Fda news release

[Chris From Cali]

Not sure if anyone has posted the audio yet. If not here is the first part of the call

YouTube - VaporTalk - FDA Call about Electronic Cigarettes - PART 1

 

[Vocalek]

“Diethylene glycol was detected in one cartridge at approximately 1%. Diethylene glycol, an ingredient used in antifreeze, is toxic to humans.”

At what dose? Millions of potentially toxic substances can be safely consumed in small quantities. Presumably, nearly 100% of the FDA-Approved drugs are toxic at high enough levels.

Searched for 'Diethylene glycol' in All of FDA

Cumulative Estimated Daily Intake/Acceptable Daily Intake Database
... Change font size. FDA Home >; CEDI/ADI Database >; CEDI/ADI Database Listing >;
CEDI/ADI Detail. DIETHYLENE GLYCOL. Return to Listing. ...
www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=cediListing&id=295 - 19k - Cached

DIETHYLENE GLYCOL​

Return to Listing​

CAS RN or Other ID Code:
000111466

ADI:
0.1

CUM DC:
143

CEDI:
0.00715

REGNUM:
175.105 175.300 175.320 177.2420 177.2800 172.820 176.180 176.210 177.1390

TOX Study Date:
01/01/1976


As part of the premarket notification process for food contact substances (FCSs), the Office of Food Additive Safety (OFAS) is The FDA is developing and making publicly available a database of cumulative estimated daily intakes (CEDIs) and acceptable daily intakes (ADIs) for a large number of FCSs. This database is referred to as the CEDI/ADI database. At this time, the database contains CEDI/ADI information on an initial subset of food-contact substances.

1. The CEDI values are expressed as dietary concentration (parts-per-billion, ppb) and as intake (milligram/kilogram body weight/person/day, mg/kg bw/d) to facilitate comparison to the applicable ADI value for the FCS.
2. Many of the FCSs listed below are only regulated for use under 21 CFR 175.105. In the absence of appropriate information, such as migration studies, on which to base a numerical estimate of exposure, OFAS assumes a default CEDI of 7 ppb (corresponding to a cumulative intake of 0.00035 mg/kg-bw/d).

So, given the above information, can someone tell me how close I would get to the Acceptable Daily Intake (ADI) of 0.1 that the FDA has set for Diethylene Glycol if it were possible for me to consume 100% of the liquid in one of my cartridges? Supposedly my cartridges are equivalent to 1/2 pack of cigarettes,but one of them lasts me two days. I'm not sure how much total liquid is in my cartridge -- maybe three drops?

Can someone provide info on what ADI amounts this would translate into for different body weights -- say 100 pounds, 150 pounds, 200 pounds? Yes, I know, Kilos.... so say 45 Kilos, 68 Kilos, and 90 Kilos.

 

[Ivisi]

Seems to me that SE and njoy could use this quote from the analysis as a basis to support their case against the FDA:

tobacco-specific impurities suspected of being harmful to humans—anabasine, myosmine, and β-nicotyrine—were detected in a majority of the samples tested.

The FDA tested, and found, that the product is derived from tobacco, and therefore the products could be considered tobacco products and not drug delivery devices.

Ivisi

 

[tannerk]

