FDA NEW STANCE Annoucement



this looks like a win! but i will hold celebrating until i get to read the whole thing, and i think we need more information on what there plans are as far as nicotine regulation.

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Soooo if I understand correctly, the culprits are nicotine and flavours. Not the deadly combo of chemicals added and/or released by combustion.
The targets are flavoured cigars and e-cigarettes but not cigarettes…:thinking:
It’s all for the kids of course because their cigar smoking is going through the roof.


I think we all know what most of those flavored cigars are bought for…


they just buy the wrappers now anyway


Yup we are on the same page there… flashbacks to my younger years lol

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Guy, Gals, Wanted to see what everyone’s reaction would be to this news before I said anything. Well here’s my 2 cents. Technically this changes nothing. All the regulations still stand but give those needing a PMTA for their product 4 more years to do so. Hmmm, so that means Vape shops and small manufacturers have 4 more years before they are put out of business because they can’t come up with millions of dollars for the multi PMTAs they will have to pay for. Most of the companies that stick around will be partnered, or bought out by big tobacco. That is not good for Vaping. What about our Equipment. We gonna be buying from Marlboro? People are saying this stance is a win. What did we win. The regs are unchanged…

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That is an interesting theory. Don’t know that I buy it, but it’s feasible. The Tobacco companies needed another four years to perfect take over of the industry. Can’t have everybody packing up their bags and going home when there could be money to be made. Buy them out slowly. Some good old fashioned hostile take overs.


Matt “Suck My Mod” has a really nice summary video of what this announcement means to the vaping industry & what we can do moving forward.


I like his thoughts but I hear as lot of speculation that may never come to be. For one lowering the cost of PMTA. In this document the FDA has already said and I quote, " It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports". These documents are a big portion of the cost of the PMTA. Also from the page laid down by the FDA, and I quote “To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.” Though this statement if implemented will save some money because manufacturers will at least know what the FDA expects from them, it in no way says it will be less expensive to obtain a PMTA. If allowed to stand, every flavor, every nicotine level, will require a PMTA. Big Tobacco, AND Big Pharma WILL take over the Vaping industry if these regulation are allowed to stand because no one but big t and big p have the money to submit PMTAs, possibly a handful of juice manufacturers…


Walt, probably am going too far with the Equipment manufacturers though we may see some buyouts. Truth be told Aspire, Smok, Kanger, Joytech, and others do have the money to get their PMTAs. That is if they choose the invest such money. Thanks to all the propaganda that was passed around Ecigarette growth has slowed a whole lot. Investor are also questioning the Ecigarette industry’s potential. There is still growth but at a much slower rate. We need to cross our fingers that the chinese manufacturers will want to obtain PMTAs for their products so they can still be sold in this country…


I can see so many avenues this could go. There is a lot of money to be had. There also a lot of tangential influences involved. It is definitely game on and is guaranteed to be interesting.


I agree. You along with many others feel the same. No one knows for sure whether the costs will lower or rise. Regarding costs, currently on the FDA website only states:

Questions on FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
What are the costs associated with submitting an application?

The costs associated with submitting an application to market a tobacco product can vary greatly and depend on a number of factors, such as the pathway to market being applied for, the type of tobacco product and the availability of data on the specific product or other similar products. Generally, high costs may come from needing to conduct original research and testing to inform the application, as well as staff time spent compiling it. For further information on the different premarket pathways, please refer to the Tobacco Product Review & Evaluation webpage.

On page 94 (Table 14) of the “deeming” Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:

  • an SE exemption report = around $1,500

  • an SE report = anywhere from around $3,500 to around $22,700

  • a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others

In general, and especially over time as manufacturers become more experienced and relevant research develops, the FDA expects many efficiencies to lower the average costs of premarket review. For example, we expect that manufacturers’ costs will be dramatically lowered by the bundling of applications for similar products; by reliance on Tobacco Product Master Files; and by bridging of data from one product to another. Due to these and other efficiencies, the FDA expects submission costs to vary across products and to diminish broadly over time, thus resulting in lower average costs per product, as reflected in the cost estimates that accompanied the rule.

Recognizing that some of the costs associated with this process may be challenging to small businesses, the FDA is taking several steps to ease this process. Those steps include: …


Clinton aids? :rofl::rofl: