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Why you should Oppose FDA Deeming Regs!
Business owners:
By the time most of you read this, the FDA Center for tobacco Products will have already released the several hundred page "deeming" regulation regarding electronic cigarettes and other nicotine and tobacco products.
Please read this comment I quickly wrote earlier tonight on why vapers and vendors should OPPOSE deeming regulation. I have reproduced it below this e-mail.
Predictably, the news stories out right now are largely being told from the FDA's point of view. The FDA is trying to sell this regulation to lawmakers, public health groups, and industry, so they are of course aiming to have their regulation portrayed in the most positive light possible in the media.
Nonetheless, from what I can gather from these news articles and my knowledge of the tobacco Control Act, the deeming regulation will be a disaster for e-cigarette product innovation, small and medium-sized businesses, and consumers. This is not a surprise to me, as people and groups like Bill Godshall, Dr. Michael Siegel, CASAA, SFATA, myself, etc. have long-noted that regulation of e-cigarettes under the Tobacco Control Act would likely do more harm than good, increase costs to consumers without benefits, and lead to products being removed from the market.
Please do not accept interview requests by journalists and TV reporters on this subject until you fully understand the ramifications of these regulations. Simply tell the reporters that, like any rational business owner, you won't be commenting until you have had the chance to actually read the proposed regulations.
For business owners and investors wishing to understand the subject more, I offer consulting services. Please call or email me for more details.
Best,
Gregory Conley, JD, MBA
231 Church Road
Medford, NJ 08055
(609) 947 - 8059
Gregory Conley Consulting, LLC
Twitter / LinkedIn
--------------------
A Brief Explanation of why the FDA Deeming Regulation Should Be Opposed
This is NOT good news and vendors and vapers should vehemently OPPOSE these regulations, as they will work to the benefit of large tobacco and e-cigarette companies with Wall Street investors that don't make the products used by 98% of this subreddit's users, while potentially shutting down hundreds or thousands of small and medium-sized businesses thanks to an extremely expensive, resource-heavy, and arbitrary system setup by the Family Smoking Prevention & Tobacco Control Act.
This is actually worse than I expected.
Two years after the regulation is written, e-cigarette companies will have to put in 'new tobacco product' applications for any product released to the market after February 25, 2007.*** This is not mere registration. This is a lengthy and expensive process. If you don't file an application, your product is banned. If you file an application and the FDA finds that your product shouldn't be on the market for one of a variety of reasons (including simply 'You failed to submit adequate evidence of x, y, and z.'), it can be pulled from the market.
After that 2 year date, any new e-cigarette product must be approved by the FDA before it goes to market. If the FDA does not approve your product, it cannot be brought to market. This is not a fast process, as evidenced by a Government Accountability Office report that was highly critical of huge delays that were and still are happening at the FDA Center for Tobacco Products. http://www.gao.gov/assets/660/657451.pdf
For just a sample of what a "new tobacco product" application is like, see here. This a document from when the FDA refused to even file (let alone approve) four "new tobacco product" applications : http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf
Also see this snippet from a Lancet article (behind a paywall) by Dr. Lawrence Deyton, the former Director of the Center for Tobacco Products, in which the burden that will be put on e-cigarette and e-liquid companies is outlined: The burden is on the manufacturer to provide evidence that permitting the produc - Pastebin.com
This is bad news for e-cigarette consumers. The chance of a flavor ban or an online sales ban from the start was never really an option. This prospect was here all along and is not positive.
*** There is also something called "substantial equivalence" which is a smaller, but still expensive, loop to jump through. However, FDA guidance on substantial equivalence, and their past decisions on other applications, indicate that it would be a fruitless effort to prove substantial equivalence for a 2016 e-cig product vs. a 2007 product.
Vapers should not only oppose this deeming regulation, but also support vendors that stick up for their businesses and consumers
Why you should Oppose FDA Deeming Regs!
Business owners:
By the time most of you read this, the FDA Center for tobacco Products will have already released the several hundred page "deeming" regulation regarding electronic cigarettes and other nicotine and tobacco products.
Please read this comment I quickly wrote earlier tonight on why vapers and vendors should OPPOSE deeming regulation. I have reproduced it below this e-mail.
Predictably, the news stories out right now are largely being told from the FDA's point of view. The FDA is trying to sell this regulation to lawmakers, public health groups, and industry, so they are of course aiming to have their regulation portrayed in the most positive light possible in the media.
Nonetheless, from what I can gather from these news articles and my knowledge of the tobacco Control Act, the deeming regulation will be a disaster for e-cigarette product innovation, small and medium-sized businesses, and consumers. This is not a surprise to me, as people and groups like Bill Godshall, Dr. Michael Siegel, CASAA, SFATA, myself, etc. have long-noted that regulation of e-cigarettes under the Tobacco Control Act would likely do more harm than good, increase costs to consumers without benefits, and lead to products being removed from the market.
Please do not accept interview requests by journalists and TV reporters on this subject until you fully understand the ramifications of these regulations. Simply tell the reporters that, like any rational business owner, you won't be commenting until you have had the chance to actually read the proposed regulations.
For business owners and investors wishing to understand the subject more, I offer consulting services. Please call or email me for more details.
Best,
Gregory Conley, JD, MBA
231 Church Road
Medford, NJ 08055
(609) 947 - 8059
Gregory Conley Consulting, LLC
Twitter / LinkedIn
--------------------
A Brief Explanation of why the FDA Deeming Regulation Should Be Opposed
This is NOT good news and vendors and vapers should vehemently OPPOSE these regulations, as they will work to the benefit of large tobacco and e-cigarette companies with Wall Street investors that don't make the products used by 98% of this subreddit's users, while potentially shutting down hundreds or thousands of small and medium-sized businesses thanks to an extremely expensive, resource-heavy, and arbitrary system setup by the Family Smoking Prevention & Tobacco Control Act.
This is actually worse than I expected.
Two years after the regulation is written, e-cigarette companies will have to put in 'new tobacco product' applications for any product released to the market after February 25, 2007.*** This is not mere registration. This is a lengthy and expensive process. If you don't file an application, your product is banned. If you file an application and the FDA finds that your product shouldn't be on the market for one of a variety of reasons (including simply 'You failed to submit adequate evidence of x, y, and z.'), it can be pulled from the market.
After that 2 year date, any new e-cigarette product must be approved by the FDA before it goes to market. If the FDA does not approve your product, it cannot be brought to market. This is not a fast process, as evidenced by a Government Accountability Office report that was highly critical of huge delays that were and still are happening at the FDA Center for Tobacco Products. http://www.gao.gov/assets/660/657451.pdf
For just a sample of what a "new tobacco product" application is like, see here. This a document from when the FDA refused to even file (let alone approve) four "new tobacco product" applications : http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf
Also see this snippet from a Lancet article (behind a paywall) by Dr. Lawrence Deyton, the former Director of the Center for Tobacco Products, in which the burden that will be put on e-cigarette and e-liquid companies is outlined: The burden is on the manufacturer to provide evidence that permitting the produc - Pastebin.com
This is bad news for e-cigarette consumers. The chance of a flavor ban or an online sales ban from the start was never really an option. This prospect was here all along and is not positive.
*** There is also something called "substantial equivalence" which is a smaller, but still expensive, loop to jump through. However, FDA guidance on substantial equivalence, and their past decisions on other applications, indicate that it would be a fruitless effort to prove substantial equivalence for a 2016 e-cig product vs. a 2007 product.
Vapers should not only oppose this deeming regulation, but also support vendors that stick up for their businesses and consumers
