FDA Regs, pretty stringent, however, there is hope IMO

[DoctorJ]

I sat down and read the FDA regs the other day and it took quite a bit of reading, a good 3-4 hours. The document is 499 pages, however, the last 50 pages or so are references, definitions and laws that were referred to in the whole document. Around 100 or so of the pages directly refer to e cigs and maybe 50 are related to e cigs as it pertains to nicotine warnings, underage sales and packaging.  

Some of the regulations I found quite humorous, such as regulating screwdrivers and lanyards because they are considered to be used directly with e cigs and the FDA has found them to be in the class of "tobacco products".  So The Home Depot is gonna need FDA approval to sell screwdrivers? And I guess all of my colleagues will need FDA approval for the lanyards with our ID's that we are required to wear while on campus. I was wondering what the sports coaches are going to do about their whistles?  I know they are referring to items that come with tanks or kits, but it doesn't really specify that in the document. 

I agree that a good part of the regs are a bit restrictive, however, so many vaping groups are screaming PROHIBITION when if you read closely, this is regulation. The FDA clearly states in the document they are not looking to ban e cigs:

"(Comment 161) Many comments expressed concern that Congress did not wish to effectively ban e-cigarettes (as they claimed would occur as a result of deeming these products), because such a ban violates section 907(d)(3) of the FD&C Act. They stated that if Congress wanted to ban them, they would have done so under their drug authority. (Response) FDA is not banning any category of tobacco product by issuing this final deeming rule."

The FDA recognizes that there may be possible health benefits to e cigs: 

"(Comment 141) Many comments stated, but did not provide supporting data, that ecigarettes: (1) Are approximately 99 percent less hazardous than cigarettes; (2) are only consumed by smokers and former smokers who quit by switching to e-cigarettes; and (3) have not been found to create nicotine dependence in any nonsmoker. They also stated that there is no evidence that ingesting e-liquid leads to fatalities. (Response) As discussed throughout this document, FDA agrees that use of ENDS is likely less hazardous for an individual user than continued smoking of traditional cigarettes."

" Until the FDA publishes a final guidance for each product category and to provide ENDS manufacturers a lengthier compliance period based on where they purport to fit within the risk continuum for nicotine-delivering products (e.g., Comment No. FDA-2014-N-0189-81859; Comment No. FDA-2014-N-0189-10852). In response to these comments, we note that nicotine use in any form is of particular concern for youth and pregnant women. On the other hand, some evidence suggests that ENDS may potentially promote transition away from combusted tobacco use among some current users and it is possible that there could be a public health benefit."

While it may seem that the FDA is coming down hard on vapers, if you read closely there are comments that suggest they are trying to help product manufacturers by way of offering guidance to get products approved. 

Instead of trying to address all of the possible passages that are "good news", I've made a list highlighting passages that we vapers can look at and possibly see that these regs aren't as bad as they seem. The FDA even states in a few places that they will take new information into consideration while drafting the "be all-end all" rules that will be in effect once it's all said and done.

All of these passages in the attachment are taken directly from the document and while some passages are not "whole", meaning I've taken a lot of the legal speak out to highlight the main point of the passage, they remain in context with the spirit of the passage itself. 

You can take these for what they are worth. There is no reading between the lines here, nor are there any of my opinions inserted in the passages. They are cut and pasted directly from the document as they appear within. 

If you believe that the government is out to kill vaping and the vaping industry, so is your right to think so. Personally I don't see any conspiracy or prohibition in this document, such is my opinion. I'm merely trying to point out some of the positive aspects of this document, as restrictive as it may seem, to show that there is a light at the end of the tunnel. And no, it is not a train coming in your direction 

FDA regs.doc

[Bebop]

I think you are missing the main point.  I agree that the FDA is not planning on banning vaping.  In fact, the regulations are poised to allow big tobacco to take over the industry.  That is the point.  Aside from a couple of large vaping manufacturers, nearly everybody else will be wiped out, paving the way for big tobacco to market their cig-a-likes, and opening the doors back up to regaining the "sin taxes".  

The fact that we will be able to keep our vaping gear and it doesn't mean a whole lot of changes for those of us who are established vapers, doesn't change the fact that new vapers will have very little choice in products and I predict that the success rate of people using vaping to quit smoking will plummet.

i don't mean to be doom and gloom. Vaping will survive. But bottom line, I think it is going to be less effective with regard to quitting cigarettes and all cost advantages will be removed thereby severely reducing it's efficacy.  

