On stockpiling after FDA deeming regulations

[crxess]

Maybe you're right, but as a betting man i'd bet Evolv has a decent chance of having an FDA approved product when it's all said and done. They've already been working on this for a good while now and the NIH grant doesn't hurt.

They will still be Required to File a PMTA and if they Aren't.............I'll start the Class action suit against the FDA

 

[Mazinny]

They will still be Required to File a PMTA and if they Aren't.............I'll start the Class action suit against the FDA

They will file, likely the same device they have developed for the NIH. Here is what the NIH says about the rights to the device and the data developed during its production :

All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP. The small business awardee owns, and has full right and title to, the data it develops under an SBIR award. Additional details can be found in Section 5.5 of the solicitation and here:

https://www.sbir.gov/faq/data-rights#t46148n390857

 

[crxess]

They will file, likely the same device they have developed for the NIH. Here is what the NIH says about the rights to the device and the data developed during its production :

All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP. The small business awardee owns, and has full right and title to, the data it develops under an SBIR award. Additional details can be found in Section 5.5 of the solicitation and here:

https://www.sbir.gov/faq/data-rights#t46148n390857

Well, I Hope it is a well received Product. I'd hate to see them get bottle necked a Boxed canyon with no way out. The way the Regulations are going - Smokers are likely not going to be Drawn to Vaping and Current serious Vapers are Done with it!
just saying.
I know, with my Retirement income I had to seriously stretch things thin and have no wiggle room left.

FDA - KMA

 

[r055co]

Yep, but I really do not expect the FDA to approve a 200 watt device...
Perhaps why they came out with the 75 watt chipset?

I still am expecting cigalike types with prefilled cartridges to be the choice of the FDA.

Again, I hope I am wrong.

Unfortunately you're not wrong IMO, prefilled cigalikes is what Big Tobacco has and we know who owns the FDA.

Sent from my Nexus 6 using Tapatalk

 

[Steamix]

I can see where the flavoring issue will effect e-liquid manufacturers but I fail to see it having any effect on the DIY crowd. These large flavoring companies were around long before vaping and will continue to be around so buying flavorings should be a non-issue, the only exception may be tobacco flavoring.

+1 that.

Flavours and fragrances has been a 20 billion bucks biz long before vaping appeared.

https://www.gov.mb.ca/agriculture/m...stics/pubs/ma_global_flavours_industry_en.pdf

Pie chart on page 3 - 4% 'other' guess that's where the vaper's share belongs

Small quantities at high margins.
Apparantly profitable enough for FA and others to play along with the FDA - for the time being.

 

[sofarsogood]

A 10 year supply of everything vape specific for me plus 100% redundancy is less than $1,000.

Btw, this is what John from Evolv said about the project prior to being issued the grant :

Just figured I'd pop in and give you all a heads up why I haven't been on the forums the past few weeks.

Back in April we applied for this NIH program

SBIR Topic 156b Development of a Standardized Electronic Cigarette for Clinical Research - Federal Business Opportunities: Opportunities

to develop a standardized research e-cigarette, and Evolv is one of the finalists. I've had to put development efforts on that into high gear, as well as spend a lot of time researching and responding to various requests from NIH. They want to award early and then on top of that they want to compress the timeline further if possible. The grants aren't for a lot of money, but it is really important for the industry for us to get this right.

If vaping is going to survive, it is because we are demonstrably healthier than smoking. Demonstrably doesn't mean "I tried it and I feel better" and it doesn't mean RJR commissioning a study. It means actual medical researchers running actual medical research. Most of the e-cigarette studies that have been done thus far have been crap. Honestly, who can blame the researchers when the only tools they have are off the shelf devices. Nobody expects cancer researchers to work with X-ray glasses purchased from the back of a comic book, but "we went down to the local convenience stores and bought some Blu e-cigs" is the best that they can do right now.

