FDA Lorillard comments to the FDA deeming regs

[Oliver]

OK, I haven't had time to read through Lorillard's submission, but I wonder if anyone who has might give their thoughts on the following?

This is me hypothesising (Devil's advocate) about Lorillard being the evil corporate entity that wishes to dominate and smash all competition, and still do this through the regulations.

Lorillard is working on the assumption that e-liquid production (and, probably, hardware too) will eventually be subject to GMP standards of production. For anyone who doesn't know what this means - it's pharma. It's a level of production that really cannot be achieved by anyone without vast resources.

Now, I don't know to what extent Lorillard are pushing back on this specific requirement, if at all, but it seems to me you could write a proposal that says:

We need innovation, we need later grandfathering dates, we are libertarian. But, make sure that all production needs to be GMP.

Thoughts?

 

[Cool_Breeze]

We need innovation, we need later grandfathering dates, we are libertarian. But, make sure that all production needs to be GMP.

Thoughts?

Rather than production standards, I'd like to see some thought given to product monitoring such as is done by the independent Consumer Products Safety Commission. I believe that to be much more cost effective, open to innovation and in a sense, libertarian. It doesn't build in vested interests backed by deep pockets.

 

[zoiDman]

...

Lorillard is working on the assumption that e-liquid production (and, probably, hardware too) will eventually be subject to GMP standards of production. For anyone who doesn't know what this means - it's pharma. It's a level of production that really cannot be achieved by anyone without vast resources.

...

I would Imagine that this is Exactly what Lorillard is Assuming. At least with Regards to e-Liquids.

Unfortunately, the information the FDA has released about the Deeming of e-Liquids has included Very Few details regarding what FDA wants to do with them.

 

[skoony]

OK, I haven't had time to read through Lorillard's submission, but I wonder if anyone who has might give their thoughts on the following?

This is me hypothesising (Devil's advocate) about Lorillard being the evil corporate entity that wishes to dominate and smash all competition, and still do this through the regulations.

Lorillard is working on the assumption that e-liquid production (and, probably, hardware too) will eventually be subject to GMP standards of production. For anyone who doesn't know what this means - it's pharma. It's a level of production that really cannot be achieved by anyone without vast resources.

Now, I don't know to what extent Lorillard are pushing back on this specific requirement, if at all, but it seems to me you could write a proposal that says:

We need innovation, we need later grandfathering dates, we are libertarian. But, make sure that all production needs to be GMP.

Thoughts?

it could be.
from they way their response is written when taken in its entirety the general impression i get is it says more as a whole than the specific exemptions its calling for in the separate parts.

regards
mike

 

[randyith]

This thread:
http://www.e-cigarette-forum.com/fo...ly-propylene-glycol-e-cigarette-industry.html

I don't know what he's talking about with the batteries though.

So what? Dow Chemicals PG sucks compared to two other USA sources for e-cigs.

 

[ClippinWings]

Lorillard is working on the assumption that e-liquid production (and, probably, hardware too) will eventually be subject to GMP standards of production. For anyone who doesn't know what this means - it's pharma. It's a level of production that really cannot be achieved by anyone without vast resources.

...
Thoughts?

They DO mention GMPs.

But in context, it appears they are asking for new GMPs to be developed that specifically apply to vapor products:

FDA could undertake several measures to better ensure
consistency and safety in the electronic cigarette market. For example, FDA could
develop GMPs for electronic cigarettes. These GMPs should focus specifically on the
properties of electronic cigarettes. Lorillard strongly believes that these GMPs should be
electronic-cigarette specific, given the substantial differences between electronic
cigarettes products and conventional cigarettes. Lorillard believes that the creation of
electronic cigarette GMPs would address many of the concerns that FDA expressed about
these products in the preamble to the Proposed Deeming Regulation, as well as in its
earlier report on electronic cigarettes, such as quality and consistency issues.

Innokin, on the other hand, not only asks for vapor product specific GMPs but pushes for much harsher GMPs that from appearances would ban Mech mods and RBAs. They also use the term(or various euphemisms) more often, spreading it out across the document.

The most important standard for FDA to establish is a regulatory maximum temperature
limit that a vaporizer device may not exceed during operation,regardless of the e-liquid,
airflow or heater coil used. This is because the chemical composition of the inhaled
aerosol will largely depend on the temperature to which the e-liquid and internal
vaporizer components (coil) are heated . Excessive heat may result in the formation of
unintended impurities/degradation compounds.

 

[bigdancehawk]

Do you think Dow's position is based on Health Concerns. Or in Shielding themselves from Potential Legal Liability?

