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FDA Regulations Explained - Updated Thread


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17 minutes ago, spydre said:

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.

They will have to raise future prices to make up for the loss now, its just a part of doing business. I will absolutely not email a picture of my photo ID, I already have a supply of stuff that will last me for years, and can wait. Maybe after I run out I will quit vaping.

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Am considering quitting as well.  At least in February.  As it is now, I'm TRYING to wean myself down from using it so much - I hit the darn thing too much - more than I had been.  Will soon be getting a new mod - hopefully - and since it won't be just sit here and hold it in my hand constantly sized (or at least my hand would get uber sweaty) I won't be hitting it as often.  It depends on budgetary concerns as well.  All of this is hitting just when our budget crunches down more - so if prices go up in our shop from them getting authorization on their liquids, that may be a factor.

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

I don't know why it's saying I'm quoting you, I'm not.  Anyway, rofl, Chris.  Have a question.  You mentioned devices needed PMTA's.  Will the stores have to get PMTA's for devices that are on the market, or just the manufacturers?  The blog wasn't clear.

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@spydre  PMTA's are required for the manufacturers only.  Retailers are not required to file PMTA's unless they are mixing their own juices in-house or building mods/tanks/RBAs/RTAs/coils/etc. (in other words... manufacturing something).

Edited by Earthling789
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1 hour ago, Earthling789 said:

@spydre  PMTA's are required for the manufacturers only.  Retailers are not required to file PMTA's unless they are mixing their own juices in-house or building mods/tanks/RBAs/RTAs/coils/etc. (in other words... manufacturing something).

And that is "manufacturing" according to the FDA's new definition of the word.  The last time I checked, changing spark plugs or oil in a car with an identical set of spark plugs or an identical blend of oil was considered maintenance.  The same should hold true for retailers.  If a person is physically or mentally incapable of changing out the 1.5 ohm coil in their Subtank Mini with a coil that is identical in every way and was physically manufactured by a different company, (i.e. another 1.5 ohm coil from Kangertech), or that person is physically or mentally incapable of opening their tank to fill it with their favorite liquid (from a bottle they already own), then that should be considered maintenance, not manufacturing.  

Some of these FDA regs make sense on the surface (excluding the extremely high fees associated with the PMTA process), but some of these regs are, in my opinion, a gross misuse of power.  Just because someone says you are permitted to do something doesn't mean you should.  And just because you do something doesn't mean it's the right thing to do.  Just because the FDA says changing a coil or filling a tank for a customer is "manufacturing" does not make it "manufacturing".  Just my 2 cents.

I'll get off my soapbox now.  It's just that these ridiculous regs, along with all the misleading information, partial information or, (in some cases) full on lies, have me rather ticked off.

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6 hours ago, spydre said:
On 8/6/2016 at 8:46 PM, Christopher said:

I don't know why it's saying I'm quoting you, I'm not.  Anyway, rofl, Chris.  Have a question.  You mentioned devices needed PMTA's.  Will the stores have to get PMTA's for devices that are on the market, or just the manufacturers?  The blog wasn't clear.

The stores will not have to get PMTA unless they manufacture something on their own. What the stores will have left to sell after PMTA is the real question. There's a good chunk of US manufactures that likely won't go through PMTA. Same goes for liquid manufactures. (The smaller guys and probably some of the mid sized operations) There's one owner I spoke to, who I won't mention, who has done well in the vaping industry. He can technically afford to go through PMTA but it would kill him if his PMTA was rejected and required another run. (In which case you have to pay for the PMTA application all over again) So, his plan is to simply retire out. It's a fairly major brand too. I suspect you'll see a lot of that. 

Companies like Kanger for example are planning to go through PMTA though it likely will be on a select number of devices and coils. (As every item needs PMTA) 

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I don't get the "manufacturing" thing if they put their hands on something, either.  And you are going to have a bunch of beginner vapers out there with beginner user errors that they can't get corrected on because no one will be able to put their hands on a device anymore to check and see if the tank is attached tight enough, or if the coil is screwed in tight enough.  These beginners will then get pissed off and toss their stuff out the window, and probably end up smoking again.....and I'm left to wonder, again, if this is what the FDA wants - for us to be sucking on a burning weed that has 4000 carcinogens, some of which are only carcinogens when burned?  They are making it easier to smoke, and easier to retail cigarettes, than they are vaping because it's "new and scary".  To a point, I understand approval of the flavors - IF they were going to make it illegal to use certain things like diacetyl or other things in the liquid, but we haven't heard about what's not allowed to be in there, just what has to be done (spend money) to get it approved.

