FDA The *** NEXT *** FDA Workshops on Electronic Cigarettes and the Public Health

[SeniorBoy]

This just came across the Federal Register:

The public workshop will be held on March 9, 2015, from 8 a.m. to 5 p.m. and on March 10, 2015, from 8 a.m. to 5 p.m. Individuals who wish to attend the public workshop must register by February 20, 2015.

Source with gory details at: https://www.federalregister.gov/art...m_medium=email&utm_source=federalregister.gov

I can hardly wait / a little tongue and cheeky

 

[MichiganGoat]

Thanks, the future of vaping depends on what happens with the FDA.


Sent from my iPhone using Tapatalk

 

[Oliver]

Thanks buddy - I'm applying to speak.

 

[Painter_]

Hopefully our side gets some people to speak. The last session seemed to have an agenda from the start.

 

[Bill Godshall]

The FDA's webpage for its so-called scientific public workshop on March 9/10 is at
March: A Public Workshop ? Electronic Cigarettes and the Public Health

The deadline for submitting a request to present at the workshop is January 22, 2015
The deadline for submitting requests to speak during the public comment period, and to register to attend the workshop is February 20, 2015

For some laughs:

The purpose of this workshop is to gather scientific information and stimulate discussion among scientists about electronic cigarettes (e-cigarettes). This is the second in a series of three workshops intended to obtain information on e-cigarettes and the public health. The information presented and discussed during the workshop series is not intended to inform the Agency’s rulemaking related to deeming additional tobacco products

Except that the vast majority of presenters FDA invited to its first scientific workshop knew very little about e-cigs, presented poorly conducted studies on obsolete vapor products, and/or urged the FDA to impose many more unwarranted e-cig regulations in addition to the proposed deeming regulation.

The focus of this workshop will be the impact of e-cigarettes on individual health. Topics to be addressed include, for example: (1) topography; (2) exposures and toxicological considerations; (3) pharmacokinetics and pharmacodynamics of nicotine exposure in users; (4) abuse liability and dependence; (5) short and long-term health effects in users; (6) considerations for high risk or vulnerable populations; and (7) human factors.

Presenters and Panelists:

FDA is interested in gathering scientific information from individuals with a broad range of backgrounds on the scientific topics to be discussed at the workshop. We are inviting presenters and panelists to address information pertaining to the questions listed below:

Toxicological considerations:
How can toxicological evaluations of the short and long-term effects of e-cigarettes in users be approached?
What are the potential roles of nonclinical models (e.g., in silico, in vitro, and in vivo) and human clinical studies?
What in vitro and in vivo models can be utilized for comparing toxicity between tobacco products?
What panel of biomarkers of exposure and toxicity in animal studies can be used to evaluate the toxicity of short and long-term e-cigarette use?
What panels of biomarkers of exposure and toxicity allow for cross-species comparisons (i.e., between animals and humans)? What are the limitations of scaling from animal to human studies?
What panel of biomarkers of exposure and toxicity could be useful for monitoring exposure and toxicity in humans across different tobacco products?
Where are aerosols delivered or deposited in humans?
What methods most effectively measure aerosol delivery/deposition/absorption?
What is the impact of local and systemic exposure (of e-liquid and aerosol)?
What aerosol constituents (e.g., chemicals, toxicants, flavorants, other additives) are delivered to users? Are there differences in delivery of aerosol constituents between new and experienced users?
What are the levels of aerosol constituents delivered to the experienced user?
How do levels of toxicant exposure compare to those in users of other tobacco or nicotine containing products (e.g., traditional cigarettes, other combusted tobacco products, smokeless tobacco, nicotine replacement therapy)?
What are the toxicological concerns associated with long-term inhalation of aerosols containing propylene glycol, glycerin and flavorings?
What is known about the toxicities of inhaled flavorings? Are some inhaled flavorings more toxic than others?
What strategies can be used to evaluate the potential toxicity of inhaled flavorings in humans?
What strategies can be used to demonstrate that an individual flavor ingredient additive does not increase the inherent toxicity of the e-liquid and aerosol?

