FDA - Further Amendments to General Regulations

[Colts Fan]

Further Amendments to General Regulations of Food and Drug Administration to Incorporate tobacco Products

Document ID: FDA-2011-N-0121-0001

Docket ID:
FDA-2011-N-0121

Regulations.gov

Looks like the FDA has already started!!

We can all make comments about their plans

DATES: Submit either electronic or written comments on the proposed
rule by June 13, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0121 and/or Regulatory Information Number (RIN) number 0910-AG60, by
any of the following methods, except that comments on information
collection issues under the PRA must be submitted to the Office of
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0121 and RIN 0910-AG60 for this rulemaking.
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document

 

[malyden]

bump bump bump

 

[GitMoe]

Marking this one so I can read it later....

 

[Vocalek]

As I read it, the Agency is using this ruse to amend the law, giving themselves far greater powers than Congress intended when it passed the Family Smoking Prevention and tobacco Control Act.

 

[crashinbrn]

the way i saw it was adding the words 'tobacco product' to labeling, and record keeping rules etc.
i wonder if a pack of cigarettes really needs an instructional pamphlet. hmmm.

maybe a MSDS?

i won't pretend i know FDA regulations, but i don't think they should change this until they define the specific 'tobacco product' they want to label.

just thinking out loud.

 

[hairball]

As I read it, the Agency is using this ruse to amend the law, giving themselves far greater powers than Congress intended when it passed the Family Smoking Prevention and Tobacco Control Act.

The question to ask would be will Congress see this and allow it?

 

[Thulium]

As I read it, the Agency is using this ruse to amend the law, giving themselves far greater powers than Congress intended when it passed the Family Smoking Prevention and Tobacco Control Act.

It looks like the FDA is simply suggesting rules for labeling and recordkeeping as well as including the required processes for public hearings on regulations. I wouldn't doubt that they may have tried to sneak something though a referenced document, but I think this may simply be FDA's attempt to obey the mandate of the appellate. What powers do you think they're trying to grab that weren't granted by the FSPTCA?

 

[DC2]

It looks like the FDA is simply suggesting rules for labeling and recordkeeping as well as including the required processes for public hearings on regulations. I wouldn't doubt that they may have tried to sneak something though a referenced document, but I think this may simply be FDA's attempt to obey the mandate of the appellate.

I was reading it the other day, but then my eyes started bleeding and my hed esplode.
But yeah, before that happened, I got the same impression you got.

 

[yvilla]

Elaine, Thad is right. This is simply the FDA implementing the provisions of the FSPTCA, as to all tobacco products deemed covered by the new law. And it is essentially just adding the term "tobacco products" to already exisiting regulations relating to other products covered by the FDCA.

Any time a new law is passed that vests an administrative agency with regulatory authority over something, that agency must then proceed to promulgate regulations in furtherance of the law. The law itself gives the broad powers (and some specifics), but expects the administrative agency to propose, promulgate, and then enforce the majority of the specific nuts and bolts regulations under which it will exercise the powers given.

As we've discussed regarding what is to come in the next couple of years in terms of ecigs, once there are specific regulations proposed like these referenced in the OP, there must be the public comment period, followed by any revisions, etc, publication in the federal register, and formal final approval of the Sectretary before taking effect.

 

[hairball]

yvilla, thank you for the explanation. I was starting to panick.

 

[Vocalek]

I could have sworn that I saw the word "contraindications" in that document. Made it sound as if they wanted tobacco products to carry the kind of prescribing information that you see issued with drugs.

Kind of takes me back to the FDA v. Brown & Williamson ruling where they said that if the FDA regulated tobacco like they do drugs that the only course FDA could take would be to ban them all.

 

[Thulium]

I could have sworn that I saw the word "contraindications" in that document. Made it sound as if they wanted tobacco products to carry the kind of prescribing information that you see issued with drugs.

Kind of takes me back to the FDA v. Brown & Williamson ruling where they said that if the FDA regulated tobacco like they do drugs that the only course FDA could take would be to ban them all.

I did get the general impression that the FDA intends to get rather annoyed if tobacco products include any documentation or anything that might remotely be construed as disagreeing with the FDA's opinion that "smokeless tobacco is not a safe alternative to quitting". If e-cig manufacturers and retailers don't want the FDA thinking up ways to make their life difficult, I strongly recommend that they do anything they possibly can to avoid appearing to make a therapeutic or even "cessation" claims. We consumers can spread the word about the health benefits of tobacco harm reduction, but retailers need to market their product simply as being more enjoyable and convenient than smoking.

