FDA Comments listing.

[Kent C]

I've went through the deeming doc and cut and pasted the 'request for comments' and PM'd them to myself for easy posting here. It's extensive - 50 questions.

I'm not sure if this would be of use to anyone. It may be just as easy to go through the doc searching "comment" and you'll have more 'background' on what they're asking. However, this list might suit people who are only interested in certain subjects and not all requests.

Also, Kristin said that CASAA might be working on their own list but if Kristin sees this, I could PM her if she wishes, with what I have.

Just a sample:

I'm editing for brevity and for ecigarettes or subjects that are likely connected to ecigs. The numbers may or may not conform to the numbers in the docs....

From the deeming doc.

https://s3.amazonaws.com/public-insp...2014-09491.pdf

Request for Public Comment--In addition to seeking comment on the overall proposed
rule, FDA is specifically seeking comment on the application of the proposed rule to certain
products or in certain circumstances, including the following:

1. FDA requests comments on the characteristics or other factors it should consider
in determining whether a particular tobacco product is a "cigarette" as defined in section 900(3)
of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors,

2. FDA is also seeking research regarding the long-term effects of flavored tobacco product usage including data as to
the likelihood of whether users of flavored tobacco products initiate cigarette usage and/or
become dual users with cigarettes.

3.Accordingly, FDA is seeking comment in this proposed rule as to how such products should be regulated. We particularly
request comment on behavioral data related to co-use of e-cigarettes and more traditional
tobacco products, including data on the effects of e-cigarettes on the initiation and continuation
of use of other tobacco products.

4. FDA is proposing to deem those products meeting the definition of "tobacco product".
FDA is seeking comment on how its proposal to exclude accessories from the scope of the deeming rule would impact the public health. We also
ask for comments, including supporting facts, research, and other evidence, as to whether FDA
should define components and parts of tobacco products and how those items might be
distinguished from accessories of tobacco products.

5. FDA is specifically seeking comment on whether and, if so, how FDA
should consider a different regulatory mechanism for newer proposed deemed tobacco products
that cannot, as a practical matter, use the SE pathway.

6. FDA recognizes that there may be the potential for varying levels of harm and negative effects
on public health for different categories of tobacco products. FDA is considering whether it
might be appropriate for the protection of the public health to stagger the compliance dates for
certain provisions for different categories of products. FDA seeks comment on this issue.

7. FDA recognizes that some of the proposals in this document might impose significant costs on
certain manufacturers.
We request comment on whether and how we should revise our existing guidance to provide for
flexibility in this area, while still being appropriately protective of the public health.

8. Some have advanced views that certain new tobacco products that are non-combustible (such
as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products
given the carcinogens in smoke and the dangers of secondhand smoke. Nevertheless, all tobacco
products containing nicotine are addictive, and FDA is not currently aware of any tobacco
products that do not contain nicotine. Thus, FDA is seeking comments, including supporting
research, facts, and other evidence, as to whether all tobacco products should be required to carry
an addiction warning and, if yes, whether different warnings should be placed on different
categories of products.

9. As explained in the Initial Regulatory Flexibility Analysis, FDA finds that this rule would
have a significant economic impact on a substantial number of small entities. FDA is seeking
comments about any unique challenges faced by small manufacturers of proposed deemed
tobacco products and how they should be addressed.

10. FDA is also seeking comment on the proposed addictiveness warning and any potential for
consumer confusion, the proposed size of the health warnings that would be required by this rule,
and on the role that the size of such warnings has in helping to convey consumer information.

 

[Kent C]

Decided to post the rest. Do with it what you will....

from pg 20

Given this initial data regarding the increased prevalence of flavored tobacco products
following the 2009 flavored cigarette ban, FDA seeks comments, data, and research regarding
the following:

11. Aside from this proposed rule, what additional actions, if any, should FDA take to address
the sale of candy and/or fruit-flavored tobacco products to children and young adults?

12. What is the likelihood that individuals who engage in flavored tobacco product use will
initiate cigarette use and/or become dual users with cigarettes?

