FDA issues its first rulings on new tobacco products

[Petrodus]

FDA issues its first rulings on new tobacco products

Lorillard gets the OK for two new cigarettes
but four other applications are denied.

 

[DaveP]

Science based decisions could be good for us or a little scary depending on how far to one side or the other the slant happens to move. We all know that we, as guinea pigs for ecigs, have experienced improvements in our lives, improvements in our blood chemistry tests, and documented improvements in lung x-rays, as posted by users.

If the FDA is out to protect BT, then we could suffer from BT lab testing of products showing them to be superior unless all manufacturers are forced to test according to a predetermined testing scheme that makes everyone subject to the same testing. BT will certainly tout their product as shown to be safe and effective in some way. The little guys might not be so fortunate as to be able to employ the same caliber of PHD chemists directly.

If they dictate the testing scheme and publish the results, the playing field should be more level and we all will benefit from knowing what's in our ejuice.

“Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”

“Today’s decisions are just the first of many forthcoming product review actions to be issued,” said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. “The FDA is committed to making science-based decisions on all product applications and providing the agency’s scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties, according to the law.”

 

[Bill Godshall]

Here's what I sent out on this FDA decision.

FDA approves two Substantial Equivalent (SE) applications for cigarettes by Lorillard, rejects four SE applications, refuses acceptance of 20 SE applications, announces 136 SE application withdrawals, creates new webpage for SE actions.
FDA announces first decisions on new tobacco products through the substantial equivalence pathway
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM358410.pdf
FDA Announces First Decisions on New Tobacco Products | FDA Voice
Tobacco Product Marketing Orders


The most important news isn't the 2 SE applications that were approved, but rather the 4 SE applications FDA rejected, the 20 SE applications FDA refused to accept, and the 136 SE applications that were withdrawn by applicants (but FDA didn't provide any details about those SE applications).

 

[Petrodus]

The CBS News article was posted in the Legislation forum ....
Very interesting discussion starting with Reply #2 !!!!!
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