FDA draft guidance on modified risk tobacco

[TomCatt]

EXACTLY what I was thinking. Anyone living in Washington, D.C. has seen television & print media ads for military equipment. It is obvious that these corporations understand the importance of not simply swaying our representatives, but their advisors and staff as well.

Tell me where to send money. If there is no one here that is knowledgeable about buying a newspaper page in the Washington Post, I'll try my best to figure it out and price it.

Bill's facts and comments are far too good to simply get buried in a menial, bureaucratic agency like the FDA.

Would this be a co-op opportunity?

 

[Bill Godshall]

Interestingly, Philip Morris International's comments to FDA about MRTP Applications support requiring tobacco companies to conduct much of the unnecessary and expensive research before being allowed to truthfully claim that a smokefree tobacco product is less hazardous than cigarettes.
Regulations.gov

Since PMI (and other large tobacco companies) are fully aware that smokefree tobacco/nicotine products are exponentially less hazardous than cigarettes, it appears that at least PMI supports FDA requiring lots of unnecessary and expensive studies in an attempt to prevent their smaller and less wealthy competitors (e.g. virtually all e-cigarette companies and smaller smokeless tobacco companies) from truthfully informing smokers that their smokefree products are less hazardous than cigarettes.

 

[wv2win]

Interestingly, Philip Morris International's comments to FDA about MRTP Applications support requiring tobacco companies to conduct much of the unnecessary and expensive research before being allowed to truthfully claim that a smokefree tobacco product is less hazardous than cigarettes.
Regulations.gov

Since PMI (and other large tobacco companies) are fully aware that smokefree tobacco/nicotine products are exponentially less hazardous than cigarettes, it appears that at least PMI supports FDA requiring lots of unnecessary and expensive studies in an attempt to prevent their smaller and less wealthy competitors (e.g. virtually all e-cigarette companies and smaller smokeless tobacco companies) from truthfully informing smokers that their smokefree products are less hazardous than cigarettes.

This is the fear that I have about larger companies like PMI and Lorrilard wanting to squeeze the small guy out of the market vastly limiting our options and choices and not improving the far inferior products such as Blu.

 

[Myk]

Interestingly, Philip Morris International's comments to FDA about MRTP Applications support requiring tobacco companies to conduct much of the unnecessary and expensive research before being allowed to truthfully claim that a smokefree tobacco product is less hazardous than cigarettes.
Regulations.gov

Since PMI (and other large tobacco companies) are fully aware that smokefree tobacco/nicotine products are exponentially less hazardous than cigarettes, it appears that at least PMI supports FDA requiring lots of unnecessary and expensive studies in an attempt to prevent their smaller and less wealthy competitors (e.g. virtually all e-cigarette companies and smaller smokeless tobacco companies) from truthfully informing smokers that their smokefree products are less hazardous than cigarettes.

Not surprising at all since the rumor was that PM gave in on their >200% SCHIPs tax as long as RYO got a 2000% increase.

Basically what I told them was the only requirements for "modified risk" was for there to be a lowered risk than cigarettes not that the "modified risk" product needed to be proven perfect. If this was being controlled by sanity that is all that would be required.
But I firmly believe our government is on the corporate payroll from top to bottom without regard to party so I'm not holding my breath for anything to change.

 

[Bill Godshall]

Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW Washington DC 20015
Tel: 202 686-8898 Fax: 202 244-0698
email: ScDBa@aol.com


June 4, 2012

TO: Division of Dockets Management (HFDA-305
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, Maryland 20852

RE: Docket No. FDA 2012-D-0071
Comments concerning draft Guidance for Industry:
Modified risk Tobacco Products Applications; Availability; Agency Information;
Collection Activities; Proposed Collection; Comment Request


· Background and General Comments
· The importance of looking not just at the 'product' but also the 'category' of the product
· Could Sec. 911, in spite of its intentions to protect public health, also have negative effects on public health?
· What are the differing scientific standards that should be applied to not only categories of products but also to individual products whether they are tobacco based or nicotine based?
· IOM Recommendation 10- Consideration of using independent third parties to undertake one or more key functions related to scientific research
· Conclusion


Background and General Comments

Having spent the last 40 years working in support of public health goals and objectives designed to reduce disease and death caused by the use of tobacco products, I appreciate the opportunity to submit these comments. Much of my efforts have been focused on bringing tobacco under the purview of the Food and Drug Administration, so I am particularly interested in seeing how regulations will be implemented.

