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FDA Regulations Explained - Updated Thread


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Hey Vapor Talkers, 

So as most of you have probably heard by now the FDA has release their deeming regulations for electronic cigarettes. It's extremly broad and a potential devastating blow to the industry. Especially for small to medium sized vape shops that produce their own hardware or e-liquids. I'll leave my own opinion out of the top post and reserve this for the most current information. There seems to be a lack of simplified summaries so I'll do my best, with what we know so far, to explain the situation.

UPDATED 7-1-2016

Hi folks SFATA provided a great breakdown that makes things very easy to understand. You can view that document - HERE

Here is a summary for everyone: 

The U.S. Food and Drug Administration (“FDA” or “the Agency”) issued a prepublication version of its final Deeming Rule on May 5, 2016. This Rule extends FDA’s authority to all tobacco products, products derived from tobacco, and devices used with tobacco products (except accessories). With this action, and as of the Rule’s effective date, the FDA will or could have authority over the following products:


● Liquids containing nicotine (products without nicotine are not under FDA’s authority)
● Batteries
● Tank systems
● Cartomizers
● Atomizers
● Digital Displays
● Device Software


The Rule was published in the May 10, 2016 edition of the Federal Register. The Rule’s effective date is 90 days from publication in the Federal Register ( i.e. , August 8, 2016). Once the Rule is published in the Federal Register, it starts the clock ticking on a number of dates. The Deeming Rule also creates a distinction among businesses in the industry: retailers and manufacturers. 

Retailers: Means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or selfservice displays are permitted.


Manufacturers: Means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product. As explained below, if an establishment mixes or prepares eliquids, or creates or modifies aerosolizing apparatuses for direct sale to consumers, such a firm would be a tobacco product manufacturer. A manufacturer could also be any business that rebuilds coils or devices beyond simple repairs. 

Depending on number of employees and annual revenues, it is possible that a manufacturer could qualify as a “small scale tobacco product manufacturer.” Qualifying for this designation will not reduce the compliance requirements, but will afford such firms with additional time to comply with certain requirements under the Rule. Under the Rule, a “smallscale tobacco product manufacturer” is a manufacturer of any regulated tobacco product that employs 150 or fewer fulltime equivalent
(“FTE”)employees and has annual total revenues of $5,000,000 or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with such manufacturer. In other words, if a firm employs 150 or less FTE employees and has $5,000,000 or less in annual total revenues, but is controlled by, controls, or under common control with another manufacturer that puts them over the 150 FTE/$5,000,000 revenue thresholds, they would no longer be
considered a smallscale tobacco product manufacturer.

IMPORTANT DATES:

  • May 10, 2016 - The Deeming Rule is officially published and will be effective 90 days thereafter.
  • August 8, 2016 - The Deeming Rule is effective, as it is 90 days after the Rule is published in the Federal Register. This starts the clock on the various premarket pathway options and it also implements some key changes in the near term.
  • December 31, 2016 - As a result of The Deeming Rule manufacturers will now need to submit a list of all products twice a year December and June of each year. Because the Rule will go into effect August 8 th December of this year will be the first time that vapor product manufacturers have to submit this information.
  • February, 2017 - Manufacturers will need to submit an ingredient list of all products that are manufactured in February of 2017. It is not clear at this time what items the FDA will be expecting although we do expect that the level of detail required will be significant. As we know more, we will provide updates.
  • August 8, 2018 - Premarket tobacco product application (“PMTAs”) are due.
  • August 8, 2019  -Three years after the Rule’s effective date. By this time, all products on the market must have been grandfathered or the subject of an FDA marketing authorization order.

How Suppliers must obtain FDA authorization 

Manufacturers of newlydeemed products that are "new tobacco products” will be required to obtain premarket authorization of their products through one of three pathways:


(1) substantial equivalence (SE): This will require a manufacturer to show that a new product is substantially equivalent to a product on the market as of February 15, 2007. As I'm sure most of you know, It is unlikely that many products will be able to demonstrate SE given both the lack of comparable products on the market in February 2007 and the differences between products then and now. These submissions are due 18 months after the effective date (Anyone remember the old pen style 801's? Yikes...) 


(2) exemption from SE; This pathway is intended primarily for cigars and is unlikely to be an avenue for vapor products. These applications are due 12 months after the effective date.