[Compenstine]

I think you are somewhat miss guided in your thoughts. It will cost me 8.5 billion to register every juice I have with all the variants. I'm just a small company with 49 flavors. The industry as a whole only brought in 5-6 billion for 2015. The numbers are facts and if just my one company needs more than the whole industry took in last year, then it will close 99% of them down. It is going to cost around 1 million per flavor per variant to apply for the PMTA and there is not a guarantee that it will even pass. Since 2009 only 1 product has passed the PMTA process and that was a Snus product. Big Tobacco are the only ones with the labs in place and money to push through the PMTA process.

Cost For PMTA on 1 of my Flavors Broke Down:

Hydra's Delight

0 mg PG 100/0 VG Cost 1 million
0 mg PG 90/10 VG Cost 1 million
0 mg PG 80/20 VG Cost 1 million
0 mg PG 70/30 VG Cost 1 million
0 mg PG 60/40 VG Cost 1 million
0 mg PG 55/45 VG Cost 1 million
0 mg PG 50/50 VG Cost 1 million
0 mg PG 45/55 VG Cost 1 million
0 mg PG 40/60 VG Cost 1 million
0 mg PG 30/70 VG Cost 1 million
0 mg PG 20/80 VG Cost 1 million
0 mg Max VG      Cost 1 million

2 mg PG 100/0 VG Cost 1 million
2 mg PG 90/10 VG Cost 1 million
2 mg PG 80/20 VG Cost 1 million
2 mg PG 70/30 VG Cost 1 million
2 mg PG 60/40 VG Cost 1 million
2 mg PG 55/45 VG Cost 1 million
2 mg PG 50/50 VG Cost 1 million
2 mg PG 45/55 VG Cost 1 million
2 mg PG 40/60 VG Cost 1 million
2 mg PG 30/70 VG Cost 1 million
2 mg PG 20/80 VG Cost 1 million
2 mg Max VG      Cost 1 million

4 mg PG 100/0 VG Cost 1 million
4 mg PG 90/10 VG Cost 1 million
4 mg PG 80/20 VG Cost 1 million
4 mg PG 70/30 VG Cost 1 million
4 mg PG 60/40 VG Cost 1 million
4 mg PG 55/45 VG Cost 1 million
4 mg PG 50/50 VG Cost 1 million
4 mg PG 45/55 VG Cost 1 million
4 mg PG 40/60 VG Cost 1 million
4 mg PG 30/70 VG Cost 1 million
4 mg PG 20/80 VG Cost 1 million
4 mg Max VG      Cost 1 million

6 mg PG 100/0 VG Cost 1 million
6 mg PG 90/10 VG Cost 1 million
6 mg PG 80/20 VG Cost 1 million
6 mg PG 70/30 VG Cost 1 million
6 mg PG 60/40 VG Cost 1 million
6 mg PG 55/45 VG Cost 1 million
6 mg PG 50/50 VG Cost 1 million
6 mg PG 45/55 VG Cost 1 million
6 mg PG 40/60 VG Cost 1 million
6 mg PG 30/70 VG Cost 1 million
6 mg PG 20/80 VG Cost 1 million
6 mg Max VG      Cost 1 million

8 mg PG 100/0 VG Cost 1 million
8 mg PG 90/10 VG Cost 1 million
8 mg PG 80/20 VG Cost 1 million
8 mg PG 70/30 VG Cost 1 million
8 mg PG 60/40 VG Cost 1 million
8 mg PG 55/45 VG Cost 1 million
8 mg PG 50/50 VG Cost 1 million
8 mg PG 45/55 VG Cost 1 million
8 mg PG 40/60 VG Cost 1 million
8 mg PG 30/70 VG Cost 1 million
8 mg PG 20/80 VG Cost 1 million
8 mg Max VG      Cost 1 million

10 mg PG 100/0 VG Cost 1 million
10 mg PG 90/10 VG Cost 1 million
10 mg PG 80/20 VG Cost 1 million
10 mg PG 70/30 VG Cost 1 million
10 mg PG 60/40 VG Cost 1 million
10 mg PG 55/45 VG Cost 1 million
10 mg PG 50/50 VG Cost 1 million
10 mg PG 45/55 VG Cost 1 million
10 mg PG 40/60 VG Cost 1 million
10 mg PG 30/70 VG Cost 1 million
10 mg PG 20/80 VG Cost 1 million
10 mg Max VG      Cost 1 million

