FDA Economic Impact Analysis

[Kent C]

Actually, they tried to claim authority over cigarettes in 1996 but the tobacco companies sued. Sounding familiar? In 2000 the Supreme Court ruled in FDA v. Brown & Williamson tobacco Corp. that Congress had not given the FDA explicit authority over tobacco or tobacco advertising, and it took the Hill until 2009 to change that.

Ok. In surfing their docs there is a 1995 law they refer to. I'll have to recheck.....

edit: That was regarding the Premarket notification (510(k)) from the earlier Federal Food, Drug, and Cosmetic Act.

 

[FireDragon1138]

One of the things I'm noting is that these regulations are disproportional when applied to electronic cigarettes in many, many ways. I wonder if the FDA is allowed to make regulations so discriminatory against a single sector of the market.

That's the whole point, e-cigs are new, and therefore issues of discrimination don't register. The bias is to see e-cigs as a danger that is only allowed to exist as a political expediency.

 

[EleanorR]

No no no no, the FDA are good righteous people trying to protect us, they are simply giving vendors an EXIT.

I would rather be exited then fired...... I think?

Oh, of course . . . it's like that job-lock thingy, right? So being "exited" is a GOOD thing, RIGHT?

 

[inter_ceptor00]

http://tobaccoanalysis.blogspot.com/2013/03/ironically-fda-seen-as-main-obstacle-to.html

 

[inter_ceptor00]

And just in case it hasn't been posted yet.

http://www.e-cigarette-forum.com/fo...asaas-first-cta-fda-proposed-regulations.html

We need to request an extension of the comment period, so we can prepare a better case for our defense.

 

[Jman8]

Help me Grandfather, you're our only hope.

I see some leeway here - but you should read and evaluate for yourselves:

Pg. 57
3. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation

And... pg 69

4. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation [Regulatory Alternative 3]

The table shows the reduced burden for cigar manufacturers but this alternative would provide even greater relief for small businesses producing electronic cigarettes.

I realize this comes up for discussion beyond post (#13), but I feel there is substantial leeway here. FDA is a regulatory agency, not a law establishing body, and has admitted it doesn't have power to change this. But Congress has that power. Vaping community and small vendors can remind Congress that they likely weren't thinking about eCigs when FSCPTA was being drawn up.

Each time I explore this tangent, I get linked to SBA and advocacy it does on behalf of "regulatory flexibility analysis." SBA wording on this reads, to me, like this absolutely needs to be addressed whenever a proposed regulation is put forth, while FDA economic impact analysis reads like, "yep, we've considered this. Now moving along to our agenda..."

As this is the hugest item that we consumers in the vaping community keep talking about, and I imagine many vendors (smaller entities) are already aware of, or very soon will be, then it does behoove us to push this point for all it is worth. IMO, this is absolutely a key point, highly significant front, for us to address these proposed regulations.

And don't really need to negotiate with FDA on this one. Assets we have going for us include: all vapers rallying behind this, SBA advocacy (as it would lift huge burden off of existing small businesses), Congress, and FDA's (and thus government's) own admission that this one step would reduce costs.

I don't see what we have to lose by pushing for this.

3. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation

Under this alternative, the grandfather date for determining which products are considered new would be moved from February 15, 2007, to the date this rule is finalized. All other aspects of the rule would remain as proposed. This would reduce costs in the first 24 months as new product submissions would not have to be prepared for products introduced into domestic commerce between February 15, 2007, and the date of the final rule; that is, manufacturers would not start with such a large multi-year backlog of new products.63 However, manufacturers would still bear the substantial costs of preparing new product submissions for the new products introduced each year.

If no valid predicate exists for electronic cigarette products, then changing the grandfather date would have additional implications for electronic cigarettes. In our analysis of the proposed rule, all electronic cigarette products would be new tobacco products and many would exit the market rather than bear the cost of submitting a premarket tobacco application, which would be required in the absence of a valid predicate product. By contrast, if we change the grandfather date, only electronic cigarette products introduced after the issuance of a final rule would be considered new, and a large number of candidate predicates would exist. We assume that new electronic cigarettes would then be marketed through the substantial equivalence (or exemptions) pathway. We would no longer assume that many electronic cigarette products would exit the market, but instead assume that all electronic cigarette labels would be changed to conform with the requirements of the proposed rule.