(3) premarket tobacco product application (PMTAs): This will be the path that almost all vapor products will need to follow. Manufacturers for both eliquids
and devices will have 24 months to submit a PMTA application. After an application has been submitted, manufacturers will have an additional 12 months to market products.


At the close of these compliance periods, products will be subject to FDA enforcement unless they are grandfathered or are the subject of a marketing authorization order. It should be noted that the administrative costs of compiling a PMTA will cost at least a few hundred thousand dollars PER product. This conservative estimate does not account for the testing that will be required to generate data sufficient to inform a PMTA submission. Such testing could cost at least $1 million per product.

Short Term:
Nothing will significantly change the way you operate your business until August 8 th . Beginning on August 8 th , the FDA can and likely will, to some degree, begin to enforce the following requirements:

∙ Products may not be sold to persons under the age of 18 (both in person and online);
∙ Age verification required by photo ID;

You've no doubt run across a few suppliers already requests age verification documents. These are suppliers getting ahead of the curve, expect this to become more normal. 

Vapor Talk

Quite a few members have PM'd me asking how this will affect Vapor Talk and what our stance is. (.... the PR firm kindly requested I refrain from using the exact words I'd like to express. But I'm sure you can take an educated guess if you know my history here!) First, the forum will always remain! No doubt forums are a gateway to the most current information. Secondly, I've taken back a large controlling share of Vapor Talk. We've just closed a joint, multi-million dollar venture and I can assure you, we're in this for the long haul (PR Release will be available at the end of the month). Vapor Talk started in 2008 and since then we've gone through early year bans, border seizures, California state ban (then reversed by good ol' Arnold) and much more. We've been doing this well before many of the new vapers arrived. 

I'll be working to expand the Vapor Talk online store, get the forum backup to spec (Many updates and bug fixed have been applied to the forum today.) as well as open new locations. VT is currently managed by the Whitney Group out of New Jersey but we'll be reopening offices in Los Angeles, a new office in Beijing (I'm flying out in two weeks so be sure to check the VT blog!) and finally England (Location TBA). Many of you have supported not just me personally but Vapor Talk as a company and community for a long time. As such we plan to stay for many, many years to come. 

 

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First of all, thank you Christopher for doing this.   I really appreciate your dedication, your time and your efforts to keep us informed on this.  You are a gentleman, a scholar, and a hell of a piano player.  Thank you for putting VaporTalk here.

 

the first thing I want to discuss is on line age verification.  I have never had to do this.  I'm curoious about how it works, what is required and the implications of leaving a hard trail and possibly compromising security, personal information and privacy issues as well as identity theft.

it's one thing to walk in to a place and flash an ID in front of a clerk and be on my way.  It's another matter when I have to supply information via electronic transfer to another location in cyberspace,  personal info that I may not want "out there" that can be accessed by a 3rd party (or 2nd party for that matter).  Particularly, if I have to do this multiple times with multiple vendors.  Seems messy and I don't like it. 

So so my questions are:  How is age verified on line? What exactly is required?  Also, is there some way I can verify my age with ONE action and then obtain an "age verification status" that can then be used in multiple transaction sites - in other words, I prove to "A" that I'm over 21 and then "A" issues me a cyber stamp that I can use at numerous locations without having to give out the specific information over and over again?  How does that work?  I would rather have a notary verify my age, for instance, and issue me a "this guy is cool" card which is then accepted by vendors without having to give these vendors my "proof of age" every time I purchase.  Does such a thing exist? All I need is to show that I'm over 21, not my actual birthdate tied to my name and address, for example. 

Im not overly paranoid when it comes to my on-line footprint but I believe in the right to privacy and the right to protect myself from excessive distribution of sensitive info. 

 

 

Mike

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I completely understand. This is something we're still looking into as the actually law surrounding this isn't completely clear. But in a worst case scenario situation (in which you have to provide an ID online) there are a couple ways vendors can verify age. One is using a 3rd party like this for example: http://integrity.aristotle.com/ basically the vendor integrates their system into their website, you input your DL number and they run it to verify it's genuine. These systems are independent and the security is managed by them. They work most of the time, in the event they don't, you have to send in your driver's license. How the vendor handles that, is up to them. Some keep a copy in a locked file cabinet accessible only to management.  (This really isn't ideal) In the event Vapor Talk had to do something like this I would never keep a hard copy. I trust my employees but some things are just too sensitive. I'd likely set up a check and review process, once approved and your DL was verified, the digital copy would be completely deleted from the server and an approval by signature would be applied to your account. (guest checkout would no longer be an option) But, as you mentioned, verifying with us doesn't mean you'd be verified with another vendor. VT also doesn't keep your CC info on file. (This is why the Vapor Talk store has no save your credit card for next time option) We can refund your order but nobody, even myself has access to the full string of your CC info. Only the merchant has this and I prefer it that way. 

