Deeming Regulations have been released!!!!

[Lessifer]

Oh... Yeah, I'll go with that.

Take #2:

I think the Entire concept of how Diketones should or should be advertised/Labeled/etc is Funny.

Does Anyone really think that an e-liquid, packaged in a Closed System - Non-Refillable - Chip Enabled Cartridge with a Proprietary Non-510 Connection, that contains detectable levels ( >5ppm ) of Diketones will receive PMTA approval?

Ok, take #2 I'm going to go with, possibly. Diacetyl is allowed in cigarettes, and yeah, I know, they didn't go through PMTA, but still it hasn't been singled out for removal. Science wise, there is no actual evidence of health risk. Also, if it was present, what are the chances that the FDA is going to require the chemical makeup of flavorings to be listed on packaging? I'm almost certain that if ingredients are required to be listed, it will say "natural and artificial flavorings."

 

[zoiDman]

Ok, take #2 I'm going to go with, possibly. Diacetyl is allowed in cigarettes, and yeah, I know, they didn't go through PMTA, but still it hasn't been singled out for removal. Science wise, there is no actual evidence of health risk. Also, if it was present, what are the chances that the FDA is going to require the chemical makeup of flavorings to be listed on packaging? I'm almost certain that if ingredients are required to be listed, it will say "natural and artificial flavorings."

Could be.

But if the Current HHS/FDA Leadership remains in Power, or if a Similar group of is instated, I don't see Diketones making it in Any e-Liquid.

 

[Lessifer]

Could be.

But if the Current HHS/FDA Leadership remains in Power, or if a Similar group of is instated, I don't see Diketones making it in Any e-Liquid.

I don't know, that makes the assumption that any of this is about health, or the appearance of health. You and I agree that if any vapor product has a shot at being approved, it's Vuse, right? What if Vuse has diketones in the liquid? If faced with the choice of approving a product with a minuscule amount of a compound that could be linked to a disease, even though there is no actual evidence of a causal link, OR not approving anything and making that de facto ban everyone has been talking about a verified reality, which would they choose?

 

[Kent C]

You sure about that? This is the agency that is trying to remove the word "mild" from an established brand name, because it implies their product may have lower health risks. Or if your objection is specifically to diacetyl free, how about smoke free?

That was a bit tongue in cheek, but I like your next reply :- )

 

[Mazinny]

Ok, take #2 I'm going to go with, possibly. Diacetyl is allowed in cigarettes, and yeah, I know, they didn't go through PMTA, but still it hasn't been singled out for removal. "

Don't think the diacetyl in cigarettes is an added ingredient. It's produced during the combustion process according to Dr. Farsalinos.

 

[Kent C]

Private citizens can't "violate" the 1st Amendment. Only government can.
Apples: Shouting "fire" in a crowded theater when there is no fire and there's an imminent threat of panic. Oranges: Shouting "dead cops now" when there is no imminent threat of violence. Speech becomes a 1st Amendment issue when government restricts it and/or when it interferes with another constitutionally protected right, e.g., freedom of the press. Thus, it has been held that when the judicial system (a branch of government) imposes common law defamation principles in such a way as to unduly restrict freedom of the press, it is a 1st Amendment violation on the part of the judiciary.

This back-and-forth has become unproductive. We share the opinion that the FDA's restrictions on vaping product advertising are unreasonable and violate of the 1st Amendment. We don't need to quibble about fire in theaters or "dead cops now." People are here to talk about vaping regulations.

I misinterpreted your apples and oranges from what you said originally after that. If you meant between 'dead cops now' and 'diketone-free' then I agree. But it didn't look that way in your post.

I agree the freedom of speech from the first mention, was off topic. And I've seen you 'clear up' others comments on parts of law as well, but the thread does seem to find it's way back.

 

[Kent C]

A bit more complicated than that.

Of course, but stopping the "monopolistic price fixing" was just one side of the story and not the whole story - just the propaganda that went forward. And we don't need to quibble about the ICC either who brought that up anyway....

 

[Lessifer]

Don't think the diacetyl in cigarettes is an added ingredient. It's produced during the combustion process according to Dr. Farsalinos.

Is that a verified fact? According to RJR, acetoin and Butyric acid are ingredients, though I don't see diacetyl on the list.
Cigarette Ingredients | R.J. Reynolds Tobacco Company

It's also a little funny to me that they get to use this to defend their ingredients:

Most of these ingredients are commonly used in foods and beverages, or permitted for use in foods by the U.S. Food and Drug Administration (FDA), or have been given the status “Generally Recognized as Safe in Foods” (GRAS) by FDA, the Flavor and Extract Manufacturers Association (FEMA) or other expert committees.

