FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

[DC2]

Oh, for the love of God, that's about all I can take...

The FDA did test some E-Juices that contained diacetyl, most E-juice companies have removed it if they used it, but some still do. It was entirely reasonable that the FDA tested what was in the E-juice and they found a couple of problem, literally 2 of 18.

Back in 2009 products from China were in question, many thousands of dogs were sickened and killed by dog food tainted with Melamine in dog food. Testing anything so new from China, was a good move. So they found a problem, and the industry reacted quickly. Some did have a dangerous chemical in 2009, don't act if nothing wrong was found. It has been quickly solved, but denying its history and its continued very limited use, is wrong. Most e-liquid companies actively state they do not use Diacetyl now....that is for cause. I do believe one E-Juice did have anti-freeze in it, something that Kristin has said was at a level that was most likely not a problem...but they found it in 1 of 18.

This is quite possibly the worst, most inaccurate post I have ever seen on this forum.
If anyone didn't understand that you don't know what you are talking about, they sure do now.

How anyone can state things so blatantly incorrect, with so much confidence and bluster is beyond me.
But it is clearly par for the course with you.


But this is the part that really ...... me off...

It has been quickly solved, but denying its history and its continued very limited use, is wrong.

Where the hell do you get off preaching about knowing history?
You clearly don't know yours.

I only have three more words for you, but they can't be printed on this forum.

 

[AttyPops]

How many remaining smokers are going to switch to electronic cigarettes in that scenario?
It makes plenty of sense for them to ban it.

OK, I concede that point. I just didn't put them in the category of "banning for the sake of banning". But if we assume that, then sure.

I think that a lot of ANTZ are really self convinced that they are doing the right thing...and are using all sorts of arguments (regardless of truth) to rationalize their actions. 99% of it is not malicious, but rather, an agenda. A rally cry of the overly-righteous. That's why education is important.

I would hope that a pseudo-sceintific-medical organization like the FDA would have more sense than that. But I'm an optimist. Previous "findings" on e-cigs by the FDA are certainly not encouraging.

 

[patkin]

Agreed and have often put this possibility forward to people freaking out over the possibility that the FDA could create rules for e-liquid that prohibit "fruit and candy" flavors. Vendors can sell unflavored liquid and sell the flavors on the side (or other companies will fill the need.) Just like those "Tasty Puff" flavorings. Unfortunately, that only helps the small portion of consumers who are willing to DIY a little and not the millions buying pre-filled cig-a-likes sold on every corner. We could only hope that as the word spreads of available flavors that smokers learn of the option.

But there is still nothing stopping the FDA from issuing a special rule for e-liquid that it cannot be sold in bottles or that e-liquid sold directly to the public must be packaged in pre-filled cartridges that are sealed to prevent tampering. That would be devastating to the mom & pop e-liquid and mod industries.

The FDA would not need an act of Congress to make such rules. The FSPTCA allows the Secretary to deem rules that "protect public health." Just as they got flavored cigarettes banned without any scientific evidence they cause harm or increase youth use, the FDA can use the same process to issue rules on e-liquid that it can claim will be "proactive" in helping reduce the risk of youth abuse.

Again, (and this is directed anyone specific) we don't bring these possibilities up just to unnecessarily scare people, but to just make them aware of just that - these are possibilities we need to be alert for in case we have to act quickly. We need to have arguments prepared for why such actions would be bad for consumers and be prepared for as many people and companies to submit comments. If we pretend that everything will be just fine and the FDA wouldn't do anything to damage the effectiveness, availability and affordability of e-cigarettes then we will be woefully unprepared in a worst-case scenario. While we are busy running around the country stopping indoor use bans in small towns, the FDA could be issuing proposed rules that could have far greater reaching impact than even 1,000 city use bans. While we still fight them, realistically most vapers can work around public use bans. But they wouldn't be able to get around what the FDA could do to us nearly so easily.

The irony is that while we were fighting mostly local bans, people complained we weren't doing enough being proactive on the national level and now that we are being proactive on the national level, we are accused of creating FUD about it and not doing enough on the local level. All we can do is what we can to handle BOTH issues as best we can. We simply won't be able to make everyone happy.