How much each vendor values and take your security seriously, is the tricky part. For example, Vapor Talk is fully PCI compliant, we have been for years. This means each year we have to go through a set of tests our online areas must pass. (The forum included) Only after we've passed (our servers must have certain procedures in place in order to pass the security tests) we're given a certificate. You should always ask for this. In fact I won't' buy from a vendor that doesn't have this information on file. The scary thing is, some vendors haven't even heard of PCI compliance. Even worse, some use bare minimum SSL requirements. Vapor Talk's lucky in the fact that I own a web development company and do this by trade. You'll notice the Vapor Talk store isn't just SSL'd at checkout, the entire process, even simply browsing items, you're in a secure environment. (Notice our entire domain is on HTTPS: https://www.vaportalkstore.com/. Go visit your favorite vendor and many of them are only SSL when you actually checkout) We also don't keep your searches on record. (As a web guy I'm naturally paranoid, I've done this for users since the beginning as I know how much a data breach can become a complete nightmare) We're also required to notify users within 72 hours of a breach. (And in the event we don't, we lose our certification) 

Unfortunately it doesn't stop there. Many business don't take online security as seriously as they should. (We have clients who opt out the extra cost all the time). For example, let's say you need to send in your DL. You do this by some secure method, maybe through an online upload platform that has SSL. The problem is what about their email system. Perhaps Dan the owner has to send Jane the admin an email to update your account. For example, most stores have support@mystore.com. (personalized email addresses) These aren't run by major companies like Google. It's on the vendor to secure their environment. Hopefully they're using a trusted hosting company. They might SSL their front end but not their back. So you go to mystore.com/mailsystem and they don't have an SSL installed. (Because it costs another 100 bucks a year) and when they're logging into their mail system, the information is sent plain text. You'd be amazed at how common this is. Some online vendors are setup like this because of pure neglect others by ignorance. Neither is an excuse. So really, it boils down to how much you trust the name and person running the store. 

Additionally, there is another thing to consider. Every online store has a web guy. The web guy usually takes backups for the site. When they take that backup (Usually the SQL database and the PHP/html files) they download it to their PC. That likely contains your personal info. Does the webguy just drop that onto his USB drive? Does he use a VPN? Is he accessing your info from the local starbucks Wifi connection.  In the case of Vapor Talk the download goes to a hot swap drive, this drive is setup to encrypt on the fly using 256 AES. In the event I have to use the data it's decrypted on a machine in my office that's not connected to the internet. (I do this even for the forum). Employees cannot access anybody's info outside of the retail store. (and even at that it's extremly limited) I can, but am always connected through a VPN. Ideally these vendors are using 3rd party, respected setups. (In which case they handle none of that. This would be e-commerce system like Volusion, Bigcommerce or Shopify) I actually witnessed a fairly popular retail in China access his customer orders from a convention room in Shanghai. When I go to China, I take a newly formatted laptop. When I return to the states, that laptop is zero bit wiped and never touches one of my networks. 

As for the notary idea, it might work. It really depends on the laws being applied in that vendors state. It's on the vendor to prove they verified your age in court. What qualifies will depend. 

Another thing to keep in mind, most vendors and businesses hate these things. They'll push back, they'll also do just enough to be compliant. For example certain laws were passed in the 90's to ensure online age verification was done. Guess what the lawyers figured out? So long as you asked their age via some kind of box, you were legally fulfilling the law. (You see this often with pornorgraphy websites) Nobody ever asks for your DL. 

Ensuring your security online and what to look for is a pretty complicated process. I could write a very long post and what you need to ask and what a vendor should have in place internally to secure your information but really, you have to make the ultimate decision. Do you trust the vendor, do they have the budget to ensure their software is secure and do they have someone knowledgeable enough on staff to ensure their system/setup is as secure as possible. I can tell you as a developer, who visits many supplier websites (simply keeping up with the competition) the answer is an oustanding no. Many online (not all) have some serious security flaws. 

