Well, one sign of Evolv's thinking is that Evolv's Escribe now comes in a US and a International version. The US version eventually getting frozen so it could meet the PMTA, while changes could still be made to the international version.
New studies find carcinogens in vg and pg at high temps, even in tootle puffers
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Do manufactures know what the FDAs approved specs are ?
Does the FDA even know what their approved specs are ?
Not sure which question you were asking, there are 2 different concepts in your quote.And how would they do that?
Just to toss another flavor into this mix ...
Evolv can prove their boards are accurate (if used as directed) quite easily. Much like I am doing with my experiments, only they got waaaay better toys to do the testing.
juice manufactures, the serious ones who will file PMTAs, have this data, I feel sure. They know, based on their recipes, exactly what temps their juices start to go into thermal degradation. Once again, being treated as "Trade Secret" in hopes of maximizing market share. "Thermal Degradation in VG is NOT a new concept, there is a lot of data on it. The only thing newish, is putting it in the context of intentional inhalation.
Flavors BTW are a wildcard because very little inhalation data existed on them prior to all of this.
Personally, I think every bottle of juice sold should have a "Maximum Safe Temp" rating listed clearly on the bottle, as prominent as the nic concentration. Yes, at some point the 3 letter acronyms would need to define "safe", but in the interim it could be something like "the point where thermal degradation rises above "X".
San Francisco not withstanding, which used to be a really cool place before the dot com era made things go crazier than the FDA on [stuff we're not supposed to mention here]. (Yes, I am old enough to remember the Haight-Ashbury days)
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No and No.......
They rely on fuzzy terms like making the manufacturer "prove" it is safe. They do list an example list of nasties they want measurements on, but it is not definitive by any means.
Of course there are.
If there Weren't any Specifications for an Manufactures to meet, the FDA wouldn't be much of a Science Based organizations now would they?
Here are the Critical Criteria's that a Manufacture must Meet or Exceed for their "tobacco" Product to receive a FDA Market Authorization.
If for Every e-Liquid there is a "Safe" Maximum Vape Temperature (SMVT), how do I, as an e-Liquid Manufacture, ensure that my product will Not Exceed the SMVT when seeking PMTA approval?
You cant because you as the manufacturer dont know how it will be used, but if you prominently label the bottle, then the User is aware and can set a TC device appropriately. If they choose to snort it or vape at 750f, that is the users responsibility at that point.
An open system could work this way. It all depends on how hardnose the FDA wants to get.
If the safe operating parameters (ie temp) are clearly labeled, then a user has been informed and knows how to use it safely. If a user chooses to ignore that information, then it is not the juice manufacturers fault. The are plenty of devices that can be operated past government established safe limits. I have had the speeding tickets to prove it. Prescription meds have dosage instructions, nothing prevents a user from taking a triple dose.
Why does that sound like "It depends on what your definition of is, is"? For some strange reason I see vaping as an improvement in health over tobacco use. It all depends on your viewpoint and what your narrative/goals are I guess.
Unfortunately, I think this would be viewed by the FDA as making a "Health Claim".
In a more perfect world where the Round Peg of e-Cigarettes wasn't being Hammered into the Outdated Square Hole of Tobacco Control, it would have merit.
There is also the Product Liability thing that a company's Legal Department might have issues with. If I say something is "Safe", do I open myself up to a Legal Tidal Wave of people saying they are Harmed? Many/Most of them former Smokers. Former Smokers who may/probably did Damage to themselves by Smoking FDA Approved Cigarettes.
The Whole thing is a Big Bag of Worms when you start thinking about it.
Ok then....... "not safe to exceed 436f"
or
"exceeding 436f is known to produce potentially hazardous carcinogens"
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Like I said, Bob in Legal might have a Aneurysm if I told him I wanted to put that on my "Juice" Label.
"Studies indicate that if this liquid is heated above xxx degrees there is a potential emission of unwanted/potentially harmful compounds". Bob in legal starting to relax?
Brainstorming a juice label without making a safety claim...
I'm thinking of something like SPF for sunscreen. Call it an Aldehyde Factor, or AF. Set some standard, and describe the relation to that standard.
Example 1:
Geiss used 10 puffs per session of the smoking machine (modified as per Behar), 3.0sec puffs, fired 1sec prior to puff, 50mL per puff, every 20sec .
