Petition to Delay PMTA! Your help needed!

[low_tar_neil]

vaping needs your help again!

I've copied the following text from Alex's CASAA email which does a better job of explaining what's happening than I would!

On August 25, Keller and Heckman LLP filed a Citizen’s Petition with the FDA requesting that the PMTA filing deadline of September 9, 2020 be delayed by 180 days. This petition is requesting that FDA go back to the US District Court for the District of Maryland to request a deadline extension, which the court recently granted for small cigar manufacturers that are being negatively impacted by this coronavirus pandemic.

• All interested parties are invited to comment on the Citizen’s Petition by filling out the form provided on this page and customizing your message.

• If you are writing on behalf of a small, open-system manufacturing company, please follow the instructions here.

If granted, the extension would move the deadline for small, open-system manufacturers to March 8, 2021. The request is predicated on a recent action taken by FDA in which small cigar manufacturers are being granted a similar extension due to complications and delays to completing PMTA’s associated with COVID-19.

• CONSUMERS: Click here to make your comment on the Citizen’s Petition!

• SMALL MANUFACTURERS: Click here for guidance on your comment and link to submit!

It is vital that people who use vapor products make their voices heard! While this pandemic is obviously putting a strain on services for businesses, people who depend on safer nicotine alternatives in order to stay smoke-free are being even more challenged by the prospects of losing access to these products and feeling pressured to go back to smoking. Whether it’s by regulation or global disaster, removing vapor products from the market threatens to inflict irreversible harm to millions of people.

 

[Lisa Belle]

I am the casaa group leader of The New Mexico Consumers For A Safer Alternative. I shared your message on my fb timeline and I shared casaa's form to petition on their site. Done. I will re-share however through out this important period.

 

[DPLongo22]

Your Comment Submitted on Regulations.gov (ID: FDA-2020-P-1797-0001)

no-reply@regulations.gov
3:35 PM (0 minutes ago)

to me

Please do not reply to this message. This email is from a notification only address that cannot accept incoming email.

Your comment was submitted successfully!
Comment Tracking Number: kee-my8e-gciv

Your comment has been sent for review. This process is dependent on agency public submission policies/procedures and processing times. Once the agency has posted your comment, you may view it on Regulations.gov using your Comment Tracking Number.

Agency: FOOD AND DRUG ADMINISTRATION (FDA)
Document Type: Other
Title: Petition for Extension of Premarket Tobacco Product Application Filing Deadline from Keller and Heckman LLP
Document ID: FDA-2020-P-1797-0001

Comment:
I was able to quit smoking completely using vapor products almost nine years ago. It's mind boggling to me that our legislative body wants to remove the one thing that's been proven successful in helping people quit smoking. Don't tell me it's about the children when "Dunkabroos" beer recently hit the market. Again - mind boggling.

Uploaded File(s):
No files uploaded

For further information about the Regulations.gov commenting process, please visit Regulations.gov.

 

[smacuser]

I'm thinking it's going to be delayed anyway.

Who wants the children to start smoking?

 

[MLEJ]

I'm thinking it's going to be delayed anyway.

Who wants the children to start smoking?

We all know who.

 

[Katdarling]

Signed, sealed, and delivered.

 

[dedi]

Done

 

[cooladdict]

Submitted! I hope it's better received than the letter to my congressman was. I am still blown away with the lack of knowledge our lawmakers have when voting on behalf of us.

Dear Ms. Reeves,

Thank you for contacting me regarding the regulation of electronic cigarettes. I’m grateful that you’ve taken the time to weigh in on this important issue.

Let me begin by saying that I understand this is an issue that spurs passions from all sides. I’ve heard from folks who have used e-cigarettes in adulthood to successfully quit smoking, and I’ve heard from parents, teachers, and students who have serious concerns about the epidemic of e-cigarette use among minors and specifically, middle and high school students.

Like you, I believe that adults should be able to access safe tools and treatments that would help them transition away from smoking cigarettes. That being said, the rising rates of e-cigarette use have undeniably impacted young people on an unprecedented level. According to the Centers for Disease Control (CDC), in 2018 alone, e-cigarette use increased 78 percent among high school students . Additionally, the alarming uptick in vaping-related respiratory illnesses among adolescents and young adults documented by the CDC – including 2,807 hospitalizations and 68 deaths in 29 states and the District of Columbia – has led to enhanced federal efforts to reevaluate how these products are marketed to, and used by, consumers of all ages. I believe that more can and should be done to ensure that these products are safe for consumers and to further restrict marketing to minors.