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Hi

Thanks so much for explaining and doing all this.

Would vendors using paypal as a confirmation and  payment option be safer. To have a paypal account you have to prove you're over 18 and your identity. I have a paypal business acct. and I remember I had to.

Just a thought.

Edna

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25 minutes ago, Edna said:

Hi

Thanks so much for explaining and doing all this.

Would vendors using paypal as a confirmation and  payment option be safer. To have a paypal account you have to prove you're over 18 and your identity. I have a paypal business acct. and I remember I had to.

Just a thought.

Edna

Yes and No. Many vendors don't have this as an option because PayPal only allows a few select vendors to operate their merchant account if they sell e-cigarettes. More often than not, most vendors at least SSL their checkout process. The merchant, if legit, usually has modest security in place. The vendor normally doesn't have access to your full string of CC information. Even still, as mentioned above, there's more to it than simply ensuring the checkout is secure. How your vendor handles your info offsite is important as well. (It's funny now that DL's are becoming a thing people are starting to think about security. But how many vendors simply toss order slips in the trash without shredding? That may not have your CC on it but it has your address and full name)

In saying all this though, people are worried about their DL info getting out while having no problem placing CC orders with sites based out of China. (Not that all Chinese sites are not secure, I just personally air on the side of caution) Use gift cards in place of your usual CC, that'll help a great deal on it's own. 

 

EDIT: By the way sorry if I want off on a tangent here :lol: Hopefully I answered everyone's question sufficiently. In case you can't tell, I love what I do :)

 

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Some may consider doing the same as me when buying online. I have a CC that has a $500 limit on it, the limit was higher at one time, but had it lowered by talking to the bank, and explaining that I was only going to use it online. The people at the bank thought it was a good idea and lowered the limit for me.

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Thank you Christopher for a very insightful answer. I appreciate taking the time to give us a detailed idea of this process. 

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Thank you, Christopher.  There are three questions that I have.  

1) Is it true that all e-juice will have to be produced in a juice making lab - a manufacturing facility, I guess.

2) Secondly - you said that anything that does NOT contain nicotine the FDA doesn't have authority over.  Does this mean that a shop can sell 0 nic juice and not have to get it approved?  Or in the alternative - for example, our local B&M will also sell the flavoring mixture of their flavors - like a bottle of Inferno flavoring, or 618 flavoring, no nic, no PG/VG.  You then add PG/VG in the proportions you want, and nic if you desire (I know people that still vape 0 nic).  Would that be affected - as in would that  have to be approved.  I know after a certain date we won't be able to get nic, but we could make up our own 0 nic juice that way in our favorite flavors.

3) Is it true that manufacturers have to apply for all nic levels per flavor?  Or will they just get a blanket approval from what, 24 down, or whatever it is?

Again, thank you for doing the leg work on this.  And congratulations on being the majority owner - although it may be a headache with the deeming regs.

Tina

Edit:  One more question.  Is it possible that online retailers won't be required to have driver's license info or anything like that?  That maybe the clicking you are 18 years or older will suffice in the long term?  

And there's a comment period before some changes take effect, right?

Edited by spydre
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I don't believe nic base was available before 2007, but pure nicotine was available. To me that means nic base needs a PMTA, but pure nicotine will not need a PMTA, it should be grandfathered in. I would much rather use nicotine diluted with VG or PG rather than use pure nicotine. I suppose I could buy pure nic and some VG and make my own base.

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6 hours ago, spydre said:

Thank you, Christopher.  There are three questions that I have.  

1) Is it true that all e-juice will have to be produced in a juice making lab - a manufacturing facility, I guess.

2) Secondly - you said that anything that does NOT contain nicotine the FDA doesn't have authority over.  Does this mean that a shop can sell 0 nic juice and not have to get it approved?  Or in the alternative - for example, our local B&M will also sell the flavoring mixture of their flavors - like a bottle of Inferno flavoring, or 618 flavoring, no nic, no PG/VG.  You then add PG/VG in the proportions you want, and nic if you desire (I know people that still vape 0 nic).  Would that be affected - as in would that  have to be approved.  I know after a certain date we won't be able to get nic, but we could make up our own 0 nic juice that way in our favorite flavors.

