U.S. Food & Drug Administration (FDA) Tobacco Products: Manufacturing and Regulations Update

[Grammie]

I've signed up on the FDA site to get email reports concerning tobacco. If this has been posted elsewhere, please Admin's delete it. I think this is somewhat urgent in regards to our e-cigs. The closing date is tomorrow. I'm thinking they've buried the information somewhere on the FDA site. I will keep the email and if anyone wants to see it, please send me a PM with their name here and an email address.

I am posting this in it's entirety because I can't find it on the FDA site. If one of you find a link to it, please post it here. Thanks!


FDA’s Center for tobacco Products (CTP) intends to release an electronic tool to be used in submission of registration, product listing and ingredient information, as well as submission of certain health and research documents. Before launching this submission system, CTP plans to pilot test each section of the tool. The first round of pilot testing will involve owners and operators of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product. The sections of the law to be tested at this time are the registration requirements specified in Section 905(b) and the product listing requirements specified in Section 905(i)(1).
Please contact CTP by phone at 301-796-4800 or by email at tobacco2@fda.gov no later than close of business on October 15, 2009 if you are interested in pilot testing the electronic tool. CTP will select a limited, but representative sample of applicants, and selection criteria will be based in part of the ability of applicants to provide feedback to FDA in a timely manner. Emails to CTP should include a contact name and phone number, the company name, company size (small, medium, large) and type of tobacco product made.
You are subscribed to Tobacco Products: Manufacturing or Tobacco Products: Regulations for U.S. Food & Drug Administration (FDA). More information about Tobacco Products at FDA is available at www.fda.gov/tobacco.


Can someone explain what this means?

 

[Kurt]

I've signed up on the FDA site to get email reports concerning tobacco. If this has been posted elsewhere, please Admin's delete it. I think this is somewhat urgent in regards to our e-cigs. The closing date is tomorrow. I'm thinking they've buried the information somewhere on the FDA site. I will keep the email and if anyone wants to see it, please send me a PM with their name here and an email address.

I am posting this in it's entirety because I can't find it on the FDA site. If one of you find a link to it, please post it here. Thanks!


FDA’s Center for Tobacco Products (CTP) intends to release an electronic tool to be used in submission of registration, product listing and ingredient information, as well as submission of certain health and research documents. Before launching this submission system, CTP plans to pilot test each section of the tool. The first round of pilot testing will involve owners and operators of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product. The sections of the law to be tested at this time are the registration requirements specified in Section 905(b) and the product listing requirements specified in Section 905(i)(1).
Please contact CTP by phone at 301-796-4800 or by email at tobacco2@fda.gov no later than close of business on October 15, 2009 if you are interested in pilot testing the electronic tool. CTP will select a limited, but representative sample of applicants, and selection criteria will be based in part of the ability of applicants to provide feedback to FDA in a timely manner. Emails to CTP should include a contact name and phone number, the company name, company size (small, medium, large) and type of tobacco product made.
You are subscribed to Tobacco Products: Manufacturing or Tobacco Products: Regulations for U.S. Food & Drug Administration (FDA). More information about Tobacco Products at FDA is available at www.fda.gov/tobacco.


Can someone explain what this means?

It looks like the "electronic tool" refers to how applications are submitted, not an electronic cigarette. This looks like a procedural statement, nothing related to actual devices or tobacco products. Is that what you were referring to? Maybe I'm missing something.

k

 

[Grammie]

Just trying to figure out what they're doing. Seems they are really focused on tobacco products moreso than other things.

Thanks for explaining!

 

[rothenbj]

I've signed up on the FDA site to get email reports concerning tobacco. If this has been posted elsewhere, please Admin's delete it. I think this is somewhat urgent in regards to our e-cigs. The closing date is tomorrow. I'm thinking they've buried the information somewhere on the FDA site. I will keep the email and if anyone wants to see it, please send me a PM with their name here and an email address.

I am posting this in it's entirety because I can't find it on the FDA site. If one of you find a link to it, please post it here. Thanks!


FDA’s Center for Tobacco Products (CTP) intends to release an electronic tool to be used in submission of registration, product listing and ingredient information, as well as submission of certain health and research documents. Before launching this submission system, CTP plans to pilot test each section of the tool. The first round of pilot testing will involve owners and operators of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product. The sections of the law to be tested at this time are the registration requirements specified in Section 905(b) and the product listing requirements specified in Section 905(i)(1).
Please contact CTP by phone at 301-796-4800 or by email at tobacco2@fda.gov no later than close of business on October 15, 2009 if you are interested in pilot testing the electronic tool. CTP will select a limited, but representative sample of applicants, and selection criteria will be based in part of the ability of applicants to provide feedback to FDA in a timely manner. Emails to CTP should include a contact name and phone number, the company name, company size (small, medium, large) and type of tobacco product made.
You are subscribed to Tobacco Products: Manufacturing or Tobacco Products: Regulations for U.S. Food & Drug Administration (FDA). More information about Tobacco Products at FDA is available at www.fda.gov/tobacco.


Can someone explain what this means?

I was going to post the noted sections, but they then referred to other sections. On thing our government can do is create a lot of paper.

Here's the link to the entire pdf-

http://www.tobaccolawcenter.org/documents/FDA-tobacco-regulation-final-bill.pdf

From what I can see, if e cigs win in court, the above will need to be adhered to. Time to forget any flavoring unless added after the fact.

Also my take is that testing will need to be done to prove that e cigs cause no more harm than existing cigs. Labeling and marketing will be controlled by the FDA and it's going to be a long, long battle for the e cig front.

 

[LUX Vaporer]

Looks like they are is up to something....

 

[Grammie]

So if companies don't sign up today, October 15th, they might be left out of the loop?

Thanks for finding that pdf file. They have a knack for "double talk" and confusing everyone in the process.

I find this all puzzling.

 

[yvilla]

Grammie, the October 15th deadline is only for those applicants wanting to participate in the "pilot testing" that will be happening - of the new procedures the FDA is putting in place to implement it's new tobacco product regulation duties.

Once they figure out if their new administrative procedures (including the electronic submission process) are working, then the FDA intends to implement them industry wide.

 

[Grammie]

Thanks, yvilla!