What are the Chinese manufacturers doing about the FDA regulations?
This entry was posted on 21st July 2016 by twus.
Cutting through the regulatory noise….
China probably has more to lose in a financial sense when it comes to these FDA regulations than the USA, as China is the power house of e cigarette manufacturing. The Chinese were pretty silent during the regulatory fight in Europe, so, what exactly are they doing to help the Industry here in the USA, if anything at all?
The threat to the Industry as we have been pointing out in the last two posts is huge. Currently there are a couple of Bills going through the legislature and there are several court cases against the FDA. We will explain more about the court cases in a separate post, but these are pretty much the only hopes we have at present to prevent the FDA from killing the vaping industry.
The Chinese for their part have set up a not-for-profit organization called SEVIA USA, which stands for The Shenzen E Vapor Industry Association USA branch, and it is based in Washington DC . (The Majority of e cigarettes are manufactured in the Industrial region of China called Shenzen, hence the name of the organization).
SEVIA USA was set up in January 2016, after a vaping conference when around 100 Chinese e cigarette manufactures met to discuss the FDA. SEVIA was set up specifically to help fight the FDA’s regulations regarding e cigarettes, and SEVIA USA now employ the Law Firm Keller and Heckman because not only do they have Chinese speaking professionals on their team, to allow for obvious ease of communication, they are also considered experts in the vaping industry.
Some of the biggest Chinese names in the Industry are SEVIA members and founders and they include:
Aspire
Kangertech
Innokin
Smok
And more recently, Joyetech
(None of the above produce 1st generation devices anymore – which are the only devices that will be PMTA free).
Two very well know vaping advocates and vapers – Phil Busardo and Dimitri Agrafiotis have taken leading roles in this organization. Dimitri is SEVIA USA’s Executive Director, and Phil’s role is as Executive Assistant. You can see from the link to the SEVIA Facebook page, they are both working very hard to ensure that SEVIA is helping the Industry, and is not just another group with an acronym. In China, there is no equivalent to the FDA. China is a communist country and is run in a completely different way to the USA. Dimitri and Phil not only have to explain what is going on here in the USA and how that applies to the Chinese manufacturers, but also explain how one government organization, namely the FDA, has the power to shut down an entire Industry. And to their credit, the Chinese manufacturers are involved, and not just financially. Last month a founding member - Innokin - sent a senior member of staff to attend a lobbying meeting in Washington.
SEVIA state that they very much want a legislative solution to the current situation, and as such they have joined forces with other Industry and consumer groups. On July 11th SEVIA released a press statement detailing their joining forces with Vapor Technology Association. VTA lobby on a Federal level for the Vaping Industry, and since their formation in January, SEVIA has contributed financially to the Right2Bsmokefree coalition, CASAA and the American Vaping Association.
SEVIA USA was also responsible for funding (approx. $75K) and producing some very important research into measuring the nicotine delivery from, an admittedly small range of devices, but this research is yet another step on the road that not only shows that 2nd and 3rd generation devices are far superior to the 1st generation devices and can help lay down protocol, but that the arbitrary grandfather date is not logical in terms of public health.
The press release for this research, that was accepted for publication in the highly respected Addiction Journal states, “A new study published today in the scientific journal Addiction evaluated a new method for measuring nicotine delivery from e-cigarettes. Researchers found that ‘first-generation’ e-cigarettes, which use ‘cartomizers’, delivered nicotine less consistently than later-generation e-cigarettes, which use ‘atomizers’ that vaporize e-liquid contained in a refillable tank. The consistency of nicotine delivery from the atomizers was similar to pharmaceutical nicotine inhalers and tobacco cigarettes and within the acceptable limits for medicinal nebulizers.” (emphasis ours)
So, what does SEVIA want, besides helping?
They state in their mission statement the following:
1) Congress SHOULD NOT regulate vapor products as tobacco products, considering these products DO NOT actually contain tobacco leaf.
2) The FDA should modify the grandfather date to allow products currently on the market in order to avoid the Pre Market Tobacco Application (PMTA) process.
3) The FDA should create a streamlined process that allows companies to submit more reasonable applications for the vapor market.
And, “We have formed a coalition of responsible Chinese electronic cigarette manufacturers concentrating our financial efforts and resources to keep vapor products affordable, accessible and with the variety needed in order to help smokers transition to a less harmful alternative. Moreover, looking forward to a regulatory path we want to enforce industry standards to assure consumers safety and confidence in Chinese manufacturing.”
One of the desires of the USA Executives is for the members of SEVIA to start compiling their own reference files on the raw materials that are used in the making of e cigarettes, i.e. the stainless steel, kanthal wire etc. This will not only help the industry globally raise standards and improve safety, but will also assist importers in the USA with PMTA’s, as they will then be able to cross reference to the files.
So, to answer what are the Chinese doing? As you can see from this post, they are rolling up their sleeves and getting stuck in.