3) Is it true that manufacturers have to apply for all nic levels per flavor?  Or will they just get a blanket approval from what, 24 down, or whatever it is?

Again, thank you for doing the leg work on this.  And congratulations on being the majority owner - although it may be a headache with the deeming regs.

Tina

Edit:  One more question.  Is it possible that online retailers won't be required to have driver's license info or anything like that?  That maybe the clicking you are 18 years or older will suffice in the long term?  

And there's a comment period before some changes take effect, right?

1. This is likely the case yes. Any answer I give on this now would be speculative as the FDA hasn't released any set guidelines as it's all pre-emptive at the moment.  Vapor Talk has moved into an ISO 8 certified facility. (and Automated) 

2. Will I can't comment on what a vape store can and cannot do, you're correct in that retailers should be able to sell 0 nic juice as  it doesn't fall under the authority of the FDA. Businesses are creative, all of not most, will do the bare minimum/walk the line of being just legal enough not to get shutdown. I suspect that once everyone is a full understanding of the law, suppliers will do their best to figure a way around the regulation. I'm not say I suppose this one way or the other, I'm just saying...where there's a will, there's a way. It's the American way. 

3. Initially it was per strength, per base, per flavor. So a flavor with 3 nic strengths and 2 VG/PG bases would have to apply for 6 PMTA applications. Every new mixture must file for a new PMTA. So it's unlikely custom VG/PG mixes would be available online/retail. But the White House Office of Management has already made changes. Most of us are waiting on the final release. (This is why many have sort of hung back for the time being, it's still changing) 

One thing to note is that initially most flavors would have had to have been removed. That has since rumored to have changed: http://mobile.reuters.com/article/idUSKCN0YN30L

At the moment we're sort of doing the "hurry up and wait" game. 

3 hours ago, FXRich said:

I don't believe nic base was available before 2007, but pure nicotine was available. To me that means nic base needs a PMTA, but pure nicotine will not need a PMTA, it should be grandfathered in. I would much rather use nicotine diluted with VG or PG rather than use pure nicotine. I suppose I could buy pure nic and some VG and make my own base.

Remember if you're doing it on your own, there is no PMTA application. While I don't recommend it, if someone where in theory to obtain everything they needed, there's nothing to stop a person from mixing and creating liquid for their own personal use. And honestly there wasn't much available before 2007. In fact, I don't believe e-cigarettes where on the market until 2007 so pre 2007 leaves a whole lot of nothing. 

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Christopher, I had seen that Reuters article.  My guess is someone in the OMB made the argument that tastebuds don't go away once you hit 18, and adults enjoy flavors, too (and being able to taste flavors, frankly, is what has kept me vaping over analogs).  Just a guess on my part.  

What is the wait on the regulations going final?  Is there some sort of commenting period?

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7 hours ago, spydre said:

Christopher, I had seen that Reuters article.  My guess is someone in the OMB made the argument that tastebuds don't go away once you hit 18, and adults enjoy flavors, too (and being able to taste flavors, frankly, is what has kept me vaping over analogs).  Just a guess on my part.  

What is the wait on the regulations going final?  Is there some sort of commenting period?

Sorry for the delay, our power was knocked out today and I was quickly sent into the stone age. 

And it's less of a commenting period and more of a "heads up before we bend you over" period. My guess is, around August we'll have more information about the actual PMTA application process and what's involved. 

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  • 4 weeks later...
  • 2 weeks later...

Chris,

According to my sister - who thinks she knows everything on the topic - a lot of stuff will have to be taken off the market by the August 8th date (Monday).  Have you found anything that has to be taken off the market?  If so, what?  Thanks.  My sister said that the vape shop she works at sometimes had to pitch over $100,000 worth of merchandise (juice) because it wasn't, um, tamper sealed yet, even though there was time before that had to happen.  I DO know that the State of Indiana passed their own laws, and shops in Indiana can only sell juice manufactured in Indiana - and the state set up six manufacturers to manufacture for all the shops in the state (sounds like what states do with um, state dispensaries - that's all I'll say).

