FDA Modified Risk Tobacco Products meeting

[rolygate]

From Bill G.:
This Wednesday 3rd is the deadline to register to attend and speak at the August 24-25th public workshop on Modified Risk tobacco Products.

As the FDA has announced its intention to regulate e-cigarettes under Chapter IX / Secion 911 (the MRTP provision) of the FSPTCA, community advocates and trade representatives should be attending this meetiing.

Details:
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm259201.htm

Agenda:
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM266138.pdf

 

[Vocalek]

You do not have to attend in person to have your voice heard:

In addition, we strongly encourage submitting comments to the docket.

Submit Comments Via the Web

• Visit regulations.gov to go directly to the notice
• Click on the orange box titled "Submit a Comment"
• Fill out the required information (you may either type your comments directly into the field or attach a separate file such as Word, PPT, or PDF)
• You may preview your comment, but please make sure to click the "Submit" button when you are finished

Submit Written Comments

To submit written comments, please identify comments with docket “FDA-2011-N-0443” and mail to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Remember that the topic is "Scientific Evaluation of Modified Risk tobacco Product Applications"

II. Workshop Objectives and Issues for Discussion

The purpose of this public workshop is to obtain information and
comments from appropriate medical and scientific experts, which may
include academia, public health groups, regulators, manufacturers of
tobacco products, health care professionals, interested industry, and
professional associations, and the public about the scientific issues
associated with assessment and ongoing review of MRTPs. The input from
the public workshop is expected to provide valuable information to
assist the Agency in developing guidance or regulations.

You can read through the entirety of Section II to get an idea of the types of scientific issues to be addressed. Regulations.gov

Each of the sub-sections A through F in Section II list the specific questions the FDA wants answered. You do not need to address all of these you can pick one sub-section to talk about, or even a specific question within a sub-section.

 

[Thulium]

And it begins...

1. What scientific evidence would inform a determination that an MRTP, as actually used, will significantly
reduce harm and the risk of tobacco-related disease to users? What types (if any) of scientific studies
other than long-term epidemiological studies could show a significant reduction in harm and the risk of
tobacco-related disease to users?

I would like to suggest that the methods and amounts of propylene glycol vapor produced by products marketed as "electronic cigarettes" be tested for its potential germicidal effects as a potential method of disease prevention. This study from 1943 can serve as a template: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2135415/pdf/387.pdf

 

[tybin]

bump for an important cause!

 

[Vocalek]

And it begins...



I would like to suggest that the methods and amounts of propylene glycol vapor produced by products marketed as "electronic cigarettes" be tested for its potential germicidal effects as a potential method of disease prevention. This study from 1943 can serve as a template: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2135415/pdf/387.pdf

Be careful what you suggest. Remember that at the moment, electronic cigarettes are not regulated products at all. Despite Judge Leon's assertion, the law as it is worded only covers cigarettes and smokeless tobacco. The FDA will be proposing regulations to expand its powers to all tobacco products (which is not what the lawmakers intended or specified.)

So the FDA will be addressing first the regulated products such as snus. Any testing that the scientists recommend will become what the companies must perform, and pay for themselves, to get their products approved. We do not want to make the testing requirements so burdonsome that no company will be able to apply for modified risk status.

There is a rich body of existing scientific research on the health effects of switching to snus. I am thinking that we want to recommend that this be considered sufficient. We would want to suggest that no further testing be required to grant snus the status of modified risk. At the moment, it is not definite that dissolvable tobacco products such as strips, sticks, and orbs are regulated products at all.

We might want to make a generic recommendation that any tobacco product that isn't smoked automatically be permitted to list harmful elements that are absent in the product: "Contains no tar, poisonous gasses, inhaled particulates, or chemicals created by combustion."

We might also suggest that labels list the quantity of TSNAs delivered by a "serving" of the product and the delivered quantity of nicotine. This would allow tobacco consumers to make informed decisions.

