FDA deeming regulations explained.



hey everybody how's it going into Jamie the owner of blue diamond vapors this video is going to talk about the new FDA deeming regulations how they affect you as a customer how they affect me as a business owner and some things that you need to know that are happening pretty quickly that are really important so before we get into the regulations themselves let's talk about some dates because understanding these dates is important to understanding the picture as a whole so first off these deeming regulations were published in May tenth 2016 they go into effect 90 days later so 90 days from a 10th is August 8 2016 there's a second pieces which is a two-year window and we'll talk about that in the middle of the video and that's obviously august eight 2018 okay so published on the tenth of them a they go into effect August 8 2016 the final piece is august eight 2018 so let's start by talking about august 8 2016 what happens there's a couple of things but the most important thing that happens on august 8 2016 is our entire market freezes what that means is you cannot introduce the product to our market that was not on the market prior to August 8 2016 that means no new hardware no new juice nothing nothing new can come out August 8 2016 for that means any flavor that you want to get any piece of harder you want to get all that stuff will need to have been made and sold prior to that Augustine 2016 date the second thing that's going to impact you as customers is that we're no longer going to be allowed to do any sort of free sampling whatsoever so with regards the blue diamond vapors as you guys know we love to do free jizz weekend okay but after august 8 2016 we're not going to be able to do that anymore because won't be able to any free sampling now this rule in these regulations extends to you testing flavors inside of a store that means when you walk into a store right now you can try flavors for free right you can try them before you decide whether or not you want to buy them but now you will no longer be able to test flavors for free there's lots of discussion amongst shop owners throughout the US as to how we're going to handle this process exactly and right now unfortunately I don't have a definitive answer for you as to how that's going to happen what I can tell you though is that you will no longer be allowed to test flavors for free after august eighth there's a couple of things that happen august eight that for us in nevada as well as a few other pieces because of some other legislation are impacted by as much so for example one of the things is there's no sales to minor band okay so you can't sell vapor related product to anybody under the age of 18 well we couldn't do that in Nevada anyways because the Nevada vaping Association lobbied the state of Nevada and Senator Farley introduced legislation last session that prevented minors from buying vapor related products which is a good thing the other thing that will happen august eighth is every bottle of e-liquid that you buy will be required to have a child-resistant cap on it but that was going to happen anyways in fact it will happen before august eighth it'll happen i believe july 26 because the child poison nicotine prevention act of 2015 that you may have watched a video i put up about that a few months ago so the no sales to minors the crc caps those are things that you know we're either coming or already happening in nevada and those are pretty much industry standards right now so that's not going to affect the time now for you guys who are coming into our store in las vegas and you're buying locals only bottles they come with dispensing caps but soon you know july 26 like I talked about my last video they're going to have CRC caps on them because the way those regulations work people have asked me hey Jamie well what about a zero and I've been on calls with our trade associations and in communication with ton of owners and we've all talked about what about zero because at Blue Diamond vapors all of our testers are zeros anyways and the consensus is that even if it's a zero nicotine product the Consumer still needs to be charged in order to sample it so let's go back and talk about market freeze and let me explain that a little more in depth for you guys so August eighth the market freezes we cannot introduce new flavors harder manufacturers cannot introduce new hardware what constitutes a new flavor well you can't reformulate something if I have a bottle of e-liquid that's 80 20 and I never sold it at 70 30 I can't release a seventy-thirty if I never sold the great mango peach I can't sell a great mango peach after august eight if you go into a store and they blend eliquid for you on the spot and you're able to pick your flavors out okay and those are unique bottles made every single time you'll no longer be able to do that because if that product didn't exist on the market prior to August aids it's no longer allowed to be made one of the things about hardware that concerns me is an owner and as someone who shows you guys hardware very honestly all the time is that I suspect manufacturers will be rushing hardware to the market in order to be that August a deadline and I have concerns about hardware that may come out that's not perfect but they beat the deadline and then they can fix the problems later so I would strongly encourage you especially as we get close to that August 88 if you see a piece of hardware coming out and you're like man that's amazing go into a store no matter what store it is okay and take a look at that piece of hardware before you buy it especially if you're somebody who traditionally only buys your products online go check it out because i said i have a huge concern that we're going to see some products rush to the market to beat that august eight deadline that turn out to be awful products as a result ok so we covered the things that are happening august 8 2016 and you're probably thinking market freeze sucks and paying for samples or to try flavors also sucks but it's not the end of the world it's not that bad this is where it gets crazy and this is honestly where it gets bad where it gets really bad so when I started this video I talk to you about you know three dates may 10 august 8 2016 and august eight 2018 on the industry owner side of things this is what happens we have until august eight 2018 to submit approval to the fda for our products so there's two pathways that you can take when you want to seek approval you can use a pathway they call substantial equivalence or you can use a path where they call premarket tobacco approval which i'm going to abbreviate to pmta now in order to seek substantial equivalence you have to demonstrate to the fda that your product was like a product that was already on the market at a certain time in the deeming regulations that time frame is februari of 2007 so when we look around our industry whether it's hardware or illiquid etc almost nothing exists in February of 2007 meaning it is practically impossible for us to seek substantial equivalence so that only leaves us with the PMT a option now substantial equivalence is less expensive than pmta by a long shot it's way less expensive okay and it's a much easier process it's still a process it still has a cost you still have to demonstrate a few things okay but it is a reasonable pathway but that pathway will not be available to us because the date used to determine substantial equivalence is februari 2007 so that leaves us with pmta or premarket tobacco approval and this is where it gets really