 

[Kent C]

Don't think the diacetyl in cigarettes is an added ingredient. It's produced during the combustion process according to Dr. Farsalinos.

https://www.faseb.org/Portals/2/PDF...sibility disclaimer & text corrections_PM.pdf pg320

126. Diacetyl FDA GRAS; FEMA GRAS; found in apple, bean, beef, butter, artichoke, avocado, black currants, blueberry, blue cheese, grape brandy, wheat, brussel sprouts; used in meat products.

From:
LIST OF INGREDIENTS
Tobacco Companies’ Combined Ingredients List For the U.S. Department of Health and Human Services (DHHS) (R.J. Reynolds Tobacco Company, 2000b) Most of these ingredients are commonly used in foods and beverages, or permitted for use in foods by the U.S. Food and Drug Administration (FDA), or have been given the status “Generally Recognized as Safe in Foods” (GRAS) by FDA, the Flavor and Extract Manufacturers Association (FEMA) or other expert committees.

And from the Pierce study:
Diacetyl and 2,3-pentanedione exposures associated with cigarette smoking: implications for risk assessment of food and flavoring workers. - PubMed - NCBI

Diacetyl and 2,3-pentanedione inhalation have been suggested as causes of severe respiratory disease, including bronchiolitis obliterans, in food/flavoring manufacturing workers. Both compounds are present in many food items, tobacco, and other consumer products, but estimates of exposures associated with the use of these goods are scant.
----

It is the formaldehyde, not diacetyl, that is a result of combustion of tobacco or from extreme (unreal) conditions in heating eliquid. As Dr. F pointed out.

 

[Mazinny]

Is that a verified fact? According to RJR, acetoin and Butyric acid are ingredients, though I don't see diacetyl on the list.
Cigarette Ingredients | R.J. Reynolds Tobacco Company

It's also a little funny to me that they get to use this to defend their ingredients:

Don't know if it's " verified ", but that's what Dr. F has said. I haven't seen any original studies about levels of diacetyl in cigarettes one way or another.

 

[Mazinny]

https://www.faseb.org/Portals/2/PDFs/LSRO_Legacy_Reports/2004_Phase 1 Feasibility disclaimer & text corrections_PM.pdf pg320

126. Diacetyl FDA GRAS; FEMA GRAS; found in apple, bean, beef, butter, artichoke, avocado, black currants, blueberry, blue cheese, grape brandy, wheat, brussel sprouts; used in meat products.

From:
LIST OF INGREDIENTS
Tobacco Companies’ Combined Ingredients List For the U.S. Department of Health and Human Services (DHHS) (R.J. Reynolds Tobacco Company, 2000b) Most of these ingredients are commonly used in foods and beverages, or permitted for use in foods by the U.S. Food and Drug Administration (FDA), or have been given the status “Generally Recognized as Safe in Foods” (GRAS) by FDA, the Flavor and Extract Manufacturers Association (FEMA) or other expert committees.

And from the Pierce study:
Diacetyl and 2,3-pentanedione exposures associated with cigarette smoking: implications for risk assessment of food and flavoring workers. - PubMed - NCBI

Diacetyl and 2,3-pentanedione inhalation have been suggested as causes of severe respiratory disease, including bronchiolitis obliterans, in food/flavoring manufacturing workers. Both compounds are present in many food items, tobacco, and other consumer products, but estimates of exposures associated with the use of these goods are scant.
----

It is the formaldehyde, not diacetyl, that is a result of combustion of tobacco or from extreme (unreal) conditions in heating eliquid. As Dr. F pointed out.

interesting. i found the Dr. F article btw :

A new study verifies the lower risk-potential of e-cigarettes but identifies an avoidable risk

Moreover, unlike tobacco cigarettes where these chemicals are produced during the combustion process, in e-cigarettes they are used as ingredients.

Perhaps it's produced during combustion and some tobacco companies add it as part of the casing, and others use butyric acid and acetoin !?

 

[bigdancehawk]

Of course, but stopping the "monopolistic price fixing" was just one side of the story and not the whole story - just the propaganda that went forward. And we don't need to quibble about the ICC either who brought that up anyway....

Ha! I can't get my favorite mod to fire so I'm feeling more combative than usual. Time for a visit to the mod doctor before I run completely amuck.

 

[Kent C]

interesting. i found the Dr. F article btw :

A new study verifies the lower risk-potential of e-cigarettes but identifies an avoidable risk

Moreover, unlike tobacco cigarettes where these chemicals are produced during the combustion process, in e-cigarettes they are used as ingredients.

