senators getting a lot of communication from vapers and those on the side of keeping vaping available (with age restrictions, content verification) are making those Reps/Senators let the FDA know that the people are watching and so are they. That to me is why this has been put off and off and off. The FDA is trying to cover every single issue before making public and starting the clock on public input.

I have always believed the strongest battle front is Congress. The more noise made to elected officials, hopefully, the more they will be aware of how much a bad set of regulations may effect their next reelection plans. So far, most of my communications seem to have on deaf ears with cookie cutter responses coming back. That, I hope, doesn't mean that they didn't get a positive message.

Trying to be reactionary with the FDA is not a good approach. If their only input comes from the ANTZ and the Pharma industry, the regulations will certainly be biased from their idea of how e cigs should be controlled. If the only additional input they receive is from the cigalike crowd, another bias enters the conversation. If you don't believe it, look at the flavor issue in cigarettes,

Was there a serious reason to ban flavored cigarettes? It wasn't a major segment of the market in the first place and not really oriented toward children. However, the issue was framed around the children. BT got involved in that discussion and everyone got a piece of the victory. To protect the children, flavors were banned, except the one that the kids actually used most, menthol. The FDA and the ?non-profit?"health" associations declared they saved the world, BT got rid of segment of the market that they weren't in and everyone but the clove and flavored cig market were happy. Do we want to be the unhappy consumers here?

 

[rothenbj]

CASAA is over concerned about deeming regulation?

http://view.exacttarget.com/?j=fe60...57677&jb=ffcf14&ju=fe1f1770756d0174701d78&r=0

The US Food and Drug Administration has announced its intent to regulate e-cigarettes soon. As such, this ordinance is unnecessary and must be stopped before it gains more momentum, whether in Chicago or elsewhere. Shortsighted initiatives such as this ordinance highlight the ignorance about e-cigarettes and result in misinformation to the public. Significantly, measures like this also unfairly limit the freedom of e-cigarette users despite the fact that e-cigarettes do not produce tobacco smoke.

The FDA is going to regulate e cigarettes, how? As a drug and drug delivery device? No, tried that and got smacked down. Tobacco product? Most probably as tobacco is defined partially as a product derived from tobacco. The question is how it will be categorized and what parts of the tobacco act will be used to control the product.

 

[Jman8]

Putting aside the debate about whether or not the FDA will attempt to regulate devices, there is one fact that cannot be ignored. Should the FDA deem e-cigarette NICOTINE LIQUID to be tobacco products, they will be held to the same requirements as all other tobacco products. There is no arguing that the FDA has made it clear it intends to deem e-cigarettes to be tobacco products under FSPTCA: Regulation of E-Cigarettes and Other Tobacco Products

1) All other tobacco products are considered "new" unless they were on the market prior to a date yet to be confirmed by the FDA. Therefore, e-liquids, once deemed tobacco products, will be considered "new" unless they were on the market prior to that date.

The "yet to be confirmed date by the FDA" is fairly significant in all this, and is possibly a date that has not come to pass.

In my reading, re-reading, 4th reading and 10th reading of the FD&C relevant sections, I find myself seeing items that are seemingly open to interpretation and/or loopholes that would allow certain devices, possibly certain eliquids to bypass the act. I don't know if this is the thread to pore over all that, but my main point is us going and looking at the wording and then coming back here to discuss doesn't seem to be working for all of us. I'm guessing attorneys on all sides of this issue aren't in 100% agreement on how to interpret FD&C Sec. 387, aka sec. 900 thru 920. Hence, people with lots more resources, time and law skills prepared to fight this should FDA go and deem something as 'not legal for sale' that is currently being sold and used by millions of people.

If anyone can read those links and find where e-liquid deemed to be a tobacco product would be exempt from the same regulatory rules required for other tobacco products, please point them out to me. But it seems pretty clear to me that if the FDA simply deems e-cigarette nicotine liquids to be tobacco products, every e-liquid on the market today would be considered "adulterated" and companies could face "regulatory action, including but not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction" until their products are reviewed and deemed either grandfathered or substantially equivalent.

This, of course, is only the case should the FDA just deem them tobacco products and doesn't create special rules for e-liquid. If it chooses to issue special rules for nicotine e-liquids, then the FDA will issue proposed rules and a public comment period will be opened.