Or maybe a little from Column "A" and a little from Column "B"?

They're motivated by what's best for their bottom line. In the case of PG, I imagine they're reluctant to risk incurring the wrath of the FDA and other elected and unelected government officials, given that practically every product they make requires governmental approval.

 

[Oliver]

GMP is going to be extremely high level. Despite it's bland sounding title, "Good Manufacturing Processes" is actually quite a specific set of requirements.

What this means is that the first paragraph you quote (Lorillard) ends up with precisely the same end-result as the second paragraph (Innokin).

"quality and consistency issues." = " Excessive heat may result in the formation of unintended impurities/degradation compounds", in other words.

GMP is out of the reach of 99% of the vaping industry as it currently stands.

 

[zoiDman]

They're motivated by what's best for their bottom line. In the case of PG, I imagine they're reluctant to risk incurring the wrath of the FDA and other elected and unelected government officials, given that practically every product they make requires governmental approval.

All for Profit Companies are Motivated by a Larger Bottom Line.

Cooperate Image could Definitely Play a Role in Dow's PG and VG Sales Policies. But I also think that Legal Liability was a Big Consideration.

Suing some Mom & Pop e-Liquid Vendor is one thing. Suing someone with Very Deep Pockets is Quite Another.

 

[Oliver]

"The most important standard for FDA to establish is a regulatory maximum temperature
limit " - I actually agree with this, but I only think it needs to apply to the "rating" of an e-liquid.

In practice, this won't happen, since temperature is not the only variable which might lead to dry burn - you'd also have to specify wicking properties, airflow, the pre-puff temperature limits.

In other words, a chip.

 

[zoiDman]

...

It would be Interesting to hear if some of the e-Liquid Trade Organizations like AEMSA have any Input on this Subject of FDA Mandated e-Liquid Manufacturing Standards?

 

[Oliver]

All for Profit Companies are Motivated by a Larger Bottom Line.

.

Oh, this is an interesting line of conversation which has huge potential to veer off topic

I think a better way of encapsulating it is something like the following:

"All modern corporations consider their primary fiduciary duty is to return profit to their shareholders."

Does that totally cover all of the "motives" within a company? No, of course not. A company is a collective of individuals, with its own character, and different sets of motivations which are largely dependent on corporate leadership.

But, they have to make profits and, depending on their shareholders, they have to make certain amounts of profit. So, the tobacco industry has been, for a long time, a money making machine - THE safest investment, with extremely good and reliable returns for those who can stomach owning the stock.

In other words - their shareholders expect those returns.

The tobacco industry needs to convince its shareholders that it is in control, and e-cigs are not a threat. It's all about storytelling and sentiment.

 

[Oliver]

It would be Interesting to hear if some of the e-Liquid Trade Organizations like AEMSA have any Input on this Subject of FDA Mandated e-Liquid Manufacturing Standards?

I'm not sure, but I'd imagine they'd be highly resistant to GMP. Or, at the very least, ask for it to be delayed with a long, long lead time to ensure its members can invest in it.

 

[bigdancehawk]

"The most important standard for FDA to establish is a regulatory maximum temperature
limit " - I actually agree with this, but I only think it needs to apply to the "rating" of an e-liquid.

In practice, this won't happen, since temperature is not the only variable which might lead to dry burn - you'd also have to specify wicking properties, airflow, the pre-puff temperature limits.

In other words, a chip.

Yeah, I'm no engineer, but I don't know how you would control maximum temperature without having some kind of thermostatic device at the coil OR by integrating the vaporizer with the power supply. Do any of Innokin's products regulate maximum temp? Nor was I pleased with several of Innokin's cheap shot--throwing mechanicals and cig-alikes under the bus.

 

[patkin]

If not from Dow, does anyone know where BT has been getting their PG all these years?

 

[zoiDman]

Oh, this is an interesting line of conversation which has huge potential to veer off topic

I think a better way of encapsulating it is something like the following:

"All modern corporations consider their primary fiduciary duty is to return profit to their shareholders."

Does that totally cover all of the "motives" within a company? ...

The Return of Profits is About the Only Reason Most Companies Exist.

But isn't this at the Core of all the Vitriol we see here on the ECF when BT is Mention. Not so much BT's desire to Make Profits, but the Methods in which they go about it?

I don't think Many here would Argue that Higher Standards of e-Liquid Manufacturing and Handling are such a Bad Thing. But the setting of Standards So High that Only BT can Afford them smacks of Government Assisted Monopolies.

I truly Believe that the FDA can Achieve their Goals of Ensuring that e-Liquids are GRAS without having to Wipe all but BT from the Market.