Getting really well controlled, accurate, instrumented, documented devices that record and report into researchers' hands will let them draw accurate conclusions. For example, formaldehyde: you really can set up an e-cig to be a formaldehyde generating machine. You can also set them up to give you virtually none. The questions that really should be asked are "what controls formaldehyde production, where is the limit, and are people actually getting formaldehyde in day to day use" but until they have a good research device, that isn't an answerable question. (Incidentally, the answer to those particular questions seem to be "Temperature, somewhere between 430F and 450F" and "yes, but only some people.")

Also, this is NIH. I have a TON of respect for the National Institute of Health. This solicitation was the only one that I felt was asking the right questions, and I'd really like to see the people asking the right questions get rewarded with the best results. FDA is running a similar development and we did not apply for that one. "The government" is not monolithic.

You can see a lot of hints of this work in the 200. The device we're proposing as the standard research e-cigarette is not the 200. You don't need to pay for an accurate clock, megabytes of data storage or extra sensors. Researchers don't need to pay for 200 watts. It is 100% an Evolv product.

Just in the course of developing and characterizing this research e-cig we'll be able to put a lot of unanswered questions to bed.

I think I am over the most time-critical portions of it (the actual device development and research I enjoy, the reams and reams of forms, paperwork, proposals, counter-proposals and all that... not so much) so hopefully I'll be back around here with more regularity.

I'm happy to talk about this to the degree that I can.

This is promising. Doesn't influence my stockpiling plans. I didn't buy a DNA40 or the 200 but said I would consider an evolv prouct with escribe that can work with a single 18650. That would be the DNA75. I like the idea of recording my vape for the sake of more control but I won't be stockpiling $100 mods. $25-35 each is more my speed.

My stockpile plan anticipates 10 years with 100% redundancy so if everything works better than expected may be the time woud be longer. This reminds me of the Mars rovers which lasted longer than the design goal. Requiring longer than 10 years feels neurotic. I can do that for my vape for well under $1000. This is similar to the survivalist hobby. They will never need all that stuff but they enjoy the activity of being prepared. Stocking vape stuff is an ineresting hobby.

 

[mattiem]

Although we were deem-onized by some right here on this forum when we started this petition we were/are still trying and could still use more supporters. The fight is not over until we stop fighting. I will not stop fighting!!!!!!!!!!

Please sign this petition-Our Vape is not Tobacco

 

[VNeil]

Although we were deem-onized by some right here on this forum when we started this petition we were/are still trying and could still use more supporters. The fight is not over until we stop fighting. I will not stop fighting!!!!!!!!!!

Please sign this petition-Our Vape is not Tobacco

I think that petition is a particularly well constructed summary of our argument.

 

[Two_Bears]

I was assured by a poster here that there was no need to stock up early. I guess somebodies crystal ball needs polishing.

Gary:

The president and the Senators and congress may act and stop this. They may not. We simply do not know what will happen.

I REFUSE to go back to the stinkies so i prep just in case the FDA carrys through on this threat.

If you prefer vaping over smoking the stinkies prep just in case.

Hope for the best but prep for the worst just in case the worst comes.

 

[Two_Bears]

It really is disengenious. Someone that doesn't realize what is truly going on may think everything will be fine according to this person. Kind of like what some stores are doing. It makes me a little

You arent the only one sister.

 

[mattiem]

I think that petition is a particularly well constructed summary of our argument.

We could see the writing on the wall and tried everything we could think of to get backing for the petition. I think we were all aware that it was/is just wishful thinking since we all know that it is all about the money. The bottom line-Vaping is not smoking and vapor products are not tobacco. I wish we could get those that could possibly do something to take the lead on this truth.

 

[chanelvaps]

another email I received in response to writing to my legislators-he does not say exactly where he stands on it




Thank you for contacting my office regarding H.R.2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate hearing from you and I am grateful for the opportunity to respond.

