Storing pg/vg long term

[mhertz]

I respectfully disagree... FDA has no business enforcing things like glycerin. The enforcement is about enforceable products... That's why I keep stating the example about pharmaceuticals, which is by law deemed to be USP compliant, therefore FDA checks for USP compliance on them. I don't believe there's a law stating FDA needs to check USP compliance on ingredients like glycerin or anyother non-pharma ingredients...

Your quoted document states not that FDA needs checking for USP compliance in general imho(unless what's mentioned by law of course)...

 

[yzer]

You can look this up easily.

"USP develops and publishes standards for drug substances, drug products, excipients, and dietary supplements in the United States Pharmacopeia–National Formulary (USP–NF). These standards have been recognized in the Federal Food, Drug and Cosmetic (FD&C) Act since it was first enacted in 1938. The FD&C Act defines the term "official compendium” as the official USP, the official NF, the official Homeopathic Pharmacopeia of the United States, or any supplement to them. USP–NF standards play a role in the adulteration and misbranding provisions of the FD&C Act (which apply as well to biologics, a subset of drugs, under the Public Health Service Act). USP has no role in enforcement of these or other provisions that recognize USP–NF standards, which is the responsibility of FDA and other government authorities in the United States and elsewhere."

USP in U.S. Law

 

[yzer]

I respectfully disagree... FDA has no business enforcing things like glycerin. The enforcement is about enforceable products... That's why I keep stating the example about pharmaceuticals, which is by law deemed to be USP compliant, therefore FDA checks for USP compliance on them. I don't believe there's a law stating FDA needs to check USP compliance on ingredients like glycerin or anyother non-pharma ingredients...

Your quoted document states not that FDA needs checking for USP compliance in general imho(unless what's mentioned by law of course)...

Glycerin USP is sold as an over-the-counter pharmaceutical product.

 

[mhertz]

yzer, that doesnt say anything new to this discusion imho... I'm not 100% sure i'm right, and if i'm wrong then I apologize in advance.

Imho, what you just quoted, means that the USP has been included in law, which is true as by law pharmaceuticals needs USP compliance, hence the USP is included in law. When there is something to enforce, then USP don't do it, but e.g. FDA does. That's my interpretation of this...

Your last post...hmm, sorry as said i'm not sure, but I still don't personally believe that there's a FDA rules about checking all USP stated products...

 

[Clo]

Ok so how long should flavoring last? I buy PG based flavoring and I am going to go ahead and buy some extra of what I used regularly and want to store it well. They already come in glass bottles. Should I keep the flavoring in the fridge to make it last much longer. I currently keep everything in a lock box at room temperature, but if it will last much longer (flavor staying potent) by keeping it in the fridge I will do that. Thanks for any info on this!

 

[mhertz]

Also, if the USP compliance was to be checked by FDA in general on everything, then why have the USP developed a 3'rd party certification program where you can get your USP product checked and have a badge stating USP certified ingredient etc About over the counter glycerin usp, then that's for general use and not stated to be a drug, meaning no laws surrounding it. However, glycerin usp is sold as cough medicine also, which needs to be FDA checked for USP compliance for even getting an MA, I think I know, not think(about MA needing FDA USP check I mean), but wasen't sure if cough medicine needs an MA if also over the counter...

Last, thanks for a nice productive discussion mate

 

[yzer]

Yes, USP is an independent non-governmental organization that establishes values of quality and test procedures that are used in the pharmaceutical industry. The FDA and other US agencies enforce compliance with USP standards in the USA.

We can go around forever with arguments about whether FDA or the other enforcement agencies are doing a proper job of enforcement or if you think they should be doing enforcement or not but that's missing the point. FDA has the authority.

 

[yzer]

Ok so how long should flavoring last? I buy PG based flavoring and I am going to go ahead and buy some extra of what I used regularly and want to store it well. They already come in glass bottles. Should I keep the flavoring in the fridge to make it last much longer. I currently keep everything in a lock box at room temperature, but if it will last much longer (flavor staying potent) by keeping it in the fridge I will do that. Thanks for any info on this!

I would contact the flavor provider with this question. Some flavors last much longer in storage than others. Generally, refrigeration or freezing (even better) will extend shelf life. Containers should have as little air space inside as possible

 

[Clo]

I would contact the flavor provider with this question. Some flavors last much longer in storage than others. Generally, refrigeration or freezing (even better) will extend shelf life. Containers should have as little air space inside as possible

Thanks! I will leave them in the glass containers in the fridge until I need them

 

[puffon]

I've read storing flavors in the fridge or freezer will degrade the flavors.?
I'm not worried about flavors, VG or PG, not being available through non vape channels.
YMMV

 

[ashtrayogdc]

Plastic is OK but Glass containers in the refrigerator or freezer is better. With the new FDA regulations now in effect you better stock up. THese regulations may not effect PG/VG to much but everything else will be effected. Flavoring, hardware, NIC etc.....