We might also want to address the fact that the current labeling requirements ("This product is not a safe alternative...") mislead smokers into believing that there is no health benefit associated with switching to a smoke-free product. The labels also harm young smokeless tobacco users by obscuring the fact that switching to smoking will greatly increase their health risks. We would like to see these labels become tied to facts. "Smoking is X% more harmful than this product."

 

[Thulium]

Be careful what you suggest. Remember that at the moment, electronic cigarettes are not regulated products at all. Despite Judge Leon's assertion, the law as it is worded only covers cigarettes and smokeless tobacco. The FDA will be proposing regulations to expand its powers to all tobacco products (which is not what the lawmakers intended or specified.)

You are of course absolutely right that we must be careful, but this suggestion is specifically answering the question, "What types (if any) of scientific studies other than long-term epidemiological studies could show a significant reduction in harm and the risk of tobacco-related disease to users?" If they are asking this question earnestly, I suggest they re-examine what we already know about the germicidal effects of propylene glycol vapor.

I suspect that this question was asked so that when they get no response, they can claim that there can be no evidence that PREP's actually reduce harm without many years of epidemiological data (that they can ignore). This is ANOTHER type of scientific study that could show a significant reduction in harm--others could include studies on the addictive potential of nicotine compared to nicotine combined with other tobacco alkaloids and byproducts of combustion should show that smoke-free products should have a sharply reduced potential for addiction when compared against the habit reinforcing MAOI's and other chemicals found in cigarette smoke.

 

[Bill Godshall]

Below is the full text of my e-mail notifying tobacco harm reduction advocates about the August 25/26 MRTP public workshop.


Tobacco Harm Reduction Advocates:

Please note that August 3 (this Wednesday afternoon) is the deadline to register to attend (and to speak during the public comment period) the FDA's August 25/26 public workshop on Modified Risk Tobacco Products at Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications

I sent the following e-mail to workshop.CTPOS@fda.hhs.gov to register to attend and to speak at the workshop, and suggest it as a sample for others who are interested in attending (and presenting).

"Per FDA's notice at Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
the purpose of this e-mail is to register to attend the August 25/26 "Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications", and to present comments (during the open comments session on August 25) addressing questions A 1, A 2, B 1, B 2, B 3, C 1, C 2, C 3, C 4, D 1, D 2, D 3, D4, E1, E2, F 1, F 2, F 3, F 4, F 5 in the Federal Register notice at Regulations.gov. Ten minutes should suffice for my public comments."

Please note that the Modified Risk Tobacco Product provisions (Section 911 of the FSPTCA) currently apply only to cigarettes, RYO and smokeless tobacco products. But when the FDA conceded to abide by Judge Leon's ruling that e-cigarettes are tobacco products, the agency also stated its intent Regulation of E-Cigarettes and Other Tobacco Products to propose a regulation that would apply Chapter IX (which includes Section 911) of the FSPTCA to ALL currently unregulated tobacco products (e.g. little cigars, large cigars, pipe tobacco, shisha/hoookah, e-cigarettes, e-liquid, at least two dissolvable tobacco products [Ariva BDL and Stonewall BDL], dissolvable nicotine products, tobacco/nicotine skin products and nicotine water).

The draft agenda for the August 25/26 workshop is at
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM260504.pdf

Also, please carefully read the Federal Register Notice at
Regulations.gov
and note the following excerpt.

"Registration to Attend the Workshop and Requests for Oral Presentation: If you wish to attend the workshop or make an oral presentation at the workshop, please e-mail your registration to workshop.CTPOS@fda.hhs.gov by close of business on August 3, 2011. Those without e-mail access may register by contacting Anuja Patel (see Contact Person). Please provide contact information for each attendee, including name, title, affiliation, address, e-mail address, and telephone number. Registration is free and will be on a first-come-first-served basis. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization as well as the total number of participants based on space limitations. Registrants will receive confirmation once they have been accepted for the workshop. Onsite registration on the day of the workshop will be based on space availability. If registration reaches maximum capacity, FDA will post a notice closing registration for the workshop at Tobacco.

