Thats exactly right , there are horror stories all over the net about some outfits mixing in the most grotesque conditions or places , some very very popular i might add lol.
E-liquids standards!
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Thats exactly right , there are horror stories all over the net about some outfits mixing in the most grotesque conditions or places , some very very popular i might add lol.
This is an insight on how to look at "standards, this is not a rant or slam on anyone ,anything.
Standards are written procedures meant to insure quality and consistency to the overall product. It is basically how to work in a Quality System. cGMP820- GOOD MANUFACTURING PRACTICE which is already part of the Federal Register is a decent start. Look this up and you will have an understanding of basic quality system requirements. A lot of it is not that hard to implement. .
Cleaning for example: How is the work area cleaned, with what, by who, when or at what frequency (daily/weekly/per batch).
We all know the nic is going to be a biggy. How do you prove nic level on label. Is your device or machine calibrated to provide the requested amount of order, who calibrates the calibrator, is device in need of routine maintenance and with what, by who, when or at what frequency (daily/weekly/per batch) is that maintenance performed. How do you accurately test each batch.
What are your procedures is what FDA will be asking, they want to see these kind of things written and implemented, and validated to the manufacturers needs.
Remember we actually have to thank the CDC for its classification of nicotine. It is a domino effect.
Standards are written procedures meant to insure quality and consistency to the overall product. It is basically how to work in a Quality System. cGMP820- GOOD MANUFACTURING PRACTICE which is already part of the Federal Register is a decent start. Look this up and you will have an understanding of basic quality system requirements. A lot of it is not that hard to implement. .
Cleaning for example: How is the work area cleaned, with what, by who, when or at what frequency (daily/weekly/per batch).
We all know the nic is going to be a biggy. How do you prove nic level on label. Is your device or machine calibrated to provide the requested amount of order, who calibrates the calibrator, is device in need of routine maintenance and with what, by who, when or at what frequency (daily/weekly/per batch) is that maintenance performed. How do you accurately test each batch.
What are your procedures is what FDA will be asking, they want to see these kind of things written and implemented, and validated to the manufacturers needs.
Remember we actually have to thank the CDC for its classification of nicotine. It is a domino effect.
Local sanitary regulations apply to any product made for human consumption
whether specifically named or not. I am not aware of any regulation stating
e-juice is exempt so I assume it wouldn't be. Even if some how e-juice is
exempt local ordinances are still sufficient.
Regards
mike
There have been some incidents this is undeniable. Most if not all have been remedied to my knowledge. Still not one single reported case of anyone being harmed.
I have read some of the requirements and I am unimpressed. Should we require that people to follow the same procedures when making Kool-Aid which is just as hard and complicated to make as e-juice.
The only hard part if you could call it hard at all would be getting the amount of nicotine to be
correct. The bigger the batch the easier it becomes. Every other ingredient is inconsequential because
no mater what the amount is, it can't hurt you anyway.(people with allergies excluded)
Complicating procedures for something as easy and safe to make as Kool-Aid is asking for
trouble. Maintaining a clean,neat and,orderly work area does not require government certification.
A visit from a local inspector would keep things in as good of order as anything.
You could train monkeys to mix e-juice but,they won't do it. It's to uninteresting and would bore them to death.
Regards
Mike
GMP ... and sanitary conditions..
Liquids are meant for human consumption, so I expect at least the same cleanliness I'd expect from a place where I sit down for some food. Same for the ingredients. USP or equivalent, anything less isn't good enough.
But even for DIY - fashioned meself a glove box, just for the heck of it to see if it can be done for less what the commercial makers are asking for one as that is way beyond my budget.
Liquids are meant for human consumption, so I expect at least the same cleanliness I'd expect from a place where I sit down for some food. Same for the ingredients. USP or equivalent, anything less isn't good enough.
But even for DIY - fashioned meself a glove box, just for the heck of it to see if it can be done for less what the commercial makers are asking for one as that is way beyond my budget.
One thing I do not understand is if one realises if a vendor is using ingredients such as PG/VG,flavorings and,food colors that are certified as GRAS (Generally Recognized As Safe) and,pharmaceutical grade nicotine base actual improvement in the quality of the ingredients is a moot point. These ingredients
are already made to strict and uniform standards by regulation. I understand subjective concerns such
as wanting kosher,organic or natural ingredients but, objectively they do not confer any real measurable
real world increase in "quality".
My local B&M will mix juice right at the counter. They have premixed bases and its just a mater of
filling the right amounts in the size bottle one wants to purchase. Unless your going below 10mm bottles it is not difficult to obtain an accuracy that is sufficient to maintain a consistency in product. They use bottles that are basically the same as one would find condiments such as mustard and ketchup with the tapered nozzles. These bottles appear clean and well kept to me. Nothing touches the ingredient but the air between the nozzle and receptacle. Considering that PG and or VG both have robust antibacterial and antiviral characteristics and the rest of the ingredients have to real nutritional
value or are known toxins such as the nicotine there is really no reason to fear that any actual
pathological contamination is occurring or even if it's possible to occur unless done deliberately.