13. The prohibition against characterizing flavors established in the Tobacco Control Act
applies to cigarettes only. Consequently, when this regulation is finalized and other
tobacco products are deemed subject to FDA's tobacco product authority, the statutory
prohibition against characterizing flavors will not apply automatically to those products.
However, once they are deemed, FDA may establish a product standard prohibiting
flavors in those products. FDA requests information and data that would support
establishing such a standard.
14. FDA requests comments on the characteristics or other factors it should consider in determining
whether a particular tobacco product is a "cigarette" as defined in section 900(3) of the FD&C
Act and, consequently, subject to the prohibition against characterizing flavors, despite being
labelled as a little cigar or other non-cigarette tobacco product.

15. FDA is aware that some e-cigarettes (as well as other products that would be deemed
under this proposed rule) are being marketed with flavors that may be attractive to young people.
FDA asks for comments, data, and research to determine whether the Agency's evaluation of the
relative risk or potential for harm reduction of such a product should be different in the presence
of flavors in these products, especially if there is evidence that these flavors make the products
more attractive to children.

16. FDA recognizes that it could be difficult for manufacturers of certain
proposed deemed products (e.g., small businesses) to fulfill these requirements. Accordingly,
FDA requests comments as to whether smaller manufacturers may be unable to satisfy these
requirements and how FDA might be able to address those manufacturers' concerns.

17. With application of this requirement, FDA would require registration of all tobacco product manufacturing establishments and product listings for all tobacco products.
FDA requests comment and data on possible ways to implement this requirement (e.g., delaying compliance
with this provision) that would reduce costs for manufacturers yet still be appropriate for the
protection of public health.

18. FDA requests comments and data showing the extent to which this restriction (no free samples) would reduce youth use of the proposed deemed products.

19. FDA will continue to analyze the potential benefits and harms of e-cigarettes, as well as their impact on
nonusers and the population level as a whole, if the deeming rule is finalized. Thus, FDA is
seeking comments, including supporting research, facts, and other evidence, as to how ecigarettes
should be regulated based on the continuum of nicotine-delivering products (as
discussed in section III) and the potential benefits associated with e-cigarettes.*

*On this request, there is quite a bit of information preceding the request and it might be a good idea to look that over before commenting. see pg 39 starting with "D. Request for Comments Regarding Regulation of E-Cigarettes".

20.E. Request for Comments Regarding Components, Parts, and Accessories FDA asks for comments, including supporting facts, research, and other evidence, as to
whether FDA should define components and parts of tobacco products and how those items
might be distinguished from accessories of tobacco products.

21. Therefore, components and parts of the proposed deemed tobacco products would fall under the
scope of this rule, but accessories would not. We are proposing to include components and parts
within the scope of this proposed rule, because they are included as part of a finished tobacco
product or intended for consumer use in the consumption of a tobacco product. However,
because accessories are not expected to be used in the consumption of a tobacco product, we
expect that accessories will have little impact on the public health. FDA is seeking comment on
its proposal to exclude accessories from the scope of the deeming rule.

 

[Kent C]

from pg 43

22. At this time, FDA is not proposing definitions for components, parts, or accessories. If
FDA were to develop definitions of these categories of products, the definitions likely would
include factors such as whether these items are directly involved in the consumption, storage, or
personal possession of tobacco products. These definitions also likely would take into account
the foreseeable effect on public health of these items and whether a tobacco product can
effectively be consumed without such items. If you believe FDA should define these terms, we
seek comment on how to define the categories of "components," "parts," and "accessories." We
also ask for comments on whether and how the use of certain components, parts, or accessories
might be used to alter the effects of the tobacco product on public health, the constituents
delivered by the product, or the potential initiation of new tobacco users.

If this deeming rule becomes final, FDA would have the authority to issue regulations to prevent youth access to ecigarettes
(such as the minimum age and identification provision, which is being proposed with
this rule). FDA asks for comments, data, and research regarding the following:

23. Given the data showing a significant increase in e-cigarette usage among youth (Ref. 4)
and the availability of fruit and candy-flavored nicotine liquids, what other regulatory
actions should the Agency consider taking with respect to e-cigarettes?