Thank you. That addresses my concern about ALL vaping and flavorings being the avenue with which to control it. While I do, of course, think nic is one battle front, its only one. The war has always been about vaping... period... with nic (tobacco) being only the first wave and an avenue to recouping revenue losses. I'm actually of a mind that those selling unflavored nic liquids may actually be in the best position with those making flavored ejuices (without nic in the future) being in the worst position and, oddly, though the kid argument with cotton candy is being put forth, I think the flavorings most affected will be tobacco ones. I won't go into my reasons for thinking this is the way it will go nor how I think ease-of-use hardware is going to be affected as we aren't there yet and its just speculation anyway.

 

[kristin]

I would hope that a pseudo-sceintific-medical organization like the FDA would have more sense than that. But I'm an optimist. Previous "findings" on e-cigs by the FDA are certainly not encouraging.

Sorry, this part struck me as humorous. The words "FDA" and "sense" are an oxymoron, lol! I just think about things like banning flavored cigarettes (with the blessing of tobacco companies) when there is no real evidence that flavored cigarettes contribute to youth initiation or smoking rates. Or wanting to ban menthol (but not doing it yet because the tobacco companies objected) with no scientific basis. Or saying that the benefits of quitting smoking with Chantix outweighs the risks (after 500 deaths and numerous heart attacks) while saying e-cigs might still have risks (that somehow outweigh quitting smoking) even after being on the market as long as Chantix with NO deaths or injury. Or telling the public e-cigarettes contain potentially harmful things like carcinogens and anti freeze when it knows full well that the levels found were too low to harm anyone. Or, non-tobacco related things like telling cereal and other food companies they are selling "unauthorized drugs" when they tell the public long-known facts about eating certain foods.

My outlook is "hope for the best but prepare for the worst" and that is what I've been saying all along.

 

[DC2]

At any rate, I am curious what you find to be inaccurate, and if you would be willing to allow for 'honest mistake' on the diacetyl claim when I'm guessing he meant diethylene glycol.

The FDA did not find diacetyl in their "study" of the Smoking Everywhere and NJoy cartridges.
The diacetyl issue arose here on this forum and was dealt with by the vendors because the consumers demanded that they do so.

The FDA had nothing whatsoever to do with it.

Also, he then seems to go on to imply that the FDA did this testing because the juice came from China and it was a prudent thing to do.
The FDA did not test the Smoking Everywhere and NJoy cartridges for that reason.

The FDA tested those cartridges because they were involved in a lawsuit with those two companies.

The one "toxic chemical" that was found in one of the cartridges tested was diethylene glycol.
That is a well-known contaminant that is expected to be found in propylene glycol.

Regardless, no analysis of electronic cigarette liquid before or since has ever detected any diethylene glycol.
The elimination of diethylene glycol had absolutely nothing to do with the FDA finding a bit in one cartridge, as was implied.

(Except of course that he said diacetyl instead of diethylene glycol)

And no, that's not an "honest mistake" as far as I'm concerned.
It's a perfect example of him not knowing enough of what he's talking about to act like he does.

 

[kristin]

Just an observation - I'll let DC respond to the rest of your post - but I don't believe Tom was confusing "diacetyl" with "diethylene glycol" as he mentions "anti freeze" as a separate issue from diacetyl at the end of the paragraph:

Most E-Liquid companies actively state they do not use Diacetyl now....that is for cause. I do believe one E-Juice did have anti-freeze in it, something that Kristin has said was at a level that was most likely not a problem...but they found it in 1 of 18.

 

[Jman8]

The FDA did not find diacetyl in their "study" of the Smoking Everywhere and NJoy cartridges.
The diacetyl issue arose here on this forum and was dealt with by the vendors because the consumers demanded that they do so.

The FDA had nothing whatsoever to do with it.

Agreed. Well, at least I think FDA had nothing to do with the issue (let's hope).

Also, he then seems to go on to imply that the FDA did this testing because the juice came from China and it was a prudent thing to do.
The FDA did not test the Smoking Everywhere and NJoy cartridges for that reason.

Agreed with idea that he implied it was FDA testing eCigs because of diacetyl, which seems mistaken. Not mistaken that FDA did run tests, but mistaken about why and/or that it would have anything to do with diacetyl. Strikes me as half truth really.

