This is what I've been talking about for a year now

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KDK

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May 27, 2010
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Just wondering, how does the FDA, at this point, get to tell any facility that they are not in compliance? So far, e-liquid hasn't been defined as a pharma drug has it? Not that I don't want it to be safely made, because of course, I do. But it looks to me as if the FDA is again, jumping ahead of itself. If they wanted to regulate it, they could have, as a tobacco product. They declined to do so, and until they are allowed to regulate it in any other manner, they do not have any authority as far as I can see. But please correct me if I"m wrong- I'm not a lawyer
 

lonercom

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The FDA issue here is that they are holding JC up to drug manufacturing standards because the FDA believes that JC products are drug/delivery devices. They believe this because JC either says or implies that they are. JC also has registered with the FDA and voluntarily submitted to the inspection. Even if JC removes all such claims they (as will all US Manufacturers) will fall under some other regulatory authority and have standards that have to be met. I say BRAVO to JC for taking the lead. It was a smart but costly move. The next step is to see how JC responds to the warning and the progress that they make in resolving these conflicts.
 

DaveP

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I believe I read that Johnson Creek is the juice manufacture for Blu cigs. With that kind of volume, I would expect pristine facilities. I would like to see a walk through video similar to the China video posted above. I was rather impressed by the clean room environment.

I have often wondered about home facilities and what their equipment was like. A garage operation would be years if not decades away from being able to afford facilities that match the big guys. It looks to me like the FDA is paving the way for shutdown of juice manufacturing starting at the top and working their way down.

Just in time for the court case.
 

GoodDog

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Anything manufactured for human consumption is registered, regulated, and inspected by FDA

How can one of the major flavoring companies that vendors use operate out of their house and say they don't have to follow state or federal regulations? They're selling food flavorings that are not just for e-cigs.
 

rothenbj

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I do hope you're joking. When those standards include headings like "Billions of dollars made per annum:" and "Hundreds of Thousands of deaths per annum:"?!

Obviously I'm being sarcastic, but seriously: "FDA approved tobacco cigarette = Good"?! Really?!

Cool, I was totally facetious with that post. The truth of the matter is that, other than the fight to keep E Cigs available for those that use them exclusively and those that are still smoking and haven't found this alternative, I don't need nicotine in my E liquid anymore. I've been using Swedish snus for the past seven months and other than the hand to mouth habit in certain situations, I vape for the flavor of the liquid now. Of course the Nazis will do everything in their power to eliminate all competition to Pharma and cigarettes so they can maintain their quit or die attitude.

My main goal at this point is to be as big a pain in the behind that I can be because I hate that they have lied for so long about so many facets of this topic.
 

bassnut

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JC also has registered with the FDA and voluntarily submitted to the inspection.

Bingo. This seems to be the crux of it. Had they not agreed to meet the cGMP specs they might not be in this situation...not saying that I blame them for trying.
If the FDA wants they can challenge JC's ability to meet the system's criteria and stall their certification over using the wrong metal alloy paper clip if the so choose.
I forgot...which e-juice supplier got the big exposure in the Wall Street Journal article that received so much attention?
 

firhill

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I challenge any Juice suppliers to post at least Picture or describe their Manufacturing process
I do not believe that any Juice distributors in the US are even near up to standards of cGMP

Well, I'm not a supplier, but this US supplier's video tour of their lab is good enough for me.
 

bassnut

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I hate to come off as pretentious,

I know this is a dirty trick, to cull this line out of your text but I feel the need to comment.
Your input and understanding of the issues at hand are appreciated, I'm sure. I read and absorb the information you provide and your professional point of view as best I can.
A little more patience would be appreciated. You are not being ignored. There's a lot of people here...many minds and different personalities, different ways of dealing with things...ultimately we all want the same thing.
 
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markmcs

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Aug 24, 2010
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Let's face it, whether e-cigs are finally designated as "drug delivery devices" or "tobacco products", the days of unregulated, backroom production for these companies is coming to an end. When the dust settles, some companies will close, some will comply, and our juice will cost more. The tobacco lobby will continue to apply pressure and the FDA will harass even the best companies. Yes, quality control is important, and I don't want to be poisoned (unless it's a little salmonella in my omelette, or e-coli in my spinach...good job, FDA!) so we need some gov't regulation and protections in place. That said, I believe the worst juice out there is a whole lot safer than my Marlboro lights were!!!



 

Shotline

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Has anyone EVER had trouble with bacteria or mold growing on or in thier juice or atomizers? This would be a serious problem due to inhalation of the vapor which could carry contaminates?