24. Does one's use of fruit and candy-flavored nicotine liquids impact the likelihood that such
individual will initiate use of combustible tobacco products and/or become a dual user
with combustible tobacco products? How should that affect FDA's regulatory decisions
regarding e-cigarettes?

25. FDA requests comments on this alternative statement.
"This product is derived from tobacco."
[See pg 93-94 on this. It could include products that aren't derived from tobacco - no nic stuff.]

26. Thus, FDA is seeking comments, including supporting research, facts, and other evidence, as to whether all tobacco
products should be required to carry the proposed addictiveness warning and if different
warnings should be placed on different categories of products.

FDA request comments, including supporting facts, research, and other
evidence regarding the following questions: [here they are trying to put 'tobacco product' on what, with ecigs, are really 'nicotine products, or 'contains nicotine'.]

27. Do the words "tobacco product" in this proposed warning have the potential to cause
confusion for consumers? If so, what are the product types where such a warning could
potentially confuse consumers?

28. If there are concerns about the use of the word "tobacco product," what other language
should FDA consider utilizing in this proposed warning?

29. Would such other proposed language still have the ability to notify consumers that certain
products (especially those that look like candy) are, in fact, tobacco products and
potentially harmful and/or addictive?

Skipped a few request for comments on extension dates since that has already passed. pg 114.

30. FDA also is soliciting comment on what FDA actions or regulatory approaches, if any,
should be taken for proposed deemed tobacco products that are "new tobacco products" under
section 910(a)(1) of the FD&C Act. A new tobacco product means "any tobacco product
(including those products in test markets) that was not commercially marketed in the United
States as of February 15, 2007;

31. Further, we request comment on whether there are
ways that we might provide additional flexibility with respect to PMTAs that would still be
appropriately protective of the public health.

FDA is soliciting data, research, information, and comments on this proposed approach to
compliance for new tobacco products, including comments on the following questions:

32. What are the benefits and/or disadvantages of a new product compliance period longer
than the proposed 24-month period?

33. If you disagree with the proposed 24-month new product compliance period, provide an
alternative compliance date and supporting information.

 

[Kent C]

pg.123

34. FDA is proposing that this compliance approach should be available to all proposed
deemed tobacco products. However, should FDA take into account other factors, such as
the type of product or other circumstances? Why or why not? If so, what factors or
circumstances would be appropriate? For example, is there a justification for having the
compliance policy instead apply to the following circumstances:

When marketing of the new tobacco product is limited to existing adult users of the
product?

When marketing of the new tobacco product is unlikely to be seen or received by
youth?

When the new tobacco product bears certain warnings?

35. Given the express grandfather date and predicate restriction provided in the FD&C Act
that govern the process for legally marketing a tobacco product, what are the implications
for proposed deemed tobacco products?

36. What is the impact on public health that proposed deemed tobacco products that entered
the U.S. market after February 15, 2007, and have no viable predicate have available only
the premarket application pathway?

37. Provide examples of proposed deemed tobacco products that would likely be able to proceed to market via the SE pathway. Describe the range of predicates that would be
available to demonstrate substantial equivalence.

38. What other alternative marketing pathways or policy options should FDA consider if, in
fact, no predicate is available?

39. Are there other legal interpretations of the substantial equivalence grandfather provision
that FDA should consider?

FDA is seeking data, research, information, and comments related to the following:

40. Should FDA consider a different compliance policy for proposed deemed tobacco
products that cannot, as a practical matter, use the SE pathway? If so, what should the
compliance policy entail and would it benefit public health? Instead of, or in addition to,
such a policy, should FDA consider ways to expedite the review of some or all premarket
applications for proposed deemed products?

41. If FDA does establish a compliance policy or an expedited review process, should the
policy or expedited process apply to all proposed deemed products or only to certain
categories of products, such as based on their relative impact on public health? Why or
why not?

42. What other FDA actions or regulatory approaches, if any, should FDA consider for
proposed deemed tobacco products that are "new tobacco products" under section
910(a)(1) of the FD&C Act and why?

43. Are there unique challenges faced by small manufacturers of proposed deemed tobacco
products and how should they be addressed?