Topography
How are e-cigarettes used in terms of actual use patterns (frequency of use) and topography (number of puffs per session, puff volume, puff duration, velocity)?
How can e-cigarette topography be evaluated to accurately capture user behaviors?
What factors impact e-cigarette topography? For example, how is topography affected by the type of device, reason(s) for use, or user subpopulation (e.g., polytobacco users, experienced users, youth)?
What strategies can be used to quantitate e-cigarette use? How can quantitative measures of e-cigarette use be compared to the use of other tobacco or nicotine containing products?

Clinical Pharmacology and Abuse Liability:
What are the pharmacokinetics and the pharmacodynamic effects of nicotine delivered via e-cigarettes?
How do the pharmacokinetic and pharmacodynamic properties of e-cigarettes differ in specific subpopulations (e.g., experienced users, naive users, dual users, youth)?
To what extent do e-cigarettes deliver nicotine via pulmonary absorption?
What are the primary subjective effects associated with e-cigarette use?
How do the subjective effects associated with e-cigarette use differ in specific subpopulations (e.g., experienced users, naive users, dual users, youth)?
What are the reinforcing effects of e-cigarettes? How do these compare to traditional cigarettes in smokers as well as to other combusted products, smokeless tobacco or nicotine replacement therapy?
What measures or methods can be used for assessing the reinforcing effects of e-cigarettes in users?
Are there ways that flavorings may enhance the abuse liability of e-cigarettes?
What non-nicotine constituents in e-cigarette aerosols may contribute to e-cigarette use and dependence?
What unique abuse liability risks may exist for e-cigarette users in specific subpopulations (e.g., former smokers, youth, polytobacco users)?
What is the impact of e-cigarette use on nicotine addiction (e.g., how may e-cigarette use increase, support or decrease nicotine addiction)?
What strategies can be used to evaluate the potential for an e-cigarette withdrawal syndrome? What strategies can be used to characterize e-cigarette withdrawal?
What are the characteristics of e-cigarettes that may affect uptake and use by nonusers, former smokers, and youth?

Health Effects in Users:
What are the known short and long-term health effects of e-cigarettes in experienced users? What are potential other short and long-term health effects of e-cigarettes in users that should be evaluated?
What are the potential short and long-term health effects of inhaling humectants (e.g., propylene glycol, glycerin), flavorings and other e-liquid additives?
What strategies can be used to evaluate the short and long-term health effects of e-cigarettes in users?
What biomarkers and clinical endpoints can be used to assess the impact of e-cigarettes on user health?
What evidence is available that e-cigarettes promote current smokers to completely switching as compared to continuing dual or polytobacco use? What data are available that indicate the characteristics of e-cigarettes that may enhance the potential for complete switching and how do these characteristics compare to approved cessation aids?

Considerations for Health Effects in Specific User Populations:
What populations of users may be at lower or higher risk of adverse effects related to e-cigarette use?
What factors could be considered in the evaluation of risk in vulnerable populations?
What are the health effects in dual users (i.e., users of e-cigarettes and traditional cigarettes or other combusted products)?
What unique issues could be considered in the evaluation of the short and long-term health effects in users of e-cigarettes in combination with traditional cigarettes, other combusted products, and smokeless tobacco?
What unique health effects may be of concern for users with underlying disease (e.g., chronic obstructive pulmonary disease, cardiovascular disease, diabetes mellitus, cancers, mental health disorders)?
What unique health effects may be of concern in youth e-cigarette users?
How can health risks associated with youth initiation and ongoing use be evaluated?
What are the short and long-term health effects of e-cigarette use during pregnancy? What is the impact of e-cigarette use during pregnancy on the pregnant woman and on the fetus?
How can the short and long-term effects of e-cigarette use during pregnancy be evaluated?
Human Factors:
What adverse events have been associated with e-cigarette use in users?
How are e-cigarette products modified by users and what are the inherent risks or consequences of the various modifications?
What strategies can be used to mitigate risks related to human factors?
What information do consumers need to adequately understand the product and mitigate risk?
What strategies could be considered to effectively communicate information about the product, especially user risks?
What labeling strategies could be considered?

