FDA Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal

[salemgold]

Refuse To Accept Procedures for Premarket tobacco Product Submissions; Withdrawal
Federal Register :: Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the direct final rule published on August 8, 2016, (81 FR 52329) is withdrawn.


Dated: November 9, 2016.

Peter Lurie,

Associate Commissioner for Public Health Strategy and Analysis.

 

[salemgold]

Ok. Looks like they are only withdrawing this part. Darn it!

The Food and Drug Administration (FDA) is issuing a proposed rule describing when FDA would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the proposed rule, FDA would refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the Start Printed Page 52372type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA would be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

I was excited for a minute!

 

[zoiDman]

...

I was excited for a minute!

I wasn't just you Salem.

I think All of our Hearts Quickened when we 1st saw this.

 

[LittleBird]

Yes, I, among them!

What do you suppose this means:
"If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule."

 

[zoiDman]

Yes, I, among them!

What do you suppose this means:
"If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule."

Many things that the FDA wants to do have a Statutory Comment Requirement. These comments usually come from Stakeholders or from Health Organizations. But the General Public can also many time submit comments also.

 

[LittleBird]

Many things that the FDA wants to do have a Statutory Comment Requirement. These comments usually come from Stakeholders or from Health Organizations. But the General Public can also many time submit comments also.

Yes, I'm familiar with the comment period and process. I'm more interested in whether they are suggesting that comments might result in changes to (or replacement of) the full deeming regs ("the final rule"). Or, is the final rule to which that statement refers only whatever they come up with for PMTAs?

ETA: Never mind. Sadly, I missed a sentence.

 

[skoony]

This really doesn't change a thing. It means they can't weed out bad applications.
they will accept them first then deny them for the same reasons along with all
the rest.

Regards
Mike

 

[Dray]

Ok. Looks like they are only withdrawing this part. Darn it!

The Food and Drug Administration (FDA) is issuing a proposed rule describing when FDA would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the proposed rule, FDA would refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the Start Printed Page 52372type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA would be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

I was excited for a minute!

Hello, I have a question. Our company has over 300 SKU's and we need help filing . Is there a firm or company that will assist with the submissions? Respectfully: Dray

 

[WorksForMe]

Hello, I have a question. Our company has over 300 SKU's and we need help filing . Is there a firm or company that will assist with the submissions? Respectfully: Dray

Azim Chowdhury may be able to help, or at least point you in the right direction.

Keller Heckman | Professionals | Azim Chowdhury

 

[sofarsogood]

I just watched part of a recent pbusardo youtube review video. He is sent a lot of new products, may be most of the new mass market stuff. He indicates he is still receiving new stuff without regard to 8-8. My vape stuff is landing on my front porch without issue though I haven't tried to buy anything that might have been introduced post 8-8. When I look at mods on FT I have no idea when most of them were introduced. Obama better hurry up and pardon all the dope smokers so there's room in his jails for the vape criminals.

 

[Verb]

This rule was reissued this week. I'm not sure of any changes. I gave it a quick read over. They state they will inform the applicant if their application is accepted or refused. I could not find if they would indicate why it was rejected. They may reject all applications that are for nicotine free liquids and devices, but not state the reason. If they are not currently going to consider zero nicotine products and devices rejecting the application without stating a reason does not prevent them from including those liquids and devices in the future.

FDA issues further guides

Federal Register :: Refuse To Accept Procedures for Premarket Tobacco Product Submissions


If as the FDA stated in the nicopure case, nicotine free products will be evaluated on a case-by-case basis. How will they complete the review if they reject the application?