The way Food Preparation is Regulated and Overseen in the USA seems like a Very Viable Model the FDA could use as a Template for the e-Liquid Market.

Ensuring Realistic Level of "Safety". While Still allowing Small Companies to afford Compliance.

 

[ClippinWings]

I'm not sure, but I'd imagine they'd be highly resistant to GMP. Or, at the very least, ask for it to be delayed with a long, long lead time to ensure its members can invest in it.

The problem here is GMP SOUNDS like exactly what most of us want.

I think that's what the FDA should do; ensure quality, purity, and safety standards... but not at the expense of a large swath of the currently availability products.

I mean, sure, verify there is no DEG in the liquids... that they're not flavored with unicorn tears... that atty's aren't built with Lead and mercury.
Don't require every ecig to feature a chip regulating the vape... part of what makes vaping work for so many different people, when nicotrol inhalers don't, is its adaptability.

 

[dragonpuff]

Yeah, I'm no engineer, but I don't know how you would control maximum temperature without having some kind of thermostatic device at the coil OR by integrating the vaporizer with the power supply. Do any of Innokin's products regulate maximum temp? Nor was I pleased with several of Innokin's cheap shot--throwing mechanicals and cig-alikes under the bus.

It wouldn't be difficult to place a tiny thermometer near the coil and attach that to the battery so that when the temperature gets too high, the battery shuts off. That would require, however, that the battery (or mod) and coil be designed to fit together, and it would make for a patentable device where no one else can take, say, Innokin's temperature sensitive battery mod and build their own coil to go with it, at least until the patent runs out.

To regulate dry puffs and whatnot, yes that would require a more complex system like a computer chip, but I'm not sure we have to go so far as to take that into account. The current research shows formaldehyde production at a certain minimum voltage with a specific coil, and it is well known that formaldehyde forms when propylene glycol is heated. Dry puffs are nasty for sure, but I'm not sure they have nearly as much to do with the safety issue at hand as the heat produced. More research is definitely needed in this particular issue, but I'm betting it is primarily a temperature issue.

Of course, if temp sensors are required, then everyone will have to start producing these batteries and tanks that go with them, and it would be a financial hurdle for the industry - I'm not sure that alone would be enough to wipe out businesses, but it would limit product choice for a while until it becomes standard. It sounds to me though, that Innokin likely already has plans in the works to make such a device; that way they stay ahead of the game.

 

[aikanae1]

The Return of Profits is About the Only Reason Most Companies Exist.

But isn't this at the Core of all the Vitriol we see here on the ECF when BT is Mention. Not so much BT's desire to Make Profits, but the Methods in which they go about it?

I don't think Many here would Argue that Higher Standards of e-Liquid Manufacturing and Handling are such a Bad Thing. But the setting of Standards So High that Only BT can Afford them smacks of Government Assisted Monopolies.

I truly Believe that the FDA can Achieve their Goals of Ensuring that e-Liquids are GRAS without having to Wipe all but BT from the Market.

The way Food Preparation is Regulated and Overseen in the USA seems like a Very Viable Model the FDA could use as a Template for the e-Liquid Market.

Ensuring Realistic Level of "Safety". While Still allowing Small Companies to afford Compliance.

That would be nice if the FDA made assurances of purity, food safety handling, etc. but I think the outcome will likely be the reverse. We will know less about what is in eliquids (propietary information) and ingrediants will be screened less. Already the purity levels of flavors and nicotine are higher than what's used in NRT, higher than FDA approvals. Now we know enough about manufacturing and sources to stear clear if warrented, but in the future that may not be known.

Why would the FDA increase their level of labeling beyond "natural and artificual flavors added"? That's what the FDA approves. No one still knows what's in a cigarette, not even nic level.

 

[Kent C]

That would be nice if the FDA made assurances of purity, food safety handling, etc. but I think the outcome will likely be the reverse. We will know less about what is in eliquids (propietary information) and ingrediants will be screened less. Already the purity levels of flavors and nicotine are higher than what's used in NRT, higher than FDA approvals. Now we know enough about manufacturing and sources to stear clear if warrented, but in the future that may not be known.

Why would the FDA increase their level of labeling beyond "natural and artificual flavors added"? That's what the FDA approves. No one still knows what's in a cigarette, not even nic level.

And any 'FDA approved' tag will wrongly assure vapers, where they themselves should know what's going on. Much of the ecoli and botulism comes from FDA or USDA approved foods. They should be able to be sued for that as well. Kinda like the 'You had one job' meme.