12 mg PG 100/0 VG Cost 1 million
12 mg PG 90/10 VG Cost 1 million
12 mg PG 80/20 VG Cost 1 million
12 mg PG 70/30 VG Cost 1 million
12 mg PG 60/40 VG Cost 1 million
12 mg PG 55/45 VG Cost 1 million
12 mg PG 50/50 VG Cost 1 million
12 mg PG 45/55 VG Cost 1 million
12 mg PG 40/60 VG Cost 1 million
12 mg PG 30/70 VG Cost 1 million
12 mg PG 20/80 VG Cost 1 million
12 mg Max VG      Cost 1 million

14 mg PG 100/0 VG Cost 1 million
14 mg PG 90/10 VG Cost 1 million
14 mg PG 80/20 VG Cost 1 million
14 mg PG 70/30 VG Cost 1 million
14 mg PG 60/40 VG Cost 1 million
14 mg PG 55/45 VG Cost 1 million
14 mg PG 50/50 VG Cost 1 million
14 mg PG 45/55 VG Cost 1 million
14 mg PG 40/60 VG Cost 1 million
14 mg PG 30/70 VG Cost 1 million
14 mg PG 20/80 VG Cost 1 million
14 mg Max VG      Cost 1 million

16 mg PG 100/0 VG Cost 1 million
16 mg PG 90/10 VG Cost 1 million
16 mg PG 80/20 VG Cost 1 million
16 mg PG 70/30 VG Cost 1 million
16 mg PG 60/40 VG Cost 1 million
16 mg PG 55/45 VG Cost 1 million
16 mg PG 50/50 VG Cost 1 million
16 mg PG 45/55 VG Cost 1 million
16 mg PG 40/60 VG Cost 1 million
16 mg PG 30/70 VG Cost 1 million
16 mg PG 20/80 VG Cost 1 million
16 mg Max VG      Cost 1 million

18 mg PG 100/0 VG Cost 1 million
18 mg PG 90/10 VG Cost 1 million
18 mg PG 80/20 VG Cost 1 million
18 mg PG 70/30 VG Cost 1 million
18 mg PG 60/40 VG Cost 1 million
18 mg PG 55/45 VG Cost 1 million
18 mg PG 50/50 VG Cost 1 million
18 mg PG 45/55 VG Cost 1 million
18 mg PG 40/60 VG Cost 1 million
18 mg PG 30/70 VG Cost 1 million
18 mg PG 20/80 VG Cost 1 million
18 mg Max VG      Cost 1 million

20 mg PG 100/0 VG Cost 1 million
20 mg PG 90/10 VG Cost 1 million
20 mg PG 80/20 VG Cost 1 million
20 mg PG 70/30 VG Cost 1 million
20 mg PG 60/40 VG Cost 1 million
20 mg PG 55/45 VG Cost 1 million
20 mg PG 50/50 VG Cost 1 million
20 mg PG 45/55 VG Cost 1 million
20 mg PG 40/60 VG Cost 1 million
20 mg PG 30/70 VG Cost 1 million
20 mg PG 20/80 VG Cost 1 million
20 mg Max VG      Cost 1 million

24 mg PG 100/0 VG Cost 1 million
24 mg PG 90/10 VG Cost 1 million
24 mg PG 80/20 VG Cost 1 million
24 mg PG 70/30 VG Cost 1 million
24 mg PG 60/40 VG Cost 1 million
24 mg PG 55/45 VG Cost 1 million
24 mg PG 50/50 VG Cost 1 million
24 mg PG 45/55 VG Cost 1 million
24 mg PG 40/60 VG Cost 1 million
24 mg PG 30/70 VG Cost 1 million
24 mg PG 20/80 VG Cost 1 million
24 mg Max VG      Cost 1 million

28 mg PG 100/0 VG Cost 1 million
28 mg PG 90/10 VG Cost 1 million
28 mg PG 80/20 VG Cost 1 million
28 mg PG 70/30 VG Cost 1 million
28 mg PG 60/40 VG Cost 1 million
28 mg PG 55/45 VG Cost 1 million
28 mg PG 50/50 VG Cost 1 million
28 mg PG 45/55 VG Cost 1 million
28 mg PG 40/60 VG Cost 1 million
28 mg PG 30/70 VG Cost 1 million
28 mg PG 20/80 VG Cost 1 million
28 mg Max VG      Cost 1 million

32 mg PG 100/0 VG Cost 1 million
32 mg PG 90/10 VG Cost 1 million
32 mg PG 80/20 VG Cost 1 million
32 mg PG 70/30 VG Cost 1 million
32 mg PG 60/40 VG Cost 1 million
32 mg PG 55/45 VG Cost 1 million
32 mg PG 50/50 VG Cost 1 million
32 mg PG 45/55 VG Cost 1 million
32 mg PG 40/60 VG Cost 1 million
32 mg PG 30/70 VG Cost 1 million
32 mg PG 20/80 VG Cost 1 million
32 mg Max VG      Cost 1 million

Grand Total      $168,000,000.00 Just for 1 flavor, 1 bottle size. and all the variants. This does not include the other 3 bottle sizes or the options for extra flavor or sweetener.