Chris, I was VERY surprised to hear that my shop that I go to was going through the PMTA process, but they started as an online business with liquid as their biggest seller, and they have a LOT of very loyal customers - enough that they've opened three satellite locations since they opened the first B&M store in June or July 2013.  I would be surprised if the shop my sister is involved with (she's friends with the owners) isn't pursuing PMTA on their line as well, as big of an operation they got to be.  But they may just go the way of selling other juices and merchandise and save themselves the money.  I think I said before, the shop we go to is getting certain flavors as only high VG's, most flavors at 50/50, and only certain nic levels, whereas before they would nic levels in between as well if you wanted.  Is six a "standard" nic level?  I mean, there has to be something between zero and nine, right?

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I was at a local B&M that also does very well online and was talking to one of the owners. He said that they're going to be cutting out some of their flavors that aren't big sellers to limit the number of applications they'll have to make and holding "workshops" for people who want to learn to build or DYI before the stuff really hits the fan in Feb. (He's doing this by word of mouth and in store notices)

Although he can't and won't be touching anything and it's more of an educational process. I hope he's not going to get in trouble for it. On the flip side though, it's really nothing different than watching a youtube video just live.I have to respect his motivation to help people stay off analogs.( I also think it's brilliant because I'm sure he'll have the FDA fear factor of  losing the right to vape and have new stuff to sell his stock.)

I know I won't be shopping online if I have to send a picture of myself holding my ID to anyone. I'm stocking up and praying for a reprieve.

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Does anyone know if it's "illegal"/ against the new "regs" if a kid (15) comes into a B&M with a parent. Like on a quick stop to say hi to a friend who works there or while their parent grabs a box of coils for example?

One of our local B&M's now has this on their door...or are they just being over-reactionary to not fully understanding the new rules?

I mean a kid can go into a bar and sit as long as it's not at the actual bar itself and the establishment serves food and/or non-alcohol beverages....

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29 minutes ago, Edna said:

Does anyone know if it's "illegal"/ against the new "regs" if a kid (15) comes into a B&M with a parent. Like on a quick stop to say hi to a friend who works there or while their parent grabs a box of coils for example?

One of our local B&M's now has this on their door...or are they just being over-reactionary to not fully understanding the new rules?

I mean a kid can go into a bar and sit as long as it's not at the actual bar itself and the establishment serves food and/or non-alcohol beverages....

It would probably depend on the state law, I didn't notice in the regs any thing about it, besides sales to minors are prohibited. You are right about kids going into bars with their parents, its been happening for years. Maybe they are afraid the second hand vape will be harmful. But being private property they can restrict minors from entering if they want, at least that's the way it used to be.

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1 hour ago, Edna said:

Does anyone know if it's "illegal"/ against the new "regs" if a kid (15) comes into a B&M with a parent. Like on a quick stop to say hi to a friend who works there or while their parent grabs a box of coils for example?

One of our local B&M's now has this on their door...or are they just being over-reactionary to not fully understanding the new rules?

I mean a kid can go into a bar and sit as long as it's not at the actual bar itself and the establishment serves food and/or non-alcohol beverages....

As @FXRich said, it will depend on the state, but in most states, there is no law against bringing your minor child into a liquor store, smoke-shop, or even "adult" stores.  The federal regs only exclude/prohibit sales to minors, but cannot overrule state regulations on entry into a shop/building which restricts sales to adults, if that minor child is accompanied by an adult.

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I think in most cases, vendors are being overly cautious and I can't really blame them. Most are new business owners and would rather air on the side of caution. For online sales there is no specific set of guidelines on what we should or should not do, it seems legally we are covered through our notification system (we  attempt to do everything possible to avoid selling to those underage) the laws and regulations are so broad it leaves so much open to interpretation. (Thus why some vendors are more stringent than others) 

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The two vapor shops I go to will actually tell the teenage child to wait for their parent outside, and they've had that policy for some time.  If it's a child that can't be left outside alone, that's one thing, but a teenager will and has get kicked out of both of those shops while their parents are shopping.  If they can't produce ID, they are out of there.  