Up until a few years ago one might have described the relationship between the tobacco control community and the tobacco 'industry' as one that was strictly black and white, confrontational and 'warlike'. The Findings and language of the FSPTC Act reflects that intense mistrust and polarization between public health and the tobacco industry -- and rightly so. Many sections of the statute are therefore more punitive than solution oriented in nature. Section 911 itself takes this approach by raising the bar so high as to seem more focused on keeping science based, significantly lower risk products off the market rather than providing incentives (IOM recommendation in Clearing the Smoke) to assist manufacturers to develop and make new products available to replace the more toxic products currently on the market. (i.e. cigarettes). The reasons for this are clear given that there were only a handful of players involved in shaping the language of many sections of the statute - language that benefited a major tobacco company that at the time only produced cigarettes, a segment of the tobacco control community that in carrying out the 'war', wanted to prevent the possibility of what happened in the 'low tar/low nicotine' debacle from occurring again; and the pharmaceutical industry that also wanted to prevent or inhibit the development or availability of lower risk products and to provide themselves with competitive advantages. While hearings were held on general provisions of the statute (I testified at one of those hearings) there were no substantive hearings or opportunities to have views heard about section 911 -- a section that is from my perspective one of the most important public health sections of the entire legislation. I have said on many occasions that many sections of the FSPTC were outdated even before President Obama's signature on the new public law was dry. Today the tobacco nicotine and alternative products environment continues to change radically and rapidly. This is no longer just about 'Big Tobacco', this is about how new science-based lower risk products (tobacco, nicotine and alternative products) should be brought to the market place (regardless of who the manufacturer is) and which could positively impact on public health. As Director Deyton has often said, FDA (as well as all of those of us in the private sector) is still learning and will continue to learn.

I recognize that the Center for Tobacco Products (CTP) has statutory obligations to fulfill, including the requirements of section 911, but that should not prevent the Center from also stepping back and looking at the issue in a new light and consider leveling the regulatory playing field by developing a more coherent and rational approach to the regulation of all tobacco, nicotine and alternative products.

Part of the requirements of section 911 included a very narrowly defined charge to the Institute of Medicine to produce a report on the scientific standards that would serve as guidance for the CTP in considering applications for MRTPs the subject of this 'notice and request' for comments. At the very first public hearing of the IoM committee, I was both surprised and dismayed that the committee was told to ignore the landmark report Clearing the Smoke.



The importance of looking at not just the product but also at the 'category' of the product

Section 911 focuses primarily on the application by a manufacturer for a product which is both appropriate and necessary. But at the same time it is well accepted in the scientific literature that there are significant degrees of risk between product categories as exemplified by the continuum of risk. FDA should give high priority to developing better mechanisms for defining the risks, relative risks and intended uses of the categories which would include combustible products, and non-combustible smoking replacement products (SRPs) under which I would include traditional forms of smokeless, lower risk products such as dissolvables, e-cigarettes as well as NRT. For those various categories FDA might allow certain statements to be made that would provide the users of any and all of these products with more complete, accurate and more useful information with respect to comparable risks (consistent with 911(h)(1). With better information being provided on the 'categories', manufacturers of individual products could then submit scientific data to the Agency that would allow for modifications to the generic labeling allowances/requirements -- that would include being able to make a spectrum of possible claims and provide additional information etc.

FDA should therefore seek to develop guidance as well as regulations for categories of products as well as setting 'risk profiles' for individual products and provide that information to the public.


Could Section 911, in spite of its intentions to protect public health also have negative effects on public health ?

