FDA to host Modified Risk Tobacco Product workshop in DC Aug 25/26, free registration still being accepted

[Bill Godshall]

FDA to host Modified Risk tobacco Product workshop August 25/26 in DC, free registration still being accepted
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm259201.htm (to register, about workshop)
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM268803.pdf (workshop agenda)

I encourage everyone who can attend either or both days of this workshop to send an e-mail to
workshop.CTPOS@fda.hhs.gov to register. Although the registration deadline was August 3, they are still accepting registrants.

At least a half dozen tobacco harm reduction advocates are already planning to attend (including Elaine Keller of CASAA, Spike Babaian of NVC, Bill Godshall of Smokefree Pennsylvania, Gil Ross of the ACSH, Jeff Stier of the NCPPR).

Although Chapter IX (including Section 911) of the FSPTCA doesn't currently apply to e-cigarettes or e-liquid, the FDA has stated that it intends to propose a regulation that would apply Chapter IX to e-cigarettes and ALL other currently unregulated tobacco products.

The most contraversial aspect of Section 911 is that it currently prohibits smokeless tobacco manufacturers from truthfully informing smokers that smokeless tobacco products are less hazardous than cigarettes. Much of the discussion at this MRTP workshop will address additional scientific studies that tobacco companies should be required to conduct (and spend lots of money on) before they can truthfully inform smokers that a smokeless tobacco product is less hazardous than cigarettes.

 

[CJsKee]

Will there be video of this workshop like there was for the dissolvables?

 

[Placebo Effect]

I will also be there representing CASAA.

And yes, there will be video.

 

[Bill Godshall]

According to the FDA's webpage posted above:

View the Webcast
FDA will provide a free, live webcast of the MRTP public workshop. The details will be posted on our website soon.

Hopefully, they'll posted a weblink today or tomorrow.

 

[Bill Godshall]

Also, the FDA will accept public comments on this matter until Sept. 23.
FDA to Host a Public Workshop on Modified Risk Tobacco Product Applications

 

[DC2]

Also, the FDA will accept public comments on this matter until Sept. 23.
FDA to Host a Public Workshop on Modified Risk Tobacco Product Applications

Obviously they should be comparing "modified risk" products with the harm from inhaling the smoke from burning tobacco.
So all you should have to do is prove that you don't light it on fire.

And in that light, EVERY PRODUCT that does not involve combustion should get IMMEDIATE status as modifed risk.
Which of course is NOT how this is gonna go down.

The term “modified risk tobacco product” includes any tobacco product that is sold or distributed for use with a claim of reduced harm or reduced risk of tobacco-related disease associated with the commercially marketed tobacco product.

So what exactly are they going to compare a potential "modified risk" product to?

 

[Bill Godshall]

DC2 asked

So what exactly are they going to compare a potential "modified risk" product to?

Each tobacco company that submits an MRTP application to the FDA determines the tobacco products it desires to compare.

If a cigarette maker wants to claim that a certain brand of cigarettes is less hazardous than another brand of cigarettes, or if a smokeless product maker wants to claim that a certain brand of smokeless is less hazardous than another brand of smokeless, it is entirely appropriate for the FDA to require the applicant to conduct and submit additional research (since there is no evidence indicating that any brand of cigarettes is less hazardous than any other brand of cigarettes, and since there is insufficient evidence indicating that any brand of smokeless is less hazardous than another brand of smokeless).

But the FDA should automatically approve, and should NOT require tobacco companies to conduct additional studies (at great cost to the company, and ultimately passed on to consumers), for any MRTP application seeking to truthfully claim that a smokeless tobacco product is less hazardous than cigarettes.

Unfortunately, the FDA has grossly misrepresented the scientific and empirical evidence by claiming

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.

at Health Fraud

 

[Vocalek]

DC2 asked


Each tobacco company that submits an MRTP application to the FDA determines the tobacco products it desires to compare.