A) I don't see how FDA can't go with special rules for eCigs, as deeming them simply as 'tobacco products' and assuming rest of language, as currently written in FD&C applies is hard to imagine. So hard, that I would think a lawyer with no experience, but simply a law degree, would be able to have a field day with finding loopholes in the language and how it simply doesn't apply to eliquid.

B) Because of how confident I am with A, I don't see current language having effect on current e-liquid that results in outright banning. This also just comes off to me is as "no way of knowing" type argument in another form. Not sure I can make this point that well without having umpteen dozen vapers attacking the point, but I just wish to make clear that the almighty date in question is seemingly unknown to all of us here and the language in FD&C as currently written simply does not take eCig / vapor into account. IOW, we don't know what precisely FDA will do, what rules will be in place. And so to jump to point of 'they will ban them' seems as well founded to me as, "because we have no way of knowing what is in eliquid, and there is no evidence that they are safe, they must therefore be banned."

When I look over sec. 900 (Definitions) and get very technical, it is very challenging to see where eCigs fit in with those definitions. If I had written those definitions myself, and eCigs were going to be deemed a tobacco product, I'd want to rewrite the definitions to add something that makes it clear what we are talking about when we get to the portion later in the document that deals with eCig regulations.

Not having that now, makes it also challenging to then apply the current rules to eCigs, though I admit, not impossible.

So, looking for loopholes in the document and I find these:

• Sec. 906 Sec. 387f - General provisions respecting control of tobacco products (B) (iv) & (v): in establishing the effective date of a regulation promulgated under this sub-section, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.
  
• Sec. 910 Sec. 387j - Application for review of certain tobacco products (a) In general (1) Special rules (A) Special rule for cigarettes: Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (in-cluding the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a charac- terizing flavor of the tobacco product or to- bacco smoke.

Going to limit my list to these 2 as this is already a super long post.
> First one tells me mom and pop manufacturers of eliquid will have at least 4 years to comply with manufacturing regulations
> Second one deals with special rules for cigarettes. And as I noted the definition for cigarette doesn't fit eCigs. Unless FDA is deeming eCigs to be "cigarettes" this provision, as it is written right now, doesn't apply to eCigs. To imply that it will and/or to perpetuate that as certainty or likelihood of FDA's future actions on eCigs strikes me as not seeing what this document is really really getting at - control of traditional cigarettes, especially in way they are promoted and distributed.

 

[rothenbj]

Good work Jman, I particularly like point one. If the e cig industry has one important variable in going mainstream in the smoking community it's time. The movement away from cigarettes to vaping has grown exponentially, particularly in the last year. I know people who were smokers that became vapers and also those that went from vaping to abstinence. A four year moratorium on the cottage industry portion of the e cig industry might just be the right amount of time to build a body of evidence that would refute the fears being sold by those opposed to the technology.

BT and BEC (if any are left after BT gets serious about the E Cig business) would get regulated first and they have the money to meet FDA regulations and to fight over regulation and four years later the boutique businesses would need to fall in line or fall out. You could almost liken it to the wine and beer industries.

 

[DC2]

[*] Sec. 906 Sec. 387f - General provisions respecting control of tobacco products (B) (iv) & (v): in establishing the effective date of a regulation promulgated under this sub-section, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.

I think most of us agree that "the date" is likely to be one of the most important factors here.

 

[Luisa]

Did you miss the description of how this is currently working in practice? There is no "clear sailing." No matter how simple or obvious it seems to you or I that two products are comparable, the FDA has been asking for minute details, not just on the product being submitted, but on the predicate product. You have to pony up extremely detailed specifications for that earlier product. If that product was produced by some other company, not your own, you might not have all that information or be able to get it.

"It is important, therefore, that you submit sufficient information to enable FDA to determine whether the new tobacco product has the same characteristics (defined as the materials, ingredients, design, composition, heating source, or other features of a tobacco product) as the predicate tobacco product, in accordance with 910(a)(3)(A)(i), or has different characteristics but it is not necessary to regulate the product under section 910(c)(1)(A)(i) because it does not raise different questions of public health, as required by 910(a)(3)(A)(ii). FDA understands this to mean that 905(j) reports are to be organized based upon the list of characteristics as set forth in section 910(a)(3). In addition to these characteristics, for products that have different characteristics, FDA may determine that additional information is needed to determine whether the products raise different questions of public health."

See pages 9 through 13 of the Guidance document for the details.

The FDA has received at least 3,500 SE applications and has acted on no more than a few dozen of them.