really bad most people suspect that to see Capri market Tobacco approval will cost around a million dollars the cost is not because you file something with the FDA and that application costs a million dollars the cost comes from doing the research and compiling the data necessary in order to submit that application to the FDA more than likely that million-dollar price point is probably too low and you'll need to seek pmta for every single product that you make so right now there are 30 locals only flavors if we want to seek pmta for our 30 locals only flavors and even if we said that a PMT a cost half a million dollars that would be 15 million dollars in order to seek pre market Tobacco approval for the 30 products that we make in locals only the crazy thing about pmta is there's no guarantee that you'll get that approval okay this is not about you show up to the FDA and you say I have the deepest pocket books of any person alive I've got all the money's okay just because you have money does not mean the FDA will approve your application and one of the things that is a big concern of all the professionals in the industry is the FDA more than likely will not approve flavor e-liquid so you go out there and let's say you spend a million dollars to work on your PMT application and you turn your application in for a strawberry milkshake flavor and the FDA says well you did your research and that stuff looks good but we have concerns that a strawberry milkshake flavor presents a danger to young adults and so we're going to not approve your application and guess what poof just like that you lost a million dollars so it's not a guarantee most people don't think the FDA will approve flavors last weekend at vapors exhibit in Las Vegas Gregory Connelly who's the president of the American vaping Association said to an assembled group of owners and industry professionals that he thought the flavor is likely to be approved where tobacco mint and maybe Scotch okay flavors that you see in adult based products according to the FDA not flavors that we use in our industry so more than likely what's going to happen come august eight 2018 if nothing changes is that all the products that we disappear they go away because no one will be able to seek pmta because of one the cost and to the fact that the FDA does not have to approve anything regardless of how much money you've invested into it so I'm going to be very honest with you guys two years down the road if nothing changes with the deeming regulations Blue Diamond vapors and my distribution company is out of business it's that simple my company is too small to seek premarket tobacco approval and even if you said to me Jamie you could seek premarket tobacco approval for five year products for a million dollars but it's not guaranteed it's simply not a risk I would be willing to take nobody is willing to take it that's crazy and that's the most frustrating thing about this process is that we don't have a pathway for substantial equivalence because the date picked is ridiculous and if we want to see premarket tobacco approval which almost nobody has the reality is is we can't afford it most vapor shops are owned by small business people like myself it's their family business the likelihood of you being able to seek pmta is almost non-existent in god forbid you tried and spent 1 2 3 5 million dollars and the fda just said no it's that simple what's happening in our industry right now there's a couple of things obviously we have some litigation pathways okay we can see the FDA and advocacy groups like safada kansaw not blowing smoke the American baking association are coming together to form a coalition to explore them the other thing is we can change the deeming regulations by legislation in Congress etc so there's a bill right now 2058 and we've been talking about that seeks to change the the date that we would use the substantial equivalence and dr. Joe heck who's a Nevada congressman is one of the sponsors of 2058 and it's it's important to point out something about this okay sponsoring 2058 came about because members of Nevada vaping Association sat down with dr. heck and it's also important that Charles Pulaski who's the owner of vapor cave in Las Vegas was the person who spearheaded that initial meeting and I feel that it's very important that not only do we recognize the NBA there but Charles as well for his work with regards to introducing this to dr. Joe hack our congressman in Nevada and making sure that he got involved in that the Nevada bathing Association will be rolling out some programs over the next few months that are designed for use consumers to get involved previously our organization was just free industry professionals but this is a fight where everyone's going to have to get involved so I'm going to do my best to keep you guys informed as our customers of what's happening on the NBA side I know the NVA will be reaching out to you if you haven't already go onto facebook like the nevada vaping association's facebook page go check out the web page take a look at all the shop owners eliquid manufacturers hardware manufacturers that are involved in making the nevada baking association work and support those people and like i said over the next few months expect some details as to how you can get involved with the NBA in order to support our industry specifically here in nevada and of course on the federal level if you go into a shop right now and that shop owner tells you don't worry about it we're going to be fine one of two things is happening either they're lying to you or they have no idea what's happening because if nothing changes our industry is not going to be fine legislation has the potential to help litigation has the potential help the other thing that I need you to keep in mind is November is right around the corner and that means elections now I'm not telling you who to vote for that's not my style what i am telling you is that you need to do some research I need to see which candidates that are running for office both locally on the state level and federally have a position that supports the vaping industry okay and which of those candidates have a position which does not support the baking industry because if the survival our industry is important to you if you want to continue to use the products that even using so that you are not using a traditional combustible product then we need to support candidates that are going to support our industry like always if you have questions or comments go ahead and leave them underneath the video on our facebook you can reach me on Instagram Twitter the whole nine and I'm always in our shop so if you ever have a question you want to ask me specifically then by all means please do so

12 Comments

  1. pretty nice brick wall

  2. dude just do penny samples like one dropet full for a penny then you sold it

  3. The right to be smoke free coalition filed suit yesterday. I'll put up a video explaining details once I have all the info.

  4. haha

  5. This was super helpful and easy to follow. I'm hoping things go in favor for the small businesses.

  6. keep us updated thanks again

  7. Thanks For the video

  8. Thanks Jamie

  9. Thanks Jamie, great job !!

  10. Thank you for the video Big Government and the lobbyists strike again. Shame!

  11. Thank you for the video. I know that your not a DIY shop so I don't know if you know the answer to this. How willThis affect DIYERS like myself who make their own juice?

  12. Thank you Jamie. Wonderful video!

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