[ Post a Response | The Sublime Desire of Cigarette Smoking ]
Posted by Friedatheant on June 12, 2009, 10:39 am
Now that the FDA has jurisdiction over tobacco products, what are cigarettes? A drug or a medical device?
Since there are no approvals currently in place, will the US retailers have to withdraw the products until the require documents are issued?
Likewise, the manufacturers have to register each factory as a Drug or Medical Device manufacturer [maybe both] and rewrite all their procedures, get them approved, qualify all their equipment, train their employees and pass an ISO 900-style inspection yearly.
Do the makers of Marlboro and Salems have to file a NDA [new drug application] for their brands? A separate one for each Brand? Or, because it is a pre-existing, already marketed drug, will they merely have to file an ANDA [Abrreviated New Drug Application]? No matter which, the process of getting FDA approval takes years and requires millions of dollars in testing, data evaluation and safety reporting.
I have heard arguments claiming that Cigarettes, Cigars and Pipes are Medical Devices so that would mean they have to file a PreMarket Announcement. That too, would mean a long and expensive time of clinical trials, effectiveness testing and safety evaluation.
And IF/WHEN they get the approvals needed, will the general public begin to consider tobacco products as much safer now that they are being scrutinized by the FDA?
Does someone out there think that by having FDA approval on tobacco products that somehow the Tobacco Manufacturers are immune from product liability?
Many questions, but who has these answers?
I don't, and I've had decades of experience in FDA approvals and inspections. I do know that the expenses and time delays are going to be staggering, & there are possible interruptions of the market's supply as these legal issues are implemented or modified.
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