In spite of the well-intentioned purposes behind section 911 to protect public health, could this section as drafted actually have a negative impact on public health, both for the individual and for the population as a whole? In evaluating the benefit to health under section 911(g)(1) and (2) there are a series of things that the FDA must take into account. All are important and should be considered. But the language of this section and the intense decades- long distrust of the tobacco industry resulted in the bar being raised so high and the 'conditions' so potentially complex that allowing such products on the market becomes difficult if not impossible. Rather than using the standard of a 'reasonable expectation' that a product will reduce risk (that was recommended by IOM in Clearing the Smoke) the standard applied in 911 requires a manufacturer to 'prove' things even before the product can even be put on the market- something that many have called a 'Catch -22'.

There are also no incentives either in the statute or in the proposed guidance (another IOM recommendation in Clearing the Smoke). Is important research and innovation therefore being discouraged if not stifled? Are the regulatory burdens so great that few if any MRTP applications will even be filed, leaving manufacturers and consumers predisposed to selling and using the highly toxic combustible products? FDA's estimation of the amount of hours that will need to be expended for the submission of an MRTP as well as the hours dedicated to surveillance and follow up, is estimated to be 337,624 hours!!!! Both the amount of time and the costs are astronomical. There may be more efficient and more cost effective pathways to allowing products to be made available and for which information might be disseminated by the agency--- designed to provide consumers and the public with truthful, non-misleading information.

And like several other sections of the statute, FDA is required to consider looking at the MRTPs in terms of risks when compared to smoking cessation drugs and devices. And here again this kind of requirement begs the question that if all of the various products are being compared and assessed against one another -- then why aren't all of these products regulated under the same umbrella and based on risks, relative risks and intended uses? Is not an NRT product that doesn't make a therapeutic claim a tobacco product? And isn't it scientifically and technologically feasible that a tobacco-based product might one day be allowed to make a therapeutic claim?

There is also one important consideration that should have been listed as something the FDA needed to take into consideration and that is:

What are the unintended consequences to both the individual and the population as a whole in not making significantly lower risk tobacco, nicotine and alternative products available, especially when compared to the use of combustible cigarettes as well as to the use of nicotine replacement therapies (many of which have been shown not to be very effective)?

N.B. I do not see anything in the statute that would prevent or restrict the FDA from making this a critical consideration in evaluating such benefits to the health of both the individual and population as a whole.



What are the differing scientific standards that should be applied to not only categories of products but also to individual products whether they are tobacco based or nicotine based?

The tobacco 'category/categories' are generally acknowledged as being different than the drug and device categories of the FD&C Act. Yet there seems to be a predisposition (obviously historically based) with only applying drug/device type regulations to tobacco products when in fact there may be value in looking at applying 'food type' standards and regulatory requirements in some cases- especially in the significantly lower risk non-combustible products. Tobacco is a plant based commodity/ product and there is a great deal to learn from FDA's and USDA's experience in setting regulatory standards for food and agricultural products. Even Swedish regulatory authorities which regulate products like snus do so under their food laws should be consulted.

What is said about the product, what information is made available to the consumer, what claims and what types of claims can be made, should be dependent on the degree of science available. Is there significant scientific agreement ? Is there a preponderance of scientific evidence ? Is there accumulating evidence ?

These are the various degrees of scientific evidence that should be used (as they are under the regulatory food policies within the FDA) that would determine the labeling and marketing restriction and allowances for all tobacco, nicotine and alternative products.


IOM Recomment 10 - Consideration of using independent third parties to undertake one or more key functions related to scientific research

Much of what will be driving FDA's regulatory actions related to tobacco, nicotine and alternative products (including those presently referred to as MRPTs) will be good science. For decades the tobacco control community, public health community as well academic research institutions have been suspect of the science conducted by the 'tobacco industry'.

Many will continue to discard industry scientific research. But given that the FDA now has regulatory oversight over tobacco (as well as nicotine), that narrowly defined position is must change, is changing, and will continue to change. Any entity/ 'person' wishing to have an MRTP considered or approved will be required to provide the necessary scientific studies to support the application- and that will include a spectrum of tobacco and nicotine interests.

