FDA draft guidance on modified risk tobacco

[Whiskey Hotel]

Released today:

FDA also issued draft guidance today on submitting applications to sell modified risk tobacco products (MRTPs). Modified risk tobacco products are tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the risk of tobacco-related disease.​

Obama administration takes action to address tobacco epidemic​

Do e-cigs fall under this category?​

 

[Bill Godshall]

FDA issues draft guidance for Modified Risk Tobacco Product Applications
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf

FDA press release
Obama administration takes action to address tobacco epidemic

FDA takes two significant actions to advance tobacco regulation

Today the U.S. Food and Drug Administration (FDA) released two separate draft guidance documents to help fight the tobacco epidemic and stop children from using tobacco. The draft guidance documents implement provisions of the Family Smoking Prevention and Tobacco Control Act that will ultimately provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products.

The first document provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products. The second document provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.

Public Health Stakeholder Call Today

Join us today, March 30, at 1:30 PM EST for a teleconference to discuss this announcement.

Conference Number:

800-593-8919 (Domestic)

1-630-395-0132 (International)

Passcode: CTP



Learn more:

Press release
Harmful and Potentially Harmful Constituents (HPHCs)
Modified Risk Tobacco Products (MRTPs)

 

[Bill Godshall]

I suggest folks download and quickly read the 50 page draft guidance for MRTP applications ASAP and call into the FDA's teleconference (that starts in 20 minutes) to ask them why the FDA wants to make it extremely expensive for a smokeless tobacco company to truthfully inform smokers that smokeless tobacco products are far less hazardous alternatives to cigarettes.

While the MRTP application draft guidance currently only applies to cigarette and smokeless tobacco companies, it would also apply to e-cig companies if the FDA approves the "deeming" regulation (that it has stated its intent to do) to apply Chapter IX of the FSPTCA to e-cigarettes.

 

[yvilla]

Do e-cigs fall under this category?

Potentially. But not unless and until the FDA goes through the lengthy process of promulgating a final regulation "deeming" e-cigs to be "tobacco products" that are subject to the authority of the FDA as granted in the FSPTCA (Chapter IX of the FDCA). See, Regulation of E-Cigarettes and Other Tobacco Products

The regulation contemplated in that April 2011 announcement cited above has not even been drafted/released for public comment yet.

Edit: I was busy reading the OP's link, so did not see that Bill beat me to a response.

 

[Vocalek]

This is an example of what we are up against.

Community tobacco control leaders

Results: Results indicated inconsistency about the definition of harm reduction: most groups included a broad range of strategies that extended beyond those typically referenced in the scientific literature. Many participants stated that harm reduction might be beneficial, particularly for smokers who could not or would not quit. However, most also expressed concern about a number of risks, including delivering a mixed message about tobacco, inadvertently benefiting the tobacco industry, and causing unanticipated negative health effects. Participants were inclined to suggest public policy measures (for example, smoking bans, increased taxes) as means for reducing harm.

Hmmm... so the logic goes, to avoid benefiting the tobacco industry, and to avoid allowing anyone to believe that there might be products that are less risky, let's continue using the same public policy measures that have not worked so far. Maybe they will magically start working.

Insanity: doing the same thing... at BrainyQuote

 

[Vocalek]

And here's another one:

Tobacco harm reduction: what do the experts think? -- Martin et al. 13 (2): 123 -- Tobacco Control

Full text: http://tobaccocontrol.bmj.com/content/13/2/123.full.pdf+html

Results: Respondents agreed that harm reduction is at minimum theoretically plausible, that characteristics of “good” and “bad” THR products can be identified, that government regulation is essential but not likely in the foreseeable future, and that additional scientific data are very much needed. However, there was no consensus on specifics, such as preferred regulatory strategies or examples of ideal THR products. Disagreement was seen not only across but also within respondent categories. Mistrust of key stakeholders—for example, tobacco control advocates distrust of tobacco industry scientists and vice versa—was pervasive, and cited frequently as a barrier to regulation and collaboration.

Conclusions: Continued dialogue and debate are essential as we enter a new and uncertain era of products purporting to reduce tobacco produced harm. Experts have concluded that effective government regulation is crucial to minimising the risks associated with THR and maximising potential benefits.