44. FDA is seeking comment on
whether manufacturers of certain categories of products (e.g., those that contain fewer or
substantially lower levels of toxicants, consistent with the continuum of nicotinedelivering
products as discussed in section III) could support their applications, and allow
FDA to make its required findings under section 910 of the FD&C Act, with types of
information that would be less burdensome to collect than information needed for other
product categories.

45. Is there anything else FDA should consider to help expedite the application review for
products that have fewer or substantially lower levels of toxicants that are seeking a
marketing authorization under section 910 of the FD&C Act?

We are considering other options as well to best address this issue in a manner that is
appropriate for the protection of the public health. FDA is seeking data, research, information,
and comments on the previously referenced possible approaches. pg 127/8

46. Request for comments regarding possibility of staggered compliance dates.

47. Request for comments regarding requirements for small tobacco product
manufacturers.

48. FDA is seeking comments about any unique challenges faced by small manufacturers of proposed deemed tobacco products and how they should be addressed. [see pg 128 &129]

FDA proposes to treat covered tobacco products in a manner consistent with FDA's treatment of
cigarettes and smokeless tobacco throughout part 1140. See "Regulations Restricting the Sale
and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents "(75
FR 13225, March 19, 2010). In current part 1140, FDA imposes restrictions on cigarettes and
smokeless tobacco, but not on the components, parts, and accessories of such products.

49. In the event that FDA determines it is appropriate for the protection of the
public health to extend the restrictions in part 1140 to components and parts that do not contain
nicotine or tobacco in the future, the Agency will issue a new rulemaking and provide notice and
opportunity to comment on such proceeding. FDA seeks comment on this approach.

Further, as stated throughout this document, FDA is not proposing to cover accessories of proposed deemed
products within the scope of this deeming regulation and, therefore, accessories would not be
subject to the additional restrictions in part 1140. [important to define 'component' and 'accessory' here]

There are a bunch of request for comments starting around pg 160 that deal with estimating time and expense.
This was part of the CASAA CTA #2 so that should have been addressed already.

50. The full analysis of economic impacts is available in the docket for this proposed rule
(Ref. 193) and at

Economic Impact Analyses of FDA Regulations

FDA requests comments on all inputs, methods and results that appear in the economic
analysis.

 

[Kent C]

Impact doc comments....

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

• FDA requests comments on all inputs, methods and results that appear in the following preliminary regulatory impact analysis.

• We do not attempt to estimate the number of manufacturers of other types of newly-regulated tobacco products, such as electronic cigarettes, because very little information about them is available. We request comment on the number of manufacturers of electronic cigarettes and other proposed deemed tobacco products.

• Components and parts of proposed deemed tobacco products would also be deemed to be subject to chapter IX of the FD&C Act, though the additional provisions of this proposed rule would not apply to components or parts that do not contain tobacco or nicotine. We have not....
...quantified the cost of deeming tobacco product components and parts that do not contain tobacco or nicotine, but we request comment on this issue.

• We request comment on whether the cost of ingredient listing would be substantially different for any proposed deemed tobacco products.

• Because most newly-regulated tobacco product manufacturing businesses would be small, FDA assumes that very few routinely develop health documents. Furthermore, this provision would generally serve as a disincentive to continue developing or start developing health documents in the future. Therefore, we expect the cost of this provision to be small and include it under miscellaneous costs. We request comments about the cost of complying with this provision.

• We assume for this analysis that 20 to 80 premarket applications would be submitted...
...within the first 24 months and an average of 10 to 20 would be submitted each subsequent year. We request comment on this assumption.

• We recognize that premarket tobacco applications would be significantly costlier, per product, than the other pathways for introducing new products. If the premarket tobacco application pathway is more widely used than we currently expect, the total cost for marketing new tobacco products would be substantially higher than we currently estimate. We request comment on the number of premarket tobacco applications FDA might receive on an annual basis and the cost of preparing them.

• Based on FDA’s estimates for substantial equivalence exemption requests for currently regulated tobacco products, we expect this to take 12 hours (76 FR 38961 at 38971).
Summing the two components yields a cost of 152 to 232 hours for marketing a product through the substantial equivalence pathway. In the case of a product that has different characteristics from its predicate, it may be necessary to submit clinical data to demonstrate that the new product does not raise different questions of public health. It is uncertain how frequently this would occur, and our estimate does not include any potential cost for conducting clinical studies. We request comment on this issue.

