SE, NJoy vs FDA -- Discussion

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so............based on the outcome of the case, can Flonase for example (or other 'drugs') be sold -on the shelf- under new names so long as they do not state therapeutic claims (or if they say they are "smoking alternatives")?

No. Regardless of therapeutic claims, drugs and devices that are clearly intended to affect the structure or function of the body remain under the regulatory purview of the FDA. This ruling is specific to tobacco products. Judge Leon and the Appellate Court agreed with the Supreme Court finding in Brown & Williamson that "traditionally marketed" tobacco products--that is, tobacco products that are marketed for recreational non-therapeutic use--are not subject to regulation under the FDCA because that would effectively ban products that Phillip Morris the government does not want banned.

After this court case began, the Family Smoking Prevention and Tobacco Control Act was signed into law giving the FDA special authority to regulate tobacco products, which the FDA now agrees they will apply to electronic cigarettes along with other currently unregulated smokeless tobacco products, premium cigars and pipe tobacco.
 
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kai kane

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Near da water ...
TW has voluntarily dismissed (without prejudice so it can refile if necessary).
... And with that, the docket watch is finally done. :toast:
:
Ah yes, let's all raise a Toast to Julie and all the rest who have served this momentous occasion!:toast:
And a final THANK YOU and MAHALO NUI LOA Julie for keeping us up to date on every move made during this long travail!
(and thanks to Jerry for being our official Instigator!)
 
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