What did we expect? Did anyone honestly think FDA is going to sit back and handover the case?
I'm not an attorney, but my argument goes like this:
E-cig is a better alternative... blah..blah.. blah. It may or may not contain chemical(s) found by the defendant. When, who, how was it tested…blah…blah…blah…? We have a study by Health NZ and LPD that completely disproves defendant theory.
Your Honor, consider this: there are more than 4000 chemicals in conventional cigarettes currently authorized to be marketed in United States. Among those chemicals are cancer causing agents:
·[FONT="] [/FONT][/FONT]Nitrosamines
[FONT=Symbol]·[FONT="] [/FONT]Crysenes
·[FONT="] [/FONT][/FONT]Cadmium
[FONT=Symbol]·[FONT="] [/FONT]Benzo (a) pyrene
·[FONT="] [/FONT][/FONT]Polonium 210
[FONT=Symbol]·[FONT="] [/FONT]Nickel
·[FONT="] [/FONT][/FONT]P.A.H.s
[FONT=Symbol]·[FONT="] [/FONT]Diberiz Acidine
·[FONT="] [/FONT][/FONT]B-Napthylamine
[FONT=Symbol]·[FONT="] [/FONT]Urethane
·[FONT="] [/FONT][/FONT]N. Nitrosonornicotene
[FONT=Symbol]·[FONT="] [/FONT]Toluidine
Furthermore cigarettes contain Aluminum, Zinc, Magnesium, Mercury, Gold, Silicon, Silver, Titanium, Lead, Copper metals and
·[FONT="] [/FONT][/FONT]Acetone (nail polish remover)
[FONT=Symbol]·[FONT="] [/FONT]Acetic Acid (Vinegar)
·[FONT="] [/FONT][/FONT]Ammonium (Floor/Toilet Cleaner)
[FONT=Symbol]·[FONT="] [/FONT]Arsenic (poison)
·[FONT="] [/FONT][/FONT]Butane (cigarette lighter fluid)
[FONT=Symbol]·[FONT="] [/FONT]Cadmium (rechargeable batteries)
·[FONT="] [/FONT][/FONT]Carbon Monoxide (car exhaust fumes)
[FONT=Symbol]·[FONT="] [/FONT]DDT/Dieldrin (Insecticides)
·[FONT="] [/FONT][/FONT]Ethanol (alcohol)
[FONT=Symbol]·[FONT="] [/FONT]Formaldehyde (preserver of body tissue and fabric)
·[FONT="] [/FONT][/FONT]Hexamine (barbecue lighter)
[FONT=Symbol]·[FONT="] [/FONT]Hydrogen Cyanide (gas chamber poison)
·[FONT="] [/FONT][/FONT]Methane (swamp gas)
[FONT=Symbol]·[FONT="] [/FONT]Methanol (rocket fuel)
·[FONT="] [/FONT][/FONT]Napthalene (mothballs)
[FONT=Symbol]·[FONT="] [/FONT]Nicotine ( insecticide/addictive drug)
·[FONT="] [/FONT][/FONT]Nitrobenzene (gasoline additive)
[FONT=Symbol]·[FONT="] [/FONT]Nitrous Oxide Phenols (disinfectant)
·[FONT="] [/FONT][/FONT]Steric Acid (candle wax)
[FONT=Symbol]·[FONT="] [/FONT]Toluene (industrial solvent)
·[FONT="] [/FONT]Vinyl Chloride (makes PVC)
Your honor, it is obvious that defendant (FDA) has overstepped its authority and is trying to use “public good” as an excuse.
Like I said, I’m not an attorney, but this is how I’d counter it….

 

[Momof3]

Lacey, thanks for the link, but nothing shows, at the moment. I'll try it again later on.
And, Rockbassraythat is a good point but not applicable with this report. E-Cigs are being judged on their own merit, or lack of merit.

The control was the Nicotrol Inhaler. So to me they used a non-tobacco cessation product against a tobacco non-cessation product. An analog as the control would have made more sense.

Is everybody saying, "Oh no. If they ban these I'm going to have to go back to using the inhaler/gum/patch/lozenge."

Not how I've been reading things, but who knows.

 

[halopunker]

Summarized FDA Conference: Kids...Kids...Kids...blah blah blah...Kids...Used to hook Kids...some toxins...Kids...Kids...

 

[Kobayashi]

FDA: Electronic cigarettes contain toxic chemicals - washingtonpost.com

 

[Vocalek]

Toxicology and Applied Pharmacology
Volume 65, Issue 3, 30 September 1982, Pages 366-372


Abstract

The effect of pretreatment with β-nicotyrine on tissue concentrations of nicotine and metabolically formed cotinine was studied in male albino mice injected with [14C]nicotine. Acute toxicity of nicotine administered ip or iv was also compared in the pretreated and untreated animals. The pretreatment with nicotyrine resulted in a significant dose-dependent increase of nicotine concentrations in the liver, blood, and brain. Concomitantly, there was a significant decrease in the cotinine concentrations suggesting an inhibition of nicotine liver metabolism. Despite the higher concentrations of nicotine in the brain of the pretreated mice, the LD50 after an ip injection of nicotine was not different from the untreated animals. On the other hand there was complete protection against the lethal effect of iv-injected nicotine in the pretreated animals suggesting a direct protective interaction of nicotyrine with nicotine in CNS.

 

[LaceyUnderall]

Lacey, thanks for the link, but nothing shows, at the moment. I'll try it again later on.
And, Rockbassraythat is a good point but not applicable with this report. E-Cigs are being judged on their own merit, or lack of merit.

FDA Announcement on Electronic Cigarettes

the trunkating screwed it up.