Under this alternative, the benefit associated with potentially preventing increased-risk products from entering the market could be reduced. Instead of having FDA evaluate proposed deemed tobacco products introduced between February 15, 2007, and the date of the final rule, such products would be grandfathered. This alternative would create an incentive for tobacco product manufacturers to rush new products to market before a final rule is issued to ensure that their products would be grandfathered. If some products introduced during that period are riskier than those existing before February 15, 2007, such products (and products found substantially equivalent to them) could be marketed in the absence of other grounds for their removal. For electronic cigarettes, the welfare effects of changing the grandfather date would be unknown (see Section II.A.4.b).

This alternative could be combined with Alternative 3 (exempt handmade cigars from labeling changes). Because they alter different aspects of the rule, the changes in estimated costs would be additive. Combining these alternatives would dramatically reduce the costs of compliance for handmade cigars.

 

[Kent C]

I realize this comes up for discussion beyond post (#13), but I feel there is substantial leeway here. FDA is a regulatory agency, not a law establishing body, and has admitted it doesn't have power to change this. But Congress has that power. Vaping community and small vendors can remind Congress that they likely weren't thinking about eCigs when FSCPTA was being drawn up.
Each time I explore this tangent, I get linked to SBA and advocacy it does on behalf of "regulatory flexibility analysis." SBA wording on this reads, to me, like this absolutely needs to be addressed whenever a proposed regulation is put forth, while FDA economic impact analysis reads like, "yep, we've considered this. Now moving along to our agenda..."

As this is the hugest item that we consumers in the vaping community keep talking about, and I imagine many vendors (smaller entities) are already aware of, or very soon will be, then it does behoove us to push this point for all it is worth. IMO, this is absolutely a key point, highly significant front, for us to address these proposed regulations.

And don't really need to negotiate with FDA on this one. Assets we have going for us include: all vapers rallying behind this, SBA advocacy (as it would lift huge burden off of existing small businesses), Congress, and FDA's (and thus government's) own admission that this one step would reduce costs.

I don't see what we have to lose by pushing for this.

Hence, the 'only hope' line. You may have been the only one that actually looked at to what I was referring. Thanks! lol. I know much of what I say here is received by the "open minded", ie. in one ear and out the other, but I appreciate those that 'get it', but you're bolded part in your above post, is exactly my point.

My bolded part on your comments here, is a crucial understanding imo. IF that is possible, it would uncut all other questions, concerns, fears, etc. Having our current ecigs or the ones upon which the current ecigs and parts are made, being grandfathered in, where the FDA has no authority to regulate, would make this a true win/win for users and vendors (not so much for the FDA and CDC).

Such an amendment to the grandfather date could very well be argued on your one point: "Vaping community and small vendors can remind Congress that they likely weren't thinking about eCigs when FSCPTA was being drawn up."

The point that while the Feb 2007 which is only the date of introduction of the bill, is an arbitrary date, is important. While very few of us even, knew of the existence of ecigs prior to that date, it is almost certain that no one in Congress did. The didn't know about the 'new kid on the block', so it isn't unreasonable for allowances to be made with regards to ecigarettes.

 

[EleanorR]

Ooh, the "Congressional Intent" gambit. Well, sometimes it works. Worth a try!

 

[Kent C]

Ooh, the "Congressional Intent" gambit. Well, sometimes it works. Worth a try!

It's part that but.... this is the FDA speaking (3. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation) :

"By contrast, if we change the grandfather date, only electronic cigarette products introduced after the issuance of a final rule would be considered new, and a large number of candidate predicates would exist. We assume that new electronic cigarettes would then be marketed through the substantial equivalence (or exemptions) pathway. We would no longer assume that many electronic cigarette products would exit the market, but instead assume that all electronic cigarette labels would be changed to conform with the requirements of the proposed rule."

When they offer this up as an alternative, I would think resources, CASAA, advocates, comment direct at this part should be along the lines of 'ok, we'll take you up on that!' and change the labels as needed.