 

[rothenbj]

I did get the general impression that the FDA intends to get rather annoyed if tobacco products include any documentation or anything that might remotely be construed as disagreeing with the FDA's opinion that "smokeless tobacco is not a safe alternative to quitting". If e-cig manufacturers and retailers don't want the FDA thinking up ways to make their life difficult, I strongly recommend that they do anything they possibly can to avoid appearing to make a therapeutic or even "cessation" claims. We consumers can spread the word about the health benefits of tobacco harm reduction, but retailers need to market their product simply as being more enjoyable and convenient than smoking.

Thad, it's a miserable, rainy day here today and I'm just recovering from stomach virus so forgive me, but I'm in a cranky mood. I can accept that the FDA insists that any smokeless tobacco product is not "a safe alternative to smoking" (yes, I changed your wording from quiting to smoking since that's what is put on the packaging). However, the FDA is far from God and they should not be able to deny that many/most smokeless tobacco products are "SAFER alternatives to smoking". If they used "science" to declare Chantix is "safe and effective", a misnomer both figuratively and literally for "yea, they spent the money, we gave them a thumbs up, now go rape the peons".

For decades "the body of evidence" has indicated that smokeless is a much safer alternative to inhaling smoke. If you're going to crucify the tobacco industry for 50-60 year old "lies" you need to use the same cross and judge what has been going on since. I'm sorry but if I were to have lived the good life, got plenty of sleep, ate properly, exercised regularly, took every test the medical community offered and adjusted for all the maligned test readings with the finest chemicals BP has to offer I still would die. What's more, I'd probably go through more anguish trying to eek out those last several years of existence and had a lot less fun.

I've had to listen to my 92 yr old mother for the last month spent rehabbing from a fall. If I heard it once, I've heard it 100 times, "What did I do wrong to end up like this" and "When I croak, be happy for me". Compared to my life, she's pretty much of a "social norm" as far as living the good life. The last five or so has been no treat for her. I've also heard her talk about how my dad suffered at the end, at 77, knowing full well she doesn't want that for herself. He also did some pretty clean living.

I'm quite frankly tired of this entire eugenic movement, trying to adjust our behaviors to the superior one's liking. This was OUR America once.

 

[Vocalek]

Call me paranoid (it wouldn't be the first time), but I see some huge potential problems for tobacco products if the FDA slips the word "tobacco" into the law wherever it suits them to try to gain as much power and control over the products as possible:

1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are:
* * * * *
(c) * * *
(1) Permit a statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling for food, drugs, devices, cosmetics, or tobacco products under the Federal Food, Drug, and Cosmetic Act.

And do any of you have any concept of the amount of recordkeeping that is required of pharmaceutical companies? There has only been ONE recall of tobacco products in our history, and 1) that was initiated by the manufacturer and 2) it turned out that the cigarettes were not the cause of the illness that triggered the recall. The FDA has entered some very low-ball estimates of what they think it will cost companies to comply, but have given us no estimates of what it will cost the taxayers to expand the FDA's recordkeeping to track all this information. Also, the FDA estimates only address the wholesale side of the business. What impact will these recordkeeping rules have on the retailers?

paragraph (a) and the heading of paragraph (b) to read as follows:
§ 1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).
(b) Recordkeeping requirements for human drugs, biological products, devices, animal drugs, foods, cosmetics, and tobacco products exported under or subject to section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act. * * *

To get a true feeling of how all-encompassing these "minor wording changes" are when it comes to enforcement powers, it is necesssary to take a look at the actual portions of the FDCA being amended by adding the word "tobacco". We could end up with each pack of cigarettes required to be accompanied by a booklet to provide all the required labeling information, with serial numbers on each tobacco product, and retailers needing to fill out a log with your driver's license information and the SN of the product each time you make a purchase (think Sudafed).

 

[Thulium]

Thad, it's a miserable, rainy day here today and I'm just recovering from stomach virus so forgive me, but I'm in a cranky mood. I can accept that the FDA insists that any smokeless tobacco product is not "a safe alternative to smoking" (yes, I changed your wording from quiting to smoking since that's what is put on the packaging). However, the FDA is far from God and they should not be able to deny that many/most smokeless tobacco products are "SAFER alternatives to smoking". If they used "science" to declare Chantix is "safe and effective", a misnomer both figuratively and literally for "yea, they spent the money, we gave them a thumbs up, now go rape the peons".