• This alternative would change the grandfather date for determining which products are new from February 15, 2007, to the date this rule is finalized. Therefore, new product submissions would not be required for products introduced between February 15, 2007, and the date of a final rule. As shown in Table 56, upfront costs would fall.68

68 Ongoing costs would be affected slightly, to the extent that there would be a change in the timing of submissions requesting a determination of grandfathered status.

 

[Stosh]

Well, this explains why Swedish Match felt it necessary to submit 100,000 pages of documentation.

Great list, not even sure where to begin.....

 

[Kent C]

Well, this explains why Swedish Match felt it necessary to submit 100,000 pages of documentation.

Great list, not even sure where to begin.....

Perhaps only as a guide. I put the pg numbers at the top so you'll know a 'range'

 

[DrMA]

Tremendous work, Kent C.

However, I seem to recall finding a website on here somewhere listing 99 items where the deeming doc requested comments, though I can't find it right now. I may edit this post later if I do find that link...

 

[Kent C]

Tremendous work, Kent C.

However, I seem to recall finding a website on here somewhere listing 99 items where the deeming doc requested comments, though I can't find it right now. I may edit this post later if I do find that link...

aikanae1 mentioned it here. I asked about it but don't think she saw it. I did my own search at fda - found nothing.....

http://www.e-cigarette-forum.com/fo...n-restrict-vaping-unless-16.html#post13384062

 

[Kent C]

This is likely the list to which aikanae referred - doesn't say 99 and I didn't add them up

Brick by Brick: the Questions | diehealthy.org

 

[AgentAnia]

Terrific job, Kent C, thank you!

I've been thinking since I first started reading the deemings, about these "requests for comments," that they don't really seem to know much about what they're proposing to regulate, do they? Seeing the RFCs separated out from the rest of their (meandering) text, I'm left with the impression that they're asking us to do their work for them.

Of course, maybe that's just me and the pissy mood I'm in today...

 

[Kent C]

Terrific job, Kent C, thank you!

I've been thinking since I first started reading the deemings, about these "requests for comments," that they don't really seem to know much about what they're proposing to regulate, do they? Seeing the RFCs separated out from the rest of their (meandering) text, I'm left with the impression that they're asking us to do their work for them.

Of course, maybe that's just me and the pissy mood I'm in today...

Well.... some here really do believe that and that they want our help. I'm not one of those guys. Yet, the way I operate is to take people at their own words, so many of my comments will likely be along those lines.

It really wouldn't take much more than a search for ecigs to find out a whole lot about them. Just coming here and looking at some basic forums would inform one quite a bit. If I were part of the FDA CTP, I'd make it a point to get informed, ask friends who I know use ecigs, etc. And if someone thinks that the fix is in for BT for cigalikes, then they would have to know what they're excluding and why. I just don't buy that they're uninformed. They're uniformed in other areas - politics, economics, etc. and most a blind to unintended consequences - even when the causal connection is solid. So they really don't think that a black market will form or that they'll actually "force" people to start smoking again.

 

[wv2win]

Great work, Kent. It's amazing that the FDA has easily spent millions of our tax dollars to come up with these mindless regulations about a product that they don't understand, don't want to understand but simply want to go away. Machiavelli and George Orwell's spirits are nodding their heads in a knowing manner.

 

[Gato del Jugo]

I'm one of those that say the FDA knows exactly what vaping is all about.. From cigalikes to APVs, from pre-filled cartridges to bottles of e-liquid to DIY..


Nobody at the FDA watches the local news on TV, reads a newspaper/magazine, or has access to the internet? Nobody at the FDA ever leaves their house & sees a vaper in the wild? They've never seen an image of a non-cigalike before? Anywhere? In the past several years??

Mitch Zeller didn't see those bottles of e-liquid that Senator Harkin kept holding up at that recent HELP hearing?

