FDA deeming rule could happen tomorrow

[Mazinny]

Am i interpreting this correctly ;

- vendors have only 90 days from today to introduce new products to the market without a PMTA application !?
- products currently on the market are ok until at least Aug 2018 !? Does that include nicotine ?

Yes, that is the understanding I am getting also.

- joyetech, innokin et al should be introducing a lot of products in the next 90 days i presume. Probably not enough time for the v2's of those products.

- Liquid vendors ditto, 90 days to introduce any new eliquid they've been working on.

- How does this affect FA, TFA etc... Do these regs apply to them ?

- How the hell, does the FDA expect to be able to enforce all these regs in the short term !?

 

[skoony]

Comment 50. Deeming shouldn't be required because the benefits outway
the requirments.
The FDA, Only if it's done our way. Our way or the highway.
Money, or,. No one rides for free.
Mike

 

[skoony]

Comment 51, age restrictions and vending machine requirements within 90
days.'
comment 52,why not wait until the science indicates what the regs should be?
The FDA we already have evidence e-cigs are bad and are moving forward.

 

[officer196]

Not sure how much good this would do, but at this point its worth a shot

Overturn the FDA's ruling on ecigarette classification as a tobacco product. | We the People: Your Voice in Our Government

 

[skoony]

Comment 54,the BT escape hatch. Why not require all currently regulated
products to the same requirements new products have to go through?
In other words make everyone start over.
The FDA,why we are.
Mike

 

[WharfRat1976]

Is all wire subject to regulation

 

[WharfRat1976]

Comment 32 validates what I have been saying for a long time.
We are tobacco users not vapers and again the chillin' and woman pregnant with chillin' card.
Mike

So says our beloved government. Do you believe everything our government tells you, Mike?

 

[Topwater Elvis]

Skoony, it is great you're reading it, obviously it is upsetting to you & most others.

Your interpretations may be a way for you to emotionally vent but they aren't really depicting the actualities.

This ---> http://cqrcengage.com/casaa/app/write-a-letter?0&engagementId=101154 <--- is our/vaping's best hope now.
I urge everyone to take the time to contact your Govt representatives.

The Feb 2007 date basically kills the industry.

 

[skoony]

Comment 55. There isn't enough time due to logistics to get the required testing done.
The FDA,# years from the effective date of this rule and we will at our discretion
issue further guidance and other hurdles as we see fit.
Mike

 

[Lessifer]

Woe!, hold the presses comment 49 actually makes sense.
"(Comment 49) At least one comment suggested that FDA should require manufacturers that have not received their marketing authorizations within 1 year after the effective date of the final deeming to include a statement on their packaging and labeling indicating that the product is pending FDA evaluation under the Tobacco Control Act. (Response) FDA declines to issue such a labeling requirement at this time. We do not have evidence that the statement will be appropriate for the protection of the public health, as 111 determined with respect to the risks and benefits to the population as a whole (which is the standard for such a requirement under section 906(d) of the FD&C Act). FDA also is concerned about consumer confusion or misconceptions that could result from such a requirement."
Mike

Actually, what they're saying there is "A label saying this product is pending FDA evaluation could be confused with 'Is FDA Approved' and we can't have that."

 

[skoony]

So says our beloved government. Do you believe everything our government tells you, Mike?

It's not what I believe that counts though. Evidently they believe it.
Scary isn't it.

Skoony, it is great you're reading it, obviously it is upsetting to you & most others.

Your interpretations may be a way for you to emotionally vent but they aren't really depicting the actualities.

This ---> http://cqrcengage.com/casaa/app/write-a-letter?0&engagementId=101154 <--- is our/vaping's best hope now.
I urge everyone to take the time to contact your Govt representatives.

The Feb 2007 date basically kills the industry.

I have been following and commenting on these pages for two years.
I may be a little emotionally involved but my opinions are based on
every thing I have read here and my own research over these two years.
I think my opinions reflect what the FDA and government et al really think
of us vapers as individuals. One of my long time premises has been that
on the individual level the concerns of us vapers was,is nor,will ever be
taken into consideration by the FDA or anyone else in government.
Anyway your analysis would contribute most helpfully.

Mike

 

[skoony]

Actually, what they're saying there is "A label saying this product is pending FDA evaluation could be confused with 'Is FDA Approved' and we can't have that."

Darn! I should have known it was to good to be true.
Mike

 

[skoony]

Comments 56 and 57. I am not familiar enough with these marketing
requirements.
mike

 

[sparkky1]

Comment 54,the BT escape hatch. Why not require all currently regulated
products to the same requirements new products have to go through?
In other words make everyone start over.
The FDA,why we are.
Mike

They've already done the "research" and have determined that there is no significant concern with any of the others

 

[zoiDman]

I hope I am Understanding this correctly...