And no, that's not an "honest mistake" as far as I'm concerned.
It's a perfect example of him not knowing enough of what he's talking about to act like he does.

So, just makes me even more curious how you would compare the two items I mentioned before. Which one seems like a more significant error (if erroneous at all) as it affect the vaping community going forward?

 

[k3vin]

Just because something isn't a lie does not mean that it isn't deceptive. A liar knows that he is a liar, but one who speaks mere portions of truth in order to deceive is a craftsman of destruction.”
― Criss Jami

 

[kristin]

Jman, he clearly wasn't confusing diacetyl with diethylene glycol. He states the FDA found "literally 2 of 18" with diacetyl and at the end of the second paragraph he says the FDA found "anti freeze" in 1 of 18. He clearly knows that the anti freeze found was not the same as diacetyl.

 

[Jman8]

Just because something isn't a lie does not mean that it isn't deceptive. A liar knows that he is a liar, but one who speaks mere portions of truth in order to deceive is a craftsman of destruction.”
― Criss Jami

bolded part would apply to everyone I've met, heard of, or read stories about.

 

[AttyPops]

"No reason to make it personal. Just post the correct information; refute the incorrect information. Easier that way. No flame wars needed. No trolls fed."
― AttyPops

 

[kristin]

I also think if deeming stuff is at OMB, then we can tone down the approach to dealing with FDA as it would seem things are already done on that front from FDA's perspective.

That is true now, but it wasn't just a week or so ago, before CASAA met with the OMB. We had a really good meeting with them, too. And CASAA is still trying to get true consumer representation on TPSAC, which has a huge influence on what the FDA does with its rules: CASAA: CASAA engages with US government to ensure consumer representation

 

[DC2]

So, just makes me even more curious how you would compare the two items I mentioned before.

Just out of curiosity, which seems more blatantly incorrect to you?

1. Chapter 910 of the TCA would ban all e-cigs currently on the market
2. The FDA did test some E-Juices that contained diacetyl, most E-Juice companies have removed it if they used it, but some still do.

I am not enough of an expert on the law and how it would be applied to comment on the first statement.
I doubt anybody participating in this conversation is qualified enough in that regard.

But if anybody is, the most likely one to know what's up would be Bill Godshall, given his extensive background in legislative efforts.
That doesn't mean he is right, or will be right, but I can't say that he's wrong based on what the FSPTCA says.

 

[DC2]

I also think if deeming stuff is at OMB, then we can tone down the approach to dealing with FDA as it would seem things are already done on that front from FDA's perspective.

Just remember that if the proposed deeming regulations look bad for us, we will need to focus even more on the FDA...
Because the comment period on those regulations will be our only opportunity to lobby for changes.

 

[SloHand]

1) "has the same characteristics as the predicate
tobacco product " [/B]
("characteristics" is defined by the FDA as "the materials, ingredients, design, composition, heating source, or other features of a tobacco." Would the FDA consider tobacco flavoring, with it's own chemicals to be "the same" as strawberry flavoring, that contains different chemicals? We don't know, but suspect the answer would be "no.")
product )

This gave me pause. Heating source? How could the FDA NOT be referring to e-cigarettes?

 

[tombaker]

@Tombaker: (re: top of post 166)

PG is an antifreeze. It's is the main agent in RV antifreeze.
So is salt, BTW. Meh.
You're talking about DEG, I think. It was a contamination mistake.
There were a few other mishaps too.

Many vendors want some degree of quality control...they either implement them or count on their suppliers to implement them. A bit of occasional checking is healthy...but expensive...so some low-cost checking would be a good thing IMO. How to keep the costs down....IDK.

The anti-freeze they found was as you say "Diethylene Glycol" DEG, the found 1 percent, which is one massive contanimation mistake, as mistakes go. They found some other stuff, and they found that the nicotine varied to what was advertised, specifially a no nicotine that had it.

My point was in response to people being freaked out that the FDA did any testing at all, and they published that the found DEG, not to be confused with PG. They also found other junk, in some carts, but none in the others, prooving it could be done both wrong, but also proving it could be done RIGHT.

Again at the time dogs were being killed, dead, from Chinese dog food tainted by Melamine. Checking to see if E-Juice as tainted was a reasonable thing to do. Glad they did it. Since then, E-Juice ingredients are much more responsive. Also the problem of Diacetyl has come about, and it was with FDA information about the Popcorn lungs.