An independent scientific research body makes sense if in fact the objective of such an entity is to further the development of scientific research and its applications and to foster dialogue in helping establish short term and long term goals, objectives and opportunities. It should not be a 'regulator ' of science. It could be a mechanism by and through which scientific discussions could take place in a more neutral, open and transparent manner. It would and should be open to a spectrum of scientific interests including those in academia, governmental agencies (such as FDA/NIH/USDA/EPA, IOM etc) including similar international counterparts, as well as a spectrum of interests in the private sector who are conducting the research and developing new products. This should include all R&D entities (tobacco, pharmaceutical, biotech and even food). Such an independent entity could also be used as a clearinghouse (again not a 'regulator' of the science) for the dissemination of research --- creating a much needed network devoted to science and not used to promote advocacy positions but at the same time potentially influencing policy decision making.

As part of this submission I would also like to draw the Agency's attention to a set of Core Principles that were produced as part of a 'safe haven' dialogue (March 2011) at the Institute for Environmental Negotiation at the University of Virginia. ( Core Principles Statement Concerning Corporate Funding for Tobacco, Nicotine and Alternative Harm Reduction Research --- A product of the University of Virginia/ Institute for Environmental Negotiation's Forum for a Civil Dialogue on Tobacco, Nicotine and Alternative Products Harm Reduction, October 2011). These Principles contain a series of recommendations on how to manage a variety of issues related to the science of tobacco and nicotine research and I believe that will be of some assistance to the agency as it thinks through what might be done with respect to the creation of an independent body that could take on a number of research function.


Conclusion

While the FDA's request for comments focuses on scientific guidance to industry for the filing of applications for MRTPs, it is clear to me and a growing number of people that what is really needed is more uniform, workable, fair and effective regulatory policy governing all tobacco, nicotine, and alternative products -- that sets regulations based on the risks, relative risks, and intended uses of those product rather than on 'who' manufacturers the product. It is time that our tobacco and nicotine policies be brought into the 21st century and I hope FDA (along with others) will use its existing authorities and provide the necessary leadership to make that happen. One way to do that is to encourage face to face dialogue with stakeholders and other experts.


For additional information go to: Tobacco at a Crossroads

* * *

 

[JD4x4]

Works for me .. if these lawsuits by Dragonite are decided in their favor .. it seems to me that would settle a lot of the 'substantially different' argument bs. (LOEC is on the list as well).

edit- And maybe the 2007 product/market issue??

 

[Luisa]

Smokefree Pennsylvania comments to FDA (part 5)

Marketing of tobacco products to minors violates the 1998 Master Settlement Agreement, laws in all 50 states, and the FSPTCA

Although some anti-tobacco activists continue to publicly accuse tobacco companies of target marketing tobacco products to youth (including dissolvable tobacco products), it is critically important to note that marketing tobacco products to minors violates the 1998 Master Settlement Agreement, statutes in all 50 states, and the FSPTCA.

During the Senate HELP Committee markup of the FSPTCA in 2009, Senators Sherrod Brown and Jeff Merkley (when proposing the amendment to require the FDA to study dissolvable tobacco products) repeatedly accused RJ Reynolds of target marketing the company’s new dissolvable tobacco products (i.e. Camel Orbs, Strips and Sticks) to minors. But no evidence was provided indicating that Reynolds (or any other tobacco company) was marketing their tobacco products to minors.

Similar unsubstantiated allegations were made against Star back in 2001/2002 when Citizens Petitions urged the FDA to ban Star’s Ariva and Stonewall dissolvable tobacco products. In the past decade, no evidence has been provided indicating that youth use Ariva or Stonewall, or that Star markets its products to minors.

All three of the 2001/2002 Citizen Petitions urging the FDA to ban Star’s Ariva and Stonewall also repeatedly referred to the products as “candy like” in an attempt to deceive the agency and the public to believe that Star was marketing to youth. A decade later, and the same false “candy like” references to dissolvable tobacco products has been repeated by those who accuse tobacco companies of marketing the products to minors.

Instead of repeating unsubstantiated accusations to the media, anyone who has any evidence that any tobacco products are being illegally marketed to youth should notify the State AG, State Health Department and/or FDA for enforcement or other remedial action.

Referring to any tobacco product as “candy” or “candy-like” can only encourage youth to use these products, which raises serious concerns about the true motives of those who call tobacco products “candy” or “candy-like’. But that’s precisely what many anti tobacco activists have done, including Karla Sneegas from the Indiana Dept. of Health, as well as in an article recently coauthored by FDA’s Lawrence Deyton.