B. Section 1140.2--Purpose


This final rule adds "and covered tobacco products" to indicate that the purpose of this
part is to establish restrictions on the sale, distribution, and access to covered tobacco products in

315


addition to those restrictions in place for cigarettes and smokeless tobacco. Therefore, the final
rule states that retailers of the newly deemed covered tobacco products may not sell them to
individuals under 18 years of age and requires retailers of covered tobacco products to verify the
purchaser's birth date by reviewing the individual's photographic identification. However, as
noted in § 1140.14(b)(2)(ii), a retailer is not required to verify the age of any person who is more
than 26 years of age. In addition, § 1140.14(b)(3) prohibits the sale of covered tobacco products
using an electronic or mechanical device such as a vending machine, unless it is located in a
facility where the retailer ensures that no person younger than 18 years of age is present, or
permitted to enter, at any time. FDA does not intend for section 1140.14(b)(3) to prohibit the
sale of tobacco products via the Internet, but the sale of covered tobacco products via any
medium, including the Internet, must only be to persons 18 years of age or older. Therefore, any
sale of covered tobacco products over the Internet must comply with the minimum age and
identification requirements in this rule.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

 

[skoony]

comment 58 discusses the reasoning for the FDA's time allowance
for warning labels as a shorter time frame may prevent nicotine addiction.
Well if anyone but myself has read this, The myth of nicotine addiction - Formindep
it might be understandable why I think this whole process stinks.
mike

 

[skoony]

I hope I am Understanding this correctly...


B. Section 1140.2--Purpose


This final rule adds "and covered tobacco products" to indicate that the purpose of this
part is to establish restrictions on the sale, distribution, and access to covered tobacco products in

315


addition to those restrictions in place for cigarettes and smokeless tobacco. Therefore, the final
rule states that retailers of the newly deemed covered tobacco products may not sell them to
individuals under 18 years of age and requires retailers of covered tobacco products to verify the
purchaser's birth date by reviewing the individual's photographic identification. However, as
noted in § 1140.14(b)(2)(ii), a retailer is not required to verify the age of any person who is more
than 26 years of age. In addition, § 1140.14(b)(3) prohibits the sale of covered tobacco products
using an electronic or mechanical device such as a vending machine, unless it is located in a
facility where the retailer ensures that no person younger than 18 years of age is present, or
permitted to enter, at any time. FDA does not intend for section 1140.14(b)(3) to prohibit the
sale of tobacco products via the Internet, but the sale of covered tobacco products via any
medium, including the Internet, must only be to persons 18 years of age or older. Therefore, any
sale of covered tobacco products over the Internet must comply with the minimum age and
identification requirements in this rule.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

The end of internet sales as this standard is impossible to meet.
Stolen or otherwise purloined cards and all that.
One must not under estimate the kiddies and the adults that will
help them in order to make sure the FDA finds out.
Mike

 

[Lessifer]

I hope I am Understanding this correctly...


B. Section 1140.2--Purpose


This final rule adds "and covered tobacco products" to indicate that the purpose of this
part is to establish restrictions on the sale, distribution, and access to covered tobacco products in

315


addition to those restrictions in place for cigarettes and smokeless tobacco. Therefore, the final
rule states that retailers of the newly deemed covered tobacco products may not sell them to
individuals under 18 years of age and requires retailers of covered tobacco products to verify the
purchaser's birth date by reviewing the individual's photographic identification. However, as
noted in § 1140.14(b)(2)(ii), a retailer is not required to verify the age of any person who is more
than 26 years of age. In addition, § 1140.14(b)(3) prohibits the sale of covered tobacco products
using an electronic or mechanical device such as a vending machine, unless it is located in a
facility where the retailer ensures that no person younger than 18 years of age is present, or
permitted to enter, at any time. FDA does not intend for section 1140.14(b)(3) to prohibit the
sale of tobacco products via the Internet, but the sale of covered tobacco products via any
medium, including the Internet, must only be to persons 18 years of age or older. Therefore, any
sale of covered tobacco products over the Internet must comply with the minimum age and
identification requirements in this rule.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

It has been my understanding that online sales restrictions of tobacco products has always been a state issue, not a federal one.

 

[skoony]

It has been my understanding that online sales restrictions of tobacco products has always been a state issue, not a federal one.

I believe you are correct. This still means the end of internet sales. Which governmental
level does it doesn't mater. It's a proverbial nail in the coffin.
Regards
Mike

 

[zoiDman]

It has been my understanding that online sales restrictions of tobacco products has always been a state issue, not a federal one.

The Allowance of Internet Sales of Tobacco Products was never Guaranteed on the Federal Level.

Some will even argue that the Allowance of Non Face-2-Face sales, with Adequate Age Verification, is an example of a "Reasonable Compromise".

Though this does Not mean though that States can not Do what they are Legally Entitled to do with regards to Net Sales.