E-Liquid can be made like crap, or it can be done right. Should the FDA do testing in the future, or require it. I see no issue at all. Plus you have E-Liquid manufacturers banding together in trade orgainizations, to make manufactuering standards, and they do facilties inspections and testing.

I wish people would not view the FDA as pure evil, they are not. They made a mistake about with trying to ban imports, they ended up paying for the mistake with a ruling that eleminated a ton of the capablites on E-Cigs......3 years later, the FDA has not been able to do anything, or chose to not do not....either way, the FDA is doing nothing, yappping they may some day. But their yapping said 2012, any day now, 2013 any day now. It's 2014, still the same. Why should I care the FDA spooked the Juice makers to be much more religous about their standards.....every E-Juice maker talks about their quality.....fine.

That Cites cite some FDA documents is meaningless, other than knowing the FDA wants more testing. Take out the FDA entirely, and the cities would do the same things. But it is what it is, the FDA tested, found some clean, others as you say contaminated, it was a correct move for an agency with the charge of F and D.
The study: http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf

 

[Rossum]

I wish people would not view the FDA as pure evil, they are not. They made a mistake about with trying to ban imports

Pick a prescription drug and compare what you have to pay for it in the USA vs. what you would pay for it in any other first-world country (e.g. Canada). Then ask yourself why such a pricing disparity exists. But no, the FDA isn't evil, and isn't in bed with Big Pharama, right?

 

[AttyPops]

The problem with the FDA Tom, is that they had to work really hard to find those particular 18 carts, and haven't found any DEG since, and they use that one case to try and "strong arm" themselves into regulatory positions with FUD...acting as if what they found was the norm for the industry.

Asserting that some quality control measures are necessary, or even random testing, fine. But damning e-cigs as a result of that test (and many quote that study...or misquote it...out of context even) is not a logical thing to do.

Now I'm totally out of my league here, but it seems that going forward, they are not doing the testing but rather demanding test results from certified sources...expensive sources...from juice vendors. Or that's the rumor. They regularly test tobacco....they could randomly test nic too....at cost since they are non-profit...as a benefit to the society. So far, I fear, that the mom-and-pop shops are in danger and only large corporations will be ably to comply with all the rules...even 4 years from now.

They have to make whatever they do "workable" and "practical". The fear is that they won't. Just certifying nic base sources and food flavors and PG and VG should be enough. The individual shops just need to prove that they purchase "good" ingredients.

Who knows what will happen? But the danger is...too much, not too little.

(Best quick summary I have patience for right now)

 

[tombaker]

(snipped for brevity)

Wrong and wrong. The 2009 FDA tests did not find diacetyl or melamine in the small sampling of cartridges tested. The DEG ("anti-freeze") found in 1 sample was at such a minuscule level as to be irrelevant and has never been found in subsequent tests. The FDA has not conducted any tests on e-cigs since 2009. The rest of your post is also irrelevant as it has nothing to do with e-cigs.

It does help to know history. You don't. Elaine, Bill, Kristen, CASAA, and many other posters here helped make that history. You're a Johnny-come-lately and have contributed nothing to that history.

Well yes I did confuse Diacteyl, and Diethylene glycol, a mistake, and error, I was wrong. The two items are both related to E-Cig ingredient problems. I never implied that Melamine was in E-Liquid, just that some unsavory manufacturers in China dumped it into some dog food products, and it kill and sickened thousand of dogs. Kind of a bummer if you dog dies for what you fed it.

1 percent of DEG in E-Liquid is enough for me to think that anyone claiming that vaping it is no problem, certainly has zero evidence to support it, and no I don't expect to get DEG with PG

My point is the testing of the FDA was not the worst thing, it found enough, and while Diacteyl within E-Liquid was not part of the study, it was part of the FDA on popcorn lung, and E-Juice makers responded quickly.

Another poster wants to attack me personally at their every post, think that I was doing some sort of clever mistake, I will never be able to convince them, that I was wrong by mistake, but I continue to stand on the same ground, I was talking about after realizing the mistake. I was wrong I confused the two chemicals.

 

[sonicdsl]

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