Dr. F and others Hajek, for one have said formaldehyde is only the result of combustion/overheating. Hajek: "When a chicken is burned, the resulting black crisp will contain carcinogens but that does not mean that chicken are carcinogenic. Without overheating the e-liquid, no formaldehyde was detected."

But for diacetyl, the above posts shows it is present in tobacco and other food products.

 

[Kent C]

Ha! I can't get my favorite mod to fire so I'm feeling more combative than usual. Time for a visit to the mod doctor before I run completely amuck.

I'm having a bit of trouble with a Cubis Pro topper too

 

[Lessifer]

interesting. i found the Dr. F article btw :

A new study verifies the lower risk-potential of e-cigarettes but identifies an avoidable risk

Moreover, unlike tobacco cigarettes where these chemicals are produced during the combustion process, in e-cigarettes they are used as ingredients.

Perhaps it's produced during combustion and some tobacco companies add it as part of the casing, and others use butyric acid and acetoin !?

There's no reference cited there, and from what I could find in ten minutes of googling, diacetyl is a product of yeast converting glucose to ethanol. I can't find any reference of it being a product of combustion. I'm leaning towards its presence in tobacco to be attributable to the added flavoring in cigarettes. Contrary to popular belief, cigarettes are flavored, they just don't have "characterizing flavors."

 

[bigdancehawk]

interesting. i found the Dr. F article btw :

A new study verifies the lower risk-potential of e-cigarettes but identifies an avoidable risk

Moreover, unlike tobacco cigarettes where these chemicals are produced during the combustion process, in e-cigarettes they are used as ingredients.

Perhaps it's produced during combustion and some tobacco companies add it as part of the casing, and others use butyric acid and acetoin !?

God only knows. But I'm perfectly OK because I smoked American Spirits.

 

[coldgin96]

Nicosurge.com

THANK YOU!

According to my calculations, this would cost twice as much as smoking and I'd have to take a hit every six minutes.

 

[Rossum]

I don't know, that makes the assumption that any of this is about health, or the appearance of health. You and I agree that if any vapor product has a shot at being approved, it's Vuse, right?

Right.

What if Vuse has diketones in the liquid?

It seems to me Vuse was specifically designed to meet the FDA's requirements for a PMTA. Heck, one might even suspect that Reynolds had advance knowledge what the regulations related guidance would look like. Moreover, diketones have been a known "concern" in vaping since roughly 2010, and they are also listed in the guidance document as such. (Whether that concern is legitimate or not is irrelevant to this discussion.)

Now do you really think that Reynolds would risk the investment it has made in this product line, which is in the mid hundreds of millions of dollars already, by having diketones in their liquid?

 

[Lessifer]

Right.


It seems to me Vuse was specifically designed to meet the FDA's requirements for a PMTA. Heck, one might even suspect that Reynolds had advance knowledge what the regulations related guidance would look like. Moreover, diketones have been a known "concern" in vaping since roughly 2010, and they are also listed in the guidance document as such. (Whether that concern is legitimate or not is irrelevant to this discussion.)

Now do you really think that Reynolds would risk the investment it has made in this product line, which is in the mid hundreds of millions of dollars already, by having diketones in their liquid?

It was more of a hypothetical. Do the guidelines say not to have particular chemicals in your product, or that you should specifically report the levels of particular chemicals?

 

[bigdancehawk]

It was more of a hypothetical. Do the guidelines say not to have particular chemicals in your product, or that you should specifically report the levels of particular chemicals?

No. Neither the regulations nor the guidelines to date prohibit any particular substances or materials, either in e-liquids or devices, nor are any specific substances or materials identified as permissible.

That's one of the most objectionable aspects of this whole thing. The FDA admits it doesn't know what's OK and what's not, so it has placed the entire burden on manufacturers to perform elaborate studies in order to spoon feed information to the FDA which it admits it has to have in order to become sufficiently educated on the products to enable it to properly regulate them.

Vaping products are being treated much like new prescription drugs as opposed to recreational products. The FDA doesn't tell BP what to put in drugs. BP concocts a new drug, conducts all kinds of tests, submits the information, and then the FDA decides if its OK to market the drug. The cost of bringing a new drug to market averages $2.5 billion, which is roughly the cost of 27 F18 jet fighter planes.

Treating vaping products the same as new drugs is the wrong approach because there are already millions of people vaping. Many people have been vaping for 7 years or longer. That's vastly more people vaping for longer periods of time than new drug testing involves. So there's already plenty of readily available information on their safety. What would elaborate and costly clinical trials tell us that we don't already know or can't easily determine?