*Sigh* Something made me feel damn old a couple months ago.  My niece's 16 or 17 year old boyfriend vapes.  And I was going to admonish him about it, until I realized, I started smoking at 15, so younger than him.  It was easier for me to get analogs than it probably was for him to get vape stuff - well, he probably bought it online before, I don't know about now.  

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The bootlegging will start if it already hasn't, someone will see a profit in selling vape gear to minors, There are teenage gang bangers in some cities that pack guns, you know they didn't buy them at a gun store and you can't buy them online. Just because something is illegal for them to buy don't mean they can't get it. When I was a teenager I didn't have much trouble getting smokes or alcohol.

I don't think some Chinese vendors will be very picky about who they sell to.

Edited by FXRich
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Thanks all,

Sorry I didn't respond sooner but my sister was hurt badly by one of her horses and I was dealing with that and I just got back into town.

Thanks @Chris @FXRich and @Earthling789

, I figured it was them being overly cautious. However I talked to another LEO friend and they're already doing stings in Dallas trying to catch under-age sales. So I guess in the long run they're just being smart.

@spydre  I know what you mean I was buying cigarettes at age 9 by just saying my mom sent me to the store for them...The good old days. I couldn't be hypocritical either.

I know minors can buy vape gear on ebay by using a one time sign in code.

My son's wife's little brother did that until their folks found out and took away his internet access. All he needed was a  "Credit" card number. He bought the generic visa gift cards and used them and had it mailed to a friends house. I can't see how they're really going to regulate mail orders from private sellers on ebay.

 

On 8/17/2016 at 0:11 PM, spydre said:

Chris, how is the VT shop handling the ID thing?

Good Question!

On 8/17/2016 at 9:43 PM, Christopher said:

I think in most cases, vendors are being overly cautious and I can't really blame them. Most are new business owners and would rather air on the side of caution. For online sales there is no specific set of guidelines on what we should or should not do, it seems legally we are covered through our notification system (we  attempt to do everything possible to avoid selling to those underage) the laws and regulations are so broad it leaves so much open to interpretation. (Thus why some vendors are more stringent than others) 

One place (vape wild)where I had been buying juice from actually asked for my b-date and the last four digits of my social security number. Like I'm stupid enough to give out that information That's enough for ID theft by a dishonest employee They'd have all they need to steal my bank account or credit card Not Happening (end rant).:mad:

Anyway...I called them let them know they lost a customer and that they're going to loose a lot more if they keep that up. It really upset me because they're the one that has 2 of my favorite chocolate flavor juices I haven't been able to duplicate properly yet. (Sorry Chris but VT doesn't have Chocolate in the juice list)

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@Edna It's a whole business, or set of businesses) that's handling that - and it's a common practice - most online vape businesses are going through companies that verify that way, rather than asking for a copy of a DL because it's actually safer, and frankly, a heck of a lot easier to have a third party that can verify within minutes in 90% of cases (I would imagine the last 4 of the SSN is to verify the DOB, but I'm not sure how they would do that).

On 8/18/2016 at 3:53 AM, FXRich said:

The bootlegging will start if it already hasn't, someone will see a profit in selling vape gear to minors, There are teenage gang bangers in some cities that pack guns, you know they didn't buy them at a gun store and you can't buy them online. Just because something is illegal for them to buy don't mean they can't get it. When I was a teenager I didn't have much trouble getting smokes or alcohol.

I don't think some Chinese vendors will be very picky about who they sell to.

Never had problems getting smokes, either.  Just had to know the right places to buy from.  Especially easy if you're a girl and wear make up and such.  Heck, one gas station sold to me knowing I was a teenager - but it was a small station, and the clerk wasn't much older than me (let's see, no license, so I was 15, I remember making the mile walk to the Shell station).  Just couldn't buy at the places near the high school - they weren't THAT stupid, every single one of them within walking distance knew to card.  The Quik Trip I always hit once I learned to drive had the "we card under age 25" policy, but the first time I was carded there was when I was 22, pregnant with my second kid (I know, bad pregnant mommy), married with a wedding ring in plain view, with my toddler in my arms after coming in from WORK as a legal secretary.  I was so pissed that I had to dig out my ID (I had the money in my hand for the gas and the smokes) that I sat my kid down on the counter while I dug out my ID.

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