If a cigarette maker wants to claim that a certain brand of cigarettes is less hazardous than another brand of cigarettes, or if a smokeless product maker wants to claim that a certain brand of smokeless is less hazardous than another brand of smokeless, it is entirely appropriate for the FDA to require the applicant to conduct and submit additional research (since there is no evidence indicating that any brand of cigarettes is less hazardous than any other brand of cigarettes, and since there is insufficient evidence indicating that any brand of smokeless is less hazardous than another brand of smokeless).

But the FDA should automatically approve, and should NOT require tobacco companies to conduct additional studies (at great cost to the company, and ultimately passed on to consumers), for any MRTP application seeking to truthfully claim that a smokeless tobacco product is less hazardous than cigarettes.

Unfortunately, the FDA has grossly misrepresented the scientific and empirical evidence by claiming

at Health Fraud

At least they were honest about their intentions when they named the page....


Oh wait. You mean they weren't talking about themselves? They were trying to accuse others of fraud?

Pot! Kettle!

 

[rothenbj]

"So what exactly are they going to compare a potential "modified risk" product to?"

That is an interesting question. Modified risk would indicate anything that you could state "xxx is a safer alternative to smoking" should be given that designation. Since they have legislated that tobacco companies can't advertise relative risk (remember nicquid is now a tobacco product), the stance may be that only Pharma products currently are eligible for modified risk designation.

Now all the pharma products have been determined to be "safe and effective" as Pharma products so I could easily see the only modified risk products being approved coming from BP. All they need to do is re-designate them as reduced risk "tobacco" products (remembering again, the courts have now ruled products derived from tobacco as tobacco products) and use the long term health history of NRT against the health dangers of smoking and you have MR products. This would free BP to market their patches, gum, lozenges (in delicious, yummy adult flavors like cherry and mint) for long term use as opposed to the 12 week cycle.

They can then use a formal, expensive and long approval process to keep the truth about comparative non-pharma tobacco products from being advertised.

Now how's that for total pessimism.

 

[Demarko]

Is Niquid a tobacco product? I can't help but wonder if that means the indoor bans in Washington State are invalid now, due to preemption.

 

[Bill Godshall]

rothenbj wrote:

Since they have legislated that tobacco companies can't advertise relative risk (remember nicquid is now a tobacco product), the stance may be that only Pharma products currently are eligible for modified risk designation.

The FSPTCA only applied Chapter IX provisions (including Section 911 on MRTP) to cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco products.

Little cigars, large cigars, pipe tobacco, hookah/shisha, e-cigarettes, e-liquid, nicotine water, and at least two dissolvable tobacco products [Star Ariva and Stonewall BDL] are all tobacco products that are NOT governed by Chapter IX regulations, and as such, can make truthful reduced risk claims (as compared to cigarettes).

rothenbj wrote

Now all the pharma products have been determined to be "safe and effective" as Pharma products so I could easily see the only modified risk products being approved coming from BP. All they need to do is re-designate them as reduced risk "tobacco" products

Drug companies are NOT going try to get their NRT products to be classified and regulated as tobacco products because doing so would be a public relations nightmare for them (as the last thing drug companies want to be portayed as are tobacco companies). Hopefully, however, some entrepreneurs will begin making and marketing products that are virtually identical to nicotine gums and lozenges as tobacco gums and lozenges (and perhaps even tobacco skin patches). That could also quickly eliminate much of the market share for NRT products, as most folks won't pay $.60/piece for a NRT lozenge or gum when you could by a nearly identical tobacco lozenge or gum for $.15-$.20/piece.

 

[rothenbj]

That's what the FDA stated when they lost the appeal. Of course they told Star that THEIR BDL products are not a tobacco product when they applied for Modified Risk. The BDLs appear to be compressed tobacco so it appears we're living in a mixed up world.

 

[rothenbj]

"The FSPTCA only applied Chapter IX provisions (including Section 911 on MRTP) to cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco products.

