I been like that lately Dale so don't feel alone.
I'm off again. Got to get on the laptop and do some stuff and then supper.
CULz
I'm off again. Got to get on the laptop and do some stuff and then supper.
CULz
Lounging By The Beach - Part 7
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And here it is . . .
Extending Authorities to Additional Tobacco Products
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf
In the PDF, on page 8, . . .
Personally, I have cut down from starting with 18mg/ml to 6.5mg/ml now, so I can claim that e-cigs have not only allowed me to quit smoking cigarettes, and that flavors were crucial in that, but have also allowed me regulate my own nicotine input via DIY, by being able to mix solutions of nicotine that are not available in standard sales or pre-mixed juices. I envision going to zero nicotine and enjoying the flavors.
By allowing up to 24 months here, it doesn't really appear to me that they are being rash or overly in a rush about it. Seems quite accommodating to me. Maybe somewhat rushed to pass the proposal, but not enforcement against e-cigs.
It's a long PDF to read and try to absorb, but these are some highlights we can comment on.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA
Extending Authorities to Additional Tobacco Products
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf
In the PDF, on page 8, . . .
.
In addition, FDA realizes that there are distinctions in the hazards presented by various
nicotine-delivering products. Some have advanced views that certain new tobacco products
that are noncombustible (such as e-cigarettes) may be less hazardous than combustible
products given the carcinogens in smoke and the dangers of secondhand smoke from
combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how
e-cigarettes should be regulated based on the continuum of nicotine-delivering products.
We welcome comment on how to implement the provisions in the FD&C Act with respect to
e-cigarettes. We also welcome any health and behavioral data about the effects of using
e-cigarettes.
In addition, FDA realizes that there are distinctions in the hazards presented by various
nicotine-delivering products. Some have advanced views that certain new tobacco products
that are noncombustible (such as e-cigarettes) may be less hazardous than combustible
products given the carcinogens in smoke and the dangers of secondhand smoke from
combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how
e-cigarettes should be regulated based on the continuum of nicotine-delivering products.
We welcome comment on how to implement the provisions in the FD&C Act with respect to
e-cigarettes. We also welcome any health and behavioral data about the effects of using
e-cigarettes.
Personally, I have cut down from starting with 18mg/ml to 6.5mg/ml now, so I can claim that e-cigs have not only allowed me to quit smoking cigarettes, and that flavors were crucial in that, but have also allowed me regulate my own nicotine input via DIY, by being able to mix solutions of nicotine that are not available in standard sales or pre-mixed juices. I envision going to zero nicotine and enjoying the flavors.
.
FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being
marketed with characterizing flavors, and that these flavors can be especially attractive to youth.
The prohibition against characterizing flavors established in the tobacco Control Act applies to
cigarettes only. 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. 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.
Also as noted in this document, some have advanced views that certain new tobacco products
that are noncombustible (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. FDA also notes the increase in e-cigarette use by youth and the availability of fruit and
candy-flavored e-cigarette liquid. We do not currently have sufficient data about these products
to determine what effects e-cigarettes have on the public health. 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.
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.
Write in and point out that e-cigs are much less harmful to the user, and that recent studies like
Electronic Cigarettes Don’t Cause Secondhand Vaping | Ecig Advanced News and others show
there are really no secondhand effect issues.
Compliance Dates for PMTAs and SE Reports--As stated previously, we understand that, for
some products, there may not be predicate products that were on the market as of February
15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes
and similar novel products. For this reason, we are proposing that these manufacturers who
cannot use the SE pathway submit PMTAs to FDA no later than 24 months following the effective
date of the final rule. We are also proposing a 24-month compliance period for the submission of
SE reports. Therefore, FDA does not intend to initiate enforcement action against products
on the market for failing to have made an appropriate submission until 24 months following the
effective date of the final rule. If a manufacturer submits a PMTA or SE application for its affected
products within the 24-month time frame, FDA does not intend to initiate action against those
products for failing to have a marketing authorization unless and until such a time as we have
responded to the application.
FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being
marketed with characterizing flavors, and that these flavors can be especially attractive to youth.
The prohibition against characterizing flavors established in the tobacco Control Act applies to
cigarettes only. 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. 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.
Also as noted in this document, some have advanced views that certain new tobacco products
that are noncombustible (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. FDA also notes the increase in e-cigarette use by youth and the availability of fruit and
candy-flavored e-cigarette liquid. We do not currently have sufficient data about these products
to determine what effects e-cigarettes have on the public health. 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.
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.
Write in and point out that e-cigs are much less harmful to the user, and that recent studies like
Electronic Cigarettes Don’t Cause Secondhand Vaping | Ecig Advanced News and others show
there are really no secondhand effect issues.
Compliance Dates for PMTAs and SE Reports--As stated previously, we understand that, for
some products, there may not be predicate products that were on the market as of February
15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes
and similar novel products. For this reason, we are proposing that these manufacturers who
cannot use the SE pathway submit PMTAs to FDA no later than 24 months following the effective
date of the final rule. We are also proposing a 24-month compliance period for the submission of
SE reports. Therefore, FDA does not intend to initiate enforcement action against products
on the market for failing to have made an appropriate submission until 24 months following the
effective date of the final rule. If a manufacturer submits a PMTA or SE application for its affected
products within the 24-month time frame, FDA does not intend to initiate action against those
products for failing to have a marketing authorization unless and until such a time as we have
responded to the application.
By allowing up to 24 months here, it doesn't really appear to me that they are being rash or overly in a rush about it. Seems quite accommodating to me. Maybe somewhat rushed to pass the proposal, but not enforcement against e-cigs.
It's a long PDF to read and try to absorb, but these are some highlights we can comment on.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA
Last edited:
OK then. I'm going into town for a while. Maybe I'll get a beer at the local Cabana Boy Tiki Bar. 
Nah, I need kitty liter. I was waiting on a store to get more in and they called me.
How exciting. 
Nah, I need kitty liter. I was waiting on a store to get more in and they called me.
How exciting.
Hi VG
I been lurking and waiting for someone to show up. Well watching TV too.
I been lurking and waiting for someone to show up. Well watching TV too.
Hi VG
I been lurking and waiting for someone to show up. Well watching TV too.
Hi JJ.
I asked last night, because you said you were watching Law and Order, if you had ever watched Suits. It about Lawyers and Corporate Law, so not really like Law and Order, but I'm enjoying it.
Hi JJ.
I asked last night, because you said you were watching Law and Order, if you had ever watched Suits. It about Lawyers and Corporate Law, so not really like Law and Order, but I'm enjoying it.
Never watch it. Never heard of it.
Never watch it. Never heard of it.
It's quite good. I'll get the channel for you. It's in advanced seasons now, but I'm watching season 1 online.
I just watched Big Bang Theory ... and now I remember why I quit 
Going to be going to bed super early tonight, working tomorrow
Going to be going to bed super early tonight, working tomorrow
I just watched Big Bang Theory ... and now I remember why I quit
Going to be going to bed super early tonight, working tomorrow
How come?
And good night.............sleep tight
It's just dumb now
And I'm not going right this minute
Meant how come you are working tomorrow. Someone on vacation or something?
I just watched Big Bang Theory ... and now I remember why I quit
Going to be going to bed super early tonight, working tomorrow
Big Bang Theory can be very funny, and also very aggravating.
K loves it and I watch it with her when I'm over there.It's just dumb now
And I'm not going right this minute
Hiya, Teacup.
Suits is on USA. I'm watching it elsewhere, but I think you can get it if you subscribe to Amazon Prime.
Hi hon, I loved it when it first came out because of the dry/sly humor ... now it's just stupidBig Bang Theory can be very funny, and also very aggravating.
Hiya, Teacup.
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