Although some surveys indicate that youth usage of smokeless tobacco products has increased slightly during the past several years, it is likely that many new youth smokeless users are also cigarette smokers who desire smokefree alternatives to cigarettes. While many anti tobacco extremists have falsely claimed that smokers who also use smokefree tobacco products increase their risks, dual usage of smokeless tobacco and cigarettes is a necessary prerequisite (that can last several weeks, months or years) for cigarette smokers to switch to less hazardous smokefree alternatives, which sharply reduces their tobacco attributable disease and death risks.

Interestingly, a newly published survey of 14-18 year old adolescents in Finland found that 10% had used NRT products, and that most users were daily smokers. The reasons for NRT use were just try (56%), to quit (33%) and smoking not possible (24%). Adolescents’ self-reported reasons for using nicotine replacement therapy products: A population-based study, Susanna Raisamo, David Doku, Arja Rimpela, Addictive Behaviors Volume 36, Issue 9, September 2011, 945-947.
http://www.sciencedirect.com/science/article/pii/S0306460311001572

Electronic Cigarettes also are Far Less Hazardous Alternatives to Cigarettes, and Have Helped About a Million Smokers Quit Smoking

Although electronic cigarettes (e-cigarettes) are not currently subject to Section 911’s MRTP provisions, approximately one million smokers have quit smoking or sharply reduced their cigarette consumption by switching to or substituting smokefree e-cigarettes. To date, there is no evidence that e-cigarette usage has harmed anyone, which is logical since the products emit a tiny amount of vaporized nicotine (similar to nicotine inhalers that are marketed as smoking cessation aids) and water vapor. Of the dozen plus laboratory tests conducted on e-cigarettes, only one (conducted by the FDA in 2009) found a trace (and well below toxic) level of one so-called toxic chemical in just one of eighteen samples tested, and levels of nitrosamines in e-cigarettes are nearly identical to those in nicotine gums and patches. Despite truthful marketing claims by many e-cigarette companies that the products are less hazardous than cigarettes, there is no evidence that youth or non tobacco users have become regular users of e-cigarettes. http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
http://www.starscientific.com/404/stepanov tsna in.pdf
http://www.casaa.org/resources/lab.asp
http://www.hsph.harvard.edu/centers-institutes/population-development/files/article.jphp.pdf
http://www.jstage.jst.go.jp/article/seikatsueisei/55/1/55_59/_article
Effect of a nicotine free inhalator as part of a smoking cessation program
http://ectoh.org/documents/3B.5 Ett...ation satisfaction and perceived efficacy.pdf
Interviews With
'It's Not the Addiction that Kills People, It's the Smoke' - The Takeaway
Electronic Cigarettes
Electronic cigarettes (e-cigs): views of af... [Int J Clin Pract. 2011] - PubMed - NCBI
http://www.scirp.org/journal/PaperInformation.aspx?paperID=6134&publishStatus=2
http://www.sciencedirect.com/science/article/pii/S0300483X11002095
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http://www.casaa.org/news/article.asp?articleID=197&l=a&p=
Behavioural Insight Team annual update | Cabinet Office

Former FDA Commissioner David Kessler has also acknowledged the benefits of smokeless tobacco, dissolvables and e-cigarettes as less hazardous alternatives for cigarette smokers at http://www.westport-news.com/busine...-Commissioner-talks-about-tobacco-1735433.php by stating "there's no doubt that in terms of risk of death there are some advantages to that substitution."

E-cigarettes also have been found to contain/emit similar or lower levels of nicotine than nicotine gums and lozenges at
http://www.healthnz.co.nz/2010 Bullen ECig.pdf
http://www.e-cigarette-forum.com/fo...eissenberg-study-vindicates-e-cigarettes.html

This indicates that e-cigarettes emit enough nicotine to satisfy the cravings of smokers, but may not emit enough nicotine to addict nonsmokers. Several published surveys have confirmed that e-cigarettes satisfy the cravings of smokers, and provide many health benefits to users who switched from cigarettes.
http://ntr.oxfordjournals.org/content/early/2011/05/12/ntr.ntr088.full.pdf+html
http://www.biomedcentral.com/content/pdf/1471-2458-10-231.pdf
THR2010. (tobaccoharmreduction.org) (see chapter 9)

Other public health organizations that have extensively studied e-cigarettes have also endorsed their use by smokers, including The American Association of Public Health Physicians at Regulations.gov and the American Council on Science and Health at NEJM editorial: e-cigarette users should resume smoking for their own good > Facts & Fears > ACSH.