The problem is that nobody has bothered to estimate how many smokers will develop lung disease, cancer, or cardiovascular disease, and how many will consequently die during all the years that it will take to jump through all the hoops trying to figure out how to prove such things as "How many people who would have quit altogether would switch?"

How do you identify those who would have quit altogether? How do you tell how many non-tobacco users will take up use of the product? How do you tell how many of the latter group will proceed to more dangerous products? (Not mentioned is estimating the likelihood of proceeding to more dangerous products if the public understood that those products ARE more dangerous instead of being told in essence that "all tobacco products are equally hazardous.")

 

[Bill Godshall]

Please note that two articles posted in the two preceding posts (by Vocalek on tobacco harm reduction) were published way back in 2003 and 2004 (before e-cigs were invented, before Camel Snus was on the market, and before I and others began to aggressively campaign in support of smokefree tobacco harm reduction products).

 

[Bill Godshall]

For those who didn't tune into the FDA's teleconference call today regarding MRTP, CASAA's Greg Conley and I asked Deyton and Ashley why the MRTP application guidance didn't acknowlege that smokeless tobacco products are far less hazardous than cigarettes, why the FDA webpage on MRTP (entitled Health Fraud) falsely claims that no tobacco product is less hazardous than any other tobacco product, and why the agency is requiring smokeless tobacco companies to spend millions of dollars before they can truthfully inform smokers that smokeless is less hazardous. Of course, Deyton and Ashley failed to answer our questions and obfuscated.

Another person (who I suspect is either on my e-mail list or who saw my posting on ECF) asked if the MRTP application draft guidance applied to e-cigarettes, hookahs and cigars, to which Deyton or Ashley truthfully acknowledged that those products aren't currently regulated by Chapter IX, but that the agency intends to propose a "deeming" regulation to apply Chapter IX to them.

The only other question asked was by someone from the American Cancer Society, but their question was so unimportant that I forgot what it was.

Nothing like raining on FDA's parade again.

 

[JD4x4]

....
FDA press release
Obama administration takes action to address tobacco epidemic

FDA takes two significant actions to advance tobacco regulation

...

Public Health Stakeholder Call Today

Join us today, March 30, at 1:30 PM EST for a teleconference to discuss this announcement.

Conference Number:

800-593-8919 (Domestic)

1-630-395-0132 (International)

Passcode: CTP



Learn more:

Press release
Harmful and Potentially Harmful Constituents (HPHCs)
Modified Risk Tobacco Products (MRTPs)

I'm curious, was the conference call meant for the press, some sort of FDA mail list, whom? Did it come out in this apparent press release dated this same morning?

 

[Vocalek]

Please note that two articles posted in the two preceding posts (by Vocalek on tobacco harm reduction) were published way back in 2003 and 2004 (before e-cigs were invented, before Camel Snus was on the market, and before I and others began to aggressively campaign in support of smokefree tobacco harm reduction products).

From what I have heard at FDA meetings and at SRNT, some of these attitudes persist. We need to keep hammering at them.

 

[JD4x4]

OK, well nevermind my earlier question.

Since I don't see a Federal Register entry, and the FDA site says public comments are accepted until June 4, can I assume that this will (should) be announced in the register on Wed Apr 4, and the 60 day clock starts ticking then?

I think it's important to comment on the language around devices if in fact the later "deeming" regulation takes place. Whereas the example of cigarette papers can be accepted somewhat since they are used to wrap burning tobacco, I don't think it's a proper stretch to leave 'devices' and 'parts' this vague in the context of a vaporizing device, and we should argue to refine their meanings solely in the context of harm producing tobacco elements.

Btw, April looks to be a fairly important & busy month for the Tobacco Control Act, eh?

 

[Vocalek]

OK, well nevermind my earlier question.

Since I don't see a Federal Register entry, and the FDA site says public comments are accepted until June 4, can I assume that this will (should) be announced in the register on Wed Apr 4, and the 60 day clock starts ticking then?

I think it's important to comment on the language around devices if in fact the later "deeming" regulation takes place. Whereas the example of cigarette papers can be accepted somewhat since they are used to wrap burning tobacco, I don't think it's a proper stretch to leave 'devices' and 'parts' this vague in the context of a vaporizing device, and we should argue to refine their meanings solely in the context of harm producing tobacco elements.

Btw, April looks to be a fairly important & busy month for the Tobacco Control Act, eh?

