FDA to send Section 918 report to Congress on Monday (will include e-cigs)

[markfm]

Perhaps this is the report: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

(It's "Report to Congress, Innovative Products and Treatments To Achieve Abstinence...Required by Section 918...")

 

[Vapor Vinny]

Can anyone discern a timeline as to a definitive decision from all of this?

 

[Ravensfan]

After reading that whole thing, it basically appears that the FDA is telling Congress they can do a lot of things, but it sounds like they are looking for some sort of word from Congress before they do anything. Basically they are waiting for BT to make their contributions to our elected officials and then they can ban everything that BT wants banned, and let them monopolize the e-cig industry since they are the only ones that can afford to keep up with the regulations.

 

[jamie]

I see from reading Bill's link that the American Cancer Society (ACS) remains wedded to pharma solutions, to conflating smoking with any tobacco or nicotine use, and to Quit or Die.

ACS - JONES: Right now we're talking about cessation from smoking and nicotine use. I think we'd be open to the possibility of learning more about what happens with extended use of nicotine or continuing to use nicotine long-term. We're not prepared to give our final position on whether that is -- I think we need more research and one big investigation on the potential health consequences of that.

They might be "open to the possiblity of learning more," apparently not actually working to do so. But they'll keep thinking about the possibility of being open to learning. Maybe do a special fundraising campaign to insure they can afford the additional thinking.

 

[markfm]

I thought the report was better than it might have been. Not a rousing endorsement of PV, but it at least seems to acknowledge that there may be reasonable alternatives to quit-or-die.

 

[DanFromRioRancho]

Page 15;

".....the current warnings and directions .... limit the effectiveness of OTC NRT products for some consumers, including .......individuals who may have difficulty adhering to the labeled regimen for use (e.g., individuals affected by mental illness)."

That's nice.....

 

[Dave_in_OK]

Bill thanks for the link read your testimony Great job!

Found the transcript of the FDA's December 17 hearing on Section 918
www.fda.gov/downloads/Drugs/NewsEvents/UCM336652.pdf++Section+918+Report+to+Congress&client=FDAgov&site=FDAgov&output=xml_no_dtd&proxystylesheet=FDAgov&ie=UTF-8&num=10&lr=&access=p&oe=ISO-8859-1]FDA Transcript: FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Inno[/url]

 

[Dave_in_OK]

Thanks for the link!

Looks to me like the FDA is wants to use the dual use (some one who smokes and vapes) as justification for upcoming regulations.

Seems we have two groups to fight those in the we must protect our cash cow camp and those with the quit or die approach. Although they have different end goals both see us (vapers) as the immediate threat to them.

Perhaps this is the report: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

(It's "Report to Congress, Innovative Products and Treatments To Achieve Abstinence...Required by Section 918...")

 

[Vocalek]

Page 15;

".....the current warnings and directions .... limit the effectiveness of OTC NRT products for some consumers, including .......individuals who may have difficulty adhering to the labeled regimen for use (e.g., individuals affected by mental illness)."

That's nice.....

They should have clarified that many people with mental illnesses keep their symptoms under control by continued use of nicotine (so they ignore the labeling). The way they worded it makes it appear they are saying that folks with mental illness are too crazy (or too stupid) to understand the labeling.

 

[Vocalek]

Should we be concerned that the FDA only reviewed 78 of the 5,366 comments received before they issued their report?

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

 

[Elnroth]

Should we be concerned that the FDA only reviewed 78 of the 5,366 comments received before they issued their report?

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

Also, there was no mention that CASAA or smoke free Pennsylvania attended or contributed to the meeting . . .

 

[Renolizzie]

They certainly played their cards close to their vest in this report. All they said was what they could do and they tried hard not to give any clues as to what they would do.

 

[Petrodus]

Also, there was no mention that CASAA or smoke free Pennsylvania attended or contributed to the meeting . . .

You can just imagine my surprise (sarcasm)

 

[Ravensfan]

They certainly played their cards close to their vest in this report. All they said was what they could do and they tried hard not to give any clues as to what they would do.