Little cigars, large cigars, pipe tobacco, hookah/shisha, e-cigarettes, e-liquid, nicotine water, and at least two dissolvable tobacco products [Star Ariva and Stonewall BDL] are all tobacco products that are NOT governed by Chapter IX regulations, and as such, can make truthful reduced risk claims (as compared to cigarettes)."

Bill, I believe you yourself questioned whether the FDA would attempt to move these non-covered TPs (except large cigars) into Chapter IX since it's now considered a loophole.

I must not understand the BDL issue. If they were not considered a tobacco product when they asked for MR designation, how are they a tobacco product in your set?

 

[Bill Godshall]

rothenbj wrote

Bill, I believe you yourself questioned whether the FDA would attempt to move these non-covered TPs (except large cigars) into Chapter IX since it's now considered a loophole.

The FDA merely stated that it intends to propose a regulation to apply Chapter IX to all currently unregulated tobacco products at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

Although the FDA (and especially CTFK, ACS, AHA, ALA, ALF, AAP) are hoping that everyone is gullible enough to believe that their portrayal of "applying Chapter IX to currently unregulated tobacco products" as merely "closing a loophole", and although many harm reduction advocates (including many e-cig companies and consumers) appear to have already conceded that the FDA will apply Chapter IX to currently unregulated tobacco products, any proposed regulation to apply Chapter IX of the FSPTCA to currently unregulated tobacco products would be an enormous and unwarranted regulatory power grab that could take several years to attain, and would likely result in multiple lawsuits against the FDA if it issued a final rule.

Congress authorized the FDA to regulate cigarettes because the companies lied to the public about the heatlh risks of cigarettes and target marketed them to children for decades. And the only reason Congress authorized the FDA to regulate smokeless tobacco was because those companies target marketed their products to children for decades.

But there is no evidence that makers of small cigars, large cigars, pipe tobacco, e-cigarettes, e-liquid, and other currently unregulated tobacco products lied about the health risks of their products, nor is there any evidence that they marketed their products to children.

As such, there is really no compelling public health or safety reasons to impose unneccessary, costly and punitive regulations upon currently unregulated tobacco products.

 

[Bill Godshall]

rothenbj inquired

I must not understand the BDL issue. If they were not considered a tobacco product when they asked for MR designation, how are they a tobacco product in your set?

Everyone agrees that dissolvables (including Star's Ariva BDL and Stonewall BDL) are "tobacco products", the issue of contention is whether or not some/many/most/all dissolvables are "smokeless tobacco products", as smokeless tobacco products are regulated by Chapter IX of the FSPTCA.

When Star applied to the FDA to make Modified Risk claims, Star believed that Ariva BDL and Stonewall BDL were smokeless tobacco products. But when the FDA ruled that those two dissolvables weren't smokeless tobacco products (and thus weren't subject to Chapter IX regulations), it is unknown whether or not some/many/most/all other dissolvable tobacco products will be considered by the FDA to be "smokeless tobacco products".

If nothing else, the FDA's decision on Star's BDL products will encourage other tobacco companies to make ultra-processed dissolvables (that more closely resemble GSK Commit lozenges than dissolvable tobacco products) to escape Chapter IX regulation, which would allow the company to not include smokeless tobacco warnings, would allow the company to make thruthful reduced risk claims without obtaining FDA permission, and would allow the company to make new products (without applying to the FDA to make a new product).

 

[rothenbj]

Compilation of what Bill wrote in previous two posts with emphasis added-

The FDA merely stated that it intends to propose a regulation to apply Chapter IX to all currently unregulated tobacco products at http://www.fda.gov/NewsEvents/Public.../ucm172906.htm.......