We need to be very careful in our wording. We don't want to suggest any specific wording that would convey the idea that we believe that they ARE currently covered. "Devices" would be a really odd choice of words for describing cigarette papers, etc. Currently the only mention of devices are when they say that drugs and devices that are regulated under the FD&C (that is, as medical products) are not included.

This is the wording in the Draft Guidance document.

Thus, the term is not limited to products containing tobacco, but also includes components, parts, or accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, cigarette rolling papers and filters are tobacco products, whether they are sold to consumers for use with roll-your own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette. This term does not include an article that is a drug, a device, or a combination product as defined in the FD&C Act. Section 201(rr)(2) of the FD&C Act (21 U.S.C. 321(rr)(2)).

To ask, at this point and in this particular document, for a specific exemption for the hardware used for PVs would be premature, since they are not regulated as tobacco products. Also, keep in mind that these requirements would not automatically apply to all PVs if the FDA succeeds in regulating them. They would only apply to the products that are applying for a designation of Modified Risk Tobacco Product.

The point at which to argue what parts of the product are covered or not covered is when the FDA puts out the deeming regulation.

Our comments on this document need to center on three issues:

1. We already have decades of studies, similar to the requirements for "postmarket surveillance," showing that all low-nitrosamine smokeless tobacco products are associated with much lower disease risks than smoking.
2. The suggested process is unnecessary for this class of products and will take a great deal of time and money to implement.
3. Meanwhile, millions of smokers will continue to smoke because the government refuses to let them know that there are less hazardous products. As a result, there will be millions of smoking-related deaths that could be avoided.

IMHO, the acid test for whether a product is safe or not comes after the product is put out for general use. In the case of drugs and medical devices, clinical trials are carefully structured and limit the characteristics of participants to control the number of variables that need to be tracked and evaluated. However, once the product is approved for sale, all types of people will use the product and some serious problems can show up that were not seen in the controlled clinical trials.

The studies that looked at cancer and cardiovascular disease among smokeless tobacco users give us an accurate picture of the population level effects of the products, compared with continued smoking. These studies did not differentiate among brands and products. They only looked at "snus users", not who was using Brand A versus Brand B. Implementing the process described in this document would require each company to put each of their products through a process that is almost identical to the process required for new drug approval.

 

[JD4x4]

Your bullet points are understood and well taken. And admittedly it was late and 'devices' was in my head because the document mentions them earlier on, specifically when it brings up the drugs & 'devices' for cessation which are not covered here.

However, I think you left out the more important wording just before the section you quote, which is-

III. Definitions
This section provides definitions of certain terms used in this guidance.
A. Tobacco Product
“Tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” Section 201(rr)(1) of the FD&C Act (21 U.S.C. 321(rr)(1)).

which gives the vague (imo) definition that the immediately following text only uses for an example-

Thus, the term is not limited to products containing tobacco, but also includes components, parts, or accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, cigarette rolling papers and filters are tobacco products, whether they are sold to consumers for use with roll-your own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette. This term does not include an article that is a drug, a device, or a combination product as defined in the FD&C Act. Section 201(rr)(2) of the FD&C Act (21 U.S.C. 321(rr)(2)).

I'm NOT saying that we ask for excluding language for a particular 'part', but rather better defining language for the ones that they cite in the example. In the example, I can only assume that the cigarette papers and filters are used because you would be hard pressed to find uses for them that don't involve 'smoking'. However, I also assume that 'cigarette' lighters or matches are not expected to be covered. The defining language I'd like to see would be in the explanation of 'why are lighters not covered as an accessory'? Thus closing any 'back door' vague definitions to use at a later date.

Since there is evidence that people currently use PV's and their 'parts' exclusively with zero-nic solutions, I DO want these 'parts' excluded at a later date, and would not be at all shy of pointing out that this language could be incorrectly applied to a non-tobacco item and it should be corrected now rather than later.

.. Just my opinion for discussion. I simply abhor poorly written legislation or regulation. It's what leads us to garbage like the walnut warning letter I linked to in another thread.

 

[rothenbj]

JD, I think the best comparison and what should be clarified is whether the FDA considers a pipe to be a tobacco product. I tend to agree that the definition they use is subject to a lot of abuse. Not to get too far OT or in trouble with the morality police, but there are other uses for rolling paper that have nothing to do with tobacco.