That's because they have no idea what they are going to do yet. While the FDA is independent from Congress, that is where they get their marching orders from. You have to give these 535 men and women time to gather their kickbacks and make their personal investments in the companies that are going to be winners and short the companies that are going to be losers. That's called insider trading. It's completely illegal for us peons (ask Martha Stewart), but perfectly legal for members of Congress. Why do you think these congressmen spend millions to get a job that pays $174,000 a year?

 

[DanFromRioRancho]

Should we be concerned that the FDA only reviewed 78 of the 5,366 comments received before they issued their report?

Concerned, yes. Surprised, no.

 

[Petrodus]

That's because they have no idea what they are going to do yet. While the FDA is independent from Congress, that is where they get their marching orders from. You have to give these 535 men and women time to gather their kickbacks and make their personal investments in the companies that are going to be winners and short the companies that are going to be losers. That's called insider trading. It's completely illegal for us peons (ask Martha Stewart), but perfectly legal for members of Congress. Why do you think these congressmen spend millions to get a job that pays $174,000 a year?

Career Politicians

 

[Vocalek]

I sent this email message to the Center for tobacco Products (CTP):

The CTP has issued its Report to Congress on Section 918 of the Family Smoking Prevention and Tobacco Control Act (which is now part of the Food, Drug, and Cosmetics Act.)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

The report states:

"This report incorporates input received at the Part 15 hearing, including comments submitted to the associated docket, as well as the results of our consultations with various scientific, medical, and public health experts."

According to the regulations.gov docket folder, 5366 comments were submitted. However only 78 comments are posted online. Regulations.gov

According to the Regulations.gov Help Desk, comments are not posted until the responsible Agency (in this case, the FDA) reviews the comments.

Questions:

Were more than 78 of the 5366 comments reviewed? If so, why are they not available for viewing on regulations.gov?

Were all of the comments reviewed? If not, why has the report been issued? Isn't the process supposed to include input from the public?

I look forward to receiving your answer to these questions.

 

[Vocalek]

I received this response today from the CTP

Thank you for your email. Only 78 comments have been posted and made available at Regulations.gov there are 4000 plus to still be processed. Also a large amount will not be posted because they include personal information which makes us unable to post that comment.

Please visit our website Guidance, Regulations & Compliance for
additional FDA guidance, compliance, and regulatory information. You may also sign up for automatic email updates on various topics on our website (Sign Up for E-mail Updates on Tobacco Products).

 

[Berylanna]

So, did they just effectively admit they don't take them into account?

 

[Apptiger]

Sorry, I didn't get to read all of the report but here is what I gathered so far.

-FDA doesn't know how to categorize vaping so they are not sure which regualtions or how to apply them under what rule, regualtion or law.
- FDA says people could vape and smoke or vape for a while and go back to smoking. There is no guarantee associated that people will quit for good so they must not be effective. Really???? You mean people could CHOOSE to do something??? Never mind the abysmal failure rate of big pharm.
- They believe nicotine in all forms is just a continuation of an addiction and they don't believe in harm reduction becasue no manufacturer has proved to them it is. Translation: none has spent the million or two for us to study it.
- They so badly want to classify E-cigs as drug delivery devices but can't ...yet.
-They can regulate nicotine in cigarettes but can't with e-cigs unless they are fully classified as a cigarette/tobacco product. Translate we can ban nicotine and render the e-cig pointless as a method for harm reduction or gateway to quitting.
Despite the growing mountain of evidence.
- The comments of vapers and the public don't matter.
-They keep talking about stakeholders - why don't they just say big pharma and big tob and big tax? I guess we are not stakeholders. At least not important ones.


On one hand they say lower nicotine is less addcitive and the other they say lower nic doesn't matter. Still harmful and a tobacco product.

They are still looking for ways to legally regulate and aren't sure it fits into any current category or. They are waiting for the politicians to tell them how to go about regulating/pass a law.

Sounds to me like it's time for an all out campaign to congress??

Please correct me if I read this wrong or missed something. I went through it very quickly.

edit- sorry no time to correct the spelling