Congress authorized the FDA to regulate cigarettes because the companies lied to the public about the heatlh risks of cigarettes and target marketed them to children for decades. And the only reason Congress authorized the FDA to regulate smokeless tobacco was because those companies target marketed their products to children for decades. (I'm assuming you mean under Chapter IX)

Little cigars, large cigars, pipe tobacco, hookah/shisha, e-cigarettes, e-liquid, nicotine water, and at least two dissolvable tobacco products [Star Ariva and Stonewall BDL] are all tobacco products that are NOT governed by Chapter IX regulations, and as such, can make truthful reduced risk claims (as compared to cigarettes).

But there is no evidence that makers of small cigars, large cigars, pipe tobacco, e-cigarettes, e-liquid, and other currently unregulated tobacco products lied about the health risks of their products, nor is there any evidence that they marketed their products to children.

As such, there is really no compelling public health or safety reasons to impose unneccessary, costly and punitive regulations upon currently unregulated tobacco products.

When Star applied to the FDA to make Modified Risk claims, Star believed that Ariva BDL and Stonewall BDL were smokeless tobacco products. But when the FDA ruled that those two dissolvables weren't smokeless tobacco products (and thus weren't subject to Chapter IX regulations), it is unknown whether or not some/many/most/all other dissolvable tobacco products will be considered by the FDA to be "smokeless tobacco products".

First, thanks for your responses. Now let me see if what you wrote was translated properly in my mind.

Since that set of tobacco products (ex. snus, E Cigs and BDL products) are not defined as smokeless tobacco products and not covered by Chapter IX, they are free to be marketed with truthful claims of reduced risk compared to cigarettes, thus they don't need modified risk classification.

The above statement is why BDL products were sent back to star because they didn't fit within the definition of a smokeless tobacco product and thus not a part of Chapter IX and do not require approval to claim reduced risk.

However, the FDA would like to have all tobacco products not covered by Chapter IX to now be defined within the scope of Chapter IX. This will be difficult to accomplish in terms of the amount of time it would take to change the regulations and the fact that the FDA would again find itself in court.

If I've translated this properly, if any of the manufacturers of this set of products feels they can truthfully state they are safer than cigarettes, they are free to do so today, basically giving them all a modified risk classification. The FDA would need to find that these claims were untruthful which would enable them to easily be brought within the context of Chapter IX.

That being said, the FDA is going to attempt to have them all reclassified as Chapter IX products and, if successful, those BDL products would again have to be submitted to the FDA for modified risk classification.

Unless something was seriously found wrong with any of that set, I can't imagine how ANY of those products could be found nearly as dangerous as cigarettes. I also don't understand from the presentations I've read about, why the topic of Pharma products enter the discussion of modified risk and extending their use past 12 weeks. That would appear to be an entirely different subject and not part of a modified risk tobacco product discussion.

 

[Vocalek]

That being said, the FDA is going to attempt to have them all reclassified as Chapter IX products and, if successful, those BDL products would again have to be submitted to the FDA for modified risk classification.

I think they would have a difficult time backtracking on the BDL products. The FDA said that they are not a smokeless tobacco product.

As far as other dissolvables go, the FDA wouldn't even have to issue a regulation to go on record that they will start regulating (non-BDL) dissolvable tobacco products as smokeless tobacco. All they would need would be an annoucement: "OK, our TPSAC tells us that dissolvable tobacco products contain tobacco and are not smoked; therefore they are a smokeless tobacco prdouct and will need to follow whatever regulations we have passed or will pass in the future that apply to smokeless products."

 

[rothenbj]

I think they would have a difficult time backtracking on the BDL products. The FDA said that they are not a smokeless tobacco product.

As far as other dissolvables go, the FDA wouldn't even have to issue a regulation to go on record that they will start regulating (non-BDL) dissolvable tobacco products as smokeless tobacco. All they would need would be an annoucement: "OK, our TPSAC tells us that dissolvable tobacco products contain tobacco and are not smoked; therefore they are a smokeless tobacco prdouct and will need to follow whatever regulations we have passed or will pass in the future that apply to smokeless products."