As you are aware, Representative Rosa DeLauro (D-CT) introduced the Preventing Online Sales of E-Cigarettes to Children Act (H.R.3942 ), which would require that online purchases of e-cigarettes receive an in-person age verification upon delivery. Current law establishes that minors cannot purchase e-cigarettes in brick and mortar stores, and that purchases of these products must verify the shopper’s age. This bill would simply extend that law to online deliveries as well—closing this loophole that has allowed more children to access e-cigarettes. This bill was passed in the House by a voice vote in October 2019, where it now awaits consideration in the Senate.

As you are aware, in the months following the consideration of this bill in the House, concerns have been raised about what the potential passage of this bill into law would mean during the coronavirus pandemic. While the bill has not yet been taken up in the Senate or signed into law by the President, I hear concerns about signature requirements for packages—not just in relation to e-cigarette purchases, but for all online orders that may require a signature. To that end, postal services have been adjusting protocol so that signature-required deliveries do not unnecessarily place people at risk. I strongly agree that during this time, it remains critical that public health is protected. That includes ensuring that people can maintain appropriate social distancing and hygiene guidelines to protect their health and their loved ones.

Again, I sincerely appreciate you reaching out and will keep your views in mind as Congress discusses these issues further. I encourage you to continue to share your views with me on this topic or any other issue. Thank you for reaching out. It is an honor to serve as your representative.


Sincerely,

Derek Kilmer
Member of Congress

 

[Katya]

"Customized" (I tried to stay civil) and submitted.

 

[zoiDman]

 

[gnees]

Done.

 

[ricks]

Vaping Versus Tobacco: The Truth You Need To Know

Signed

 

[riverwinds]

Done.

 

[kayakiit]

Done and shared!

 

[MLEJ]

Submitted! I hope it's better received than the letter to my congressman was. I am still blown away with the lack of knowledge our lawmakers have when voting on behalf of us.

Dear Ms. Reeves,

Thank you for contacting me regarding the regulation of electronic cigarettes. I’m grateful that you’ve taken the time to weigh in on this important issue.

Let me begin by saying that I understand this is an issue that spurs passions from all sides. I’ve heard from folks who have used e-cigarettes in adulthood to successfully quit smoking, and I’ve heard from parents, teachers, and students who have serious concerns about the epidemic of e-cigarette use among minors and specifically, middle and high school students.

Like you, I believe that adults should be able to access safe tools and treatments that would help them transition away from smoking cigarettes. That being said, the rising rates of e-cigarette use have undeniably impacted young people on an unprecedented level. According to the Centers for Disease Control (CDC), in 2018 alone, e-cigarette use increased 78 percent among high school students . Additionally, the alarming uptick in vaping-related respiratory illnesses among adolescents and young adults documented by the CDC – including 2,807 hospitalizations and 68 deaths in 29 states and the District of Columbia – has led to enhanced federal efforts to reevaluate how these products are marketed to, and used by, consumers of all ages. I believe that more can and should be done to ensure that these products are safe for consumers and to further restrict marketing to minors.

As you are aware, Representative Rosa DeLauro (D-CT) introduced the Preventing Online Sales of E-Cigarettes to Children Act (H.R.3942 ), which would require that online purchases of e-cigarettes receive an in-person age verification upon delivery. Current law establishes that minors cannot purchase e-cigarettes in brick and mortar stores, and that purchases of these products must verify the shopper’s age. This bill would simply extend that law to online deliveries as well—closing this loophole that has allowed more children to access e-cigarettes. This bill was passed in the House by a voice vote in October 2019, where it now awaits consideration in the Senate.

As you are aware, in the months following the consideration of this bill in the House, concerns have been raised about what the potential passage of this bill into law would mean during the coronavirus pandemic. While the bill has not yet been taken up in the Senate or signed into law by the President, I hear concerns about signature requirements for packages—not just in relation to e-cigarette purchases, but for all online orders that may require a signature. To that end, postal services have been adjusting protocol so that signature-required deliveries do not unnecessarily place people at risk. I strongly agree that during this time, it remains critical that public health is protected. That includes ensuring that people can maintain appropriate social distancing and hygiene guidelines to protect their health and their loved ones.

Again, I sincerely appreciate you reaching out and will keep your views in mind as Congress discusses these issues further. I encourage you to continue to share your views with me on this topic or any other issue. Thank you for reaching out. It is an honor to serve as your representative.


Sincerely,

Derek Kilmer
Member of Congress

At least he -- or his office -- replied with more than a form letter.
The reply is actually instructive; we see in it the misconceptions that lawmakers have re: vaping and so know how to best direct efforts at educating them. Thanks for sharing the letter.

Also - Form submitted.