The counter is neat,clean and,well organized. The counter person is not sneezing,attending a runny
nose nor scratching inappropriate places.
If anyone knows of any pathogen ever having being spread by e-juice let me know. As of today
I have never heard of a single case of such a thing happening no mater where the juice was made
and how bad one could imagine the hygiene of the person who made it was.
Having researched the what the ingredients in e-juice are and how they are made it's my humble
opinion the ingredients and the process used to make the final product add a robustness to safety
hard to find in most processes used to manufacture products in general. A neat,clean and organized
work area using clean and or well maintained equipment is all that's necessary to insure a safe
consistent product.(aside from concerns of some of the flavorings or long term effects of vaping
itself) It's my belief one would have to deliberately adulterate the product with something known
to cause immediate harm to a user for there ever to be a problem to occur. The only other worse case
scenario is bad tasting juice. We certainly wouldn't want to vape it but, if we did it wouldn't hurt us.
Regards
Mike
Mike, "If" a vendor is using GRAS -certified products, what does that mean? I understand what GRAS means, but I don't think it is followed. The presence of China and SE Asia (and/or other countries) really scares me. Also, the FDA is now saying that food flavors/seasonings are not GRAS for the purpose of smoking with a e-cigarette because the evaluation on those products was done with the understanding that they would be eaten, not smoked. That just came out in the leaked documents last month.
You have a statement, "If anyone knows of any pathogen that was ever spread via e-juice...", but couldn't their be a pathogen that we just don't know about? What will the National Institutes of Health/FDA have to say on that.
I think that some of the obvious things that vaping advocates have determines as not to be a "fight", will indeed be one.
Towards the end you say, "It's my belief one would have to deliberately adulterate the product with something known to cause immediate harm to a user for there ever to be a problem to occur" Well, to prevent that, shouldn't nicotine and nicotine delivery devices be a controlled item to be managed or that their be a certification process to possess and use such items?
Mike, I wish not to argue or in-flame, I am just pointing out a different view of some of the points being made. All in all, I think that we should keep writing our Legislators and the newspapers Opinion pages. Laws and ordinances will eventually come, lets keep trying to sway things. Oh, and stockpile.
Frenchfry
You don't think that most e juice for sale is from legit inspected and certified facilities do you ? There is a HUGE amount of "Joe blows" out their selling juice from their bedroom and basements , garages you name it .
Nope.
Ever see a health department inspection score card up on the wall of a vape shop that makes Ejuice?
They are unlicensed operations that the laws do not yet cover.
But they will. It is inevitable and to me not undesirable.
I have seen many threads over the years where a (who knows who) said they sell their homemade (at home) juices to vape shops regularly and they are never asked how it's mixed and in what conditions .
Here was a question asked by somebody wanting to get into selling juice :
So what? Before government "regulates" something, don't you think they should have to make a good case that such regulations prevent harm? And that would mean they'd have to be able to show some harm caused by at least one of the huge number of Joe's out there, right? Well... Where is it?
I am not speaking about harm at all , none of my posts are about harm reduction .
Why don't you ask where is the harm from vaping diketones since i know your stance on that .
What i am saying is most people would prefer to not have juice made in a bathroom lol, yes, some have mixed and sold juices made in their bathroom , a very popular juice is known for it actually.
There may never be harm from mixing wherever you feel like mixing but consumers i doubt would feel very comfortable with that . They want to know juice is mixed in a clean facility i would think , maybe not.
The ingrediants are all used in food. PG and nicotine supress the organisms that spoil food. Finally, there are 10 of millions of people vaping around the world. There has been vaping for something like 8 years so, where are the reports of doctors treating illnesses caused by using electronic cigarettes? If that's not enough make your own e liquid. It is easy and you save a lot of money.
If someone isn't comfortable with how something is made, why would they buy it?
Yes, you're correct, I don't want diketones in my juice. But I've never once suggested laws or regulations to prohibit them. I simply won't buy products if I'm not confident that they're diketone-free. To accomplish this, I insist on seeing test results. If you want products that are mixed in a "clean" environment, you could insist on seeing your local vendor's mixing area (or photos of an on-line vendor's), or not buy from any vendors who aren't members of the AEMSA.
But using the FORCE OF LAW to tell Joe he can't mix juice and sell it should require EVIDENCE that him doing so has at least some risk of harm associated with it.
Fair enough , my point was that imo , most people who buy juice automatically think it's made in a proper clean facility but since the hammer hasn't been dropped who knows.
I don't think there is any harm either and if there is i never heard about it . Trust me i am not a fan of Government and think they over do it with everything .
Laws and regs are only as good as their enforcement.
