FDA Fresh Insights into Tobacco Regulation

[Hype]

I don't know exactly what difference there is between "sold" and "marketed" but the wording specifically says "marketed" for whatever that's worth.

Here's the Guidance as it pertains to already regulated tobacco products: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM416498.pdf

And here's some of the examples they give could serve as proof of 'marketing'. Not necessarily that a retail purchase was made.

dated copies of advertisements
dated catalog pages
dated promotional material
dated trade publications
dated bills of lading
dated freight bills
dated waybills
dated invoices
dated purchase orders
dated customer receipts
dated manufacturing documents
dated distributor or retailer inventory lists
any other document you believe demonstrates that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007

 

[Hype]

Thank you. Exactly Look at the issue from the FDA's point of view with respect to "flavors" "NIC" and "component parts". None of which are properly documented in the deeming with any details as you point out and in IMHO the same tactic will be deployed in the final rule in the federal registry. The reason the FDA is "silent" on these issue is because they have "Enforcement Discretion" so take a gander at this google querry to see:

fda discression - Google Search

Thus the FDA wants the "path of least resistance" to place the final rule under the TCA and IMHO, that's exactly how it's going to play out. Or, as others have said...they don't have to get specific!

Likely they'll do the same as they did with cigarettes...the final rule will be general enough and then Guidance documents will serve as the details. The Big tobacco boys are currently suing FDA for doing this as it circumvents the regulatory process and doesn't allow for any public input. While Guidance documents are not 'legally binding' and are just FDA"s current thinking (and FDA says so right in the doc), across all the regulated Industries courts tend to favor FDA's interpretation.

 

[skoony]

I don't know exactly what difference there is between "sold" and "marketed" but the wording specifically says "marketed" for whatever that's worth.

the above post is informative.
my understanding is marketed and or sold by a vendor
in the United States to a retail customer.
i am not sure this would include wholesale
purchases. it might.
regards
mike

 

[Cool_Breeze]

Nicotine is no more substantial / threatening / dangerous than caffeine. The FDA doesn't regulate caffeine, now do they..?

 

[AndriaD]

Nicotine is no more substantial / threatening / dangerous than caffeine. The FDA doesn't regulate caffeine, now do they..?

They'd probably like to, I mean, it's a drug, right? But they're skeered of all the coffee-tweakers who'd storm DC.

Andria

 

[SeniorBoy]

I'm posting the following to present a more detailed and expansive trail of exactly what enforcement discretion is in FDA speak with respect to other industries. IMHO, it's part of the DNA of the FDA and never has been and or never will be limited to a single industry. I'm not trying to split hairs boys and girls. Only trying to convey how the FDA operates and IMHO, will operate with respect to v a p I n g.

Mobil apps
Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion

Nutrition Keys program
Letter of Enforcement Discretion to GMA/FMI re "Facts Up Front"

Medical Device & Diagnostic Industry
FDA Enforcement Discretion | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices
FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices | Focus on Regulation

Pet food and human food
Enforcement Discretion | Truth about Pet Food

Enjoy!