The truth is in the math and given at a Min cost of $300,000.00 per flavor and variant the cost is $50,400,000.00

Sorry about the table below I can't delete it...

Edited May 30, 2016 by Tam
Tried to delete table

[FXRich]

The FDA cannot legally ban ecigs, it isn't in their power to do that, only Congress can do that, and that's not going to happen. In my opinion they are trying to regulate it out of existence by causing it to be more expensive than smoking.

[Tam]

Wow, Comp, that's some table you got there. I tried to delete it for you but couldn't.   

[Compenstine]

Yeah it is a stubborn sucker.

[Compenstine]

As an added note to my post, companies will/would pass this added cost on to customers. I would have to sell $138,083.00 in product per day to pay (if the PMTA cost was only $300,000.00) for the PMTA on one flavor and bottle size. When you start breaking down the cost per bottle it would go far beyond the ability for most to afford or want to spend. Why spend $100-500 or more dollars for 1 10ml bottle when you can buy a couple packs of smokes for $18-25? At these prices it would be years, if ever, a company making juice would see a profit. For me and my sales I would have to charge way more than $5000 per bottle and still not see a profit. There would be no point in staying in business. You will find this to be the case with 99% of the companies out there. They only way a company could survive this is be by selling 100s of thousands of bottles a day.

[DoctorJ]

Not exactly sure what point it is that I'm missing or how I'm misguided (and I'm not asking for an explanation either ). Just pointing out there is some hope for the industry.

Guess my optimism is just me, seems that most have doomed the industry. Sorry to try and break up the pity party for the demise of vaping. My bad.

 

[FXRich]

The vape industry is not doomed, but after 2 or 3 years the only companies that will be able to sell vape products will be the large multibillion dollar companies that can afford the PMTA testing. The hardware choices will also be limited to a few select items. We can only hope that the FDA rules will be changed or done away with in the next few years. Personally I have enough hardware, and DIY supplies to last several years, who the new rules will affect is the new people that want to vape instead of smoke. Just have to wait and see.

 

[jasonculp]

2 hours ago, DoctorJ said:

Not exactly sure what point it is that I'm missing or how I'm misguided (and I'm not asking for an explanation either ). Just pointing out there is some hope for the industry.

Guess my optimism is just me, seems that most have doomed the industry. Sorry to try and break up the pity party for the demise of vaping. My bad.

 

I tend to agree with you.  I don't think this is the end of vaping as we know it.  I am optimistic that most of us, who have been doing it a while, will be able to continue, at least for the next 2 years.

I am also optimistic because a lot can change in 2 years.  I think with support of vaping organizations we could possibly see some changes.

 

The groups I am concerned about are people who are just starting to vape, or those who are still smoking, who want to quit.  The regulations could severely hamper their ability to keep/start vaping.

I am also concerned for small businesses like @Compenstine 's  He will virtually be put out of business overnight just because it will be cost prohibitive for him to supply us with great products. ( I do think his DIY advice and services can survive, as he would be providing no actual vape products)

 

I personally will not be affected greatly by the regulations as I have enough supplies to keep me going for many years.  I will not have my normal juice, but I can DIY something that is vapable (with Comp's help).  I will also continue to purchase mods, tanks, replacement boards, 510 connectors, wire, etc.  I would have probably bought most of them anyway since I am an overpreparer, with shinyitus.... 

[Bebop]

4 hours ago, DoctorJ said:

Not exactly sure what point it is that I'm missing or how I'm misguided (and I'm not asking for an explanation either ).

 

??? 

no explanation is  further needed.

[Tam]

1 hour ago, Bebop said:

??? 

no explanation is  further needed.

Please to be 'splainin' to meeeee.   

[Compenstine]

As Jason said there is the fact that these regs will affect everyone differently. Me, personally, I'm set for a very long time. It is the new vapers and the ones still smoking and want to quit that will be done the most harm. I do have hope, but I must look at a more realistic view. Ever here the old saying "Hope for the best and plan for the worst", That would apply here.

[1nfect]

Isn't there some type of class action suit vs the FDA?

..let meadd that I would donate to fund such action.

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