H.R.2058 was introduced by Rep. Tom Cole (R-OK) and aims to change the grandfather date on the Federal Food, Drug, and Cosmetic Act by allowing e-cigarettes and vapor products to be remain on the market instead of being subjected to a new approval process after the FDA deemed e-cigarettes as tobacco products. Should this bill pass, all currently approved vapor products would be allowed to remain on the market without going through the pre-market approval process under the new tobacco regulations.

Currently, H.R. 2058 has been referred to the in the House Energy and Commerce Committee. Should this or similar legislation come up for consideration in the Senate, I will be sure to keep your thoughts in mind as I consider my vote.

Thank you again for contacting me. Please visit my webpage at http://isakson.senate.gov for more information on the issues important to you and to sign up for my e-newsletter.


Sincerely,
Johnny Isakson
United States Senator

 

[bnrkwest]

I sometimes offer spinning supplies and if I sell cotton, which I do from time to time plus other fibers, how would anyone

another email I received in response to writing to my legislators-he does not say exactly where he stands on it




Thank you for contacting my office regarding H.R.2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate hearing from you and I am grateful for the opportunity to respond.

H.R.2058 was introduced by Rep. Tom Cole (R-OK) and aims to change the grandfather date on the Federal Food, Drug, and Cosmetic Act by allowing e-cigarettes and vapor products to be remain on the market instead of being subjected to a new approval process after the FDA deemed e-cigarettes as tobacco products. Should this bill pass, all currently approved vapor products would be allowed to remain on the market without going through the pre-market approval process under the new tobacco regulations.

Currently, H.R. 2058 has been referred to the in the House Energy and Commerce Committee. Should this or similar legislation come up for consideration in the Senate, I will be sure to keep your thoughts in mind as I consider my vote.

Thank you again for contacting me. Please visit my webpage at http://isakson.senate.gov for more information on the issues important to you and to sign up for my e-newsletter.


Sincerely,
Johnny Isakson
United States Senator

I got an about identical response from my senator, I wonder if this is a form response given to all senators??

 

[jwbnyc]

Pigs at the trough

Sent from my Nexus 6 using Tapatalk

You malign the pigs.

 

[MMW]

My return response:

May 9, 2016

Dear Todd,


Thank you for reaching out to me with your views regarding proposed regulations of electronic cigarettes by the Food and Drug Administration (FDA) under the Tobacco Control Act of 2009 (TCA). Listening to my constituents is a fundamental part of my job as it helps me to best represent you and New Hampshire’s priorities in Congress.

Thank you for sharing your positive experience with electronic cigarettes. As you know, the FDA released its proposed regulations on e-cigarettes in April of 2014. These rules would mandate that manufacturers win premarket approval for their products within two years, with the exception of those that had been grandfathered in. While traditional cigarettes were grandfathered in, electronic cigarettes were not, meaning that their manufacturers must go through the premarket approval process. Recently, several Members of Congress wrote a letter to Health and Human Services (HHS) Secretary Sylvia Burwell, requesting that the grandfather date of February 15, 2007 (the date the TCA was introduced in Congress) be changed to April 25, 2014 (the day the FDA’s proposed regulations were announced). If the grandfather date was changed to the date proposed by these Members, e-cigarettes would essentially be grandfathered in.

I appreciate your concerns regarding limits on e-cigarettes, but also believe that our government has a responsibility to maintain prudent restrictions on the marketing and labeling of consumer products. The FDA approval process is tasked with preventing products with harmful side effects from being distributed on the open market without the proper testing. As your Representative, I also take my responsibility to oversee federal agencies very seriously and will continue to monitor the FDA’s activities to ensure it is fulfilling its mission of protecting public health without needlessly obstructing medical progress. If I have the opportunity to vote on legislation concerning the FDA’s limits on electronic cigarettes, please know that I will keep your thoughtful views in mind.