 

[halopunker]

FDA: Electronic cigarettes contain toxic chemicals - washingtonpost.com

"R.J. Reynolds spokesman David Howard said the company is focused on being the "total tobacco company," pointing to its products like dissolvable tobacco, rather than technology like e-cigarettes."

 

[stevo_tdo]

We all need to do something about this. The ball is in our court now. The ECA is collecting all this money and where are their studies huh? I'll chip in what I can for a study. The fda states that the approval process would be expedited in products that show a potential for great benefit. We all know that anything imported in from china is going to have a hard time being proved safe. The focus now should be on the u.s. pv manufacturers and juice makers. Independent studies, government studies, everything. For many people that sell these things it is their lifeline, their business. For others they have been a godsend for quitting smoking. I for one am not going to give my right to choose. Let me say though that the fda news release was bullsh*t. So what if we have to give up our fruity flavors because they are "marketed towards children" unlike cigarettes all we have to do is add some loranns to the juice. I mean how would that sound. A us company selling us made pvs with us made liquid. I'm sure they could sell plain juice without flavoring. Just add your own then huh. **** this has me all ...... off today. I love my pv

 

[OutWest]

doctor Winickoff went on and on about kids and appeal to kids. And said that that it is unclear what safety measures are in place to prevent a kid from puffing all the way through a full cart. Um, it's very clear. If you use the batteries that come included in the kits, they cut off if you puff too many times in too short of a period of time. Not to mention that there isnt any thing in place to prevent a kid from chewing too many tabs of nicotine gum in a short period of time (as we just saw with the kid in the UK that ended up in the hospital, using gum that was given out by the local quit smoking group)

 

[LaceyUnderall]

So what if we have to give up our fruity flavors because they are "marketed towards children"

Don't forget though, in the announcement today, they also noted that putting on products "Adults Only" is a direct attempt to market towards children.

 

[Ryle]

Has anyone asked the FDA or anyone else for that matter that is claiming "save the children" as an excuse..."How do you think a child is going to have an easier time acquiring a product that costs on average $60 up front vs. a product they can drop a $10 on have it the same day and still have change left over?" I'd really LOVE to hear their excuse on how they think that PV's are more of a danger to children than analogs are.

 

[need_2quit]

I know the whole concept is " to get people to quit smoking PERIOD", but the patch isnt doing it, the gum isnt doing it, and i think myself and countless other suppliers hear form our customers how much this has helped them more then a patch or gum

there's the crux. none of us have actually quit anything. all we've done is substitute a different delivery system for nicotine. for many on here, they plan to vape for life. personally, I'd like to know what i'm vaping, because after a throat burn and chemical burn on my lip from juice, i'm not buying that they are totally safe. anyone that tells you that is probably a juice supplier.

truth is, they don't know either.

if the fda banning e-cigs is more of a fear than safety, then maybe it's time to really quit everything. as a long time smoker from back in the day when there were no warning labels, i can tell you warnings are not a bad thing. it lets the consumer decide what risk they are willing to take.

but for juice suppliers to say there is no danger is insane. thus the FDA asking for input on incidences.

lol run for the hills.

 

[Sun Vaporer]

The Wahington Post went so far as to state this today:

FDA officials declined to comment on whether they would take action against the two manufacturers whose products were tested.
The agency did say it's "planning additional activities" to address safety issues with the products, which may include recalls or criminal sanctions

That is their take on "additional activities"

See washingtonpost.com

Sun

 

[Ryle]

Don't forget though, in the announcement today, they also noted that putting on products "Adults Only" is a direct attempt to market towards children.

Does that mean porn is directly marketed towards children??


That would have been MY comeback to the comment

 

[T-BAYJ]

as a FNG here who just received his first 510 starter kit , I'm a bit confused what can they ban ? the juice ? certainly not the devices as I can buy a .... or Bowl or rolling papers from my convenience store a few blocks away
and we all know Marijuana is illegal in the usa esp in the south , Your ... will go to jail for some stems and seeds in possession of

 

[OutWest]

Don't forget though, in the announcement today, they also noted that putting on products "Adults Only" is a direct attempt to market towards children.

Which is such a crock. Using that logic, liquor and porn are both marketed to children.

edit - sniped by Ryle

 

[TropicalBob]

This is grim.

And a day before NBC Nightly News was to broadcast a report on e-smoking. And right about the time Judge Leon must make his decision known.

There is nothing to hang your hat on in those comments. No side runs around this reality. The only question left for the FDA to answer is: What will you do about it?