Reading this has made me concerned. Is it likely that flavoring will be regulated? That was one of the things I thought I could buy at anytime for the usual price. If they will be regulated, I will stock up.

Tia for opinions.

 

[mhertz]

Yes, USP is an independent non-governmental organization that establishes values of quality and test procedures that are used in the pharmaceutical industry. The FDA and other US agencies enforce compliance with USP standards in the USA.

We can go around forever with arguments about whether FDA or the other enforcement agencies are doing a proper job of enforcement or if you think they should be doing enforcement or not but that's missing the point. FDA has the authority.

OK, then lets agree to disagree then Btw, I do understand everything you state, the difference is that you believe that FDA needs checking everything and I believe they by law needs to check what the law dictates. Of course FDA has the authority, never doubted that... "Enforcement" to you is to check everything. To me it's to enforce what needs enforcement, as the USP is in law for some things...

Sorry for repeating myself

 

[yzer]

Reading this has made me concerned. Is it likely that flavoring will be regulated? That was one of the things I thought I could buy at anytime for the usual price. If they will be regulated, I will stock up.

Tia for opinions.

I scanned through the 500 page deeming rule today for various tidbits. Not a comprehensive read by any means. It appears that FDA will be looking into flavorings on an individual basis. They recognize that some of these flavorings may not be currently in use. From page 210...

C. Toxicity and Nicotine in E-Liquid and Aerosol
210
Although FDA noted in the NPRM that we do not currently have sufficient data about ecigarettes
and similar products to fully determine what effects they have on the public health, we
identified concerns regarding the toxicants in e-liquid and the exhaled aerosol and the nicotine
delivery from e-cigarettes. Comments were divided on the safety and toxicity of e-liquids, ecigarettes,
and the exhaled aerosol.
(Comment 117) The comments expressed concerns that e-cigarette users subject
themselves to dangerous constituents, including formaldehyde and other toxicants. One
comment stated that the release of formaldehyde occurs only when the voltage on e-cigarettes is
set to 4.8 volts or higher (Ref. 67). Some comments also submitted studies showing the
existence of other e-liquid constituents, including prescription weight loss and erectile
dysfunction drugs (Ref. 117).
(Response) Studies show that e-liquid tobacco products contain nicotine, propylene
glycol, glycerin, tobacco specific nitrosamines, tobacco alkaloids, carbonyls, ethylene glycol,
diacetyl, and acetyl propionyl (Refs. 19, 118, 119). Chemicals such as nicotine, carbonyls,
tobacco specific nitrosamines, heavy metals, and volatile organic compounds have been
identified in e-cigarette aerosols (Refs. 19, 118, 119, 120, 121, 122).
In addition, several studies substantiated the data included with comments, finding that
flavored e-liquids contain chemicals that could be dangerous to consumers when inhaled. For
example, researchers in one study tested 159 e-liquids with sweet flavors, such as toffee,
chocolate, and caramel, and found that almost three quarters of the samples (74 percent)
contained diacetyl or acetyl propionyl (Ref. 123), both of which pose known inhalation risks
(e.g, Ref. 124). Among those that tested positive, nearly half of the e-liquids in the study could
expose users to levels that exceed recommended workplace limits for breathing these chemicals
211
(Ref. 123). An additional recent study analyzed 51 types of flavored e-cigarettes for total mass
of diacetyl, 2,3-pentanedione, and acetoin (Ref. 125). Researchers detected diacetyl above the
laboratory limit of detection 39 of the 51 flavors tested, ranging from <limit of qualification
(LOQ) to 239 μg/e-cigarette. 2,3-pentanedione and acetoin were also detected in 23 and 46 of the
51 flavors tested at concentrations up to 64 and 529 μg/e-cigarette (id.). It is noted that the study
involved a convenience sample of 51 types of flavored e-cigarettes and may not be representative
of the types of e-liquids currently available to users. Absent a regulatory standard, FDA
acknowledges that it may not be possible to account for the wide variability of concentrations of
constituents in the flavors of current ENDS products. Another study analyzed 30 e-cigarette
liquids and found that many flavors, including cotton candy and bubble gum, contained
aldehydes, a class of chemicals that can cause respiratory irritation, airway constriction, and
other effects (Ref. 126). Specifically, researchers noted that two flavors, a dark chocolate and a
wild cherry, would expose e-cigarette users to more than twice the recommended workplace
safety limit for the aldehydes vanillin and benzaldehyde (id.). Similarly, researchers found that
several cinnamon-flavored e-liquids contained a chemical, cinnamaldehyde, which researchers
stated was highly toxic to human cells in laboratory tests (Ref. 127).
Some studies have found that lower levels of toxicants are observed in e-cigarette
aerosols than in combusted tobacco smoke (Ref. 122). FDA recognizes that specific product
design parameters, such as voltage, can affect toxicant deliveries (Ref. 67).