The overwhelming majority of FDA's questions are an unscientific regulatory witch hunt to identify, scare the public about, and impose lots of very expensive unwarranted regulations for hypothetical, neglibible and/or already disproved risks of e-cigs.

But I highlighted the question I think are the most important questions for consumer and public health in red.

 

[Kent C]

While many of the topics may imply the effects of 2nd hand vapor, none directly address it. Though - that may be a prominent factor in the actual workshop, since that is a main tool to promote regulation.

 

[Bill Godshall]

Painter wrote

Hopefully our side gets some people to speak. The last session seemed to have an agenda from the start

.

That's because the FDA wrote the agenda and then chose everyone that was invited to present and participate on their panels (among the many who submitted requests to present).

That's why the FDA invited lots of FDA deeming regulation proponents (including many federal bureaucrats) to present and serve on panels, while FDA didn't allow Igor Burstyn (the leading expert on e-cig aerosol) to present, why just one THR advocate (from the UK) was invited to present, and why just one THR advocate (Farsalinos) was invited to serve on a panel.

While the FDA is almost certainly going to do the same at this next so-called public workshop, it can be helpful to our cause if many different vaping advocates request to present at this conference, and even more request to present during the public comment period.

After the FDA rejects most or all vaping advocates who request to present, we can issue a press release accusing the FDA of continuing to abusively push its unscientific political agenda (to impose the deeming regulation, misrepresent the scientific evidence, and further demonize e-cigs) at the expense of consumer and public health, human rights and scientific objectivity.

 

[Jman8]

I really hope there is another public comment period after the FDA finally figures out what an eCig is.

(or perhaps not necessary if Pubs in Congress exempt eCigs from FSPTCA)

 

[nomore stinkies]

"As stated in the proposed deeming rule, FDA “is aware of the recent significant increase in the prevalence in e-cigarette use” (79 FR 23141 at 23152), and there is much to be learned about these relatively new entrants to the market.
These workshops are intended to better inform FDA about these products." By WHOM?

Ya Think? And why the increase usage? Oh, it must be more chiiildren. They haven't learned or listened to a thing on our side.

 

[MichiganGoat]

Here my issue:
The term e-cigarette is already harming vaping. We are aligning with cigarettes because analog smokers who switch are the largest demographic, but vaping and smoking are very different and the general public needs to know this.

Second the devices are not the question (expect for battery safety and such), the juice is the issue. Unfortunately juices are so very different and some of them have bad additives which anti-vapers will focus on. The Blu device and others are likely filled with nasty chemicals, but those of us who use organic and regulated VG and flavors commonly found in baking know we aren't using harsh chemicals and pride ourselves in being aware.

So the voices of us need to heard but sadly the focus will be in the big tobacco e-cigs (which should be regulated and tested) and that will make all the good organic juices we know become a poisonous and regulated (therefore taxed) substance.

Knowledge is what's missing

 

[DrMA]

Just because it's clearly part 2 of the 3-part FDA witch trial on vaping, doesn't mean we shouldn't keep trying to get our voices heard. I encourage CASAA to try again to get Dr. Phillips on the agenda. I hope other THR researchers who understand the huge potential of vaping will also continue to send requests to make presentations about the true science of vaping.

 

[caramel]

These workshops are intended to better inform FDA about these products." By WHOM?

Excellent question. Either sufficient studies exist - at which point FDA could just spend some time at the library, draw some conclusions, publish them then have a public debate - or they don't, at which point FDA should commission such studies with several independent parties (universities, medical staff etc).

 

[philoshop]

The FDA is not looking for information or answers. They're looking for justification. Independent studies have largely been dismissed thus far precisely because they're 'independent'.