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Showing content with the highest reputation on 08/24/2016 in all areas

  1. It's a slow day at work. Meetings were cancelled and as a result I have a lot of time on my hands. Having a lot of time on my hands leads to boredom. Boredom leads to Todd (Me - Adversarious1) to either getting into trouble or getting on soapboxes and dissecting the heck out of things. So I've been sitting here reading and re-reading this FAQ from the FDA that @Christopher shared and I have been picking things apart in my brain. The FDA is talking out of both sides of their mouth in their OWN answers in their OWN documents. I think they are creating an intentional spin to confuse rather than clarify. My case in point: • a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others That is only one small portion of the FDA response to the question, "What are the costs associated with submitting an application?" I have a huge issue with the way the FDA phrased that. The "not in the millions of dollars described by some others" is used way out of context on the part of the FDA and could potentially lead people (manufacturers, particularly e-liquid manufacturers) into a false sense of security. I follow a number of different advocacy groups and I have not seen a single e-liquid manufacturer claim that a single PMTA fee is in the "millions of dollars". Many have, however, stated it would cost them "in the millions of dollars" to go through the PMTA process for their entire line of e-liquids. According to the next excerpt and my understanding, the FDA directly contradicts the "not in the millions of dollars" statement in a portion of the answer to the very next question that was addressed in the FDA's faq. Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted. FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product. According to page 94 of the Economic Analyses document that is linked above, there are two costs associated with e-liquid PMTAs. One is listed as "PMTA, E-liquid, Initial Submission (Year 2)" and the other is listed as "PMTA, E-liquid, Years 3-20". I don't know and I'm not going to pretend to know what the difference is without reading through the entire document, but the second statement highlighted above almost directly contradicts the first. As I understand it, that fee is the fee for each e-liquid. So if a manufacturer offers a single e-liquid flavor in a single strength (we'll use 0 nicotine for sake of argument) in a single size (let's say 30ml, again for the sake of argument), then the absolute lowest fee that manufacturer would be looking at is $117,486. Yet if a manufacturer offers e-liquid in six different flavors, each flavor in a single ratio and each of those flavors is available in 4 different strengths for a total of 24 different e-liquids (provided the liquids were only available in one size), then 24 different PMTAs that would need to be submitted because, in their own words, they consider them different products. That makes the figure jump to $2,819,664. A more extreme example is one of my local B&M's. Even though they sell vape hardware and accessories, their primary business is e-liquids. They currently have 121 different flavors of e-liquid. Yes, 121. 21 of those flavors come in multiple PG/VG ratios, which, again according to the FDA, qualifies them as different products. So we are up to 142. Each and every flavor/ratio is available in 6 different nicotine strengths; 0 nic, 3mg, 6mg, 9mg, 12mg and 18mg. Each flavor at each strength is available in three sizes – 35ml, 60ml and 120ml. This may be where the "Substantial Equivalency" portion comes into play; I'm not sure. For sake of ease (and my sanity) I'm only going to count the possible flavor/nicotine contents. 142 flavors times 6 strengths comes out to 852. Multiply that by $117,468 per application and you are looking at a whopping $10,008,736. Yes…over TEN MILLION DOLLARS! That is at a single size per flavor. And then you have the most extreme case I could think of – Fadora Vapor. For those who have ordered from @Compenstine before, we know he will essentially custom mix each order. I don't even want to try to figure out all of the possible combinations on the Fadora Vapor site, but the possible options on a single flavor in the basic line came out to 704. That's right; 704 possible combinations of a SINGLE flavor. There are over 50 flavors listed on the Fadora Vapor website and I know some of those flavors exceed 704 possible combinations because they are offered in more PG/VG ratios and/or more nicotine strengths. Plus he offers the option of adding flavoring and/or extra sweetner for his flavors. So for the sake of argument, let's round it down to 700 possible combinations of each flavor and limit it to 50 flavors total. That would be 35,000 different PMTA's according to the FDA because it would be 35,000 different products. Multiplied by $117,468 and you're looking at over $4.1 BILLION dollars in PMTA fees. Yes...BILLION! So the FDA's assertion that a PMTA is not in the millions of dollars is complete and utter bullit...err, hogwash. I'll get off my soapbox for now, but stand by to stand by because I hear another soapbox calling my name.
    4 points
  2. Earthling789

    FDA new PMTA FAQ's

    You hit the nail on the head... Law are supposed to be written to protect us from each other... not from ourselves... The "Nanny-state" has been running amok for FAR too long!
    3 points
  3. FXRich