Thank you again for sharing your thoughts with me. I strive to maintain an open dialogue with the people of New Hampshire about issues important to our district. If you have any further questions or concerns, please feel free to contact my Concord office at (603) 226-1002 or my Washington, DC office at (202) 225-5206. I also encourage you to visit my website at http://Kuster.house.gov, follow me on Twitter at @RepAnnieKuster, or check out my Facebook page at http://www.facebook.com/CongresswomanAnnieKuster.


Sincerely,

Ann McLane Kuster
Member of Congress

 

[mikepetro]

I sometimes offer spinning supplies and if I sell cotton, which I do from time to time plus other fibers, how would anyone

I got an about identical response from my senator, I wonder if this is a form response given to all senators??

Very similar to the blow off response I got from mine.

 

[r055co]

I sometimes offer spinning supplies and if I sell cotton, which I do from time to time plus other fibers, how would anyone

I got an about identical response from my senator, I wonder if this is a form response given to all senators??

Yes they're canned responses, you were blown off.

Sent from my Nexus 6 using Tapatalk

 

[LouisLeBeau]

My return response:

May 9, 2016

Dear Todd,


Thank you for reaching out to me with your views regarding proposed regulations of electronic cigarettes by the Food and Drug Administration (FDA) under the Tobacco Control Act of 2009 (TCA). Listening to my constituents is a fundamental part of my job as it helps me to best represent you and New Hampshire’s priorities in Congress.

Thank you for sharing your positive experience with electronic cigarettes. As you know, the FDA released its proposed regulations on e-cigarettes in April of 2014. These rules would mandate that manufacturers win premarket approval for their products within two years, with the exception of those that had been grandfathered in. While traditional cigarettes were grandfathered in, electronic cigarettes were not, meaning that their manufacturers must go through the premarket approval process. Recently, several Members of Congress wrote a letter to Health and Human Services (HHS) Secretary Sylvia Burwell, requesting that the grandfather date of February 15, 2007 (the date the TCA was introduced in Congress) be changed to April 25, 2014 (the day the FDA’s proposed regulations were announced). If the grandfather date was changed to the date proposed by these Members, e-cigarettes would essentially be grandfathered in.

I appreciate your concerns regarding limits on e-cigarettes, but also believe that our government has a responsibility to maintain prudent restrictions on the marketing and labeling of consumer products. The FDA approval process is tasked with preventing products with harmful side effects from being distributed on the open market without the proper testing. As your Representative, I also take my responsibility to oversee federal agencies very seriously and will continue to monitor the FDA’s activities to ensure it is fulfilling its mission of protecting public health without needlessly obstructing medical progress. If I have the opportunity to vote on legislation concerning the FDA’s limits on electronic cigarettes, please know that I will keep your thoughtful views in mind.

Thank you again for sharing your thoughts with me. I strive to maintain an open dialogue with the people of New Hampshire about issues important to our district. If you have any further questions or concerns, please feel free to contact my Concord office at (603) 226-1002 or my Washington, DC office at (202) 225-5206. I also encourage you to visit my website at http://Kuster.house.gov, follow me on Twitter at @RepAnnieKuster, or check out my Facebook page at http://www.facebook.com/CongresswomanAnnieKuster.


Sincerely,

Ann McLane Kuster
Member of Congress

Well, this is at least clearly an ACTUAL RESPONSE, and not some crappy form letter. Still pretty obvious that HER opinion is on the side of the FDA. I can always tell when my representatives actually AGREE and intend to vote the same as my interests, MAN do they get enthusiastic about their agreement!

 

[Robert Cromwell]

For anyone interested Vaporbeast has the Velocity mini for under $9 using the CC DAD.
Just ordered another one. Needs a backup.

 

[Robert Cromwell]

Well, this is at least clearly an ACTUAL RESPONSE, and not some crappy form letter. Still pretty obvious that HER opinion is on the side of the FDA. I can always tell when my representatives actually AGREE and intend to vote the same as my interests, MAN do they get enthusiastic about their agreement!

She prolly just has an agree form letter and a disagree form letter.