Robinson suggested 15 puffs per session as standard, therefore as comparable to one tobacco cigarette. Table 2 shows vaping the measured Kayfun 3.1 at 10W (the subjectively preferred power level of the "experienced vaper" in Table 4) produced an order of magnitude less formaldehyde than the ISO3008 medium tar tobacco cigarette, and three orders of magnitude less acetaldehyde.
Geiss took FLIR images of the coil, wick saturated with the tested juice, fired 5 times, with a peak around 500°F.
So, WLOG, using the above, define AF as the number of "cigarette equivalent vaping sessions" required to equal one tobacco cigarette in exposure to any toxic aldehyde at a given temperature.
Which would put Heaven Juice Traditional Tobacco 7 Leaves, (0.9% nic, 50% VG, 40% PG, 6% H20, 3% flavor) as:
AF 10 @ 500°
Obvious improvements could include:
1. Direct measured coil temp in situ, as this thread.
2. Refinement of standards.
3. Elimination of dependence on as many of the 18 points of influence as possible.
Example 2:
Same as Example 1, but referenced to another standard (OSHA limits, IARC, etc.)
Example 3:
Same as Example 1, but using a standard volume of e-liquid instead, to eliminate puff variation.
Example 4:
Establish a device-independent protocol for measurement (Wang's reactor, e.g.)
Validate against in situ temperature measured (Geiss + thermocouple)
Vaporize some standard amount of eliquid completely and measure the resulting aldehyde.
List the point at which no aldehydes beyond background detected.
For pure VG, per Wang:
AF0 420°
Example 5:
Same as Example 4, but only list the temperature at which it crosses some standard's threshold.
So using the @mikepetro standard for unknown e-liquid, per Wang:
AF 450°
None of these make any claim of health or safety beyond which direct evidence would exist. All provide a temperature which is both easily processed by the beginner ("I'm supposed to limit my temperature to what it says on the bottle") All provide accurate and useful information to the power user. None engage in alarmism, even to the ignorant.
I'm thinking of something like SPF for sunscreen. Call it an Aldehyde Factor, or AF. Set some standard, and describe the relation to that standard.
Example 1:
Geiss used 10 puffs per session of the smoking machine (modified as per Behar), 3.0sec puffs, fired 1sec prior to puff, 50mL per puff, every 20sec .
Robinson suggested 15 puffs per session as standard, therefore as comparable to one tobacco cigarette. Table 2 shows vaping the measured Kayfun 3.1 at 10W (the subjectively preferred power level of the "experienced vaper" in Table 4) produced an order of magnitude less formaldehyde than the ISO3008 medium tar tobacco cigarette, and three orders of magnitude less acetaldehyde.
Geiss took FLIR images of the coil, wick saturated with the tested juice, fired 5 times, with a peak around 500°F.
So, WLOG, using the above, define AF as the number of "cigarette equivalent vaping sessions" required to equal one tobacco cigarette in exposure to any toxic aldehyde at a given temperature.
Which would put Heaven Juice Traditional Tobacco 7 Leaves, (0.9% nic, 50% VG, 40% PG, 6% H20, 3% flavor) as:
AF 10 @ 500°
Obvious improvements could include:
1. Direct measured coil temp in situ, as this thread.
2. Refinement of standards.
3. Elimination of dependence on as many of the 18 points of influence as possible.
Example 2:
Same as Example 1, but referenced to another standard (OSHA limits, IARC, etc.)
Example 3:
Same as Example 1, but using a standard volume of e-liquid instead, to eliminate puff variation.
Example 4:
Establish a device-independent protocol for measurement (Wang's reactor, e.g.)
Validate against in situ temperature measured (Geiss + thermocouple)
Vaporize some standard amount of eliquid completely and measure the resulting aldehyde.
List the point at which no aldehydes beyond background detected.
For pure VG, per Wang:
AF0 420°
Example 5:
Same as Example 4, but only list the temperature at which it crosses some standard's threshold.
So using the @mikepetro standard for unknown e-liquid, per Wang:
AF 450°
None of these make any claim of health or safety beyond which direct evidence would exist. All provide a temperature which is both easily processed by the beginner ("I'm supposed to limit my temperature to what it says on the bottle") All provide accurate and useful information to the power user. None engage in alarmism, even to the ignorant.
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