    FDA new PMTA FAQ's

    Personally I'm getting tired of the government telling me what's best for me. I can make my own decisions on what's best for me, I don't need a bunch of politicians in DC telling me how to live my life. I also know a society needs a certain number of laws, but right now I believe we have too many laws that infringe on our freedoms.
    3 points
  4. Shes got a mean left hook
    2 points
  5. Expensive, convoluted and in reality just a complicated version of the rhetorical BS answers they have been giving from day one. I'm willing to bet the studies they looked at are studies conducted exclusively with combustible tobacco. What about studies solely conducted on nicotine, without the introduction of combustible tobacco (and therefore without the tar and other carcinogens that go along with it). I know of at least one study that was conducted, likely many more, that focused specifically on nicotine without the actual tobacco. I know about this study because I know one of the people who was directly involved with it. She conducted the study as part of her Masters degree in Neuroscience. I have spoken to her at length about nicotine without tobacco and in her professional opinion, though highly addictive and deadly in high enough quantities, she agrees that nicotine in and of itself presents minimal risk to the end user as long as the delivery method is safe and the nicotine is delivered in a diluted manner. In other words, while she would prefer to see people give up nicotine altogether, she is a proponent of using ENDS devices to help people quit smoking combustible tobacco, which is the REAL danger. Unfortunately her work with nicotine is focused on the effects on the brain and not the effects on the cardiovascular system, so she can't be called upon as a subject matter expert in the area. Basically we all know the FDA is using incomplete and/or inaccurate information to support the spread of misinformation to the public at large. I'm curious to know if various advocacy groups and people involved with various lawsuits are even aware of the existence of nicotine studies where the nicotine was conducted without the presence of combustible tobacco.
    2 points
  6. Girlfriend gave this dude a black eye for not sharing his vape with her, lololo Sent from my XT1585 using Tapatalk
    1 point
  7. FXRich

    FDA new PMTA FAQ's

    I think your interpretation is close if not right on. Don't know what the FDA is going to do with all that money, but I figure it isn't going to be used to reduce the cost of running the FDA. It seems to me the more money the government gets the more it wants, just my opinion.
    1 point
  8. Still on my soapbox. The FDA needs to go back and fix their FAQ. The above answer to the above question is incorrect as of August 16th. I started this topic last week with a link to a story specifically about a federal judge ruling that a label change in and of itself does not constitute a distinct product and does not require FDA approval if only the label has changed.
    1 point
  9. iQuit

    FDA new PMTA FAQ's

    All good points, guys. I would probably not use and announce comp's business model post 8/8, for privacy/security reasons. Not being a nanny or telling y'all hat to do. Just looking out for fellow vapors' well-being and their means of earning a living. Cheers guys.
    1 point
  10. FXRich

    Don't piss your GF off

    I think he will share in the future.
    1 point
  11. Edna

    Sigelei Fuchai 213

    Thanks to you when I went into the local B&M today and was looking at mods I looked at this mod.Killing time, The sales guy said it was great and I said it's not for me because I told him that it didn't turn on and off and he thought I was nuts until he popped batteries into it and tried it out. I told him to read your review to get the low down on the mod.
    1 point
  12. aufin

    FDA new PMTA FAQ's

    Well, so much for being the "information age". The U.S has become a nation of sheeple. I've just about given up trying to steer someone away from the dark side. I get looks like I'm trying to sell snake oil, or get excuses- "I've heard it can cause pneumonia", "ecig are just as bad as cigarettes", "I'm afraid it might blow up". Ya just can't fix stupid. The U.S and Europe are going in opposite directions with vaping. Just doesn't make any sense. Sent from my SM-G900V using The Vapor Talk mobile app
    1 point
  13. Earthling789

    Coil killing dark juice

    I forgot to mention the new Top-EVOD tanks... they still fit the Ego-style batteries, slightly larger, top-fill, and are Pyrex glass, so you can vape fruits and mints without worrying about cracking the plastic tank. Also, if you like what you are using, you can thin your juice.... a few drops of PG (or distilled water) in the tank (then shake well) will dilute it and thin it out nicely without altering the flavor too much (if at all). Pure PG can be bought online or at most any pharmacy, and distilled water is available by the gallons at any grocery.
    1 point
  14. For 1.2 Ohm, usually 6/5 wraps of 28ga or 9/8 wraps of 26ga on 3mm mandrel.... I like a larger diameter (2.5-3.0mm) for better wicking of 50/50 or thicker juices. I think my last one was 7/6 wraps (3mm mandrel) of 28ga for dead-on 1.4 Ohm on my Russian 91%? Which was perfect for my Chocolate Raspberry juice For my Subtank Mini RBA deck, 3mm works well too, but I've found 2.5mm and a macro-coil (coils spread out a bit) seems to vape better.
    1 point
  15. Earthling789

    Coil killing dark juice

    I've got a couple of really dark juices too... and yeah, they rip through coils, compared to my clearer or very light juices But, I've found that if I use dark juices only with my RTA's, and like @Tam stay above 1.2 Ohms with my builds... I can usually get a week or more before I have to re-wick and clean the coil. The coil itself can hold out 4-6 weeks if I dry-burn and re-wick about once a week. If I use a pre-built coil... my 1.5 Ohm coils (12-15W) can last about 10-days on average (if I can re-wick them, I can get about 3 weeks before tossing them or fully rebuilding them). Lower resistance coils don't last as long with dark juices....
    1 point
  16. Good news. He deserves a goat for worrying us....[emoji14] Sent from my LG-D851 using The Vapor Talk mobile app
    1 point
  17. Bebop

    NEED A MOD

    Well. It would be smart to be wary of eBay suppliers. They have been known to cause a considerable amount of grief with consumers with counterfeit mods and tanks that are loaded with problems. Just a caution as we see so many complaints from those who have used eBay as a source of products. Not all, of course, but a significant number.
    1 point
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