A vendor who sets and maintains own standards without being forced to do so by laws or regs takes his bidness seriously and take me seriously too. It will still be possible for said vendor to take perfecly good base materials and GMP and all that and come up with unpalatable results...
PG and heat - very unlikely that bacteria make it past the coil.
Chemical contaminants. Hm. Seen enough 'lab results' getting the copy-paste.
Honestly, I got off a 3 pack a day 'habit' - you really think I'm gonna loose sleep over a few stray molecules of this n that in my liquid ?
Question is rhetorical - I DIY, so I do have a clue what the soup's made of
A vendor who sets and maintains own standards without being forced to do so by laws or regs takes his bidness seriously and take me seriously too. It will still be possible for said vendor to take perfecly good base materials and GMP and all that and come up with unpalatable results...
PG and heat - very unlikely that bacteria make it past the coil.
Chemical contaminants. Hm. Seen enough 'lab results' getting the copy-paste.
Honestly, I got off a 3 pack a day 'habit' - you really think I'm gonna loose sleep over a few stray molecules of this n that in my liquid ?
Question is rhetorical - I DIY, so I do have a clue what the soup's made of
Would you be willing to overlook a pubic hair , i have to say that might make me dump it and just take the loss .
Some people might consider finding "one strand" a minor inconvenience , i can even see myself being somewhat tolerant, (i have zero tolerance) and even being somewhat forgiving, ( i never forgive) but if i see a "handful " of unfamiliar hairs in my juice someones getting their a_ _ kicked for sure.
Pubic or other hair is a bit bigger than a few molecules. Not acceptable. (Prefer shaved anyway
)Kidding aside - do liquids get 'really' manufactured ?
The 'manufacturing' or creative process is mixing pre-existing components which are - ideally - of a certain standard. Is more like a barkeeper or a chef. Freshest lettuce around, but how does he know that it hasn't been overexposed to pesticides? How can a barkeep be certain that the vodka he bought for mixing cocktails isn't some cheap relabeled 'shine with methanol in it ?
USP . Ph.Eur. UKP. etc .etc. These ARE standards.
Pouring and blending them together would require an environment where these existing standards aren't compromised.
Simple as that.
If sloppy Joe's bathroom satisfies the airborne particle counts for a clean room he might be doing better than some big scale manufacturer who hasn't bothered to change filters in his for a year. Or just pulled some nice pics from the web for show ... In fact , when it comes to average prarticle/pathogen counts the bathtooms are fairung better than kitchens.
Standards ? Definitely !
But certainly not some FDA-overkill .
Standards then:
Paper trail - Nic base, PG, VG, water (yes, there is a USP monograph for that too ) all USP, with a paper trail to evidence it ( batch test certificates or own acceptance tests )
Batch numbers - i.e. paper trail still so that you can keep track of whats been mixed with what and when and from whom .
Labelling - some jurisdictions require certain texts. I don't expect mixers to bare their best and profitable recipes.
But if there is stuff in it that people can or do have issues with, do tell. ( Ethanol , diacetyl, known allergens )
Closed circuit mixing. Or environs suffciently clean to maintain the USP limits.
Won't do much good when the purest ingredients get stirred together in an open bucket that hasn't been cleaned and sanitized.
So good standards would ensure that the standards that are exsting already are not being compromised on the way to the consumer. No need for the FDA to re-invent the wheel...
Contaminants wise, what concerns me the most is plastic fibers or similar getting into the juice... In uncooked food plastic fibers would likely be passed through undigested. Not only would this be even worse than hair, they are far more likely to actually get in it than an intact hair fiber. Microbes that are a concern with food aren't a big problem.
I disagree that DIY necessarily means you know what's in it. Tested juices are safer regarding the things they test for. However, I see no exact test results except for a 2-3 specific chemicals. These are definitely of interest though. Most stuff, if it tastes good it probably is good. With diketones, the better it tastes the worse it is. However, DIY does mean they didn't throw .1% of mystery flavor in it.
Incidently, all my DIY ejuice is made in my spare bathroom. I looked at my house and what room gets the least use, and it wasn't even close. It also has a fan, sink and no windows (can be left dark). It's no longer used as a bathroom and is now the cleanest room in the house. I'd probably mix wherever but I have a cat and like to leave my stuff out and ready to go.
I disagree that DIY necessarily means you know what's in it. Tested juices are safer regarding the things they test for. However, I see no exact test results except for a 2-3 specific chemicals. These are definitely of interest though. Most stuff, if it tastes good it probably is good. With diketones, the better it tastes the worse it is. However, DIY does mean they didn't throw .1% of mystery flavor in it.
Incidently, all my DIY ejuice is made in my spare bathroom. I looked at my house and what room gets the least use, and it wasn't even close. It also has a fan, sink and no windows (can be left dark). It's no longer used as a bathroom and is now the cleanest room in the house. I'd probably mix wherever but I have a cat and like to leave my stuff out and ready to go.
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