 

[cooladdict]

At least he -- or his office -- replied with more than a form letter.
The reply is actually instructive; we see in it the misconceptions that lawmakers have re: vaping and so know how to best direct efforts at educating them. Thanks for sharing the letter.

Also - Form submitted.

I know. I just wish they were more informed. I got a similar reply from another congressman a few months ago that was even worse. Talked about how vaping has caused numerous children to fall ill and that he can't condone that. I replied back, informing him that what he is talking about was actually traced back to black market thc products and my reply bounced back to me. He never saw it and, I'm quite sure, has never bothered to fact check his information. It's so frustrating.

 

[Katya]

Talked about how vaping has caused numerous children to fall ill and that he can't condone that.

Same here. They are all form letters written by a staffer that are being sent to constituents who send pro vaping comments. I've received numerous letters and emails in the past and they all sound the same. "We understand .. we will take your remarks under advisement... but we have to save the children." Every single one of them.

 

[MLEJ]

Congresspeople fear two things: losing lobbyist money ("campaign contributions") and losing elections. The former is why they do the bidding of big pharma, for example; the latter why so many side with the NRA, for example. Every player in the vaping industry world-wide would have to work together for the industry to influence congress enough, which just ain't gonna happen (JUUL works actively against the industry, for crying out loud). If every vaper, grateful family member or friend of a vaping former smoker, and vape business employee, along with a healthy handful of individual-liberty-supporting Americans, showed just once the kind of voting bloc mobilization that the NRA's membership has, we'd have a fighting chance. If there was ever hope of something close to that happening, I fear it's too late now.

 

[pearlcrest]

Customized and signed!

 

[Katya]

Sorry, folks, this just in from VTA:

FDA Says It Will NOT Extend September 9 Deadline: Late on Friday afternoon, we received an e-mail from FDA, responding to our request for an extension of the PMTA deadline, saying that FDA will not extend the September 9 deadline. The FDA wrote, in part:

"Dear Mr. Abbound [sic]: Thank you for contacting the U.S. Food and Drug Administration’s (FDA’s or the Agency) Center for Tobacco Products (CTP) to request an additional extension of the premarket application deadline on behalf of your members with deemed new tobacco products. […]

FDA has received many individual requests for a further extension of the September 9, 2020, premarket application deadline. After considering your request, FDA has determined that it will not grant a further extension of the September 9, 2020, premarket application deadline set by the Court for members’ products. Any additional delay would impede FDA’s critical public health priority to promptly require submission of premarket tobacco applications.”

Important Guidance for Companies Filing Applications: In the email, FDA went on to explain that it “intends to prioritize enforcement decisions on a case-by-case basis such as prioritizing enforcement based on the likelihood of youth use or initiation. However, FDA intends to take individual circumstances into account as it considers your members’ premarket tobacco product applications that are submitted by the September 9, 2020, deadline.”

Because FDA is making decisions on a case-by-case basis, it is imperative that you make your specific case if, for example, there are certain elements that may be incomplete in your application. Specifically, FDA said: “FDA encourages your members to explicitly identify any content that may be missing from an application and clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has affected ability to provide such information.”

Also, FDA has said that it will work with companies to get their applications through the process during the 12-month review period under certain circumstances: FDA wrote: “If an application is sufficient to be accepted, filed, and proceed to scientific review and, during such review, your member would subsequently provide the needed information and make substantial progress toward addressing deficiencies in an application, we intend to take that into account in deciding whether to initiate enforcement action against products for being on the market without premarket authorization, even where FDA is reviewing applications after September 9, 2021. The decision as to whether to enforce after the one-year review period may take into account responsiveness to our requests, the particular nature and extent of scientific evidence that is lacking, and evidence of demonstrated hardship due to the COVID-19 pandemic, recent natural disasters, or other unforeseen circumstance in obtaining such evidence.”

In addition to extending the deadline, VTA has encouraged FDA to work with companies as they navigate the process. Last Friday's email sends the message that, while they are not moving the deadline further, they are planning to take into account each companies’ special circumstances.

Today, FDA published another statement regarding upcoming PMTA submissions. The “Perspectives” piece published today by FDA today covers a number of topics. Here are the most relevant:

FDA Expects a Large Number of Applications and the One Year Review Timeline May Be Exceeded. FDA acknowledged “there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.” […] Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.”

FDA Will Work With Companies By Sending Deficiency Letters: “Further, although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond.” Giving companies an opportunity to cure deficiencies in their applications, rather than simply rejecting the application, is something we have encouraged FDA to do.

FDA Says It Will Devote Resources to Expedite Review for both Small and Large Manufacturer Applications: Director Zeller wrote, “As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways. Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe—with the above guiding principles in mind. To help with this, we are refining our review processes to shorten the overall review time."