An open comment session will be held during the public workshop on August 25, 2011, from 11 a.m. to 12:30 p.m., during which comments from the public will be accepted. If you would like to make an oral presentation during the open comment session, you must indicate this at the time of registration. FDA has included questions for comment in section II of this document. You should identify the question number(s) you will address in your presentation and the approximate time requested for your presentation."

Please note that any new scientific studies, surveys, data, etc. the FDA may require tobacco companies (that apply to make a Modified Risk Tobacco Product claim) would be paid for by the companies with costs passed on to consumers, and that excessive research requirements could discourage tobacco manufacturers from submitting MRTP applications, even to truthfully claim that a smokeless tobacco product is less hazardous than cigarettes.

My February 3 presentation to the IOM Committee that the FDA has commissioned to recommend scientific studies for MRTP applications is at Vapers Forum - View Single Post - IOM Committee on Scientific Standards for Studies on Reduced Risk Tobacco Products during which I recommended that the FDA require NO additional studies for a smokeless tobacco company to apply, and be approved, to make a truthful claim that a smokeless tobacco product is less hazardous than cigarettes.

Feel free to contact me ASAP if you have any questions or concerns, or if you desire more information.

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com

 

[Bill Godshall]

Below is an important update I just sent to tobacco harm reduction advocates about the August 25/26 MRTP workshop.


Tobacco Harm Reduction Advocates

The FDA has updated the preliminary agenda for its August 25/26 "Scientific Evaluation of Modified Risk Tobacco Product Applications: A Public Workshop" at http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM266138.pdf

Considering the facts cited below, it is very important that many tobacco harm reduction advocates attend this public workshop (please see last night's e-mail for registration details), and that many attendees remind the FDA (especially during the public comment period) about the scientific and empirical evidence confirming that:
- smokeless tobacco products (and other smokefree alternatives) are exponentially less hazardous than cigarettes,
- switching to smokefree tobacco alternatives reduces a smokers health risks nearly as much as quitting all tobacco usage,
- millions of smokers have quit smoking or sharply reduced cigarette consumption by switching to smokefree alternatives,
- dual product usage is a prerequisite for smokers to switch to smokefree alternatives,
- federal health agencies have deceived the public about the health risks of smokeless tobacco products for 25 years,
- it is already illegal to market and sell tobacco products to minors.


FACTS about the FDA, Tobacco Harm Reduction and Scientific Evidence

According to the preliminary agenda for the MRTP workshop, the FDA has invited many tobacco harm reduction opponents to present, but only one tobacco harm reduction advocate (Scott Ballin) who doesn't work for a tobacco company. http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM266138.pdf

At its webpage entitled "Tobacco-Related Health Fraud", the FDA falsely and deceptively claims:
"All tobacco products are harmful to your health, despite what they taste, smell, or look like. Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use. FDA considers these kinds of claims to be health fraud. These kinds of claims can only be made after scientific evidence to support them has been submitted to FDA, and FDA has issued an order permitting their marketing use. To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."
Health Fraud

The FDA's notice about the August 25/26 MRTP workshop in the June 22, 2011 Federal Register failed to acknowledge the scientific consensus that smokeless tobacco products are less hazardous than cigarettes, falsely implied that Section 911 of the FSPTCA applies to ALL tobacco products (it only applies to cigarettes, RYO and smokeless tobacco products), and asked workshop participants to focus discussion on more than a dozen questions that deceptively presume/imply that all tobacco products are similarly hazardous and that there is no scientific or empirical evidence confirming that smokeless tobacco products are less hazardous than cigarettes.
Regulations.gov

The FDA commissioned IOM Committee on "Scientific Standards for Studies on Modified Risk Tobacco Products" invited many tobacco harm reduction opponents to present at its May 9, 2011 meeting, but didn't invite any tobacco harm reduction advocates (who don't work for a tobacco company) to present.
Agenda - Institute of Medicine

