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Why doesn't EVALI occur in Europe, the second largest vaping market in the world?

11/11/2019

8 Comments

 
Picture
Audience: Vape product manufacturers and regulators in the United States

The United States is the largest market for vape products (34%) and cases of EVALI occur only in the United States. The European Union is the second largest market for vape products (25%), and no cases of EVALI have been reported in the EU to date.

Aside from prohibiting sales to minors (under 18 years old), the US vape market is not regulated. By contrast, the EU market is regulated by the Tobacco Products Directive (TPD), which came into force in May 2016. Safety and quality standards for vaping devices are among the regulations contained in the TDP. These mandate manufacturers disclose toxicological data on ingredients and additives , describe the components and manufacturing process, and comply with limits on heavy metal content.
 
Rational Implementation of Harm Reduction and Regulation
We are not proposing immediate implementation of regulations as comprehensive as the TDP in the United States. The TDP was implemented carefully, over time, and in sections. This gave ample time for industry and regulatory agencies to coordinate with each other and provide feedback on the requirements. In this manner, only vape devices with a specified threshold of safety are allowed into the consumer market. There have been no reported cases of EVALI in the EU, and we believe this is the predictable outcome of a well-regulated vape market.

The cause of EVALI in the United States remains unknown, but it is evident that not all cases were caused by black market products (ex. at least two verified cases were linked to legal dispensary products in Oregon), and not all were from THC products; 11% of EVALI patients reported using only nicotine products. This suggests poor quality hardware is responsible, and this may be addressed by regulation.

Banning vaping altogether, by contrast, would not be effective, would cost taxpayer money to enforce, and would almost certainly do more harm.  Blanket banning would cut the legs out from an adolescent industry on its way to becoming organized and safer, and drive it right back into the black market. Europe has demonstrated it is possible to effectively regulate vaping. 

​The US already regulates nicotine, and at the state level, THC. Why not regulate the hardware?


The 2014 EU Tobacco Product Directive (TPD): https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf

Author

Cindy Blair

8 Comments
Cryonix
11/11/2019 02:00:20 pm

With respect on the TPD2 Directive i hope, this will remain. It`s possible they will regulate stronger next year

EVALI not in Europe? Only a question of time. On my private investigation via hundreds of websites and forums I found an Thickener w. 85% Vitamine E & 15% C8 MCT in Europe. You can order at 24,-€ per 10ml until now!
By absolutely no declarations for typicall Cutting agents i found even an Diluent with 20% Squalane. Even available in Europe.
By sharing their cutting secrets in forums there was one question:
"500g of TEC temper is $598 and the same volume of just triethyl citrate is about $50 from perfumers apprentice. Why not use?"
Vitamin E Acetate, Triethyl-Citrate, Squalane are all very inexpensive ingredients for cosmetic formulas.
For all only dermal skin tests are existing - never had these substances tested for inhalation toxicity.

About the Vitamine E Thickener I had a long phonecall with Dr. Henkler-Stephani (BfR = Bundesinstitut für Risikobewertung; )
(German Agency for health risk analsysis). He is the expert in Vapingproducts and promised to inform officials to got them off market.
Please excuse my very bad english
Cryonix

Reply
Cindy Blair
11/11/2019 03:32:47 pm

Cryonix, your English is very good! I've been studying Spanish for some time now and recently asked someone if I could hit their dog when I was actually trying to say that I wanted to pet it. So, I understand why you would want to put a disclaimer.

I'm going to clip an exchange from our Facebook page to respond to your comment.

Q;"What do you think about newest CDC theory about vitamin E acetate causing all of this? I mean, we kinda already knew that few months ago but they seem to have evidence now."


A: "It's misleading. While it is true that 29 of 29 lung biopsies were positive for Vitamin E acetate, the correlation doesn't hold up with the cartridge testing results. Of the 300 illness-linked cartridges tested by the FDA, only 37% (~112 cartridges) contained Vitamin E acetate, 38% contained only THC (no Vitamin E), and 25% (75 cartridges) contained only nicotine (no Vitamin E). Where present, Vitamin E acetate may contribute to the illness, but it cannot be the root cause of it."

Reply
Chris Overstreet
11/12/2019 02:25:30 am

Would it be unreasonable to think that the reason only 30% of the 300 cartridges tested contained vitamin e acetate were because people are primarily getting sick AFTER having finished a contaminated cartridge and are onto the next cartridge when they fall ill? It seems like that could cause the discrepancy couldn’t it?

Reply
Frank Conrad
11/12/2019 09:55:28 am

Well reasoned. It *would* be possible, if these were the only numbers, but they are not. 11% of patients reported using only nicotine products, and their blood samples confirm they do NOT have THC in their system (i.e. they were not lying about not using THC). Nicotine formulations are water soluble and thinner viscosity; there is no reason to add Vitamin E acetate and it would actually interfere with vaping because the oil Vitamin E would not mix well with the hydrophillic nicotine components. This would suggest a different common causal agent than Vitamin E acetate, which is the basis of our power supply/heavy metal hypothesis. DIY nicotine cartridges are usually #510 threaded and can use the same power supply as THC cartridges.

Reply
Cryonix
11/15/2019 10:10:30 am

Here I am again ... with a sad message
1st young man in europe (Belgium) died after inhaling vapor from an CBD cart.
Doctors assume, that the fatal pneumonitis caused by EVALI. There is no analysis , that could determine D-a-Tocopheryl-acetate
( in German: https://www.aerzteblatt.de/nachrichten/107437/Belgische-Behoerden-melden-ersten-Todesfall-nach-E-Zigarettenkonsum )

Reply
Frank Conrad
11/16/2019 08:28:01 am

Thank you for the information, Cryonix. It was not clear from the news story whether he died from lipoid pneumonia (from vitamin E) or from chemical injury pneumonitis (EVALI). Please post, if the story is updated.

Reply
james
11/18/2019 01:46:38 pm

@Frank @Cindy greatly appreciate your write-ups. At this time, is there anything else you think that could be causing EVALI? Do you believe heavy metals to be the sole cause of the pathology we're seeing, or do you think there are still other undiscovered causes of the same pathology manifestation?

Reply
Frank Conrad
11/19/2019 12:37:36 pm

"Do you believe heavy metals to be the sole cause of the pathology we're seeing, or do you think there are still other undiscovered causes of the same pathology manifestation?"

I believe there are multiple contributing factors, including frequency of use (which would be fairly user specific). That alone might explain the widespread geography of patients, but also the limited number of them. It is possible only high frequency users are exposed enough of the causal agent to require hospitalization. It also might suggest there are many more subclinical individuals, who haven't developed illness, but may have been exposed to the causal agent.

I am not discounting Vitamin E acetate, btw. Vitamin E acetate *is* consistent with the pneumonia observed in some patients. No mechanism has been proposed for how it would cause chemical pneumonitis, however, which is the prevailing feature of patients with EVALI.

Reply



Leave a Reply.

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