From what I have been able to gleen from the research I have done, nothing can grow in the PG/nicotine solution and it would seem that the heating of the atomizer would kill any bacteria.
 

Auntbeast

Moved On
Sep 1, 2010
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Markarich159 if you don't continue to post in these threads, I will be very sad.

This is something people are passionate about and sometimes our passions can overrule our heads. The fact is, we are inhaling this and how it ends up being classified is a pretty big deal. I have no idea if it is absolutely safe, but I'm smart enough to know that it might not be. I eagerly anticipate learning more from your posts and I certainly hope you feel appreciated for what you are writing. You are.

I'm also pretty sure some of these discussions throw you into a tizzy. I frequent a board with a chemist, we can't say "solution" without flinching. When you are in the industry, your appreciation of the nuances of what is going on is heightened. As a Pharmacist, I'm pretty darn sure you know more than I do.
 

PlanetScribbles

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The simple solution is to make your own juice, then you know exactly what is in it.
I can't help thinking, however, that FDA are holding JC to the very same standards as the likes of GSK and J&J. That isn't fair, and is again shoving the false presumption that e-cigs are 'drug delivery devices' down our collective throats. Don't drink the kool-aid, we all know the agenda that is at play here. However they dress it up.
 

Kate51

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I would throw out an opinion here, not knowing who supplies the "major flavoring company" : I would venture a guess they are not processing from scratch the ingredients they use. Extracts and 'concrete's' etc.: Just for example, Somara Botane supplies my tobacco absolute; they do not process it at their facility. They are a vendor for other suppliers. But even if I baked cookies in my kitchen for public consumption I would need a permit, which would require FDA registration and inspection at least at the State level to be elegible for a permit.
 

GoodDog

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I would throw out an opinion here, not knowing who supplies the "major flavoring company" : I would venture a guess they are not processing from scratch the ingredients they use. Extracts and 'concrete's' etc.: Just for example, Somara Botane supplies my tobacco absolute; they do not process it at their facility. They are a vendor for other suppliers. But even if I baked cookies in my kitchen for public consumption I would need a permit, which would require FDA registration and inspection at least at the State level to be elegible for a permit.

This is what I don't understand, Kate. California doesn't issue permits for home based food businesses. Just trying to make sure what I inhale is in fact the safest it can be and that's one reason I DIY with the best available ingredients. It bothers me when a company won't disclose this information. I see a lot of opportunists entering this industry because of the money that can be made right now. It's only a matter of time before something catastrophic happens IMO.
 

Kate51

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Quite a few people in this area were baking specialty cakes, weddings, birthdays, etc., and they need to have a separate kitchen from 'family', which has to be inspected and regulated as a food business. I really think all states must comply with FDA regs for permits, so there aren't many who can financially comply on a "hobby" basis.
If someone got sick from eating your cake you wouldn't need to worry about your house, forget the kitchen. You'd be liable for any litigation brought against you. Cross-contamination is potentially the greatest liability.
 

Vocalek

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Bingo. This seems to be the crux of it. Had they not agreed to meet the cGMP specs they might not be in this situation...not saying that I blame them for trying.
If the FDA wants they can challenge JC's ability to meet the system's criteria and stall their certification over using the wrong metal alloy paper clip if the so choose.
I forgot...which e-juice supplier got the big exposure in the Wall Street Journal article that received so much attention?

They registered with FDA as a lab that manufactures products for human consumption, not as a pharmaceutical manufacturing facility. I don't know whether they ever agreed to meet cGMP specs. If I had to guess, I would say that the Warning letter they just received from FDA (almost an entire year after the FDA inspection) was the first they were told those were the applicable specs.
 
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GoodDog

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Quite a few people in this area were baking specialty cakes, weddings, birthdays, etc., and they need to have a separate kitchen from 'family', which has to be inspected and regulated as a food business. I really think all states must comply with FDA regs for permits, so there aren't many who can financially comply on a "hobby" basis.
If someone got sick from eating your cake you wouldn't need to worry about your house, forget the kitchen. You'd be liable for any litigation brought against you. Cross-contamination is potentially the greatest liability.

Thanks Kate. So wouldn't the same apply to someone developing and selling flavorings for human consumption in their home? It seems e-liquid would also fall into this category but maybe vaping is different than consuming or are vendors just ignoring these regulations???

There are many small bakeries that don't have millions to invest in complying with FDA Regulations so it must not be that difficult.
 
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