A single predicate product does not mean that multiple companies can all use the same predicate product. These applications contain proprietary information that the FDA is obligated to keep securely. You cannot grab another company's document and copy/paste. That would be considered corporate espionage.

"FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products."

What the "clear language" means is that they want each application to use only ONE predicate product. In other words, you can't claim that features 1-10 of your new product are comparable to features in Predicate Product X, but that features 11-20 are comparable to features in Predicate Product Y. Get it?

This current guidance does not apply to products that are not regulated yet as tobacco products. No doubt they will need to write a separate SE Guidance document to cover e-cigarettes, since they are very different from tobacco cigarettes. Our concern is that so far, the FDA has been very, very picky, sending back SE applications asking for more and more detailed information. "A coil is a coil is a coil" very likely will not cut it with tobacco regulators. If they follow the same pattern as this document, they will be asking for all of the metals that went into making a coil, design drawings, etc., and will want the new product to be identical in every way with the predicate product, unless the applicant can pony up proof that the new design does not present any changes in health risks.

Tobacco companies might be able to absorb all these costly analyses, but those e-cigarette companies not owned by a tobacco company could be bankrupt by this process if it continues to be administered in this fashion.

Just look at the EPA and you can see the nightmare awaiting us.

 

[kristin]

Jman, read again the first link in my last post. That letter to stakeholders gives a pretty good clue what the FDA intends for e -cigs and it reiterates the 2007 grandfather date in the same breath as e-cigarette regulation. It seems pretty clear that at the time it wrote that letter the FDA still intended to use that original date. I only used the "yet to be confirmed" comment so Tom didn't go off on a tangent over the date again, because the point was what could happen regardless of whatever date is set.

Yes, we've always said that these issues are what we face should the FDA deem without issuing special rules. But issuing special rules wouldn't automatically make these other rules not apply. ALL tobacco products must get such approvals/orders before marketing, regardless of what kind of tobacco product they are. Any special rules would be on top of them unless the FDA chooses to exempt them with special rules. E-liquid would still need to go through the process of being deemed grandfathered or substantially equivalent, just like every other product, unless they get an exemption under any additional, e-liquid-specific rules the FDA creates. Reading that letter to stakeholders that specifically mentions market approval requirements for tobacco products, knowing the history of how the FDA already tried to remove them from the market once using a different tactic and knowing how the FDA has worked to portray e-cigs as a public threat, how likely is it that the FDA will exempt market approval for e-liquid when it's required for ALL OTHER tobacco products?

Again, leaving the device argument aside, as I personally think the FDA won't bother with devices not sold packaged with nicotine.

And I agree - we hope that should the FDA deem anything that would force all e-cigs off the market for any length of time that someone will successfully sue. But with Sottera vs. FDA to back up its deeming e-cigs a tobacco product and the FSPTCA giving it the ability to make some pretty oppressive and devastating rules, I hope the e-cig companies can afford some really good lawyers to argue the FDA can't do what it may try to do.

The FDA doesn't have to ban them or issue e-cig-specific rules. It just has to say, "You sell a tobacco product. As such, you cannot keep selling your product until it has market approval by either proving you were on the market before the date or proving you are substantially equivalent to a product that has proven it was on the market before the date. Send us the required paperwork and we'll get back to you with our answer some day."

 

[Luisa]

They don't.
"Electronic cigarettes, or e-cigarettes, are battery-powered devices that provide doses of nicotine and other additives to the user in an aerosol. Depending on the brand, e-cigarette cartridges typically contain nicotine, a component to produce the aerosol (e.g., propylene glycol or glycerol), and flavorings (e.g., fruit, mint, or chocolate). Potentially harmful constituents also have been documented in some e-cigarette cartridges, including irritants, genotoxins, and animal carcinogens. E-cigarettes that are not marketed for therapeutic purposes are currently unregulated by the Food and Drug Administration, and in most states there are no restrictions on the sale of e-cigarettes to minors. Use of e-cigarettes has increased among U.S. adult current and former smokers in recent years; however, the extent of use among youths is uncertain."

Coupled with the fact that the FDA has yet to publish any of it's own findings I'm just not inclined to feel threatened yet. Yeah, it's done a study or two. Much like the industry they're in a lurch since a study or two doesn't produce enough evidence to establish a finding. Oh awesome! I just noticed that the notorious Bill (I kid) has posted. I know nothing of him but I'm excited to see he exists! LOL!

Where were you in 2009 when the FDA issued their press release saying e-cigs contained carcinogens and anti-freeze?