This entry was posted on 21st July 2016 by twus.
Cutting through the regulatory noise….
China probably has more to lose in a financial sense when it comes to these FDA regulations than the USA, as China is the power house of e cigarette manufacturing. The Chinese were pretty silent during the regulatory fight in Europe, so, what exactly are they doing to help the Industry here in the USA, if anything at all?
The threat to the Industry as we have been pointing out in the last two posts is huge. Currently there are a couple of Bills going through the legislature and there are several court cases against the FDA. We will explain more about the court cases in a separate post, but these are pretty much the only hopes we have at present to prevent the FDA from killing the vaping industry.
The Chinese for their part have set up a not-for-profit organization called SEVIA USA, which stands for The Shenzen E Vapor Industry Association USA branch, and it is based in Washington DC . (The Majority of e cigarettes are manufactured in the Industrial region of China called Shenzen, hence the name of the organization).
SEVIA USA was set up in January 2016, after a vaping conference when around 100 Chinese e cigarette manufactures met to discuss the FDA. SEVIA was set up specifically to help fight the FDA’s regulations regarding e cigarettes, and SEVIA USA now employ the Law Firm Keller and Heckman because not only do they have Chinese speaking professionals on their team, to allow for obvious ease of communication, they are also considered experts in the vaping industry.
Some of the biggest Chinese names in the Industry are SEVIA members and founders and they include:
Aspire
Kangertech
Innokin
Smok
And more recently, Joyetech
(None of the above produce 1st generation devices anymore – which are the only devices that will be PMTA free).
Two very well know vaping advocates and vapers – Phil Busardo and Dimitri Agrafiotis have taken leading roles in this organization. Dimitri is SEVIA USA’s Executive Director, and Phil’s role is as Executive Assistant. You can see from the link to the SEVIA Facebook page, they are both working very hard to ensure that SEVIA is helping the Industry, and is not just another group with an acronym. In China, there is no equivalent to the FDA. China is a communist country and is run in a completely different way to the USA. Dimitri and Phil not only have to explain what is going on here in the USA and how that applies to the Chinese manufacturers, but also explain how one government organization, namely the FDA, has the power to shut down an entire Industry. And to their credit, the Chinese manufacturers are involved, and not just financially. Last month a founding member - Innokin - sent a senior member of staff to attend a lobbying meeting in Washington.
SEVIA state that they very much want a legislative solution to the current situation, and as such they have joined forces with other Industry and consumer groups. On July 11th SEVIA released a press statement detailing their joining forces with Vapor Technology Association. VTA lobby on a Federal level for the Vaping Industry, and since their formation in January, SEVIA has contributed financially to the Right2Bsmokefree coalition, CASAA and the American Vaping Association.
SEVIA USA was also responsible for funding (approx. $75K) and producing some very important research into measuring the nicotine delivery from, an admittedly small range of devices, but this research is yet another step on the road that not only shows that 2nd and 3rd generation devices are far superior to the 1st generation devices and can help lay down protocol, but that the arbitrary grandfather date is not logical in terms of public health.
The press release for this research, that was accepted for publication in the highly respected Addiction Journal states, “A new study published today in the scientific journal Addiction evaluated a new method for measuring nicotine delivery from e-cigarettes. Researchers found that ‘first-generation’ e-cigarettes, which use ‘cartomizers’, delivered nicotine less consistently than later-generation e-cigarettes, which use ‘atomizers’ that vaporize e-liquid contained in a refillable tank. The consistency of nicotine delivery from the atomizers was similar to pharmaceutical nicotine inhalers and tobacco cigarettes and within the acceptable limits for medicinal nebulizers.” (emphasis ours)
So, what does SEVIA want, besides helping?
They state in their mission statement the following:
1) Congress SHOULD NOT regulate vapor products as tobacco products, considering these products DO NOT actually contain tobacco leaf.
2) The FDA should modify the grandfather date to allow products currently on the market in order to avoid the Pre Market Tobacco Application (PMTA) process.
3) The FDA should create a streamlined process that allows companies to submit more reasonable applications for the vapor market.
And, “We have formed a coalition of responsible Chinese electronic cigarette manufacturers concentrating our financial efforts and resources to keep vapor products affordable, accessible and with the variety needed in order to help smokers transition to a less harmful alternative. Moreover, looking forward to a regulatory path we want to enforce industry standards to assure consumers safety and confidence in Chinese manufacturing.”
One of the desires of the USA Executives is for the members of SEVIA to start compiling their own reference files on the raw materials that are used in the making of e cigarettes, i.e. the stainless steel, kanthal wire etc. This will not only help the industry globally raise standards and improve safety, but will also assist importers in the USA with PMTA’s, as they will then be able to cross reference to the files.
So, to answer what are the Chinese doing? As you can see from this post, they are rolling up their sleeves and getting stuck in.
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