This is from:

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

'C. Additional Flexibility' section starts on pg 67.

Alternative '4.Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation [Regulatory Alternative 3]' is pg 69

"The table shows the reduced burden for cigar manufacturers but this alternative would provide even greater relief for small businesses producing electronic cigarettes.

This is all under Section III. The introduction:

III. Small Entity Effects

FDA has examined the economic implications of this proposed rule for small entities as required by the Regulatory Flexibility Act. If a proposed rule would have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. FDA finds that this proposed rule would have a significant economic impact on a substantial number of small entities. Consequently, this analysis, together with other relevant sections of this document, serves as the Initial Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act.

 

[Fitzie]

Anyone interested in reading the legislative history of the FSTPCA can find it online. It's part of the Congressional Record for the 111th Congress. I've tried to post a link, but have been unsuccessful.

Actually, this would be good reading for anyone planning to comment on FDA's proposed regs. The Congressional Record is the place to go for legislative history on federal laws. I haven't read it yet, but plan to in the near future.

 

[pamdis]

Anyone interested in reading the legislative history of the FSTPCA can find it online. It's part of the Congressional Record for the 111th Congress. I've tried to post a link, but have been unsuccessful.

Actually, this would be good reading for anyone planning to comment on FDA's proposed regs. The Congressional Record is the place to go for legislative history on federal laws. I haven't read it yet, but plan to in the near future.

Thank you! I was searching c-span videos and planning to listen to the debates on the FSPTCA, as part of my research for my comments. I read much faster than I listen, so this is perfect!

 

[Kent C]

Anyone interested in reading the legislative history of the FSTPCA can find it online. It's part of the Congressional Record for the 111th Congress. I've tried to post a link, but have been unsuccessful.

Actually, this would be good reading for anyone planning to comment on FDA's proposed regs. The Congressional Record is the place to go for legislative history on federal laws. I haven't read it yet, but plan to in the near future.

Does this one work for you? And, is it what you're reading?

http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf

 

[pamdis]

I think he was talking about this:

http://www.gpo.gov/fdsys/pkg/CREC-2009-04-01/pdf/CREC-2009-04-01-pt1-PgH4318-2.pdf#page=4

This is just the start - the introduction in the house, then the debate following. Introduction and debate in Senate, amendments and debate, etc. on different days throughout Apr, May, and June are all in different sections and must be searched for on thomas.gov congressional record home page.

 

[Kent C]

I think he was talking about this:

http://www.gpo.gov/fdsys/pkg/CREC-2009-04-01/pdf/CREC-2009-04-01-pt1-PgH4318-2.pdf#page=4

This is just the start - the introduction in the house, then the debate following. Introduction and debate in Senate, amendments and debate, etc. on different days throughout Apr, May, and June are all in different sections and must be searched for on thomas.gov congressional record home page.

Ah, I bet you're right. Thanks pam.

 

[Fitzie]

You got it Pam. But I think it's easier to read on "Thomas." Google "congressional record on thomas." You'll get both the House and Senate records in chronological order.

 

[Fitzie]

Wow, check out Article 83 on Thomas' version of the Congressional Record. Lotsa stuff about e-cigarettes, snuff and other potential harm reduction vehicles. Pretty interesting reading IMO.

I don't know if it means anything with regard to the proposed FDA regs, but it does show Senators Burr and Hagan were concerned about what the statute would do to e-cigarettes in the future and offered an amendment (which wasn't adopted) to address their concerns.

Senator Burr (referring to The Lancet):
" ...A reputable health publication that basically says: The absence of effective harm reduction strategies acts against the rights of smokers and public health. But the base bill, H.R. 1256, has no effective harm reduction strategy, no pathway to harm reduction products. But they claim it is a public health bill. A health care publication says that cannot happen. It is ``perverse.'' It is ``unjust.'' Well, they said it. I did not. But I think what they mean is, that to consider passing H.R. 1256, with the knowledge that has been given, would be perverse, unjust.