You let the healthists and politicians get involved in these discussions and you end up with RIP/FSC cigarettes that are probably worse, in every way, to the original design specifications.

http://www.huffingtonpost.com/rebecca-brooks/fire-safe-cigarette-laws_b_519867.html

 

[JD4x4]

JD, I think the best comparison and what should be clarified is whether the FDA considers a pipe to be a tobacco product. I tend to agree that the definition they use is subject to a lot of abuse. Not to get too far OT or in trouble with the morality police, but there are other uses for rolling paper that have nothing to do with tobacco.

You let the healthists and politicians get involved in these discussions and you end up with RIP/FSC cigarettes that are probably worse, in every way, to the original design specifications.

http://www.huffingtonpost.com/rebecca-brooks/fire-safe-cigarette-laws_b_519867.html

Well, the objective of a pipe is similar to the papers.. smoking. Granted we are supposed to be talking about tobacco here, but my thought was that a 'cigarette' lighter is more likely to be recognized as having a use other than smoking something and it draws the thought process closer to something else that doesn't involve smoke or even the 'evil' nicotine in all cases.

I never looked into what the fallout was with the fire safe cigarette mandate, so thanks for that link. In 2003-4 when it was being discussed myself and Stevie Wonder could plainly see that it wasn't going to be good for a smoker, so I started rolling my own and did so until Jan of this year when I quit. Glad I did. Saved money as well as my health some, I'm sure. It also became obvious that commercial cigarettes were highly altered, since genuine unadulterated RYO tobacco tends to self-extinguish much more easily. Even if dried to the same crisp as packaged cigarettes.

 

[Bill Godshall]

JD4x4 inquired

I'm curious, was the conference call meant for the press, some sort of FDA mail list, whom? Did it come out in this apparent press release dated this same morning?

This is an excellent question. The FDA only sent the notice about its teleconference call to a separate e-mail list of "Public Health Stakeholders" in an attempt to give them a heads up about the HPHC list and the MRTP application draft guidance, which is why I forwarded it to many other stateholders that the FDA doesn't consider its allies.

 

[Myk]

What about this,
"“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.”"

Weren't e-cigs marketed in the US before 2007?

 

[TennDave]

What about this,
"“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.”"

Weren't e-cigs marketed in the US before 2007?

I think the question is going to be "have they been modified?" Most of what we are using today are different than what was sold back then- at least they look different unless you basically have the 3-piece e-cigs...battery w/ light on the end, atomizer and cartridge on the end of that.

 

[Myk]

I think the question is going to be "have they been modified?" Most of what we are using today are different than what was sold back then- at least they look different unless you basically have the 3-piece e-cigs...battery w/ light on the end, atomizer and cartridge on the end of that.

Tobacco pipes have changed over the years but the basics are the same.
Cigarettes change filter designs and recently had a government forced change with FSC paper.
E-cigs have changed too. The basic design behind all of them has stayed the same.

If e-cigs have been sold in the US since that date I wouldn't put it passed the FDA to claim improvements like tanks would constitute too much modification to get around their own rules but I bet a court wouldn't agree.

 

[EJH]

Tobacco pipes have changed over the years but the basics are the same.
Cigarettes change filter designs and recently had a government forced change with FSC paper.
E-cigs have changed too. The basic design behind all of them has stayed the same.

If e-cigs have been sold in the US since that date I wouldn't put it passed the FDA to claim improvements like tanks would constitute too much modification to get around their own rules but I bet a court wouldn't agree.

I agree. The argument can easily be made that modern PVs are *no* different than the original e-cigarette. What is the purpose of an e-cig? To deliver vaporized liquid to the user. That's it.

How does the PV do this? Electricity is used to activate a heating element which boils a liquid that has been delivered to the element from a reservoir. This describes a pre-2007 e-cig as well as a modern PV. No difference, period.

Any number of analogies could be made. Take the hammer. Thousands of years ago, a caveman strapped a rock to a stick and then proceeded to pound something with it (probably his neighbor's head) Fast forward to today: Fiberglass is fused to alloyed steel to create the finest pounding technology ever, though it is functionally no different than Granpa Oook's neighbor basher. The modern hammer is still essentially a rock lashed to a stick.

I have faith (perhaps naively) that simple common sense will eventually win out over stupidity and greed, that vaping and smokeless will someday become the norm.