At its July 21/22 meeting on dissolvable tobacco products, the FDA failed to acknowledge that dissolvable (and other smokefree) tobacco products are less hazardous than cigarettes, and asked TPSAC to focus its discussion/study/report on very small, hypothetical and grossly exaggerated risks of dissolvable tobacco products instead of conducting an objective evaluation of the risks and benefits of the products.
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM263294.pdf

After consenting to comply with Judge Leon's ruling in Sottera Inc v FDA at Electronic Cigarettes the FDA continues to post many false and misleading claims about the health/safety benefits/risks of e-cigarettes, about the marketing of e-cigarettes, and about the legal status of e-cigarettes (which are not subject to Chapter IX of the FSPTCA, and which are not regulated by the FDA as drug devices) at:
Regulation of E-Cigarettes and Other Tobacco Products
FDA Warns of Health Risks Posed by E-Cigarettes
E-Cigarettes: Questions and Answers
FDA and Public Health Experts Warn About Electronic Cigarettes

The FDA has invited many tobacco harm reduction opponents (including several with conflicts of interest) to serve on its TPSAC, but no tobacco harm reduction advocates (who don't work for the tobacco industry).
Roster of the Tobacco Products Scientific Advisory Committee

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com

 

[rothenbj]

You are of course absolutely right that we must be careful, but this suggestion is specifically answering the question, "What types (if any) of scientific studies other than long-term epidemiological studies could show a significant reduction in harm and the risk of tobacco-related disease to users?" If they are asking this question earnestly, I suggest they re-examine what we already know about the germicidal effects of propylene glycol vapor.

I suspect that this question was asked so that when they get no response, they can claim that there can be no evidence that PREP's actually reduce harm without many years of epidemiological data (that they can ignore). This is ANOTHER type of scientific study that could show a significant reduction in harm--others could include studies on the addictive potential of nicotine compared to nicotine combined with other tobacco alkaloids and byproducts of combustion should show that smoke-free products should have a sharply reduced potential for addiction when compared against the habit reinforcing MAOI's and other chemicals found in cigarette smoke.

Those "habit reinforcing" MAOI'S provided through WTAs may very well make e liquid much more satisfactory to those that currently find something missing in E cigs. As someone who could never completely quit smoking on current E liquid, I have an interest in what the WTAs can provide to someone like myself. As far as I know, the other, minor WTAs do not pose near the risks associated with smoking. The WTAs do not have to come from combustion.

 

[rothenbj]

Sounds like being invited to a card game where you know they marked the cards and hoping somehow to come away a winner.

 

[Vocalek]

Sounds like being invited to a card game where you know they marked the cards and hoping somehow to come away a winner.

If you are talking about these FDA hearings, you've got that right, my friend.

 

[Tendril]

Thanks for keeping us posted and for the valuable information. I can't attend but would like to email my comments. Vocalek kindly posted how to do that here. Does anyone know the deadline for submitting comments?

 

[Bill Godshall]

Per the FDA notice at Regulations.gov
the deadline to submit written comments is September 23, 2011.

 

[Bill Godshall]

Anyone who is presenting or submitting comments on the FDA workshop on MRTP, please note that e-cigarettes are NOT currently subject to Section 911 of the FSPTCA (regarding MRTP), and especially note that any suggested scientific studies for MRTP applications (and any studies that the FDA ultimately requires for MRTP applications) would have to be paid for and conducted by the companies that submit an MRTP application, which would increase the cost of the products for consumers, and which could very well be so expensive and time consuming to conduct that NO company will apply to make even a truthful MRTP claim.

The latter possibility is the obvious goal of tobacco harm reduction opponents, who want to prohibit any company from being able to truthfully inform smokers that smokeless tobacco products (and other smokefree tobacco products that may be required to comply with Section 911 and other Chapter IX provisions in the future) are far less hazardous alternatives to cigarettes.