I am not going to have an opportunity to talk fully at this time because I have a colleague who will take the floor. But let me say, I talked earlier about Camel Orbs and the way CNN portrayed this product as candy and staged a news event--well, ``news'' would be--let's say ``entertainment'' event by taking this from behind the counter in a convenience store and putting it in the candy section and having a kid go up and pick the Orbs up out of the rack to say that it was candy.

Orbs represents a 99-percent reduction in death and disease associated with tobacco use compared to cigarettes.

I ask my colleagues, if the objective of Federal legislation is to reduce the risk of death and disease--with nonfiltered cigarettes, it is 100 percent; with filtered cigarettes, it is 90 percent; and with Orbs, it is 1 percent--isn't it perverse and unjust not to allow the American consumer to have this product to switch from cigarettes? I think the answer to the question has already been answered."

I found this on Wikipedia regarding "Orbs:"

"Camel Dissolvables is a new line of products manufactured by R.J. Reynolds. The Camel Dissolvables line includes Camel Orbs, Camel Strips, and Camel Sticks which are currently in test markets in Columbus, Ohio, Indianapolis, and Portland, Oregon. The Camel Dissolvables brands are marketed as "a convenient alternative to cigarettes, and moist snuff for adult tobacco consumers."[3] Camel Dissolvables "will not be positioned as a smoking cessation or reduced risk product," and are evolutions from the loose and pouched smokeless tobacco options.[4] With marketing still being developed, R.J. Reynolds has announced that "print ads, direct marketing, sampling at bars and nightclubs and point of purchase" advertising will support the campaign.[4]"

 

[DC2]

It's part that but.... this is the FDA speaking (3. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation) :

"By contrast, if we change the grandfather date, only electronic cigarette products introduced after the issuance of a final rule would be considered new, and a large number of candidate predicates would exist. We assume that new electronic cigarettes would then be marketed through the substantial equivalence (or exemptions) pathway. We would no longer assume that many electronic cigarette products would exit the market, but instead assume that all electronic cigarette labels would be changed to conform with the requirements of the proposed rule."

When they offer this up as an alternative, I would think resources, CASAA, advocates, comment direct at this part should be along the lines of 'ok, we'll take you up on that!' and change the labels as needed.

This is from:

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

'C. Additional Flexibility' section starts on pg 67.

Alternative '4.Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation [Regulatory Alternative 3]' is pg 69

"The table shows the reduced burden for cigar manufacturers but this alternative would provide even greater relief for small businesses producing electronic cigarettes.

This is all under Section III. The introduction:

III. Small Entity Effects

FDA has examined the economic implications of this proposed rule for small entities as required by the Regulatory Flexibility Act. If a proposed rule would have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. FDA finds that this proposed rule would have a significant economic impact on a substantial number of small entities. Consequently, this analysis, together with other relevant sections of this document, serves as the Initial Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act.

This is the first thing I've seen that seems to have some real potential.

 

[Kent C]

This is the first thing I've seen that seems to have some real potential.

I think it does. I think it did when I first posted it Perhaps someone could run it past Bill, Julie, CASAA lawyer, et. al. if it's worth the attention/time.

 

[Katya]

Senator Burr (referring to The Lancet):
" ...A reputable health publication that basically says: The absence of effective harm reduction strategies acts against the rights of smokers and public health. But the base bill, H.R. 1256, has no effective harm reduction strategy, no pathway to harm reduction products. But they claim it is a public health bill. A health care publication says that cannot happen. It is ``perverse.'' It is ``unjust.'' Well, they said it. I did not. But I think what they mean is, that to consider passing H.R. 1256, with the knowledge that has been given, would be perverse, unjust.

Yes it is! This is the perversity of the ANTZ. You quit our way or you die.

This is the study published by The Lancet Sen. Burr is referring to (I believe):

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60677-1/abstract

There was little difference in health-adjusted life expectancy between smokers who quit all tobacco and smokers who switch to snus (difference of 0·1—0·3 years for men and 0·1—0·4 years for women).

 

[Katya]

I think it does. I think it did when I first posted it Perhaps someone could run it past Bill, Julie, CASAA lawyer, et. al. if it's worth the attention/time.

Yes, it is!

Please, start a thread in either CASAA or the FDA Regs forum. They need to know--and Bill G needs to know.

Great find, Kent!