About Smokefree Pennsylvania

Since 1990, Smokefree Pennsylvania has advocated local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers and the public that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and in 2007 we convinced Senator Mike Enzi to amend the FSPTCA to require picture warnings on cigarette packs.

Disclosure

For disclosure, neither Smokefree Pennsylvania nor I have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

Many times I feel everything we do only falls on deaf (or deliberately deaf) ears. It seems no bureaucrat or pseudo scientist wants to hear the truth or have their beliefs challenged by the truth.

 

[Vocalek]

Many times I feel everything we do only falls on deaf (or deliberately deaf) ears. It seems no bureaucrat or pseudo scientist wants to hear the truth or have their beliefs challenged by the truth.

It can seem that way, because there are so many prohibitionists in power (e.g., on state or local boards of health, who all seem to be singing from the same hymnal). But there are legislators who do listen, so we cannot give up. I give you these success stories: Successful CASAA Campaigns (Also include the State of New York that decided to pass the ban on sales to children instead of banning all sales.)

 

[kiffy]

Just a quick question, Here in Ireland there is no policy on E-Cigs/Vaping in the EU. Though I have been told it's in the pipeline.
What I'm not sure of with your FDA is it only nicotine liquid that faces a ban? What about nicotine free liquid, surely that doesn't come under the same umbrella?
I used non nico liquid for 4 days not realising it didn't contain any nicotine (bought it on holidays in Greece) and only noticed it when I went back to the shop to buy more and it was pointed out to me, so I could (if any ban comes in) vape this rather than go back on cigarettes.
I had been smoking 30 a day for 39 years and never lasted longer then 3 days of sheer hell before going back to cigarettes, even after my father died of lung cancer, and in the 40 days since vaping I haven't even had the slightest interest in putting one back in my mouth. So I would vape non nicotine liquid rather than smoke again.
Maybe this point has been raised in other posts but it would take an age to find it.
Can anyone shed any light on where non nicotine liquid stands in any FDA or other government plans?
Thanks.

 

[Vocalek]

It's anybody's guess Kiffy. There are no regulations in place. In fact, the FDA does not yet have authorization to regulate e-cigarettes. First they would need to issue a "deeming" regulation, stating that they are going to regulate the products. The actual regulations would not be issued until after the deeming has been accomplished.

There's all kinds of speculation, but nobody knows for sure whether they would or even could regulate liquid with no nicotine as a tobacco product.

 

[Luisa]

It can seem that way, because there are so many prohibitionists in power (e.g., on state or local boards of health, who all seem to be singing from the same hymnal). But there are legislators who do listen, so we cannot give up. I give you these success stories: Successful CASAA Campaigns (Also include the State of New York that decided to pass the ban on sales to children instead of banning all sales.)

I know,Elaine,and you and so many others have worked so hard and the successes are to be celebrated. It just seems as if one bad situation is blocked,100 others pop up. "They",also, seem to come up with new truth distortions almost daily.

 

[Vocalek]

True enough Luisa. But we must not give up hope. If we do nothing, they win by default.

If they win, many people will suffer and die unnecessarily. The hard part is convincing them that they are not the life-savers they picture themselves to be. They feel that if they can just convince smokers not to switch to another alternative, keep up the punishment, and wait long enough, eventually all smokers will "quit completely."

The two problems with their viewpoint are as follows:

a. No matter how draconian they get with all their prohibitions, there are people who will never "quit completely." They'll be willing to become criminals before they would do so.
b. Even if eventually many smokers do eventually "quit completely" the damage inflicted by their continued years (or even months, for that matter) of smoking will trigger illnesses that result in unnecessary suffering and earlier deaths.