Tina

Edited by spydre
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33 minutes ago, spydre said:

Chris,

According to my sister - who thinks she knows everything on the topic - a lot of stuff will have to be taken off the market by the August 8th date (Monday).  Have you found anything that has to be taken off the market?  If so, what?  Thanks.  My sister said that the vape shop she works at sometimes had to pitch over $100,000 worth of merchandise (juice) because it wasn't, um, tamper sealed yet, even though there was time before that had to happen.  I DO know that the State of Indiana passed their own laws, and shops in Indiana can only sell juice manufactured in Indiana - and the state set up six manufacturers to manufacture for all the shops in the state (sounds like what states do with um, state dispensaries - that's all I'll say).

Tina

Not yet though the changes will start to kick in. It's taken me almost this entire time to wrap my head around the coming regulations. (Our legal time drafted up a summery for us finally) I'll likely created a podcast in the next week or so explaining the entire process that takes place between now and 2019. (I'll upload it to the Youtube channel and here once complete) 

Give me just a moment and I'll whip up a new post breaking down what everyone can expect (It'll take me ten minutes) 

     

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    1 minute ago, Christopher said:

    Not yet though the changes will start to kick in. It's taken me almost this entire time to wrap my head around the coming regulations. (Our legal time drafted up a summery for us finally) I'll likely created a podcast in the next week or so explaining the entire process that takes place between now and 2019. (I'll upload it to the Youtube channel and here once complete) 

    Give me just a moment and I'll whip up a new post breaking down what everyone can expect (It'll take me ten minutes) 

     

    Thanks, Chris.  

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    THANK YOU!  Granted, all of these regulations are bad news, and big tobacco's way of using the feds to put vaping out of business (big tobacco basically wrote the regs, supposedly, because they are losing so much money to vaping, and the FDA just bent over), and the regs make you think they want you to smoke rather than vape, my sister came along with today, "So are you ready for Monday?" and conversation like everything was going away Monday.  I think her friends that own the shop and wholesale are putting wrong stuff in her head, and she thinks whatever comes out of their mouths is gold for certain reasons, including the fact that they give her most of her juice for free and her mods at cost, if at any charge at all.

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    You're welcome. The grip is going to start tightening without a doubt but this won't immediately affect consumers. (At least not on the scale your sister was talking about) But expect to see some products drop off the shelves. I'm actually amending a few things on the blog post and will post back here once updated. 

    EDIT: Blog post updated to reflect a few corrections. 

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    On 8/11/2016 at 11:21 PM, FXRich said:

    What good is a picture ID if the online retailer can't see if you are the person in the picture? Kids have been using fake ID to get into bars for years.

     We went to do an online purchase the other day, and it required, not a picture of his ID, since he's under 27, but a picture of him holding his ID.......wtf?  They've got to come up with a better system.  And that's the thing - a vape shop isn't going to know a fake ID, so nothing is going to stop someone from getting a fake ID (or some other ways to get an ID that says you are above the age) to get product.  We said to heck with it and drove the 30 minutes to the store.  They are charging $1 for taste testing, but I was the first one that asked, so they hadn't really had it set up yet.  I'm 42 years old, and they had to see my ID before they could talk to me...I certainly wasn't getting carded for analogs when I was buying those, but the FDA is requiring them to card EVERYONE, evidently. But happy day, evidently this shop does well for itself, because it's going through with the FDA approval of what they can get approved in certain strengths, and some will only be say, high vg, some will only be straight 50/50, etc.  I don't expect them to be able to sell the flavoring mixture blend for that much more - right now we can purchase a bottle of flavoring to add our own nic, pg and vg to, but I'm guessing after February, that will go.  

    On 8/6/2016 at 10:46 PM, Christopher said:

    You're welcome. The grip is going to start tightening without a doubt but this won't immediately affect consumers. (At least not on the scale your sister was talking about) But expect to see some products drop off the shelves. I'm actually amending a few things on the blog post and will post back here once updated. 

    EDIT: Blog post updated to reflect a few corrections. 

    My sister was talking about she and the other shop employees were helping throw out over $100,000 in product, and I was wondering why.  Well, at first, the government was going to let them sell out of their stock of bottles that were just child proof, not tamper proof before requiring the tamper proof bottles be sold.  Well, they had a butt-ton of non-tamper proof bottles.  Someone changed their mind and said they had to switch to tamper proof immediately, so they pitched close to $200,000 bottles that weren't tamper resistant.  I feel for that shop a bit because they never incorporated, (despite being so large with their wholesale side) so they are eating all of these losses personally.  

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