 

[mhertz]

yzer, I apologies mate You're right in that FDA or other local regulatory agency is enforcing all USP compliant products, as it's in various acts of there's that every USP compliant _anything_ must be 100% USP compliant or else deem misbranded.

However, I still don't understand the corrolation between when you can just add USP on your product and when you need to have FDA specifically approve the testing you already done yourself before you can sell it. Most of the VG we buy, is listed as USP, but is either from big drums and often repacked without the use of a cleanroom and also the exact labeling is also not correct most of the time, which is described in the general section of the USP, as needing monograph name with directly preceding USP, either just after or directly under, and no VG or vegetable glycerin as main name.

As I understand it, you can make e.g. 'glycerin usp' if you follow everything in the USP, and then the FDA by law demands you're compliant with it, but it doesn't really need to _certify_ you as it's just an ingredient and not a pharma-drug, but again I don't know for sure. Also, the USP certification program they have on there page(USP's page, not FDA), I found out is a voluntary thing, where manufacturers can get GMP checkings on-site and then get a USP compliant badge to have on the product...

I found the official document from USP about USP and FDA correlation, but it's a little over my head, because I have a hard time differentiating between what e.g. glycerin is i.e. a drug, ingredient, suplement whatever, lol E.g. about dietary supplement it states:

"
Dietary Supplements

USP standards for dietary supplements have less legal recognition than its standards for drugs; a dietary supplement will be considered misbranded only if it is represented as conforming to USP specifications and fails to so conform. FDCA §403(s)(2)(D), as added by Dietary Supplement Health and Education Act (DSHEA)"

Anyway, here's the online-doc:
Working with U.S. FDA

 

[jmur]

Very informative info, @yzer , it's appreciated.
I'm wondering about this tho. I buy a pre-mixed Nic/PG/VG @24mg (laziness on my part, I know, but I really enjoy using this). So for a pre-mix Nic/PG/VG do the same standards apply for freezing? What's the estimate for longevity freezing this? I haven't really seen this mentioned in discussions. Unless I missed this and in that case I apologize in advance.

 

[mhertz]

The same standards apply if you buy in bulk and need to store without oxidation for prolonged time e.g. many years. We don't have exact data, except that several have shown no issues with freezed nic in 4'ish years, maybe 5, can't remember, and is speculated to last many years more... This is base in higher mg's normally, but it's the same with lower mg's, except that lower mg's generally will last longer out in unfreezed environment, as less nic in the bottle to react and go "bad"(oxidized rather). No matter mg amount, then freezing is a good means to avoid/lessen oxidation...

You need glass(amber/colour'ed isn't as important in a closed freezer, but if it's continously opened then still nice to have) and good caps, like polycone or euro-droppers(also acts as good gasket)... For stocking up, a higher mg's will take much less space though, so is preferred by most.

 

[yzer]

Lots of questions here but the best answer I have is this. FDA does not have the financial resources available to enforce all compliance with USP specs. The little fish are getting away with murder (hyperbole, on my part). I don't understand where FDA is going to get enough funding to enforce the new deeming regulations on e-cigs, either.

 

[yzer]

Very informative info, @yzer , it's appreciated.
I'm wondering about this tho. I buy a pre-mixed Nic/PG/VG @24mg (laziness on my part, I know, but I really enjoy using this). So for a pre-mix Nic/PG/VG do the same standards apply for freezing? What's the estimate for longevity freezing this? I haven't really seen this mentioned in discussions. Unless I missed this and in that case I apologize in advance.

If you look back into the historic posts on several threads here on ECF including the Nicotine Comparisons thread in the DIY liquid forum you will find anecdotal accounts regarding the benefits of freezing nicotine base. Essentially, freezing the base with as little airspace in the containers as possible inhibits oxidation of nicotine (and by inference oxidation other ingredients). Oxidation of nicotine is easily observed by yellowing of the nicotine base. The exact values are unknown but expect freezing to extend shelf life by at least a few years.

 

[AngiBe]

I'm gettin panic attacks reading all this stuff and I don't understand all this. UUUGGGHHHHH

If you guys open the container of PG and VG to use for DIY, how do you store the rest of the opened container? Do you have to transfer that as well into glass containers? I feel like I need to open a chemist lab and buy a gazillion glass bottles, amber bottles, beakers and crap. This is so overwhelming.

 

[salemgold]

No need to panic. VG and PG will still be available. I store mine in the gallon jugs that I receive it in. VG, PG and food flavorings aren't going anywhere.