For decades "the body of evidence" has indicated that smokeless is a much safer alternative to inhaling smoke. If you're going to crucify the tobacco industry for 50-60 year old "lies" you need to use the same cross and judge what has been going on since. I'm sorry but if I were to have lived the good life, got plenty of sleep, ate properly, exercised regularly, took every test the medical community offered and adjusted for all the maligned test readings with the finest chemicals BP has to offer I still would die. What's more, I'd probably go through more anguish trying to eek out those last several years of existence and had a lot less fun.

I've had to listen to my 92 yr old mother for the last month spent rehabbing from a fall. If I heard it once, I've heard it 100 times, "What did I do wrong to end up like this" and "When I croak, be happy for me". Compared to my life, she's pretty much of a "social norm" as far as living the good life. The last five or so has been no treat for her. I've also heard her talk about how my dad suffered at the end, at 77, knowing full well she doesn't want that for herself. He also did some pretty clean living.

I'm quite frankly tired of this entire eugenic movement, trying to adjust our behaviors to the superior one's liking. This was OUR America once.

I completely agree, Jim. Unfortunately, as they say, "It is what it is" and if e-cig manufacturers want to be able to sell their products as a smoking cessation aid, they'll probably have to pay their dues in the clinical lab and legal fees before the FDA will approve any claims of reduced exposure or status as modified risk tobacco products.

Fortunately, we consumers remain free to tell our tobacco harm reduction stories to anyone willing to listen and there are enough non-therapeutic benefits of using smoke-free alternatives that getting the green light to put health claims on e-cig packaging isn't really necessary. E-cigarettes can be more convenient and more enjoyable than analog smoking anyway--in fact, if smoke-free alternatives aren't more enjoyable AND more convenient than cigarettes, we should be trying to improve them them until they are!

 

[Vap0rJay]

As I read it, the Agency is using this ruse to amend the law, giving themselves far greater powers than Congress intended when it passed the Family Smoking Prevention and Tobacco Control Act.

Hmm, a government agency --- using a ruse --- to give themselves far greater powers than Congress intended...
Yeah, that sounds about right lol *sigh*

 

[rothenbj]

I totally understand Thad, but it feels so good to get 30 years of anger out in a few paragraphs. Had I known there was a product like snus available back then, I could have avoided some 300,000 cigaretes, 15,000 packs and had about $400k extra in my retirement fund and they are all low estimates.

Instead I smoked, felt guilty, wasted money on quit attempts then smoked some more. Enough.

 

[ShannonA]

I did get the general impression that the FDA intends to get rather annoyed if tobacco products include any documentation or anything that might remotely be construed as disagreeing with the FDA's opinion that "smokeless tobacco is not a safe alternative to quitting". If e-cig manufacturers and retailers don't want the FDA thinking up ways to make their life difficult, I strongly recommend that they do anything they possibly can to avoid appearing to make a therapeutic or even "cessation" claims. We consumers can spread the word about the health benefits of tobacco harm reduction, but retailers need to market their product simply as being more enjoyable and convenient than smoking.

Perhaps more enjoyable and cost effective would be better. One thing I would not call vaping is more convenient than smoking. Or perhaps cleaner you know no ashes all over the place no tar stains on the wall... but vaping is a bit more trouble than lighting up in all honesty.

 

[DC2]

Perhaps more enjoyable and cost effective would be better. One thing I would not call vaping is more convenient than smoking. Or perhaps cleaner you know no ashes all over the place no tar stains on the wall... but vaping is a bit more trouble than lighting up in all honesty.

As a dripper, I would have to say, vaping is far more convenient for me than smoking ever was.
But for anyone using cartridges or cartomizers, yeah, probably not as convenient.

 

[Thulium]

As a dripper, I would have to say, vaping is far more convenient for me than smoking ever was.
But for anyone using cartridges or cartomizers, yeah, probably not as convenient.

I consider the ability to use my PV pretty much any time and anywhere I want a MAJOR convenience, but the fact that I can't yet buy supplies as easily as I can get cigarettes from nearly any store is a serious inconvenience.