Accoring to the deeming regs, they obviously know about hookah flavorings & tongs -- but not about an eGo or a ProVari? Yeah, sure, okay...


And I don't buy the line from SFATA's lawyer & former FDA head counsel Ralph Tyler, that SFATA's members need to "educate the FDA" about vape gear... Sounds more like an intentional attempt to waste valuable time & effort, a dead-end, and a distraction from other more important stuff that would acutally help us & SFATA's members win this war..

Obviously not my call to make about who gets to be their lawyer & keynote speaker, but come on, use a little common sense & logical thought, here, before your industry gets led to slaughter...

 

[aikanae1]

Harkin and other congress members have staff that look things up on the internet. I wouldn't be surprised if the FDA/CDC live the same way. This is why listening to any gov't offical about computers, internet or tech in general is an eyeroll. They've had over 20+ years from the time that congress complained about the internet being "too complicated" to increase their knowledge by NOTHING. They seriously know squat and are highly resistant to increasing their knowledge to a level of basic squat. This is a huge pisser that involves anyone dealing with tech.

They do not know how most people live.

 

[sky4it]

Nice job Kent that looks like a lot of work.


as a sidebar note, The FDA is the agency that gave us Human Growth Hormone. At around a 1000 a month. Its used on kids. Little kids. What for? When children have leukemia and other cancers, chemo therapy and other drugs cause growth problems, growth can be stunted. so the survivors of cancer are given an options of human growth hormone. and the agency that gave us Fen Phen, the heart wrecker, and serial tooth decay with some antidepressants.

What is one of the side effects of Human Growth Hormone? Cancer........ There is (at least a some years ago) a sharp increase in cancer amongst people who take Human Growth Hormone vs the regular population. Not mentioned when a NON oncologist offered it here, is the fact 2nd time repeaters of cancer rarely survive. Repeat cancer options mostly go the bone marrow transplant way. The oncologist who took care of this child, didnt even mention taking it, because he knew that too. Risk reward wise, it shouldn't even be considered.

Of course I live in an area where Cancer is quite a bit higher per capita than other parts of the US. What is the likely culprit? The rock formation in Northern Minnesota is amongst the oldest and most stable formations on the planet. There will be no earthquakes or mud slides there. It also was mentioned as a target of nuclear waste material some years ago by the US government. nobody knows for sure, but I suspect. I am not talking about nuclear generator waste, but nuclear bomb waste. Its different. In addition, theres an old standing joke in North Dakota, that if North Dakota succeeded form the union they would be the third most powerful country on the planet. Minot, Grand Forks Airbases used to be fortresses of Nuclear bombs, and there are underground missle silos stretching throughout North Dakota. Many of those silos are now empty, but some are probably not. Still the US army does drive nuc's around here in and out incognito. Maybe cancer will go down. Cause>>>>>> Effect.

 

[Kent C]

Nice job Kent that looks like a lot of work.

Thanks. Actually it was more work that it looks There was odd coding or formatting and a straight copy/paste didn't go so well. Just for example. Where one would usually use 'delete' in the blank space between the text and next part, to move a passage up, delete acted like a 'return/enter' moving it down?? But I caught on to it. lol... even though I'd still try it from time to time. Nope! lol

Interesting other stuff - thanks.

 

[Just Me]

Harkin and other congress members have staff that look things up on the internet. I wouldn't be surprised if the FDA/CDC live the same way. This is why listening to any gov't offical about computers, internet or tech in general is an eyeroll. They've had over 20+ years from the time that congress complained about the internet being "too complicated" to increase their knowledge by NOTHING. They seriously know squat and are highly resistant to increasing their knowledge to a level of basic squat. This is a huge pisser that involves anyone dealing with tech.

They do not know how most people live.

You are absolutely correct on all points. I know several highly educated people who are actually very...well, I hate to say...dumb. They were educated, worked in their closed system environment and don't really know what goes on in the real world. They get whisked into their career system (political, medical, educational, corporate, etc.) and learn to faithfully follow that corridor with blinders on. That's just what systems do. Unfortunately, the ones I know don't accept correction or suggestions well and don't want to learn anything. I heard this expression once--educated idiots. You nailed it.