It's getting late, but I think that goes full circle back to my earlier statement. Tobacco products, BDL Stonewalls, Ariva and from what I understand future BDL moist snuff (snus), are being declared not smokeless products by the FDA while a product derived from tobacco, E Cigs, could be regulated as tobacco products. Is it just late, am I just being thick headed or this just bureaucratic lunacy.

 

[Vocalek]

It's getting late, but I think that goes full circle back to my earlier statement. Tobacco products, BDL Stonewalls, Ariva and from what I understand future BDL moist snuff (snus), are being declared not smokeless products by the FDA while a product derived from tobacco, E Cigs, could be regulated as tobacco products. Is it just late, am I just being thick headed or this just bureaucratic lunacy.

Yes, maybe, and yes.

 

[Bill Godshall]

rothenbj wrote

Since that set of tobacco products (ex. snus, E Cigs and BDL products) are not defined as smokeless tobacco products and not covered by Chapter IX, they are free to be marketed with truthful claims of reduced risk compared to cigarettes, thus they don't need modified risk classification.

Snus is a "smokeless tobacco product", but not e-cigs or Star's Ariva BDL or Stonewall BDL (or any of the other tobacco products I listed in previous post). And yes, legally, any currently unregulated tobacco product can truthfully claim it is less hazardous than cigarettes. But untruthful claims (e.g. a cigar maker claiming their cigars are less hazardous alternatives than cigarettes) could/would likely be reigned in by the Federal Trade Commission. The reality, however, is that e-cigarette and e-liquid makers/vendors are currently the only unregulated tobacco products that have been truthfully claiming they are less hazardous than cigarettes.

rothenbj wrote:

If I've translated this properly, if any of the manufacturers of this set of products feels they can truthfully state they are safer than cigarettes, they are free to do so today, basically giving them all a modified risk classification.

No. Modified Risk Tobacco Product classification can only be granted by the FDA for tobacco products that are regulated under Chapter IX and that successfully apply to the FDA to obtain MRTP approval. Although ALL noncombustible tobacco products are far less hazardous alternatives, only smokeless tobacco products (and cigarettes) can currently apply for MRTP status.

rothenbj wrote

That being said, the FDA is going to attempt to have them all reclassified as Chapter IX products and, if successful, those BDL products would again have to be submitted to the FDA for modified risk classification.

If/when FDA proposes a regulation to apply Chapter IX to dissolvables or some/many/all other currently unregulated tobacco products, it wouldn't be practical (or wise) for the FDA to propose retroactively applying many Chapter IX provisions to currently unregulated tobacco products.

vocalek wrote:
"I think they would have a difficult time backtracking on the BDL products. The FDA said that they are not a smokeless tobacco product."

While I tend to agree, CTFK, ACS, AHA, ALA, ALF and more than a dozen Democrats in the US Senate have urged the FDA to backtrack on Star's BDL products.

vocalek wrote:

All they would need would be an annoucement: "OK, our TPSAC tells us that dissolvable tobacco products contain tobacco and are not smoked; therefore they are a smokeless tobacco prdouct and will need to follow whatever regulations we have passed or will pass in the future that apply to smokeless products."

Even before enacment of the FSPTCA in 2009, Star and RJ Reynolds considered their dissolvables to be "smokeless tobacco products", and put government mandated smokeless warnings on their packages. Altria similarly considers its Skoal and Marlboro Sticks to be smokeless tobacco products, and puts smokeless warnings on them.

I've urged Star, Reynolds and Altria to apply to the FDA to make MRTP claims for all of their dissolvables, as doing so will force the FDA to determine (as it did with Star BDL products) if those products are or aren't "smokeless tobacco products".

I doubt if the FDA's TPSAC will weigh in on the legal status of dissolvables. But even if they do, the FDA's lawyers (and perhaps the courts) are the ones that will actually determine the FDA's position on their legal status, which may differ for various dissolvables.